THE EFFECTS OF MUSIC ON PAIN: A REVIEW OF SYSTEMATIC REVIEWS AND META-ANALYSIS
A Dissertation Submitted to the Temple University Graduate Board
In Partial Fulfillment of the Requirements for the Degree DOCTOR OF PHILOSOPHY
by Jin-Hyung Lee May, 2015
Examining Committee Members:
Cheryl Dileo, Advisory Chair, Music Therapy Wendy Magee, Music Therapy Joseph Ducette, Educational Psychology Deborah Confredo, Music Education
ii
© Copyright 2015
By
Jin-Hyung Lee All Rights Reserved
iii
ABSTRACT
The purpose of this study was twofold: to critically review existing systematic reviews and meta-analyses on the topic of music and pain; and to systematically review and conduct a meta-analysis of clinical trials investigating the effect of music on pain encompassing a wide range of medical diagnoses, settings, age groups, and types of pain.
For the review of systematic reviews, the author conducted a comprehensive search and identified 14 systematic reviews and meta-analyses. These studies were critically analyzed to present a comprehensive overview of findings, to evaluate methodological quality of the reviews, to determine issues or gaps in the literature, and to generate research questions for the following meta-analysis.
For the meta-analysis, the author conducted electronic searches of 12 databases and a handsearch of related journals and reference lists of relevant systematic reviews, with partial restrictions on design (i.e., randomized controlled trials); language (i.e.,
English, German, Korean, and Japanese); year of publication (i.e., 1995 to 2014) and intervention (i.e., music therapy and music medicine). Analyzed studies included 87 music medicine (MM) and 10 music therapy (MT) trials; eighty-nine of the included studies involved adults and eight trials focused on children. In terms of the types of pain, there were 51 trials on acute, 34 on procedural, and 12 on cancer or chronic pain; the trials were conducted in over 20 different medical specialty areas. For the assessment of study quality, I used the risk of bias tool developed by the Cochrane collaboration, and pooled data from the included studies were analyzed using the Revman 5.3 software according to the effects of music on levels of pain intensity, amount of analgesic use, and changes in vital signs. iv
The results indicated that music interventions resulted in a significant reduction of
1.13 units on 0-10 scales and a small to moderate pain reducing effect on other scales
(SMD = -0.39). Participants in the music group experienced a significantly lower level of
emotional distress from pain (MD = -10.8), and required significantly fewer anesthetics
(SMD = -0.56), opioids (SMD = -0.24), and non-opioid medications (SMD = -0.54).
Moreover, the music group showed statistically significant decreases in heart rate of 4.25
bpm, systolic blood pressure of 3.34 mmHg, diastolic blood pressure of 1.18 mmHg, and
respiration rate of 1.46 breaths per minute.
Findings from several analyses of moderator variables suggest: MT has a stronger
effect in reducing self-rated pain intensity than MM; MT is more effective in reducing chronic/cancer pain than other types of pain, but MM seems to be more effective in
managing procedural pain; children benefit more from music interventions than do adults,
and more from MT than MM; providing different levels of choices in the selection of
music yields different outcomes for MM; having a rationale for selection of music greatly
improves the treatment outcome for MM; and an active MT approach is more effective in
relieving perceived levels of pain than a passive MT approach.
The results from the current meta-analysis demonstrate that music interventions
may have beneficial effects on pain, emotional distress from pain, use of anesthetics and
pain killers, and vital signs including heart rate, systolic blood pressure, diastolic blood
pressure and respiration rate. However, these results need to be interpreted with caution
due to highly heterogeneous outcomes among the included studies. Considering all the
possible benefits, music interventions may provide an effective complimentary approach
for the relief of acute, procedural and cancer/chronic pain in the medical setting. v
Dedicated to the most incredible woman I know:
My loving mother, Songmi Hong
vi
ACKNOWLEDGMENTS
First, I would like to thank my family: my son Eugene, my wife Juri, my mom
Songmi Hong, and my mother-in-law Jeongae Park. I cannot thank you enough for your love and support during my long absence. I could not have done this without your incredible patience and trust in me. I love you all so very much and I cannot wait to be reunited as a family. You have been the source of my energy and the light of my life!
To my incredible advisor, Dr. Cheryl Dileo, I am deeply touched and humbled by
the support, wisdom and trust you have shown me throughout my education at Temple.
There are no words that could describe what I am feeling now. You are my inspiration
and role-model! Thank you!
To my wonderful dissertation committee: Dr. Wendy Magee, Dr. Joseph Ducette,
and Dr. Deborah Confredo. I thank you for your invaluable guidance and support during
my dissertation. Not only that, you also influenced me greatly as an educator and
researcher during my education at Temple.
To my fabulous mentor, Dr. Darlene Brooks, you helped me to complete four out
of five PhD projects, which means that you literally held my hand through this program. I
cherish every second with you at Temple and appreciate your penetrating insights, ever-
evolving feedback and unconditional support.
To my ‘papa dragon’ Dr. Kenneth Bruscia, your absence at Temple did not stop
me from learning and working closely with you, and I am forever grateful for your
incredible insights and mentorship. Please don’t stop kicking my butt to stay ‘reflexive!’
To my loving supporters in Cleveland: Dr. Barbara Guy and Dr. Deforia Lane. I can’t thank you enough for your enormous love and support during the past 15 years. vii
Barbara, your genuine interest in helping me to write better and succeed, definitely got
me this far. Deforia, your presence itself is incredibly healing and inspiring to many, and
it keeps me going as a clinician. I truly miss working with you.
To my wonderful violin professor, Dr. Marla Mutschler, your belief in me helped
me to overcome my fears and expand my potential. I am forever indebted to you.
Professor Barbara Crowe, your guidance helped me to keep my love for music therapy all
these years and helped me to seek all possibilities. Dr. Kenneth Aigen, though brief I
definitely enjoyed our discussions and your astute insights in music therapy. To
Benedikte Scheiby and Marilyn Clark, I cherish all the invaluable experiences you
provided which helped me to grow as a person and a clinician.
I send much love to my sisters, Myung, Sungkyo and Sunmi for their love and
support. I would like to take a moment to thank and remember Sanghun, my beloved
brother who passed away, but influenced me to become a better man.
I’m grateful for my American family: the Guys in Cleveland, the Fahrenkrugs in
Normal, IL, and the Koslowskys in Mesa, AZ for their love and support. Sorry I can’t
name everyone here, but I’m thankful for all my friends at Temple who journeyed with
me throughout our study. I thank Dr. Yuki Mitsudome for her help with my dissertation. I
am grateful to my colleagues in Korea: Dr. In yong Lee, Dr. Hyun ju Chong, Dr. In ryung
Song, Dr. Dong min Kim, Dr. Eunmi Kwak, Dr. Soo ji Kim, Dr. Nan bok Lee and all the
officers of the NAKMT for their support during my absence from our association.
Lastly, I thank the Cochrane Collaboration for their invaluable contribution to the
research community and all the researchers who conducted the numerous clinical trials that made my meta-analysis possible. viii
TABLE OF CONTENTS
Page
ABSTRACT ...... iii
DEDICATION ...... v
ACKNOWLEDGMENTS ...... vi
LIST OF TABLES ...... xiv
LIST OF FIGURES ...... xvi
CHAPTER
1. INTRODUCTION ...... 1
Understanding Pain and Pain Related Issues ...... 1
Definition of Pain ...... 1
Classification of Pain ...... 1
Prevalence of Pain ...... 3
Factors Associated with the Undertreatment of Pain ...... 4
Detrimental Effect of Pain ...... 7
The Need for an Effective Non-pharmacological Pain Management ...... 8
Music as a Means of Alleviating Pain and Other Symptoms in Hospitals ...... 9
Background ...... 9
Description of Music Medicine in Practice ...... 10
Description of Music Therapy Practice ...... 14
Overview of Pain Theories in Relation to Analgesic Effect of Music ...... 17
Specificity and Pattern Response Theory ...... 18 ix
Gate Control Theory ...... 18
Neuromatrix Theory...... 20
Biopsychosocial Model of Pain ...... 22
2. REVIEW OF SYSTEMATIC REVIEWS ON MUSIC AND PAIN...... 25
Introduction ...... 25
Evidence Based Practice ...... 26
Definition of Systematic Review and Meta-Analysis ...... 27
Significance of Systematic Reviews and Meta-analysis ...... 29
Criticisms of Systematic Reviews and Meta-Analysis ...... 30
Ensuring the Quality of Systematic Reviews ...... 31
Purpose of this Chapter ...... 31
Method ...... 32
Inclusion and Exclusion Criteria ...... 32
Search Strategy ...... 32
Data Collection and Extraction ...... 33
Quality Assessment of the Systematic Reviews ...... 33
Results ...... 34
Search Results ...... 34
General Characteristics of Included Systematic Reviews ...... 35
Methodological Overview of Included Systematic Reviews ...... 38
Quality Assessment of Included Systematic Reviews ...... 39
Summary of Findings ...... 42
Description of Music Interventions in Included Systematic Reviews ...... 51 x
Implications for Current Dissertation ...... 53
General Description and Overview ...... 53
Quality Appraisal ...... 53
Focus on Music Intervention ...... 55
Sub-analysis for Further Exploration ...... 56
The Rationale for the Present Dissertation ...... 57
Research Questions for Current Study ...... 58
3. METHOD ...... 59
Inclusion Criteria ...... 59
Types of Studies ...... 59
Types of Participants...... 59
Types of Interventions ...... 60
Types of Outcome Measures ...... 60
Search Methods for Identification of Studies ...... 61
Database Search ...... 61
Additional Search...... 61
Data Collection and Analysis...... 62
Study Selection ...... 62
Data Extraction ...... 62
Outcomes ...... 62
Assessment of Study Quality and Risk of Bias ...... 63
Measures of Treatment Effect ...... 66
Management of Missing Data ...... 66 xi
Assessment of Heterogeneity ...... 67
Assessment of Reporting Biases ...... 67
Data Synthesis ...... 67
Moderator Analysis ...... 68
4. RESULTS ...... 70
Description of Studies ...... 70
Results of the Search ...... 70
Characteristics of Included Studies ...... 71
Results of Risk of Bias Assessment ...... 81
Assessment of Reporting Biases ...... 84
Results of Meta-Analysis ...... 85
Research Question 1: The Effects of Music on Pain ...... 85
Research Question 2: The Effects of Music on Analgesic Use ...... 87
Research Question 3: The Effects of Music on Vital Signs ...... 88
Research Question 4: Music Therapy vs. Music Medicine ...... 91
Research Question 5: Moderator Variables ...... 95
Methodological Moderators ...... 111
5. DISCUSSION ...... 114
Overview of the Study ...... 114
Presentation of Discussion ...... 116
Discussions on Proposed Research Questions ...... 117
Research Question 1: The Effects of Music on Pain ...... 117
Research Question 2: The Effects of Music on Analgesic Use ...... 121 xii
Research Question 3: The Effects of Music on Vital Signs ...... 123
Research Question 4: Music Therapy vs. Music Medicine ...... 126
Discussion on Moderator Variables ...... 132
Moderator Variable: Types of Pain ...... 132
Moderator Variable: Age Groups ...... 133
Moderator Variable for MM: Levels of Choice in Music Selection ...... 136
Moderator Variable for MM: Rationale for Selection of Music ...... 141
Moderator Variable for MT: Active vs. Passive Approach ...... 143
Methodological Moderators ...... 144
Limitations of the Study...... 146
Implications for MM and MT Practice ...... 147
Referrals for MM and MT ...... 147
Implications for MT Intervention ...... 148
Implications for MM Intervention ...... 148
Recommendations for Future Research ...... 149
Recommendations for All Types of Research Studies ...... 149
Specific Recommendations for Future Meta-Analyses ...... 150
Specific Recommendations for Future MM and MT Clinical Trials ...... 152
REFERENCES ...... 155
REFERENCES (Excluded Studies from Review of Systematic Reviews) ...... 173
REFERENCES (Excluded Studies from Meta-Analysis) ...... 177
xiii
APPENDICES
A. LIST OF EXCLUDED STUDIES FROM REVIEW OF SYSTEMATIC REVIEWS ...... 198
B. R-AMSTAR ASSESSMENT ITEMS ...... 200
C. LIST OF EXCLUDED STUDIES FROM META-ANALYSIS ...... 202
D. CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES ...... 209
E. GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES ...... 214
F. GENERAL CHARACTERISTICS – MUSIC THERAPY STUDIES ...... 219
G. INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES ...... 220
H. INTERVENTION CHARACTERISTICS OF MUSIC THERAPY STUDIES ...... 225
I. RISK OF BIAS GRAPH ...... 226
J. RISK OF BIAS SUMMARY TABLE ...... 227
K. ASSESSMENT OF RISK OF BIAS WITH SUPPORT FOR JUDGMENT ...... 230
L. FOREST PLOTS OF META-ANALYSES ...... 262
M. ELECTRONIC SEARCH STRATEGIES ...... 302
xiv
LIST OF TABLES
Page
1. General Characteristics of Included Systematic Reviews ...... 37
2. Methodological Quality of Included Systematic Reviews...... 41
3. Quality Evaluation of All Included Systematic Reviews ...... 43
4. R-AMSTAR Scores Across Studies ...... 44
5. Results of Included Systematic Reviews ...... 45
6. Descriptions of Music Interventions in Included Systematic Reviews ...... 51
7. Region and Country of Included Trials ...... 72
8. Medical Specializations & Settings of Included Studies ...... 74
9. Interventions by Types of Pain, Age Groups & Settings ...... 74
10. Titles Used to Describe MM in Different Regions ...... 79
11. Titles Used to Describe MM in Different Regions According to Four Time Frames ...... 80
12. Meta-Analysis of Music Interventions on Pain ...... 86
13. Meta-Analysis of Music Interventions on Analgesic Use ...... 88
14. Meta-Analysis of Music Interventions on Physiological Measures ...... 90
15. Comparison between MT and MM on Pain ...... 92
16. Comparison between MT and MM on Analgesic Use...... 93
17. Comparison between MT and MM on Physiological Measures ...... 95
18. Types of Pain on 0-10 Pain Intensity Scales ...... 98
19. Children vs. Adults on All Pain Intensity Scales ...... 100
20. Levels of Choice in Music Selection on 0-10 Pain Intensity Scales ...... 102 xv
21. Levels of Choice in Music Selection on the Use of Analgesics ...... 103
22. Levels of Choice in Music Selection on Physiological Measures ...... 105
23. Rationale for Selection of Music on Pain Intensity and Analgesic Use ...... 108
24. Rationale for Selection of Music on Physiological Measures ...... 110
25. Music Experiences in Music Therapy on 0-10 Pain Intensity Scales ...... 111
26. Analysis of Moderator Variables: Methodological Qualities ...... 113
xvi
LIST OF FIGURES
Page
1. The Evidence Pyramid ...... 29
2. Flowchart of Study Selection Process (Review of Systematic Reviews) ...... 36
3. Flowchart of Study Selection Process (Meta-Analysis) ...... 72
4. Funnel Plot: Music vs. Standard Care on 0-10 Pain Intensity Scales ...... 84
CHAPTER 1
INTRODUCTION
Understanding Pain and Pain Related Issues
Definition of Pain
According to the International Association for the Study of Pain (IASP, 1994), pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” IASP emphasizes that pain is “always subjective,” indicating that the experience of pain cannot be generalized nor compared across individuals. In other words, how one understands and uses the word
‘pain’ is influenced by his or her multi-layered physical, psychological, social and cultural experiences associated with unpleasant stimuli or injuries in early life. Therefore, pain is considered to be a “multidimensional and complex phenomenon” (Davies &
McVicar, 2000; McGuire, 1992). Based on this fundamental viewpoint, IASP recommends that medical personnel address pain issues based on how patients express it regardless of their ability to verbalize it (1994). In order to address pain issues effectively, pain treatment services need to be multidisciplinary in nature, comprised of physicians, nurses, mental health professionals, and physical therapists, and utilize outside disciplines as consultants when needed (IASP, 2009).
Classification of Pain
Pain can be classified as procedural, acute or chronic (Allen, 2013a). Procedural pain occurs when medical procedures, ranging from venipuncture to elective surgeries, result in tissue and/or nerve damage. Due to the subjective nature of pain, a number of ２
factors can impact the perception of procedural pain. These include past memory of
hospital visits, present emotional or psychological state, evoked level of anxiety or
anticipated pain, and level of comprehension of the procedure itself (Marsac & Funk,
2008). For children, adequate management of procedural pain is very important because they have limited ability to understand the necessity of medical procedures and lack proper coping skills. As a result, they are more likely to develop fear and posttraumatic stress disorder following poorly managed procedural pain (Rennick, Johnston, Dougherty,
Platt, & Ritchie, 2002).
Sharp and sudden pain not caused by medical procedures is called acute pain.
Acute pain is often associated with a single treatable event of injury or illness that can usually be managed within seven days (American Society for Pain Management Nursing,
ASPMN, 2010). However, severe injuries such as torn ligaments, broken bones or burns can cause longer a duration of acute pain. Acute pain is different from chronic pain in that the pain subsides once the cause of pain is treated, it usually responds to analgesic medications, and it does not last longer than six months.
Chronic pain, also known as persistent pain, lasts longer than the anticipated duration of healing (ASPMN, 2010). Chronic pain can occur continuously or intermittently and may or may not have a known cause. ASPMN (2010) lists the following examples of chronic pain: “low back pain, diabetic neuropathy, post herpetic neuralgia, multiple sclerosis, and phantom pain” (p. 3). The American Pain Society includes cancer-related pain as a type of chronic pain and further distinguishes its ３
subtypes (2006), whereas ASPMN recognizes cancer pain as a separate category
(ASPMN, 2010).
Cancer pain is different in that the conditions causing pain are potentially fatal in
nature (ASPMN, 2010). Cancer pain arises mainly due to cancer itself. For example, pain
can be caused by the tumor compressing bones, nerves or other organs. Pain may also stem from diagnostic or therapeutic procedures such as fine needle aspiration or lumbar puncture. Lastly, side-effects or toxicities resulting from cancer treatments can further exacerbate pain issues (Ransom, Pearman, Philip, & Anwa, 2012). Examples of cancer pain provided by ASPMN include: “cancer of the pancreas, spinal cord compression caused by tumor infiltration, postsurgical pain associated with cancer treatment, post mastectomy syndrome” (2010, p. 3).
Prevalence of Pain
Pain is an indicator of potential or ongoing physical harm. It prompts one to take
care of the condition causing the pain and to remember to prevent similar injuries or
illnesses in the future. Without the ability to feel pain, one’s ability to protect oneself
would be greatly compromised. Although pain plays an essential role in health and
wellbeing, many patients, including children, suffer from unnecessary procedural and acute pain during their course of treatment or recovery, and even prolonged chronic pain thereafter (Brennan, Carr, & Cousins, 2007; Groenewald, Rabbitts, Schroeder, &
Harrison, 2012). Despite the fact that pain is the very reason why people seek medical care, scholars argue that pain management is not given the high priority it needs in medical practice or research (Brennan et al., 2007; Fishman, 2007). ４
A large scale poll revealed a high prevalence of pain among the general public in
the U.S. (ABC News, USA Today, & Stanford Medical Center, 2005). The survey results indicated that approximately 44% of the respondents had struggled with pain issues during the preceding two weeks, and 60% of them rated it to be ‘moderate’ or ‘high’ in intensity. About 40% of the participants experienced pain frequently, and 20% suffered from chronic pain. Not surprisingly, studies point to a high incidence of pain among
medical patients as well. With regard to hospitalized children, a recent study found that
44% of surgical patients and 40% of intensive care patients reported experiencing
moderate to severe pain (Groenewald et al., 2012). Also, 40% of adult patients indicated
having received inadequate pain management in spite of moderate to high levels of
postoperative pain (Bardiau, Braeckman, Seidel, Albert, & Boogaerts, 1999; Dolin,
Cashman, & Bland, 2002). In addition, studies revealed that approximately 50% of
hospice patients experience pain (Brennan et al., 2007), and this number increases to 75-
90% for patients battling cancer (Running & Seright, 2012). Despite the high prevalence
of pain and its negative impact, pain is generally undertreated, especially in infants,
children and minorities (Anderson, Green, & Payne, 2009; Brennan et al., 2007;
Groenewald et al., 2012; Taddio, Shah, Gilbert-MacLeod, & Katz, 2002).
Factors Associated with the Undertreatment of Pain
Brennan et al. (2007) note that pain issues are not adequately addressed due to
multifaceted and various “cultural, attitudinal, educational, political, religious, and
logistical reasons” (p. 205). These reasons can be divided into two types. The first type ５
relates to the patients or their caretakers’ directly and the second type is associated with
medical personnel or the medical community or system in general.
In the first type, patients from certain cultures are known to perceive and cope with pain differently (Kagawa-Singer, Valdez Dadia, Yu, & Surbone, 2010). For example,
some patients choose to endure the pain rather than seek treatment (Im, Guevara, & Chee,
2007; Im, Lim, Clark, & Chee, 2008); avoid opioids due to the fear of developing addiction (Anderson et al., 2002); leave important medical decisions to their family members (Maly, Umezawa, Ratliff, & Leake, 2006); reject the idea of palliative care
(Mazanec, Daly, & Townsend, 2010); or fear that the effect of opioids will wear off if taken too soon (Ransom et al., 2012). In addition, certain patients show poor compliance with treatment regimens and fear the potential side effects of pain medications (Ransom et al., 2012). These problems occur more frequently in children resulting in the undertreatment of pain among pediatric patients, as many children cannot express themselves clearly, and their parents make medical decisions for them based on the misconceptions discussed above (Bradt, 2013b). Also, some children fear that they will be exposed to more painful injections and/or treatments if they complain, thus failing to inform their caretakers of their pain (Mathews, 2011).
On the other hand, pain is often undertreated due to issues related to medical staff or the system. Chang (2012) argues out that pain is undertreated due to improper measurement methods. The subjective and complex nature of pain, as well as communicational and cultural barriers, often interfere with its accurate assessment. ６
In terms of medical personnel, the relative scarcity of pain specialists or pain centers, the focus on the illness itself and its treatment, the lack of current medical knowledge of pain management, the unwillingness to prescribe Schedule II medications, and the high cost of addressing complex pain issues, have resulted in the undertreatment of pain (Ransom et al., 2012). In addition, some physicians are unable to discriminate between patients who are in pain and those who are demonstrating drug-seeking behaviors (Ransom et al., 2012). Todd et al. (2000) propose racial discrimination as another reason, as they found that African-American and Hispanic patients received significantly less analgesic medicine in emergency departments in comparison to
Caucasian patients with the same medical issues and care.
Additional misconceptions may influence medical staff who treat pediatric pain.
These misconceptions include: children do not remember painful experiences; children feel less pain than adults; children are too fragile to take certain pain medications; children are more susceptible to addiction; pain during medical procedures is an unavoidable part of the process; due to medical urgency, there is no time to focus on pain; medical staff can judge the child’s level of pain more accurately than the child him or herself; and playing children do not experience pain (Bradt, 2013b; Mathews, 2011).
Experts in pediatric pain management dispute these arbitrary beliefs, and call for increased awareness and improved pain management for patients of all ages (Bradt,
2013b; Mathews, 2011). Lastly, Fishman (2006; 2007) adds that heightened awareness of prescription drug abuse and the publicized arrests of doctors for such illegal actions ７ discourage law-abiding physicians from prescribing necessary and appropriate medications.
Detrimental Effect of Pain
Undertreated pain has been identified as a “public health crisis” (Fishman, 2007, p.
8) and as “poor medicine, unethical practice, and abrogation of a fundamental human right” (Brennan et al., 2007, p.205). To illustrate the negative impact of untreated pain,
Brennan et al. (2007) and King and Fraser (2013) summarized its physical, psychological, social, and economic consequences. Physically, untreated acute pain may induce immunological or neural alterations that lead to the development of chronic pain
(Stephens, Laskin, Pashos, Peña, & Wong, 2003). Overlooked, postoperative pain can negatively impact gastrointestinal and urinary tract function and increase cardiac output and catabolic hormones, risking further complications (Stephens et al., 2003). In addition, chronic pain can limit one’s mobility, diminish strength, weaken immune functioning, and cause malnutrition and sleep disturbances (Lipman, 2005; Lohman, Schleifer, &
Amon, 2010). It can also extend the illness recovery period and result in recurrent pain syndromes (Coulling, 2007). For children, pain was identified as one of the main factors increasing the chance of missing appointments (Marsac & Funk, 2008), consequently delaying timely and necessary medical care.
Pain is also known to have negative social, behavioral and psychological consequences. The European Federation of IASP chapters stresses that individuals experiencing pain are far more susceptible to maladaptive and inappropriate social behaviors, dependency on others, suicidal thoughts and inability to continue everyday ８
activities (n.d.). In a similar manner, a study conducted by the World Health Organization
(WHO) concluded that patients experiencing pain on a persistent basis were more
vulnerable to psychological disorders. Specifically, they found that patients suffering from chronic pain were four times more likely to develop depression or anxiety-related disorders (Gureje, Von Korff, Simon, & Gater, 1998). Furthermore, pain is known to be linked closely with psychological states such as “feelings of depression, fatigue, uncertainty, loss of control, anxiety, fear, hopelessness, and loneliness” (Kreps, 2012, p.
44).
Lastly, pain affects patients’ ability to focus, thus contributing to the loss of jobs or decreased productivity (Stewart, Ricci, Chee, & Morganstein, 2003). As a result, pain increases overall medical costs and places an enormous economic burden on individuals and the health-care system (European Federation of IASP Chapters, n.d.). Due to its negative impact on every aspect of one’s life, pain can significantly diminishes one’s quality of life (King & Fraser, 2013; Reyes-Gibby, Aday, & Cleeland, 2002).
The Need for an Effective Non-pharmacological Pain Management
Based on this overview of pain issues, the following problems have been identified: 1. Too many individuals worldwide suffer from untreated and undertreated pain; 2. Untreated and undertreated pain have a detrimental effect on one’s health and quality of life; 3. Pharmacological pain therapies present issues of negative side-effects and misuse or abuse; and 4. Current understanding of pain warrants the need for pain treatment that addresses the individual needs of patients, provides sensory blocks, distracts, and addresses the multidimensional, biopsychosocial dimensions of pain, ９ including one’s physical, psychological, social, cultural and spiritual wellbeing. One approach that has been utilized in practice and researched extensively for quite some time is music.
Music as a Means of Alleviating Pain and Other Symptoms in Hospitals
Background
The use of music in hospitals began in veterans’ hospitals after World Wars I and
II, when live music played by volunteer musicians for wounded soldiers unexpectedly resulted in the alleviation of physical and emotional suffering; this work provided the momentum for music therapy to evolve as a health profession from that time until the present
(Davis, Gfeller, & Thaut, 2008). During this time, the music therapy profession in the U.S. blossomed with the establishment of professional associations, nationwide board-certification, licensure in several states, over 70 university degree programs, hundreds of clinical training and internship sites, and extensive research studies in various areas of practice. Since its inception, the scope of music therapy has expanded immensely to help individuals with developmental, physical, neurological, behavioral, medical and psychological issues, and the practice of music therapy is informed by theory and research. Numerous definitions of music therapy exist due to vast differences in populations served, settings, theoretical orientations, clinical issues, goals, therapeutic approaches, and cultural contexts (Bruscia, 1998). However, considering the essence of music therapy practice as defined by professional music therapy organizations worldwide (Bruscia, 1998), music therapy can most simply be explained as an individually tailored music intervention provided by a trained music therapist with the goal of optimizing the client’s health. １０
Alongside this development, individuals with various backgrounds and interests
continued to employ recorded music as an agent to alleviate pain and anxiety in medical
settings to study its effectiveness using clinical trials. Although most of the early studies
titled their music interventions simply ‘music,’ some began to refer to them
interchangeably as ‘music’ or inaccurately as ‘music therapy,’ and continue to do so (Lee,
2013).
Due to vast differences in the purpose, scope, approach, and in the individuals
providing the service, a distinction between music therapy and the receptive use of music
in medical settings was necessary. Therefore, the receptive use of music in hospitals by
medical personnel has been classified as ‘music medicine’ (Dileo, 1999). According to
Dileo and Bradt (2005), music medicine is an intervention “involving pre-recorded music
listening experiences administered by medical personnel” (p. 5) and "the therapeutic effects of music itself as an intervention” (p.9). On the other hand, music therapy is an intervention "involving a relationship between client and therapist, a therapeutic process and a "live" music experience" (Dileo & Bradt, 2005, p. 9).
Description of Music Medicine in Practice
General Description
As explained previously, music medicine is provided by medical personnel, most frequently nurses and doctors, using pre-recorded music. It generally involves portable players such as CD or MP3 players with a set of headphones or earphones. A loud speaker can be utilized in place of headphones when appropriate. In fact, several studies favored the use of loud speakers over headphones for patients who needed to stay alert １１ and communicate with the medical staff throughout medical procedures (Kwekkeboom,
2003) or teenagers receiving immunization shots (Kristjánsdóttir & Kristjánsdóttir, 2011).
Population Served
Most frequently, music medicine is provided to patients awaiting, undergoing, or recovering from painful medical or surgical procedures for the purpose of alleviating pain and anxiety (Dileo, 1999). Studies have been conducted in most of the medical specialty areas including oncology, general surgery, cardiology, general medical, intensive care,
OB/GYN, pediatrics, rehabilitation, and palliative care.
Dosage of Music Intervention
The ‘dosage’ of music varies greatly from five to 60 minutes or throughout whatever medical procedures patients are undergoing. If music is used to accompany a medical procedure, it is provided as a single treatment; however, some studies have administered music up to four times a day for several days during hospitalization.
Selection of Music
Three types of music selection procedures are generally used and I have categorized these as follows: researcher-chosen, patient-preferred and patient-chosen music. In researcher-chosen music, medical personnel provide a single piece of music or several music selections to the patient for listening. The music is often referred to as
‘soothing, quiet and instrumental’ music, and the pieces vary from a specific classical piece (e.g., Pachelbel Canon in D, Vivaldi Four seasons, etc.) to various other types (e.g., piano, pan flute and flute) and genres (e.g., new age, jazz, easy listening, etc.). In this １２ category, the patient has no choice regarding the music; the researcher alone determines the music.
Patient-preferred music entails the use of staff-provided categories or lists of music. The pre-programmed categories may consist of various genres (e.g., classical, new age, country/western, lullaby, etc.), instruments (e.g., piano, flute, etc.), or combinations of other sounds (e.g., solo instrumental, orchestral, music with nature sound, etc.).
Patients choose the category they prefer, but do not have a choice over individual pieces of music. If a list of available music is provided by the staff, patients can select particular pieces to create a personal compilation of music. The latter type, however, usually takes a longer time to prepare, and can cost more as a more extensive music library and specific equipment are required (e.g., laptop, iPod, etc.). The advantage of patient-preferred music is that the interventionist / researcher has some control, providing specific musical parameters or styles that have been found to be more beneficial in previous studies or are recommended by experts in the field.
When patient-chosen music is used, typically patients are asked to bring music that they consider relaxing or soothing from their personal libraries. Naturally, this implies that there will be a large difference in the musical styles, genres and characteristics among the music selections patients bring. With the development of online music services such as iTunes™, patients can also put together a personal compilation right in their hospital beds if the right equipment and adequate funds are provided.
１３
Strengths and weaknesses
A main strength of music medicine is that it can be implemented easily for a large
number of patients at the same time. It is inexpensive, applicable in many different
settings and requires only brief training of the medical personnel involved. In addition,
music medicine interventions are prone to fewer external variables than music therapy,
because they do not involve a patient-therapist relationship or other types of music
experiences. Consequently, music medicine clinical trials can be conducted more easily
with much larger groups of participants.
The main weaknesses of music medicine are that it cannot effectively help
patients experiencing intense distress or complicated issues, cannot accommodate each
patient’s individual needs or preferences; and cannot utilize the effect of music to its
fullest extent. In addition, it is still unclear what kind of music intervention is most
beneficial to patients. Clinical trials and systematic reviews have yielded inconsistent
results with regards to the type, dosage or selection of music that are most effective for alleviating symptoms among medical patients. For example, in one meta-analysis investigating the effects of music on coronary heart disease patients, participants who had
a choice of music showed a greater reduction in anxiety (Bradt, Dileo, & Potvin, 2013).
In contrast, a meta-analytic study focusing on pain revealed that the group having a
choice of music experienced no pain-reducing effect. Furthermore, in a different meta- analysis, a group that listened to researcher-chosen music showed a significant effect
(Cepeda, Carr, Lau, & Alvarez, 2006). Pelletier also reported that listening to researcher- chosen music based on previous findings had a greater stress-reducing effect than using １４
patient-chosen music (2004). The variance found in individual clinical trials is much
greater, and it is not possible to draw a conclusion with regard to the most effective music
intervention, thus more research is needed.
Description of Music Therapy Practice
General Description
The most fundamental difference between music medicine and music therapy is
the presence and role of a trained therapist in the therapeutic process. The differences
between the two are well delineated by Dileo (1999). A qualified music therapist is able
to assess each client’s needs, co-determine priority goals and appropriate music
experiences, and interact musically and non-musically through the relationship that
develops in the therapeutic process. Therefore, music therapy centers its therapeutic focus
on the whole person, not just the symptoms associated with medical procedures or
conditions (Dileo, 1999). For instance, a systematic review of eight music therapy and seven music medicine studies focusing on pediatric patients, revealed that while music medicine trials mainly focus on symptoms, such as pain and anxiety as dependent variables, music therapy studies target both symptoms and personal attributes, such as
coping skills, attitude towards medical treatments and sense of self-worth (Lee, 2013).
Population Served
Music therapy services in medical hospitals are commonly offered to patients when medical staff such as physicians, nurses, psychologists or social workers, in addition to child life specialists in pediatric hospitals, make a referral for an individual patient. Thus, patients who are referred to music therapy are often experiencing marked １５
distress, uncontrolled pain, complicated psychosocial issues and conflicts or a poor prognosis. Thus, as mentioned previously, the scope of music therapy is much broader than symptom management. This was also apparent in a recent systematic review on the
effect of music in pediatric hospitals, where music medicine studies often targeted
patients undergoing minor medical procedures, such as venipuncture or immunization,
whereas music therapy studies involved more painful and stressful procedures, such as
donor site dressing changes or post-op recovery from extensive surgeries (Lee, 2013).
Nevertheless, music therapists work with patients of all ages from pre-term infants in
neonatal intensive care units to actively dying patients in both outpatient and inpatient
units. In addition, music therapists often include family members in the therapeutic
process to address issues related to communication, coping skills, family support or other issues unique to each family.
Music Therapy Interventions
Because music therapists are trained to tailor their approach to fit the individual patient’s developmental, clinical and cultural needs and preferences, music interventions can vary greatly from one patient to the next. Typically, music therapists do not have a pre-planned music intervention, as this is determined during individual assessment and discussion with the patient or his/her caregivers. Unlike music medicine, a music therapy intervention is not limited to listening; rather it encompasses all types of active and passive experiences that include playing, composing, re-writing, learning, singing, improvising, performing, listening and combining with other arts modalities. In addition, music therapists utilize specific therapeutic strategies, such as music-assisted relaxation, １６
music and imagery and music entrainment when indicated. Clinical applications of music
therapy are well documented by experts in this field (Allen, 2013b; Bradt, 2013a; Dileo,
1999).
Strengths and Weaknesses
Because patients’ experiences of hospitalization, pain, distress, as well as ways of
coping with these issues are highly subjective, various types of individualized and unique
treatment plans are required. Thus, the most important strength of music therapy is the
presence of a trained therapist helping each patient with his or her unique challenges
through an individually-tailored approach. Consequently, music therapy can address
various psychosocial needs in accordance with the patient- and family-centered care
movement in medicine.
Numerous meta-analyses, synthesizing quantitative data from clinical trials, have
reported positive health benefits for music therapy, such as reduced pain, anxiety and
stress (Dileo & Bradt, 2005); music therapy is also associated with improved patient
satisfaction and quality of life (Bradt, Dileo, Grocke, & Magill, 2011; Dileo & Bradt,
2005; Zhang et al., 2012). In addition, cost benefit analyses have reported that music
therapy is associated with decreased medical cost (J. Standley & Walworth, 2005;
Walworth, 2005).
The weaknesses of music therapy are directly related to its strength. Music
therapy cannot reach as many patients as music medicine can, since the presence of a music therapist is essential. Also, due to the individually-tailored approach offered within a therapeutic relationship, no two therapy sessions are identical. Consequently, １７ implementing randomized controlled trials in music therapy is more challenging as it is difficult to control for all the variances in the therapeutic process and possible therapist effects.
Overview of Pain Theories in Relation to Analgesic Effect of Music
Over the past century, numerous theories have been developed to explain the phenomenon of pain. The predominant theories of pain in modern times in particular, have explained pain through multidimensional perspectives, which in turn better explained how music may be effective in managing pain. In this section, I will attempt to explain the predominant theories of pain and how they relate to the analgesic effect of music.
The early theories on pain were rooted in the traditional biomedical model of disease. Although every theory emphasizes different concepts and mechanisms, an understanding of the biomedical phenomenon called nociception is essential in order to discuss each theory. Nociception occurs when nerve cells called nociceptors detect and process painful stimuli. Nociceptors are located throughout the body in the skin, joints, ligaments, muscles, and organs. Thus, it can be said that nociception is the first stage of pain perception that transduces potential or actual tissue damage into pain signals which are transferred to the brain through neural pathways in the spinal cord (Gatchel, Haggard,
Thomas, & Howard, 2012; Gatchel, Peng, Peters, Fuchs, & Turk, 2007). All theories agree on this initial stage, but each explains the next stage of transmitting and modulating pain signals differently.
１８
Specificity and Pattern Response Theory
The dominant nineteenth-century theory was that of specificity which originated
with the ancient Greeks. Basically it suggests that unique pain receptors that are different from tactile sensors and corresponding pathways exist; these link the nociceptors, spinal cord, and brain. This theory is based on simple cause and effect and the parallel relationship between visible tissue damage and pain receptors (Gatchel et al., 2007).
Rejecting this receptor specificity, pattern response theorists argue that most receptor fibers are identical, and the differences in intensity and pattern of responses in these fibers produce the sense of pain (Gatchel et al., 2007). Although these two theories dominated medical thinking until the early twentieth-century, they did not explain much of what was observed in experimental or clinical settings. These issues led to the development of new theories that focused on the link between pain and emotion, the subjective nature of pain, and pain as a motivator of behavior, all of which played a catalytic role in the development of the famous the Gate Control theory (Gatchel et al.,
2007).
Gate Control Theory
The Gate Control theory, developed by Melzack and Wall in 1965, was the most influential theory of pain in modern medicine for many years, and was responsible for the recognition of the affective and cognitive components of pain. It postulated that pain signals from nociceptors travel through thin nerve fibers, while other tactile senses such as touch, pressure and vibration travel through large diameter nerve pathways. When a painful event occurs, nerve sensors transmit both pain and tactile information to the １９
dorsal horn of the spinal cord which acts as a gate, deciding whether to route the information to the thalamus and cerebral cortex, or suppress the signals with inhibitory cells. Both pain and tactile information can activate transmission cells at the dorsal horn, yet only the tactile senses passing through the large diameter fibers can trigger the inhibitory interneurons. This is how they explained why one massages or “smacks” his or her shoulders, because tactile information can impede pain information from being fired at the dorsal horn (Gatchel et al., 2007; Melzack, 2010). Interestingly, in addition to the tactile senses, the large diameter fibers also transmit visual and auditory inputs, thus
explaining how interventions such as imagery and music can alter pain perception
(Whipple & Glynn, 1992).
It is also postulated that, due to the bilateral communication between the brain and
spinal cord, the brain processes noxious stimuli then transmits signals back down to the
spinal cord, thus modulating the Gate Control system. In other words, depending on how
one feels and interprets the unpleasant stimuli, the brain can open or close the gate, thus
increasing or decreasing the perceived level of pain (Melzack, 2010). This innovative
theory changed the fundamental approach to pain, as Melzack writes: “The theory forced
the medical and biological sciences to accept the brain as an active system that filters,
selects and modulates inputs” (1999, p. S123). This explains the close link between pain
perception and anticipation, comprehension, locus of control, emotional arousal, and
concentration level (Bradt, 2013b; Gatchel et al., 2012). The gate theory was highly
influential in that it sparked the development of psychological and behavioral ２０
interventions for pain management and extensive research on pain and the brain (Melzack,
2010).
In summary, the Gate Control theory presents two essential mechanisms that can
impact pain perception. First, sensory input, in particular auditory, visual and tactile
information, can reduce pain perception through the bottom-up channel. Second, affective/cognitive variables such as one’s emotional state, level of comprehension, locus of control, attention-distraction levels, and expectation can impede pain perception
through the top-down channel. Because music is a multimodal experience accessing the
auditory, tactile (via vibration), visual (via melodic themes and associations), emotional
and cognitive domains, this theory explains all the empirical evidence of music’s effect
on pain.
Neuromatrix Theory
Melzack has continued his investigations on pain and the brain and has further
developed the Gate Control theory in order to address the questions that were left
unanswered. Due to his fascination with phantom limb pain, and chronic pain without a
known cause, he developed the neuromatrix theory (Melzack, 1999) which is the
predominant theory of pain today. He explained this puzzle by looking at the independent
function of the brain in processing and feeling pain. He notes “Chronic pains, clearly, are
not a warning to prevent physical injury or disease. They are the disease - the result of
neural mechanisms gone awry” (Melzack, 2001, p. 1378). He suggests that we are born
with a genetically-determined neural network in our brain, which becomes retuned as we
experience and process various sensory stimuli. This neural network is called the “body- ２１
self neuromatrix,” and this matrix creates the perceptions we have of our body and our
sense of self. He proposes that this body-self is made up of loops between the thalamus
and cortex, and the cortex and limbic system. Therefore, when sensory information goes
through this cyclical processing repeatedly, the brain identifies and creates characteristic
patterns. This pattern is termed a “neurosignature.” Normally, these neural processes are
activated and modulated by noxious and/or tactile signals as previously noted in the Gate
Control theory; however, he discovered that the brain can act without such external
signals due to neurosignatures. Melzack states that this neurosignature is responsible for
unexplained chronic pain or phantom pain in amputated limbs (Melzack, 1999).
The neuromatrix theory proposes much more extensive involvement of the brain than just sensory thalamus and cortex which were originally proposed in the Gate Control theory. Now this theory includes the limbic system, somatosensory projections, visual and vestibular mechanisms, and higher cognitive processing levels (Melzack, 2001).
Thus, Melzack suggests that pain and tactile stimuli may trigger the brain to react, but it
is solely up to the brain to determine the quality of the sensory experience. Consequently,
he describes the healthy state, from a different point of view:
Injury disrupts the brain’s homeostatic regulation systems, thereby producing “stress” and initiating complex programs to reinstate homeostasis… Stress is a biological system that is activated by physical injury, infection, or any threat to biological homeostasis as well as by psychological threat and insult of the body-self. Both are correct and important (Melzack, 2001, p. 1380).
His bold emphasis on homeostasis, on the multidimensional aspects of pain and
on integrative health views that address psychological and environmental variables led
him to integrate the constructs of cognitive-evaluative; sensory-discriminative; and ２２
motivational-affective components of pain, which were delineated separately in the Gate
Control theory (Gatchel et al., 2007). Consequently, he emphasizes that the sensation of
pain is the output of the widely spread neural network in the brain, impacting pain
perception and the development of action and stress-regulation programs (Melzack,
2001).
With the advancements in neuroscience and functional neuroimaging technologies,
researchers have been investigating the relationship between music and the brain over the
past decade and have produced a wealth of new discoveries. Archie, Bruera, and Cohen have consolidated these findings in their recent review (2013). They summarized that music has been found to modulate activities in multiple limbic and paralimbic structures of the brain (i.e., ventral striatum, dorsomedial midbrain, amygdala and hippocampus).
These findings are significant because irregular or abnormal activities in these parts of
brain are associated with pain, anxiety and depression; these parts also house ligand-
binding receptors that transmit endogenous opioids, GABA, and dopamine (Archie et al.,
2013). These findings support Melzack’s description of how neural structures are associated with pain perception. Furthermore, they suggest that abnormal neural
structures associated with pain, anxiety and depression, can be accessed and reactivated
through music.
Biopsychosocial Model of Pain
As the title suggests, the biopsychosocial model emphasizes the close and
dynamic interrelationship between the physical, psychological and social factors of health.
Proposed by Engel in 1977, the biopsychosocial model criticizes the traditional ２３
biomedical model of medicine, and challenges medical professionals to look beyond the
physiology of disease (Engel, 1977). It is rooted in General Systems Theory, moving
away from the linear causal way of thinking, and towards “assumptions of hierarchical
organization of phenomena and non-linear, circular causal effect” (Wood, 2012, p. 171).
In this way of thinking, Engel suggests that care providers attend to the humanness of the
patient, and take a holistic approach, focusing on the mind-body relationship. Thus, psychological and social elements are more than secondary factors that have some causal impact on the body. Rather, all factors are considered equally important when treating
illness, hence thorough and comprehensive assessments and individualized treatments are
needed (Engel, 1977; Gatchel et al., 2012).
The biopsychosocial model is considered a meta-theory, meaning it is a
“philosophical component of a paradigm that determines how models and theories are to
be constructed (Wood, 2012, p. 178). Thus, discussing the biopsychosocial model as part
of pain theories here does not mean that one should adhere to one or the other. It can be
even said that the aforementioned new theories with regard to human pain perception
may all be part of the biopsychosocial movement. The biopsychosocial model has already
brought numerous and significant changes to the healthcare systems in U.K., Germany,
and the U.S.A. (Adler, 2009). For instance, most hospitals have adopted a multi-
disciplinary team approach, and many medical schools include biopsychosocial medicine or related courses as part of their regular curriculum (Waldstein, Neumann, Drossman, &
Novack, 2001). This impact is also apparent in the number of peer-reviewed articles published with the word “biopsychosocial” in the title or abstract. A preliminary search ２４
using the PubMed database on August 2, 2014 yielded a total of 3,412 articles. When
limited to the years of publication, I found 273 articles from the 1980s; 612 articles from
the 1990s; 1,404 articles from the 2000s; and 1,123 articles from January of 2010 to July
of 2014.
In order to investigate the relationship between these dimensions, a number of
studies have been conducted. Some of the psychosocial factors that are known to impact one’s pain perception include: psychological distress, empathy, social support, location of care, feelings of belonging, fear, work stress, distraction, mobility, level of energy, expectation, personal beliefs, locus of control, motivation, anxiety, memory span,
empowerment, and so on (Gatchel et al., 2012; Kikuchi, 2008; Wood, 2012).
The theories and factors that impact pain perceptions discussed thus far warrant, if
not validate, the very existence of music in health care settings, because music itself is a
“multidimensional, biopsychosocial phenomenon” (Dileo, 1997, p. 131).
２５
CHAPTER 2
REVIEW OF SYSTEMATIC REVIEWS ON MUSIC AND PAIN
Introduction
An overview of the research on pain elucidates the seriousness of undertreated pain and justifies a need for an effective non-pharmacological approach to relieving pain.
As an established integrative approach, music is known to alleviate pain for cancer and hospice patients (Dileo, 2006), post-surgical patients (Cepeda et al., 2006) and patients with coronary heart disease (Bradt et al., 2013). In addition, it has been reported that music interventions have additional benefits, such as improved mood, quality of life and patient satisfaction (Dileo, 2006; Dileo & Bradt, 2005; Zhang et al., 2012).
Generally, medical practices and administrations currently operate under the patient-centered care and evidence-based model of practice. The essence of these two dominating paradigms is incorporating the choices and preferences of patients and family members in medical decisions (Cliff, 2012; Kassirer, 1994), and offering the best available care based on rigorous scientific research (Sackett, Rosenberg, Gray, Haynes, &
Richardson, 1996). Montori and colleagues (2013) state that research evidence alone does
not guide the best evidence-based medicine, unless the practice is optimized by reflecting
patients’ views of well-being. In other words, these two movements are complementary
rather than contradictory. In addition, the patient-centered care movement has evolved
over time going beyond addressing the basic needs of patients based on their diagnosis to,
incorporating patients’ values and culture (Cliff, 2012). Consequently, this movement
explains the wide spread use of the multi-disciplinary team approach and of psychosocial ２６
care in medicine. As a part of this movement, music medicine and music therapy have
been offered to patients of all ages with varying needs. However, the clinical use of
music is more likely to serve a wider range of patients if there is a continued effort to
secure high-quality research evidence and further develop evidence- based practice.
Evidence Based Practice
The evidence-based practice (EBP) movement has become prominent in the
clinical, administrative, educational, and research practice of all helping professions
(Chronister, Chan, Cardoso, Lynch, & Rosenthal, 2008; Littell, Corcoran, & Pillai, 2008).
Considered as the pioneers of the EBP movement, Sackett and his colleagues explain
EBP as follows:
Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research (Sackett et al., 1996, p. 71).
Despite this recommendation, the overwhelming number of new studies being published every day and their vast differences in findings, often make it very challenging for clinicians to integrate new findings with existing knowledge, and make well-informed decisions based on that integration (Sauerland & Seiler, 2005). In order to help clinicians make sound and effective decisions, efforts have been made to synthesize existing study results, and one of the most rigorous and powerful methods is systematic review and meta-analysis (Durlak, Meerston, & Foster, 2003; Sauerland & Seiler, 2005).
２７
Definition of Systematic Review and Meta-analysis
According to the PRISMA statement that presents a rigorous guideline for reporting systematic reviews and meta-analyses, a systematic review is:
A review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Meta-analysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. (Moher, Liberati, Tetzlaff, Altman, & PRISMA Group, 2009, p. 1)
In other words, a systematic review is a rigorous and comprehensive synthesis of
clinical trials for uncovering reliable and generalizable evidence in a specific area of
practice. It is essential to search and identify studies in a highly comprehensive,
organized, transparent, and replicable manner (Littell et al., 2008), and evaluate each
reviewed study with established tools for assessing methodological rigor and risk of bias.
A systematic review also presents tabulations of essential clinical and methodological
characteristics for easy overview and comparison among reviewed studies (Sauerland &
Seiler, 2005). A systematic review may or may not include a meta-analysis depending on
the feasibility of combining statistical data for further analyses (Littell et al., 2008).
The primary objective of meta-analysis is to “synthesize evidence on the effects
of interventions or to support evidence-based practice” (Borenstein, Hedges, Higgins, &
Rothstein, 2009, p. xxiii). To illustrate this point, Borenstein and colleagues (2009) depict
an exemplary meta-analysis performed in 1992 (Lau et al., 1992). The study synthesized
33 randomized controlled trials investigating the effect of streptokinase, also known as clot buster, on preventing death among patients having a heart attack. Although only six ２８ of the 33 studies reported statistically significant results from this treatment, Lau’s team concluded that streptokinase decreased the risk of death among participants by 21% with a reasonably consistent effect with a p-value of 0.0000008. Thus, meta-analysis can increase the statistical power of clinical trials by combining them together and yield meaningful insights from the meticulously pooled data (Durlak et al., 2003).
The process of meta-analysis involves extracting data from selected studies, and translating the results of each study into effect sizes to calculate the magnitude of intervention effect (Durlak et al., 2003). Subsequently, these effect sizes become standardized, so they can be compared with other studies, which in turn, increase the statistical power of the overall results. By doing this, researchers can compare studies that use different methods while identifying patterns and inconsistencies among findings. To analyze several studies as one, meta-analysts should confirm that measures used for each study are identical or comparable. During meta-analysis, effect sizes are weighted to reflect the sample size of each study, because studies involving larger samples are considered more reliable (Durlak et al., 2003). In addition, the weighting process can minimize the influence of bias from any particular study. These multiple steps enable researchers to reach more accurate and credible conclusions regarding the treatment effect under study. For these reasons, meta-analysis is considered to be at the top of the hierarchy of evidence with lower risk of bias (Akobeng, 2005; Chronister et al., 2008;
Polit & Beck, 2008).
２９
Significance of Systematic Reviews and Meta-analysis
One of the commonly presented concepts that delineate the strength of research evidence by its type is the evidence pyramid. Various versions of evidence pyramids have been developed by researchers according to their particular field of study even though the overall structures are similar. Figure 1 shows a frequently citted example.. It illustrates that among the various types of research studies and scholarly inquiries, systematic reviews and meta-analyses sit at the very top, indicating thhat they present the highest level of evidence in the healthcare literature.
Figure 1. The Evidence Pyramid (SUNY Downstate Medical Center, n.d.)
From Guide to Research Methods, from SUNY Downstate Medical Centeer, Medical Research Library of Brooklyn.
３０
Criticisms of Systematic Reviews and Meta-Analysis
Although systematic reviews and meta-analyses are considered the gold standard of evidence based research, some authors point out that they are also susceptible to the risk of bias. While acknowledging this, experts in meta-analysis explain that misleading results arise from illogical or wrongful application of the method, not due to the nature of
the method itself (Borenstein et al., 2009; Littell et al., 2008). Nevertheless, all parties
agree on the necessity of establishing rigorous guidelines for conducting systematic
reviews and meta-analyses.
Moreover, critics also argue that pooling data without adequate theoretical
constructs or conceptualization yields meaningless data, again leading to fallacious
conclusions (Littell et al., 2008). For example, when meta-analyses are conducted by
analysts who do not have a full understanding of relevant theoretical constructs, clinical
implications, and/or contextual effects, the outcomes from such analyses may become
irrelevant or meaningless. Another concern addresses the issue of including and
analyzing studies that are low in quality. This is often referred to as ‘garbage in, garbage
out,’ and experts recommend the use of a priori design predetermining research questions
and clear inclusion criteria (Littell et al., 2008).
In addition, it has been pointed out that summary effect sizes reported in meta-
analyses are not easily understood by many people, especially because there are a few
different types with corresponding guidelines for interpretation. Consequently, scholars
suggest meta-analysts summarize their results using forms such as raw percentages in
addition to effect size metrics. Lastly, external validity of meta-analyses is also a ３１
controversial topic, because it is difficult to eliminate all heterogeneity issues in terms of
settings, interventions, populations and research contexts among clinical trials (Littell et al., 2008). In response to many of these criticisms, a number of standards have been established to improve the quality of systematic reviews.
Ensuring the Quality of Systematic Reviews
In order to improve the quality of systematic reviews, PRISMA (i.e., Preferred
Reporting Items for Systematic Reviews and Meta-Analyses) was developed to offer
guidelines on how to conduct systematic reviews and meta-analyses (Moher et al., 2009), and AMSTAR (i.e., Assessment of Multiple Systematic Reviews) presents a method for evaluating methodological rigor of systematic reviews (Shea et al., 2007).
In my preliminary searching for systematic reviews and meta-analyses concerning the effects of music on pain, I retrieved 57 systematic review-like articles that were published in the last 15 years on this topic, yet the methodologies used by these reviews were vastly different. Researchers assert that without strict and standardized guidelines,
systematic reviews can also skew the research findings and misrepresent a body of research studies (Littell et al., 2008). Therefore, it is very important for systematic
reviewers to follow guidelines such as the PRISMA (Moher et al., 2009) and AMSTAR
tool (Shea et al., 2007).
Purpose of this Chapter
The primary objective of this chapter is to critically review existing systematic
reviews and meta-analyses on the topic of music and pain. The review will include a
comprehensive overview of findings, a careful evaluation of the methodological quality ３２ of the reviews and an exploration of issues or gaps in the investigations. Furthermore, this review will provide the basis of the research questions for this dissertation.
Method
Inclusion and Exclusion Criteria
This review included only systematic reviews or meta-analyses investigating the effect of music on pain. In order to determine the eligibility of studies, the aforementioned definition of systematic reviews proposed by the PRISMA guideline was used (Moher et al., 2009).
In addition, the following inclusion criteria were established prior to systematic review selection: 1) publication in English or Korean-language peer-reviewed journal between the years of 2000 and 2014; 2) containing only controlled trials such as randomized controlled trials or quasi-randomized clinical trials; 3) containing syntheses of at least two or more clinical trials investigating the effect of music medicine or music therapy on pain; and 4) representing the following core components of systematic reviews specified in the PRISMA statement (Moher et al., 2009): clear inclusion/exclusion criteria; search strategy; assessment of risk of bias (e.g., randomization, allocation concealment, blinding and attrition rate); and the results of risk of bias synthesized in the result. There were no other restrictions with regards to age, population, or types of pain.
Search Strategy
During the week of August 4, 2014, I conducted an electronic database search using the Medline, CINAHL, PsycINFO, Cochrane Library, Proquest Dissertations & ３３
Theses A&I, HealthSTAR, and PubMed using the search terms (music OR song OR sing
OR Lullaby OR Lullabies OR alternative OR complimentary) AND (pain OR suffering
OR discomfort OR distress OR analgesic OR opioid) AND (review OR systematic review OR meta-analysis) as title, abstract, or keyword. When available, keywords such as pain, music and systematic reviews were reentered with MeSH or Subject Terms search options. At the same time, I checked all reference lists of obtained articles for relevant studies, then hand-searched the following music therapy journals: Journal of
Music Therapy, Music Therapy Perspectives, Music and Medicine, Australian Journal of
Music Therapy, British Journal of Music Therapy, Canadian Journal of Music Therapy,
New Zealand Journal of Music Therapy, Nordic Journal of Music Therapy, Voices:
World Forum for Music Therapy, Journal of Music and Human Behaviors (Korea), and
Korean Journal of Music Therapy.
Data Collection and Extraction
A 57-item Microsoft Excel™ file was created to extract generic, methodological, statistical, and qualitative information from the reviews. To minimize sampling error, I repeated the extraction process twice checking for errors or inconsistencies.
Quality Assessment of the Systematic Reviews
The revised version of Assessing Methodological Quality of Systematic Reviews
(R-AMSTAR) was used to assess the methodological rigor and quality of included studies (Kung et al., 2010). R-AMSTAR was chosen over AMSTAR because it allows quantification of the assessment results while maintaining the validity and reliability established in its original version (Kung et al., 2010). The R-AMSTAR is a checklist ３４
comprised of 42 items that appraise the quality of 11 essential areas of systematic reviews.
These areas examine study design, search strategies, data management, inclusion criteria,
reporting style, integration of assessment results and findings, and exploration of
heterogeneity, publication bias and the researcher’s potential conflict of interest (Shea et
al., 2007). The total score ranges from 11 to 44, as each item is rated from 1 – 4 (Kung et
al., 2010). In this review, studies that received 37 or higher were considered ‘high
quality,’ 25 to 36 were ‘moderate,’ 13 to 24 were ‘low,’ and 12 or below were rated ‘very
low’ in quality, based on a similar review of systematic reviews (Bao et al., 2014).
Results
Search Results
From the initial search of electronic databases, I found 432 articles. Following an
inspection of titles and abstracts, 373 irrelevant or duplicate articles were removed. A
total of 63 articles was retrieved and reviewed after exploration of reference lists and handsearch of music therapy related journals. After this full review, 49 systematic reviews were excluded for the reasons listed in Appendix A. Of these excluded studies,
12 studies were not systematic reviews; 11 articles included too few studies on music or
pain (two or less); eight studies did not perform or inadequately performed risk of bias
assessments; another seven studies did not utilize or inadequately utilized music
interventions; five included uncontrolled studies; three studies did not investigate pain as
outcome; and three were excluded for other reasons specified in Appendix A.
Consequently, 14 systematic reviews and meta-analyses investigating the effect of
music on pain were included in this review. For a detailed illustration of this search ３５
process, see Figure 2 which contains a flowchart of the study selection process. In
addition, Table 1 presents the basic characteristics of the included studies.
General Characteristics of Included Systematic Reviews
The final sample consisted of six systematic reviews and eight meta-analyses.
Four reviews investigated the effects of music on procedural pain, four on cancer pain,
three on surgical pain, and three on two or more types of pain. However, one study could not be classified as one specific type of pain because the participants were more likely to suffer from complex pain due to heart failure. In terms of medical specialty areas, there were four trials in oncology, two in gastroenterology, two in surgery, two in pediatrics, and one each from cardiology, general medical, neonatology and intensive care.
Of the 14 studies, five included all ages of participants, whereas three focused on adults, two on neonates, two on children and adolescents, one on adolescents to older adults, and one on a group of unknown age. In terms of the first reviewer’s country of residence, six were from U.S.A., two from Canada, and one each from China, Hong
Kong, South Korea, Sweden, Switzerland, and Taiwan. The total number of pain studies
reviewed by each systematic review ranged from 4 to 51, averaging 11.9 studies per
review. The total number of participants included in these reviews ranged from 64 to
3,663, making the average number around 1,032 participants per review.
３６
Figure 2. Flowchart of Study Selection Process
432 titles from initial search 4 relevant titles obtained from: 309 titles reviewed & removed (years available for online hand-search) 123 relevant titles Journal of Music Therapy (1996-2014): 0 Medline: 22 Music Therapy Perspectives (1996-2014): 0 CINAHL: 25 Music and Medicine (2009-2013): 1 PsycINFO: 3 Australian JMT (1996-2014): 0 Cochrane Library: 28 British JMT (1987-2014): 0 Proquest: 0 Canadian JMT (2004. 2006-2014): 0 HealthSTAR: 0 New Zealand JMT (1987-2013): 0 PubMed: 45 Nordic JMT (1992-2014): 2 Voices: World Forum for MT (2001-2014): 0 Music and Human Behaviors (Korea) (2004-2014): 1 Korean JMT (1999-2014): 0
64 duplicates removed, 59 remain
63 full-text articles obtained and reviewed 49 articles removed (See Appendix A for a list of excluded studies and reasons for 14 systematic reviews included & analyzed removal) 8 meta-analyses 6 reviews without meta-analysis
Table 1. General Characteristics of Included Systematic Reviews
Total N Total N of N range of Meta- Reviewer & year Country Age group Setting Type of pain of studies* participants* participants analysis Bardia et al., 2006 USA 3 (18) 64 (1,499) 9-40 N/A Oncology Cancer no Gastroenterology: Bechtold et al., 2009 USA 8 712 32-166 Adult Procedural yes Colonoscopy Bradt et al., 2011 USA 5 (30) 391 (1,891) 30-136 All Age Oncology Cancer yes Bradt et al., 2013 USA 8 (26) 630 (1,369) 40-139 All Age Cardiology Various yes Cepeda et al., 2006 USA 51 3,663 11-233 All Age General Various yes Engwall & Duppils, 2009 USA 18 1,604 17-500 Adult Surgical Surgical no Surgical & Hartling et al., 2009 Canada 6 (9) 303 (388) 11-31 Neonatal Neonatology no Procedural Haslbeck, 2012 Switzerland 4 (43) n/a n/a Neonatal Intensive care Procedural no
Klassen et al., 2008 Canada 5 (19) 465 (1,513) 14-200 1 mo. - 18 yrs. Pediatric Procedural yes
Lee, 2013 S. Korea 7 (15) 527 (987) 11-150 1 mo. to 18 yrs. Pediatric Various no
Nilsson, 2008 Sweden 22 (42) 2,422 (3,936) 38-500 Adult, 17+yrs Operative Surgical no Gastroenterology: Tam, 2008 Hong Kong 6 (8) 592 (722) 32-166 15-68 Procedural yes Colonoscopy Tsai et al., 2014 Taiwan 6 (21) 455 (n/a) 40-126 All Age Oncology Cancer yes Zhang et al., 2012 China 10 (32) 887 (3,181) 40-140 All Age Oncology Cancer yes Note.* Number of participants/studies relevant to this review (IV: music, DV: pain). Numbers in parenthesis indicate the total number of studies/participants investigated regardless of the type of intervention or outcome. 37 38
Methodological Overview of Included Systematic Reviews
On average, the reviewers included studies that were published 11.5 years prior to the time of their investigation (see Table 2). Reviewers investigated studies that were conducted as far back as 40 years and as recent as one year. In general, the gap between the year of their latest retrieved article and the year when their systematic review was published was small, about 2.3 years on average excluding one review (Bardia, Barton,
Prokop, Bauer, & Moynihan, 2006). This particular review was excluded from the calculation because their study, which was published in 2006, includes only three articles on music and pain that were published in the years of 1986, 1989 and 1991, raising some questions regarding the strategies of their study selection and/or literature search.
In terms of study design, ten studies targeted RCTs whereas three included quasi- randomized clinical trials (qRCT) in addition to RCTs (Bradt et al., 2011; Engwall &
Duppils, 2009; Tsai et al., 2014). Studies were considered qRCT if a study used a systematic method of allocating participants, such as by alternation, date of birth or medical record number (Higgins & Green, 2011). One study by Haslbeck (2012) was unclear about the specific type of study included. The researcher stated that she included
“empirical primary research reports which embraced a clear methodological stance and were high-quality studies” (p. 206).
Some of the methodological elements that can increase the integrity of systematic reviews are: having multiple researchers extract and compare data; contacting authors for clarifications on missing or unclear data; testing publication bias; and most importantly conducting a quality assessment of included clinical trials (Kung et al., 2010). When the 39
included systematic reviews were assessed to determine if they met the above criteria, it
was found that nine studies employed two or more data extractors, whereas four did not.
One study utilized another adaptive method of a second researcher verifying already
extracted data. Six reviewers attempted to contact authors of the clinical trials to secure
missing data, whereas eight did not. In terms of testing publication bias, five of the eleven
meta-analyses performed publication bias testing; inspection of funnel plots was the most
frequently used method. Three meta-analyses used the Egger’s regression test (Klassen,
Klassen, Liang, Tjosvold, & Hartling, 2008; Tam, 2008; Tsai et al., 2014), and one of
them also conducted the Begg’s adjusted rank correlation as well (Klassen et al., 2008).
Due to the lack of statistical data to examine publication bias, none of the non-meta-
analytic studies could perform this test. Lastly, Jadad (1996) was found to be the most
frequently implemented tool to assess the quality of clinical trials, as six studies utilized it, followed by the Cochrane Risk of Bias tools (three studies), and the GRADE system
(three studies). Haslbeck (2012) used a self-devised index based on guidelines by Beck
(1995) and Polit & Beck (2004), whereas Nilsson (2008) took an appraisal tool from another systematic review (Rubin & Hotopf, 2002). Two studies did not describe the details of their assessment methods (Cepeda et al., 2006; Engwall & Duppils, 2009).
Table 2 presents these details.
Quality Assessment of Included Systematic Reviews
The alphabets ‘A’ through ‘E’ listed in Table 4 indicate the specific R-AMSTAR
items that each study fulfilled. These items were converted into scores, and the total
scores of R-AMSTAR were calculated for each study according to the guidelines 40
provided (Kung et al., 2010). The scores ranged from 20 to 38; the average score for all
14 studies was 28, which is considered ‘moderate’ in quality (see Table 3). Specifically three were ‘high,’ nine ‘moderate,’ and two were rated ‘low’ in quality. The top six highest scoring studies (43%) were all meta-analyses; three of them (50%) were
Cochrane reviews. All three Cochrane reviews included in this review were in this high- scoring group, reflecting the rigorous standards set by the Cochrane collaboration. On the other hand, five of the six lowest scoring reviews were systematic reviews without statistical analysis. This was unavoidable because items 9 and 10, which concern heterogeneity and test of publication bias in R-AMSTAR, are only applicable to full systematic reviews with statistical analysis.
When analyzing each item across studies (see Table 4), it can be observed that studies usually score ‘high’ for items 1, 3, and 6, whereas they score relatively low for items 8, 9 and 10. Items 1, 3, and 6 are designed to indicate if studies conduct ‘priori design,’ duplicate data extraction, and description of general characteristics respectively.
The items relevant to significant improvement overall (8, 9 & 10) address the issues of reaching a conclusion with quality assessment under consideration; carefully analyzing and combining data with emphasis on possible heterogeneity; and addressing the issue of publication bias.
Table 2. Methodological Quality of Included Systematic Reviews
Reviewer Articles Included Multiple Contacted Quality Publication R-AMSTAR & year from years study designs extractors authors assessment bias Rating Bardia et al., 2006 1986-1991 RCT yes no Jadad no moderate Bechtold et al., 2009* 2002-2006 RCT yes yes Jadad Funnel plots moderate Bradt et al., 2011* 2006-2010 RCT, qRCT yes yes Cochrane, GRADE no high
Bradt et al., 2013* 1995-2012 RCT yes yes Cochrane, GRADE Funnel plots high
Cepeda et al., 2006* 1986-2004 RCT yes yes Self-devised no moderate Engwall & Duppils, 2009 1998-2007 RCT, qRCT no no Self-devised no low Hartling et al., 2009 1989-2004 RCT yes no Jadad no moderate Haslbeck, 2012 1970-2010 unclear no no RM. Polit & Beck no low
Klassen et al., 2008* 1987-2006 RCT verified no Jadad Funnel plots, BRC, ERT moderate Lee, 2013 2000-2011 RCT no no CONSORT no moderate
Nilsson, 2008 1995-2006 RCT no no RM. Rubin & Hotopf no moderate
Tam, 2008* 2002-06 RCT yes yes RM-Jadad Funnel plots, ERT moderate
Tsai et al., 2014* 2003-11 RCT, qRCT yes no Jadad, Cochrane Funnel plots, ERT high
Zhang et al., 2012* 2003-10 RCT yes yes Cochrane, GRADE no moderate Note. * indicates meta-analysis; BRC: Begg's adjusted rank correlation test; ERT: Egger's regression test (Egger et al., 1997); qRCT: quasi-randomized clinical trials; RCT: randomized controlled trials; RM: researcher modified 41 42
On another note, items 2, 4, and 10 show a rather high variance among reviewed studies, indicated by the three highest standard deviations. Item 2 asks if data have been
extracted by more than one person, known as double extraction, and by using reliable and
consistent methods. As discussed in the previous section, nine studies fully or partially
met the criteria, and one study sought to minimize the selection bias by employing another method (Table 2). Thus, this large discrepancy seems to be due to the four studies that did not use double extraction. Item 4 asks if a comprehensive list of literature was considered regardless of publication type including unpublished grey literature. Here, the
variance appears to be due to numerous studies with extreme scores at both ends.
Consequently, it raises the need for reviewers to expand their search strategies and
describe the process in full. As noted before, the variance in item 10, testing publication
bias was largely due to the fact that all non-meta-analytic studies could not run
publication bias tests without the necessary statistical data. For a complete listing of all
items and corresponding criteria, see Appendix B for the R-AMSTAR assessment tool.
Summary of Findings
Fourteen systematic reviews and meta-analyses investigated the effects of music on various types of pain. The most frequently employed method of measuring pain was the patient’s subjective perception of pain intensity based on a numerical rating scale,
visual analog scale, or faces pain scale. Depending on the population under investigation,
observational tools or surveys, such as the McGill Pain Questionnaire, were also used. In
addition to the pain scores, the use of sedation or the amount of analgesics used during or
after operations or unpleasant procedures were reported as well (Table 5).
Table 3. Quality Evaluation of All Included Systematic Reviews (R-AMSTAR: Revised Assessment of Multiple Systematic Reviews) 1 2 3 4 5 6 7 8 9 10 11 Sys. Reviews \ Items Review Data Search PUB Inclusion Data Quality Integrated Hetero- PUB. Conflict Total Rating design extraction strategy type Criteria table appraisal conclusion geneity bias interest Bardia et al., 2006 ABC ABC ABCDE BCD ABCD AC ABCD AB BCD AB AB 38 High Bechtold et al., 2009* ABC ABC ABCD ABD ACD ABC AB A BCD ABC AB 36 High Bradt et al., 2011* ABC ABC ABCDE BD ABCD AC AB A BD A AB 32 Moderate Bradt et al., 2013* AB ABC ABCD AB ABCD AC AB BCD ABC 32 Moderate Cepeda et al., 2006* AB ABC ABCD BCD ABCD AC AB A BCD A 31 Moderate Engwall & Duppils, AB BC ACDE ABD AD ABC AB A BCD ABC 31 Moderate 2009 Hartling et al., 2009 AB ABC ABCD AB AD AC AB A AB 27 Moderate Haslbeck, 2012 ABC A ABCDE A ABCD AC A ABC 26 Moderate Klassen et al., 2008* BC ABC ABC AD ABC ABCD A C B 26 Moderate Lee, 2013 ABC ABC ABCD ABC AB A B 24 Moderate
Nilsson, 2008 ABC A ABCD AD AC AB A B 23 Moderate Tam, 2008* ABC ABC A AD ABC A 21 Low
Tsai et al., 2014* B ACDE AB AD C A A 20 Low
Zhang et al., 2012* B ABCD AC AC C B 19 Low
Note. * indicates meta-analysis; PUB: publication; see Appendix B for a detailed R-AMSTAR assessment items and criteria.
43
Table 4. R-AMSTAR (Revised Assessment of Multiple Systematic Reviews) Scores Across Studies 1 2 3 4 5 6 7 8 9 10 11 Sys. Reviews \ Items Review Data Search PUB Inclusion Data Quality Integrated Hetero- PUB. Conflict Total design extraction strategy type Criteria table appraisal conclusion geneity bias interest Bardia et al., 2006 4.00 2.00 4.00 1.00 2.00 3.00 2.00 1.00 1.00 1.00 2.00 23.00 Bechtold et al., 2009* 3.00 4.00 4.00 1.00 2.00 3.00 2.00 1.00 3.00 3.00 1.00 27.00 Bradt et al., 2011* 4.00 4.00 4.00 3.00 4.00 4.00 4.00 1.00 2.00 2.00 3.00 35.00 Bradt et al., 2013* 4.00 4.00 4.00 4.00 4.00 3.00 4.00 2.00 3.00 3.00 3.00 38.00 Cepeda et al., 2006* 3.00 4.00 4.00 4.00 4.00 3.00 2.00 1.00 3.00 1.00 2.00 31.00 Engwall & Duppils, 2009 4.00 1.00 3.00 2.00 2.00 4.00 1.00 1.00 1.00 1.00 1.00 21.00 Hartling et al., 2009 3.00 4.00 4.00 3.00 2.00 3.00 2.00 1.00 1.00 1.00 3.00 27.00 Haslbeck, 2012 2.00 1.00 4.00 3.00 2.00 2.00 1.00 1.00 1.00 1.00 2.00 20.00 Klassen et al., 2008* 3.00 3.00 4.00 4.00 2.00 4.00 2.00 1.00 3.00 4.00 1.00 31.00 Lee, 2013 4.00 1.00 3.00 1.00 4.00 4.00 2.00 1.00 1.00 1.00 2.00 24.00 Nilsson, 2008 2.00 1.00 4.00 3.00 2.00 4.00 2.00 1.00 1.00 1.00 2.00 23.00 Tam, 2008* 3.00 4.00 4.00 3.00 4.00 3.00 2.00 1.00 3.00 4.00 1.00 32.00 Tsai et al., 2014* 4.00 4.00 4.00 4.00 3.00 4.00 2.00 1.00 3.00 4.00 3.00 36.00 Zhang et al., 2012* 3.00 4.00 3.00 1.00 2.00 4.00 4.00 1.00 1.00 1.00 2.00 26.00 Mean 3.29 2.93 3.79 2.64 2.79 3.43 2.29 1.07 1.93 2.00 2.00 28.14 SD 0.73 1.38 0.43 1.22 0.97 0.65 0.99 0.27 1.00 1.30 0.78 5.76 Note. * indicates meta-analysis; PUB: publication; see Appendix B for a detailed R-AMSTAR assessment items and criteria. Highlights indicate three highest mean scores, bold/underline means three lowest mean scores, bold/italics notes three highest standard deviations.
44
Table 5. Results of Included Systematic Reviews
Reviewer N of Studies / Age group Setting Pain types Pain outcome Other relevant outcomes & year Participants Bardia et al., 2006 N/A 3 / 64 Oncology Cancer not pooled, no benefit reported VS - effective but inconsistent. moderate effect, Bradt et al., 2011* All Age 5 / 391 Oncology Cancer Homogeneous for high quality moderate inconsistency studies in HR, DBP, SBP Tsai et al., 2014* All Age 6 / 455 Oncology Cancer moderate effect but inconsistent Zhang et al., 2012* All Age 10 / 887 Oncology Cancer moderate effect, inconsistent Engwall & Duppils, Adult 18 / 1,604 Surgical Postoperative not pooled, inconsistent 2009 Pre-,peri-, not pooled, 13/22 reported AR - not pooled, Nilsson, 2008 Adult, 17+yrs 22 / 2,422 Surgical post-operative benefit 5 of 7 reported less analgesic Diagnostic: Bechtold et al., 2009* Adult 8 / 712 Procedural no effect SR - no effect Colonoscopy Diagnostic: SR - moderate effect, Tam, 2008* 15-68 6 / 592 Procedural Colonoscopy substantial heterogeneity Haslbeck, 2012 Neonatal 4 / n/a Intensive care Procedural not pooled, may benefit Procedural Hartling et al., 2009 Neonatal 6 / 303 Neonatology not pooled, inconsistent AR - not pooled, no benefit & surgical Klassen et al., 2008* 1mo - 18yrs 5 / 465 Pediatric Procedural small effect, inconsistent Bradt et al., 2013* All Age 8 / 630 Cardiology Various moderate effect but inconsistent AR - no effect moderate effect - postop pain, Cepeda et al., 2006* All Age 51 / 3,663 General Various other types - small to large effect AR - small effect but inconsistent Lee, 2013 1mo to 18yrs 7 / 527 Pediatric Various not pooled, 5/7 reported benefit SP – one reported benefit Note. * indicates meta-analysis; AR: analgesic requirement; DBP: diastolic blood pressure; HR: heart rate; SBP: systolic blood pressure; SP: sedation process; SR: sedation requirement; VS: vital signs. 45
46
Cancer Pain
Four systematic reviews (Bardia et al., 2006; Bradt et al., 2011; Tsai et al., 2014;
Zhang et al., 2012) dealt with cancer pain in patients of all ages. Three of the reviews
included four identical trials in their analysis, but Bardia et al. (2006) did not review any
trials that were also analyzed in other systematic reviews. Without pooling data, Bardia
and colleagues reported two studies with no pain-reliving effect and one study with a
significant effect which provided music listening with positive suggestions (2006). They
added that the quality of the included studies was low with small sample sizes, and thus
concluded that more quality research was needed.
Initially, Bradt et al. (2011) did not find a positive effect, but when data were
analyzed with one study (Kwekkeboom, 2003) excluded, they found a moderate and
significant effect of music on pain for cancer patients (SMD = -0.59, 95%CI -0.92 to -
0.27, p = 0.0003). However, the heterogeneity test revealed a moderate inconsistency
between the five studies involving 391 participants (I² = 54%). Kwekkeboom’s study
(2003) which was excluded from the above analysis, had yielded an insignificant effect, negatively impacting the overall effect size when pooled. It was proposed that wearing headphones was not an effective method of alleviating anxiety and pain while undergoing a medical procedure (i.e., biopsy), because patients could not hear the surgeon’s instructions well, and it was making some of them even more anxious.
In addition, data from physiological measures (i.e., heart rate, respiration rate, diastolic and systolic blood pressure) were pooled as a secondary indicator of pain. The analysis revealed a moderate but inconsistent effect. By performing a sensitivity analysis 47
of high quality studies, they found a significant effect of music on heart rate (MD = -3.78,
95% CI -6.50 to -1.06, p = 0.007); systolic blood pressure (MD = -5.95, 95% CI -10.80 to -1.10, p = 0.02); and diastolic blood pressure (MD = - 4.28, 95% CI -7.14 to -1.42, p =
0.003).
Zhang et al. (2012) and Tsai (2014) conducted a similar meta-analysis on the subjective rating of cancer pain intensity, involving 887 and 455 participants; both studies found music to have a moderate and significant pain relieving effect (MD = -0.54,
95%CI -0.88 to -0.20, p <0.005) and (g = -0.656, 95%CI -1.016 to -0.295) respectively.
However, both studies were substantially heterogeneous (I² = 73% and 65%) indicating an inconsistent effect among trials.
Procedural Pain
Procedural pain was the most frequently reviewed area as seven systematic
reviews investigated this topic. However, these studies differed in their population of
interest, as two studies targeted neonates (Hartling et al., 2009; Haslbeck, 2012), one
children one month to 18-years-old (Klassen et al., 2008), and two studied adults
undergoing colonoscopy (Bechtold et al., 2009; Tam, 2008).
Of the two studies on colonoscopy, Tam et al. (2008) analyzed and pooled data
from six trials involving 592 participants, and found a statistically beneficial effect of music on sedation requirements (MD = -0.46, 95%CI -0.91 to -0.01, p = 0.05), although the result turned out to be largely heterogeneous (I² = 86%). Analgesic requirement was not an outcome of interest in this particular review. However, Bechtold et al. (2009) conducted a similar meta-analysis adding two more trials to the list used by Tam et al. 48
(2008), to examine both sedation and analgesic requirements. These authors pooled data from eight trials involving 712 participants, but did not detect any significant effect of music on pain levels, analgesic requirements or sedation amounts for patients undergoing colonoscopy, perhaps due to the ongoing issue of heterogeneity.
Two reviews (Hartling et al., 2009; Haslbeck, 2012) investigated the pain- reducing effect of music on premature babies without conducting a statistical analysis.
Hartling et al. (2009) reviewed music’s effects on procedural and surgical pain in six studies comprising 303 babies who underwent either a heel prick or circumcision. The results were highly inconsistent among studies with varying methodological quality, although some benefits were evident in heart rate, oxygen saturation and behavioral stress.
Similarly, Haslbeck (2012) summarized findings of four trials and reported a positive trend in the analgesic effect of music, as observed in improved oxygen saturation and decreased behavioral signs of stress.
Klassen et al.’s meta-analysis (2008) focused on the effect of music on pediatric procedural pain by surveying five studies which involved 465 participants; the authors found a small to moderate effect (SMD = -0.39, 95%CI -0.66 to -0.11, p = 0.03), but some heterogeneity was observed (I² = 52.4%).
Surgical Pain
Nilsson (2008) performed a comprehensive review of 42 RCTs implementing various music interventions; 22 of them (N = 2,422) investigated pain before, during and after surgery. Without pooling data, she reported that 13 of the 22 studies (59%) showed a statistically significant pain-relieving effect for music based on subjective ratings. 49
Likewise, seven of 15 studies (47%) that measured analgesia requirements during and
after surgery reported that the music group required a significantly smaller amount of
pain killers, although these findings show substantial heterogeneity.
A similar study by Engwall and Duppils (2009) focused on the effect of music on
postoperative pain in its review of 18 trials (N = 1,604). Without a statistical analysis, they reported that 15 of the studies reviewed (83%) showed significant results, and
concluded that music may have a positive effect on postoperative pain.
Various or Other Types of Pain
Bradt, Dileo and Potvin (2013) conducted a Cochrane review, a specialized
systematic review and meta-analysis managed by the Cochrane collaboration for
generating the highest quality medical evidence (Sauerland & Seiler, 2005), and
investigated the effect of music on patients with coronary heart disease. Data from eight
trials entailing 630 patients were pooled, and the results indicated a significant pain-
reducing benefit of music (SMD = -0.43, 95% CI -0.80 to -0.05, p = 0.03); however, the
effect was inconsistent to a great extent (I² = 81%). On the other hand, a sub-analysis of
trials (three studies, N = 210) that provided music interventions more than once, yielded a
small, but significant benefit (SMD = -0.27, 95% CI -0.55 to -0.00, p = 0.05) without an
indication of heterogeneity (I² = 0%).
This author conducted a systematic review investigating the effects of music on
various types of pain among pediatric patients (Lee, 2013), whereas Cepeda et al. (2006)
focused on all types of pain for patients of all ages. Without a statistical synthesis, I have
found that in five of the seven reviewed trials, the music group participants experienced 50
significantly lower levels of pain than those in the control group, both during medical procedures and after surgeries (Lee, 2013).
Cepeda et al. (2006) reviewed 51 trials (N = 1867) in their Cochrane review, concentrating solely on the effect of music on pain. Due to substantial heterogeneity, several sub-analyses focusing on different age groups, types of pain, choice of music were conducted. In spite of this effort, the effect of music on adult pain perception was significant, but remained heterogeneous (30 studies, MD = -0.46, 95%CI -0.75 to -0.17, p
= 0.002, I² = 85%). Interestingly, the group that did not have a choice of music experienced significantly less pain than the control group (12 studies, MD = -0.77,
95%CI -1.28 to -0.26, p = 0.003, I² = 88%), while the group with a choice did not. A significant and homogeneous effect was detected among patients experiencing acute pain following medical procedures or surgeries (11 studies, MD = -0.51, 95%CI -0.87 to -0.15,
p = 0.005, I² = 35%). For four studies that reported the number of participants who had at
least 50% pain relief, a separate analysis was conducted; this indicated that the music
group had a 70% higher chance of experiencing a reduction in pain than the control group
(RR = 1.7, 95%CI 1.21 to 2.37, p = 0.002, I² = 0%). Moreover, the authors noted a
significant reduction in morphine requirements for the music group measured at two
hours post-surgery (three studies, MD = -1.08, 95%CI -1.95 to -0.21, p = 0.01, I² = 0%),
and 24 hours after surgery (five studies, MD = 5.68, 95%CI -8.78 to -2.58, p = 0.0003, I²
= 0%).
51
Description of Music Interventions in Included Systematic Reviews
In order to systematically appraise clinical trials investigating the health benefits of music, it seems essential to fully and systematically assess the music interventions implemented; however, I found a large difference among the systematic reviews in this respect as shown in Table 6.
Table 6.
Descriptions of Music Interventions in Included Systematic Reviews
Reviewer Description of Field of Refer to Age group & year music intervention reviewer MM as MT Bardia et al., 2006 N/A no Medicine no
Bechtold et al., 2009* adult genre Medicine yes Bradt et al., 2011* all age genre, choice, equipment, MT no duration, frequency, Bradt et al., 2013* all age genre, choice, equipment MT no duration, frequency Cepeda et al., 2006* all age choice, equipment Medicine no Engwall & Duppils, 2009 adult genre, choice Nursing no Hartling et al., 2009 neonatal genre, duration, frequency Researcher no Haslbeck, 2012 neonatal overall summary MT no Klassen et al., 2008* 1mo to 18 yrs. genre, duration, frequency, equipment Researcher yes Lee, 2013 1mo to 18 yrs. genre, choice, frequency, duration, MT no equipment, protocol style, interventionist Nilsson, 2008 adult 17+ yrs. genre, choice, duration, frequency, Nursing yes equipment Tam, 2008* 15 - 68 yrs. genre Nursing unclear Tsai et al., 2014* all age genre, choice, frequency, duration, Nursing yes active or passive, interventionist, group/individual Zhang et al., 2012* all age duration, frequency, interventionist Researcher no
Note. * indicates meta-analysis; MM: music medicine; MT: music therapy;
In terms of the characteristics of interventions provided, the systematic reviews reported: musical genre (n = 10, e.g., classical, jazz, pop, etc.); choice of music (n = 7, 52
i.e., researcher-chosen, patient-chosen, patient-preferred genre or piece from provided
list); active or passive participation (n = 1); and group or individual session (n = 1). With
regard to the ‘dosage’ of music intervention, they reported: duration of exposure to music
(n = 8); and frequency of music interventions (n = 8). Details about delivery method were
also recorded: equipment used for music intervention (n = 6, i.e., use of headphones,
earphones, loudspeaker, CD player, mp3 player, etc.); and interventionist (n = 3, i.e.,
intervention provided by medical personnel or music therapist). In addition, one reviewer
tabulated protocol style (n = 1, i.e., individually tailored flexible protocol vs. standardized
universal protocol). Bardia et al. (2006) did not discuss the music interventions, whereas
Haslbeck (2012) provided an overall summary of interventions implemented in the
studies she reviewed.
Generally two types of professionals provide music interventions to patients: medical personnel (i.e., physicians, nurses, etc.) or trained music therapists. The distinctions between the two are delineated in the previous chapter, and their interventions are identified as music medicine and music therapy respectively. Of the 14 systematic reviews analyzed in this study, only four (Bechtold et al., 2009; Klassen et al.,
2008; Nilsson et al., 2008; Tsai et al., 2014) designated music medicine practice as
‘music therapy’ or used the terms ‘music,’ ‘music intervention’ or ‘music therapy interchangeably.’ Excluding systematic reviews conducted by music therapists (Bradt et al., 2011; Bradt et al., 2013; Haslbeck, 2012; Lee, 2013), two of the twelve reviewers
(Bardia et al., 2006; Zhang et al., 2012) explicitly distinguished the two types of music interventions using the terms ‘music medicine’ and ‘music therapy,’ and four of the 53
reviewers identified music medicine practice simply as ‘music’(Cepeda et al., 2006;
Engwall & Duppils, 2009; Hartling et al., 2009; Tam, 2008).
Implications for Current Dissertation
General Description and Overview
This review of systematic reviews examined 14 studies that investigated the pain-
relieving effect of music in various settings for patients of all ages suffering from
numerous types of pain. In terms of the classification of pain previously described, acute
pain has been studied in terms of procedural and surgical pain; many reviews involved cancer pain. However, it was apparent that chronic pain had not been addressed frequently and requires further research.
The AMSTAR checklist recommends the use of tables to provide detailed information on participants, interventions, and outcomes (Shea et al., 2007). Although most studies met this requirement, a few studies did not report the total number of participants, age groups, age range, mean age, or gender distribution. Thus, the checklist underscores the importance of fully describing and reporting the general characteristics of included trials.
Quality Appraisal
Included studies were mostly ‘moderate’ in quality. The outcome of the R-
AMSTAR elucidates the quality issues found in these systematic reviews. In general, most studies need to enhance their methodological standards in the areas of: data mining, considering all types of publications, clarifying inclusion/exclusion criteria,
implementing a standardized quality assessment tool, integrating findings in the 54
conclusions, testing heterogeneity and publication bias, and finally claiming potential conflicts of interests.
There seems to be some debate among reviewers and meta-analysts regarding certain methodological aspects of conducting systematic reviews. One is the issue of including or excluding qRCTs (quasi-randomized clinical trials). In this study, 10 reviewers indicated that they included RCTs (randomized controlled trials) only, whereas three researchers incorporated qRCTs in addition to RCTs. The reasons for including or excluding qRCTs vary, but many researchers seem to believe that inclusion of qRCT
studies threatens the integrity of systematic reviews because of increased risk of bias. A
Cochrane editorial article addresses this issue and explains why qRCTs need to be
considered (Lasserson, 2012).
According to Lasserson, the risk of bias from quasi-randomization remains high,
and one needs to be careful when integrating data. However, this issue often arises from
poor reporting, as many researchers indicate that ‘participants were randomized’ without
describing the full process. Thus, an automatic exclusion of qRCTs might mean
excluding fully-reported high quality studies, while including RCTs that are poorly
reported and low in quality (Lasserson, 2012). Therefore, he suggests the inclusion of
both RCTs and qRCTs with rigorous quality appraisal and sensitivity analysis based on
the randomization method.
Another large inconsistency was found in the quality assessment tools used by
included reviews. As shown in Table 2, five systematic reviews implemented tools that
were uncommon, self-devised or created for another review. Based on the majority of the 55
studies, the general consensus appears to be that the Jadad (1996) or Cochrane Risk of
Bias tools (Higgins & Green, 2011) are the most appropriate. Due to the fact that the
Jadad scale does not take allocation concealment into consideration, some studies use a
separate tool, such as Schulz and colleague’s (1995) approach to allocation concealment
(Hartling et al., 2009), although there were no reviews in this study that incorporated this.
Nevertheless, a study comparing the Cochrane Risk of Bias tools, Jadad, and Shulz’s approach found that these tools show a low agreement between the tests, and recommended that reviewers implement quality assessment tools with care and ample training (Hartling et al., 2009).
One last issue to consider is the use of grey literature. In this study, only five authors (Bradt et al., 2011; Bradt et al., 2013; Klassen et al., 2008; Lee, 2013; Tam, 2008) included or attempted to retrieve grey or unpublished literature. Authors appear to have different rationales supporting or opposing the idea of including grey literature in their reviews. Some fear low internal validity or high risk of bias and exclude them, whereas
others cautiously include them to avoid selection or publication bias. Both AMSTAR
(Shea et al., 2007) and the Cochrane collaboration (Higgins & Green, 2011) recommend
consideration of grey literature in order to conduct effective systematic reviews,
consequently reviewers will need to incorporate them while implementing a strict method
of quality appraisal.
Focus on Music Intervention
As illustrated previously, the systematic reviews included in this study described
music interventions in a highly inconsistent manner, making it difficult to synthesize 56 findings. This certainly is not the only problem of systematic reviews. A number of trials
I reviewed previously (Lee, 2013), omitted much information about music interventions in their reports, making it impossible to generate a comprehensive table without too much missing data. Robb, Burns and Carpenter (2011) proposed a comprehensive guideline for reporting music based interventions. Their list not only covers all the information accumulated in this review, but also adds characteristics such as ‘intervention theory’ and
‘treatment fidelity;’ following such guidelines is likely to help reviewers investigate the issue of heterogeneity more effectively and improve the quality of music medicine and music therapy research. Nevertheless, when essential information is missing from research studies, one should attempt to contact authors to gather as much missing data as possible; this is considered an essential step in conducting high quality systematic reviews (Shea et al., 2007).
Sub-analysis for Further Exploration
As seen in many meta-analyses in this study, heterogeneity has been a major issue preventing researchers from drawing a sound, evidence-based conclusion. In an effort to identify and minimize heterogeneity and also to gain a better understanding of existing data, sub-analyses have been run based on age groups, types of pain, choice of music, and frequency of interventions (Bradt et al., 2011; Cepeda et al., 2006). In addition to continuing this investigation, if a sufficient number of trials can be pooled, further analysis can be performed featuring: benefit of music therapy vs. music medicine (Dileo,
2006); effects of different genres of music (e.g., classical, jazz, new-age); impact of stimulative vs. sedative music (i.e., distractive vs. anxiolytic music); comparison of 57
equipment used (i.e., headphones vs. loudspeakers); level of alertness during procedures; duration of exposure to music prior to procedures; and secondary measurement of pain,
such as vital signs.
The Rationale for the Present Dissertation
From the current review of systematic reviews and meta-analyses, it has been
observed that the most recent meta-analysis solely devoted to the effects of music on pain
was conducted by Cepeda et al. (2006) which included trials published between the years
1986 and 2003. Thus, a new, full systematic review is timely because a number of
clinical trials have been added to the literature during the last decade. Furthermore,
Cepeda et al. (2006) pooled trials without distinguishing between music medicine and
music therapy; this, presents numerous heterogeneity issues due to the fundamental
differences in the role of music, the interventionist, and catalyst for change. Consequently,
a subsequent comprehensive systematic review is vital in an attempt to synthesize the
current literature and resolve these heterogeneity issues.
I could not locate systematic reviews focusing on chronic pain or specific areas
such as hospice, labor and delivery or dental procedures for this review. Likewise,
reviews involving neonatal and pediatric patients were relatively scarce compared to
other areas. Moreover, only a few reviews examined the effect of music on analgesic use.
Therefore, a more up-to-date, comprehensive review is needed entailing all populations
across different settings and age groups.
In addition, the heterogeneous results found in various meta-analyses warrant the
need for a further investigation of the source of heterogeneity. Because music 58 interventions are one of the frequently suspected sources of inconsistencies, a comprehensive analysis and sub-analysis, according to various musical variables, may yield different insights and understandings of the existing data.
Research Questions for Current Study
The primary focus of this study is to answer the following questions:
1. How effective is music in reducing pain for patients of all ages and populations
when compared to standard care?
2. How effective is music in reducing analgesic use when compared to standard care?
3. How effective is music in alleviating pain as measured by lowered vital signs (i.e.,
heart rate, respiration rate, and systolic and diastolic blood pressure) when
compared to standard care?
4. Is there a difference between the effectiveness of music medicine and music
therapy in reducing pain, analgesic use and vital signs when compared to
standard care?
5. As moderator variables, how influential are pain subtypes (i.e., procedural, acute,
chronic, cancer pain), patient-characteristics (e.g., age, gender, race, etc.), and
intervention-characteristics (e.g., genre, style, choice, dosage, delivery, timing,
etc.) on the effectiveness of music in reducing pain, analgesic use, and vital signs
when compared to standard care?
59
CHAPTER 3
METHOD
Inclusion Criteria
Types of Studies
Studies included in this review were limited to randomized controlled trials (RCT)
published between 1995 and 2014 in English, German, Korean and Japanese. Articles in
these languages were included as I am fluent in English and Korean, and I have two
colleagues fluent in the other two languages. In general, with the development of research
guidelines, starting with the Standardized Reporting of Trials (SORT) statement in 1995,
clinical trials from more recent years are considered higher quality in their methodology
and reporting style (Tsai et al., 2014). Consequently, studies from the past two decades
were chosen as an effort to reduce the heterogeneities found in the previous meta-
analyses. Unpublished grey literature was also sought out if the study met the inclusion
criteria. All search strategies used are described below.
Types of Participants
Because of the large difference in the scope of practice and issues, studies involving musicians who sustained neurological or musculoskeletal injuries from playing instruments were excluded from this study. There were no age restrictions on participants, or in type of medical procedure. There were no other limitations in regards to gender, ethnicity, types of pain, or medication use.
60
Types of Interventions
As delineated in the first chapter, this review intended to survey all music therapy
and music medicine studies that incorporated a standard care group. However, I
eliminated studies that combined two or more approaches (e.g., music and video,
progressive muscle relaxation, massage, or nature sounds), or studies that employed non-
standard care groups as comparison groups, specifically comparison groups that received
another form of intervention such as imagery or audiobooks. Music medicine studies that
fell outside of the usual practice, such as those that used live musicians, directed/guided
imagery techniques or vibroacoustic equipment were excluded. These exclusion criteria
were developed to minimize heterogeneity caused by differences in interventions.
Types of Outcome Measures
The main outcome was participants’ self-reported level of pain, measured by validated visual analog scales (VAS), faces scales, numerical rating scales (NRS), and other validated pain scales or questionnaires (e.g., the McGill pain questionnaire). In addition, pain or distress data measured by validated observational tools (e.g.,
Observational Scale of Behavioral Distress–Revised (Elliott, Jay, & Woody, 1987)) were included. Assessment tools were considered validated if there was at least one published article in a peer reviewed journal supporting the reliability and validity of the tool. The secondary outcomes were physiological measures, such as heart rate, systolic blood pressure, diastolic blood pressure and respiration, and amount of anesthetic and opioid intake.
61
Search Methods for Identification of Studies
Database Search
I consulted two university reference librarians to develop a strategy for a
comprehensive database search. In addition, search steps developed in previous systematic reviews and meta-analyses were cross-checked to ensure a thorough search.
During the first three weeks of December, 2014, I conducted electronic searches using
the following databases: Academic OneFile, Academic Search Premier, CINAHL, Global
Health, Google Scholar, Healthstar, Medline, ProQuest Digital Dissertations, PsycINFO,
RILM Abstracts of Music Literature, RISS International (Korean DB), Web of Science.
The search strategies used for each search are listed in Appendix M.
Additional Search
The following music therapy and related journals were hand-searched: Australian
Journal of Music Therapy (1995-2014), British Journal of Music Therapy (1995-2014),
Canadian Journal of Music Therapy (2004-2014), Japanese Music Therapy Association
Journal (2001-2013), Journal of Music and Human Behaviors (Korea, 2004-2014),
Journal of Music Therapy (1995-2014), Korean Music Therapy Association Journal
(1999-2014), Music and Medicine (2009-2014), Music Therapy Perspectives (1995-2014),
New Zealand Journal of Music Therapy (1995-2014), Nordic Journal of Music Therapy
(1995-2014), Voices: World Forum for Music Therapy (2001-2014). I also cross-checked reference lists of all included clinical trials, systematic reviews and meta-analyses, as well as Google Scholar and available online conference proceedings in order to locate unpublished grey literature, on-going studies and studies that are not catalogued 62 electronically. Lastly, I contacted directors of eighteen Ph.D. music therapy programs worldwide to inquire if they were aware of any unpublished or yet-to-be published controlled trials on this topic.
Data Collection and Analysis
Study Selection
First, I examined titles, keywords and abstracts of identified articles to eliminate irrelevant studies. Then, full texts were inspected to check against the inclusion and exclusion criteria. When I encountered studies that were questionable as to whether they met the inclusion criteria, I contacted my research advisor to discuss the details and clarify issues before making a final decision.
Data Extraction
I modified the data extraction form used by Bradt, Magee, Dileo, Wheeler, and
McGilloway (2010) and converted it into a Microsoft Excel™ file to extract data from selected articles. The form captured: (1) general information, (2) research design, (3) participant characteristics, (4) methodological quality, (5) outcome measures, (6) statistical data, and (7) details about type and nature of music interventions. I used only the information reported originally in the research article or dissertation extracting and analyzing data; I did not attempt to obtain missing data from the author(s) because of time limitations.
Outcomes
Statistical data extracted from each study included sample sizes, and means and
standard deviations for both treatment and control groups. If only the mean and standard 63 deviation of change scores from pretest to posttest were available, it was noted, and data were extracted in the same manner. For studies that use wait-list control group or crossover design, scores from the first phase of the clinical trial were extracted.
Assessment of Study Quality and Risk of Bias
I evaluated the quality of each study according to the Cochrane Handbook for
Systematic Reviews of Interventions (Higgins & Green, 2011). Specific areas assessed for quality and bias appraisal were: (1) randomization, (2) allocation concealment, (3) blinding of research personnel who administer music or music therapy intervention, (4) blinding of study participants indicated as ‘subjective assessors,’ (5) blinding of objective outcome assessors, (6) intention to treat analysis, (7) selective reporting, and (8) other sources of bias. Each area was rated as ‘low,’ ‘unclear’ or ‘high risk of bias’ according to the criteria specified below.
Randomization
If a method of group allocation ensured that every participant had an equal chance of being selected for either group with no chance for the researcher to predict the result, it was rated as ‘low bias’ (e.g., coin flipping, drawing of lots, computer-generated number list, or table of random numbers). It was rated as ‘unclear’ if the researcher did not specify or discuss the process of group allocation. If a study used a quasi-randomization or systematic method of allocating participants such as by alternation, date of birth or medical record number, it was excluded from the meta-analysis.
64
Allocation Concealment
If the research staff responsible for recruitment and group allocation is aware of the result of allocation before or during the recruitment process, it may influence the consent decision or group assignment (Higgins & Green, 2011). Therefore, allocation concealment was rated as ‘low risk of bias’ if appropriate methods of concealing the information, such as serially-numbered, opaque sealed envelopes, or central randomization were used. If authors did not discuss the recruitment or allocation process in detail, it was rated as ‘unclear.’ If a researcher could predict the allocation results prior to group assignment, it was rated as ‘high bias.’
Blinding of Research Personnel
For this item, I evaluated if the research personnel providing music intervention or music equipment were blinded to the group allocation. It is impossible for music therapists to be blinded to the treatment condition, so all music therapy studies were rated as ‘high bias’ for this item. Some music medicine studies used blank CDs and headphones for the control group, in order to achieve the blinding of research staff.
Studies were rated ‘unclear’ if the authors did not discuss the process in detail.
Blinding of Subjective Outcome Assessors
Blinding outcome assessors can ensure objectivity of data, yet it cannot be achieved when participants discover their group allocation by listening to music or participating in a music therapy experience. Thus, most participants in the experimental group were aware of their group allocation factor unless music was introduced when the participants were under general anesthesia. Because of this limitation, most studies that 65 use subjective data (e.g., participant’s reported level of pain or distress) were rated as
‘high bias.’ If studies did not report the use of subjective outcome measures, they were rated as ‘low bias.’
Blinding of Objective Outcome Assessors
Studies that used independent outcome assessors for data collection could achieve this blinding by carefully controlling the time and place of assessments, or by utilizing blank CDs and headphones for music medicine studies. Blinding was rated as ‘unclear’ if detailed information about the steps of data collection were omitted or unavailable.
Intention-to-treat Analysis
For this item, I examined if each study reported the attrition rate with corresponding reason for dropouts. If the attrition rate was less than 20% and reasons for dropouts were similar for both groups, it was rated as ‘low bias.’ When either one of these conditions was not met, it was rated ‘high bias.’ If attrition was not reported or the information was not unavailable, it was rated as ‘unclear.’
Selective Reporting
Selective reporting was indicated when studies failed to clearly report data for all intended outcomes. Thus, I compared outcomes listed in the method section with data reported in the result section for each study. If all statistical data, such as means, standard deviations, and/or levels of significance were clearly stated for all intended outcomes, it was rated as ‘low bias.’ If the result was discussed briefly, indicative only of the significance level, it was considered ‘unclear.’ When authors omit results of one or more outcomes, it was rated as having a ‘high risk of bias.’ 66
Other Sources of Bias
This item examined if there were any indications of financial or other conflicts of
interests. Generally, I rated this as ‘low’ if authors indicated a funding source which had
no foreseeable financial-interest in the research outcome or declared no conflict of
interest in their report. It was rated ‘unclear’ if no statements about the funding source or
conflict of interest were found.
Risk of Bias Table with Support for Judgment
A risk of bias table for each study with corresponding reasons for each appraisal
was created (see Appendix K). These tables include a section called support for judgment, which lists direct quotes from each study that led to each decision. When clarification was necessary for certain studies, I conferred with my research advisor to verify the accuracy of quality assessments.
Measures of Treatment Effect
All outcome data were processed as continuous variables to calculate the standardized mean differences (SMD) or mean differences (MD) with 95% confidence intervals. SMD is used when outcomes from various scales are combined, whereas MD is calculated to present outcomes that utilize an identical assessment tool (e.g., 0-10 numeric rating scales, vital signs).
Management of Missing Data
If essential data needed for meta-analysis (e.g., means and standard deviations) were missing, I excluded those studies without attempting to impute missing outcomes.
67
Assessment of Heterogeneity
The study used I² statistics to evaluate heterogeneity among pooled data. This is a
statistical tool for reporting heterogeneity by estimating the percentage of total variation
across trials (Higgins & Thompson, 2002). Interpretation of the results are conducted
based on the guidelines proposed by Higgins and Thompson, which indicate that
percentages roughly around 25%, 50%, and 75% can be considered ‘low,’ ‘medium’ and
‘high’ heterogeneity respectively (2002). In addition, forest plots were visually inspected
to identify and explore significant outliers.
Assessment of Reporting Biases
Publication bias was examined by visually inspecting a funnel plot generated
from 0-10 pain intensity scales. The potential reporting bias was assessed using the
guidelines presented by Sauerland and Seiler (2005).
Data Synthesis
I used the Review Manager (RevMan 5.3.3) to process the statistical data from all included studies. As indicated earlier, it was anticipated that some studies would only report change scores from pretest to posttests. According to the Cochrane Handbook, one
may pool means and mean change scores together under one analysis, if mean difference
(MD) is used to run pooled-estimates in place of standardized mean difference (SMD)
(Higgins & Green, 2011). One limitation of using the mean difference is that all included studies must use the identical assessment tool, thus only the change scores derived from
commonly used measurement tools were included in the final meta-analysis. Because
heterogeneity is anticipated from observation of previous meta-analyses, I used the more 68 conservative random-effect model to calculate the pooled estimates while examining heterogeneity with the I² statistics (Higgins & Thompson, 2002).
Moderator Analysis
Moderators are factors that cause variability in effect sizes. Variability can occur from differences in characteristics of participants, treatments, study designs, and many other aspects of clinical trials (Littell et al., 2008). One way of conducting a moderator analysis is by running subgroup analyses between studies with and without certain characteristics that are predetermined as potential moderators.
For this study, predetermined moderators were intervention types (i.e., music therapy vs. music medicine); age groups; pain types (i.e., acute, procedural, & chronic / cancer); levels of choice in selection of music in MM studies (i.e., researcher-chosen, participant-preferred, and participant-chosen music); and intervention styles among MT studies (i.e., passive engagement vs. active engagement). Although not predetermined, I added one additional analysis on the presence/absence of rationale for music selection in
MM studies. This decision was made based on my observations during data analysis and also recommendation by Robb and colleagues (2011).
In order to minimize heterogeneous results found in previous meta-analyses, additional analyses were conducted on methodological moderators (i.e., randomization method, allocation concealment, and blinding of outcome assessors). The first analysis compared studies that utilized both clear randomization method and allocation concealment with studies that met only one or neither criteria. The second analysis examined studies that did or did not blind their objective assessor in their observational 69 assessment of pain. When necessary, sensitivity analysis was performed by removing outliers to test if a single study influenced the overall effect size or heterogeneity. All results from the above analyses are listed in the following results section.
70
CHAPTER 4
RESULTS
Description of Studies
Results of the Search
The electronic search of 12 databases yielded 11,323 citations. After reviewing titles and abstracts, 10,966 irrelevant or duplicate titles were removed and 357 articles remained. An additional 16 articles were identified by cross-checking reference lists of
all relevant systematic reviews and meta-analyses, hand-searching 12 music therapy-
related journals, and by contacting directors of 18 Ph.D. music therapy programs worldwide. In all, I retrieved and reviewed a total of 357 studies, and excluded 256 studies based on the inclusion and exclusion criteria specified in the previous chapter.
Figure 3 illustrates the process of study selection, and the list of excluded studies and reasons for their removal can be found in Appendix C.
As a result, 101 articles were included in this meta-analysis consisting of ninety music medicine and eleven music therapy studies. Of the 101 articles, seven published in peer-reviewed journals were based on the first author’s doctoral dissertation (Allred,
Byers, & Sole, 2010; Binns-Turner, Wilson, Pryor, Boyd, & Prickett, 2011; Broscious,
1999; Ghetti, 2013; Huang, Good, & Zauszniewski, 2010; Phumdoung & Good, 2003;
Siedlecki & Good, 2006). Thus, I obtained data from both their dissertations and peer- reviewed journal articles, but did not count them twice. This brought the number of included studies to 84 for music medicine and 10 for music therapy. On the other hand,
two music medicine articles reported two separate clinical trials each (Koch, Kain, Ayoub, 71
& Rosenbaum, 1998; MacDonald, Mitchell, Serpell, Davies, & Ashley, 2003), increasing the number of included MM studies to 86. Lastly, because Schou (2008) compared three groups comprised of a music therapy, a music medicine and a standard care group, I entered them separately, once as music therapy vs. standard care and again as music medicine vs. standard care, with corresponding group data as separate clinical trials.
Therefore, the final number of studies analyzed for this meta-analysis was 97; 87 for music medicine and 10 for music therapy, and the total number of participants involved in these studies was 9,212. The actual number of participants analyzed varies according to the type of intervention and outcomes. More detailed information can be found later in this section under each outcome evaluation.
Characteristics of Included Studies
General Characteristics
The final sample consisted of 69 2-arm parallel, 19 3-arm parallel, five 4-arm parallel, and three randomized crossover RCTs. The studies were conducted all over the world, but most frequently in Asia, Europe and North America. Only a few studies were from Africa, the Middle East and South America. Table 7 lists all the countries and regions for the included studies. Ninety trials were reported in English, whereas six were in Korean (Hyun et al., 2004; Jeon, 2004; Kim & Kim, 2009; Kim & Kim, 2010; Kim et al., 2004; Seo & Hong, 2010). None of the retrieved articles in German or Japanese language met the inclusion criteria.
72
Figure 3. Flowchart of Study Selection Process
# of records identified through Excluded = 10,965 database searching = 11,323 Duplicates = 548 CINAHL = 792 Irrelevant/ PsyINFO = 887 no RCT = 10,397 Academic OneFile = 1,828 In untranslatable Academic Search Premier = 664 foreign language = 20 Medline = 1,018 ProQuest = 782 HealthStar = 1,072 # of additional records GlobalHealth = 61 Identified through RILM = 1,487 other sources = 16 Web of Science = 1,544 Reference lists = 14 Google Scholar = 1,001 Hand-searching = 1 RISS International = 187 Ph.D. directors = 1
Excluded = 257 Atypical intervention = 39 Full papers reviewed = 358 Foreign language = 5 Full text unavailable = 5 Insufficient data = 38 Not RCT = 73 No pure control group = 22 Included articles = 94(7) Participants not relevant = 17 Music medicine = 84(6) Quasi-RCT = 25 Music therapy = 10(1) Secondary analysis = 4 (additional articles of same trials) Unrelated outcome = 29
Table 7. Region and Country of Included Trials Region # of studies Country Africa 1 Egypt Asia 27 China & Hong Kong SAR, India, Japan, Malaysia, South Korea, Taiwan, Thailand, Vietnam Europe 24 Denmark, Finland, France, Greece, Iceland, Italy, Scotland, Sweden, Turkey, UK
Middle East 6 Iran, Israel North America 37 Canada, USA South America 1 Colombia 73
Characteristics of Participants
The trials ranged in sample sizes from 25 to 617 with a mean sample size of 95.96
(SD = 79.72) and a median of 66.5. Studies were conducted with participants receiving medical care within 20 different medical specialties as listed in Table 8. Fifty studies targeted acute pain, whereas 34 investigated procedural pain. Only 12 studies focused on cancer or chronic pain. Eighty-eight studies involved adult patients, but only eight trials involved children. Of the 88 studies, one trial also included adolescents over 15 years
(Jose, Verma, & Arora, 2012), and two studies solely focused on the elderly population
(Masuda, Miyamoto, & Shimizu, 2005; Ottaviani, Bernard, Bardin, & Richette, 2012).
The eight studies involving children included studies targeting newborn babies (Zhu et al.,
2014) and adolescents (Kristjánsdóttir & Kristjánsdóttir, 2011). Based on reported information from 81 studies, the mean age was 48.37 for the adults and 9.36 for the children.
Table 9 illustrates different populations and settings according to types of pain and music intervention. The data indicate that RCTs on pain from both music medicine and music therapy concentrated heavily on adult inpatient settings. In terms of specific types of pain under investigation, more music medicine studies focused on acute pain, whereas music therapy studies investigated cancer pain more than other types
(Fredenburg & Silverman, 2014; Gutgsell et al., 2013; Kim & Kim, 2009; Kim & Kim,
2010).
74
Table 8. Medical Specializations & Settings of Included Studies
Specialization Inpatient Outpatient Total Cardiology 10212 Dentistry 22 Emergency Medicine 3 3 Gastroenterology 55 General medicine 2 1 3 General surgery 8210 Hospice 3 3 Intensive care 1 1 Neonatology 1 1 Nephrology 22 Neurology 123 OBGYN 15 5 20 Oncology 8210 Oriental Medicine 1 1 Orthopedic 6 1 7 Pain clinic 1 1 Pediatric 1 1 Radiology 112 Rehabilitation 1 1 Urology 358 Total 59 37 96
Table 9. Interventions by Types of Pain, Age Groups & Settings Adults Children Interventions / pain types Total Inpatient Outpatient Inpatient Outpatient Music Medicine 50 30 2 4 86 Acute pain 40 7 47 (55%) Cancer/Chronic pain 5 2 7 (8%) Procedural pain 5 21 2 4 32 (37%) Music Therapy 6 2 1 1 10 Acute pain 2 1 3 (30%) Cancer/Chronic pain 4 1 5 (50%) Procedural pain 1 1 2 (20%) Total 56 32 3 5 96 75
A total of sixty one studies reported the gender of participants; these included
53.8% male overall with 49.9% male participants for the adult group and 57.7% male for the children’s group. The gender distribution was similar for MM and MT groups. About half (56.8%) of the studies conducted in North America reported the ethnicity of their participants; 19 of these studies reported the mean number of Caucasians as 76.98%, with a range from 40 to 100%. However, 70% of the participants were African-Americans in a study by Simcock and colleagues (2008), and in another study, 85.6% were Hispanic
(Guerrero, Castano, Schmidt, Rosario, & Westhoff, 2012). Ethnicity was not reported in studies conducted in other regions. Because most studies had ‘language proficiency’ as one of their inclusion criteria for participation, it could be inferred that participants were ethnically homogeneous, particularly among studies conducted in Africa, Asia, and the
Middle East. Appendix D lists characteristics of participants in all included studies.
Outcome Measures
A total of 75 studies (78%) relied upon participants’ own rating of pain intensity using 0-10 scales such as Visual Analog Scales (VAS), Faces Scales (FS), Numeric
Rating Scales (NRS), and Verbal Rating Scales (VRS). Other subjective tools included the Magill Pain Questionnaire (MPQ), visual analog scale of emotional distress from pain
(VAS-Distress), and Brief pain inventory (BPI). Five studies employed objective assessments of pain using validated tools, such as CAMPIS-R: Child-adult medical procedure interaction scale-Revised (Yinger, 2012); CHEOPS: Children's Hospital of
Eastern Ontario Pain Scale (Yu, Liu, Li, & Ma, 2009); FLACC: Face, Legs, Activity, Cry,
Consolability Scale (Gutgsell et al., 2013); NIPS: Neonatal infant pain scale (Zhu et al., 76
2014); and OSBD-R: observational scale of behavioral distress–revised (Hartling et al.,
2013).
The secondary outcomes of pain were physiological measures, including heart
rate, respiration rate, mean arterial blood pressure, systolic blood pressure, and diastolic
blood pressure. A number of studies also investigated analgesic intake during or after
medical or surgical procedures. These were categorized as anesthetics (i.e., Propofol,
Isoflurane & Sevoflurane), opioids (i.e., Alfentanil, Fentanyl, Meperidine, Morphine &
Tramadol), non-opioids (i.e., Acetaminophen & Diclofenac), and sedatives (Midazolam
& Versed). General characteristics and outcome measures of all included studies are tabulated and presented in Appendix E and F.
Intervention Characteristics of Music Medicine Studies
As described previously, there were 87 randomized clinical trials that investigated the impact of music medicine on various types of pain. Fifty-five studies (63%) prepared lists of music from which the participants chose specific songs, a style, instrument type or genre of music that they preferred. In this meta-analysis, this type of music selection was identified as ‘participant-preferred’ (PP). Genres of music commonly provided were classical, easy listening, new age, slow jazz and soft rock. Other genres of music offered, although not as frequent, were folk, rock, disco, inspirational, religious, Caribbean, country western, sound tracks, blues, swing, country, Celtic, reggae, hip-hop, alternative, top ten, and soul music. Some selections were based on the participants’ preference for certain instruments, including piano, harp, orchestral, synthesizer, acoustic, flute, violin, and other ethnic instruments, such as reed flute or bamboo flute. Sometimes, religious 77 music was offered, including gospel, hymns, Buddhist hymns and devotional songs. Also, specific ethnic music was offered, including Chinese classical, Spanish, Malay,
Taiwanese, Korean country, Korean art, K-pop, Hindi, Cazab, traditional Japanese
(Gagaku, Noh songs & Enka), traditional Vietnamese, Greek folk, Turkish art, folk & classical, and Israeli music. Lastly, meditative music, nature sounds combined with music, and specially composed relaxation music (e.g., Musicure) were also used.
Ten clinical trials utilized procedures wherein participants were asked to bring their own music (Ayoub, Rizk, Yaacoub, Gaal, & Kain, 2005; Ebneshahidi & Mohseni,
2008; Koch et al., 1998, Trial 1 & 2; Kulkarni, Johnson, Kettles, & Kasthuri, 2012;
MacDonald et al., 2003, Trial 1; Şen, Ateş et al., 2009; Şen, Sizlan et al., 2009; Simcock et al., 2008); this was classified as ‘participant-chosen’ music (PC) in this analysis. Due to vast differences in musical tastes, participants brought a wide variety of music; however Macdonald and colleagues reported that about 70% of the participants in their experimental group selected popular music (2003). Other studies did not describe the type of music participants selected for themselves.
Twenty-two trials (25%) used researcher-chosen (RC) music in which participants listened to particular pieces of music selected by their researchers. Among them, six studies listed the specific pieces of music that they utilized (Beaulieu-Boire et al., 2013;
Bechtold, Perez, Puli, & Marshall, 2006; Blankfield, Zyzanski, Flocke, Alemagno, &
Scheurman, 1995; Hartling et al., 2013; Nagata et al., 2014; Zhu et al., 2014), whereas 11 studies only provided the style or genre of music that they used. Four studies did not specify or describe their choice of music (Laurion & Fetzer, 2003; Ottaviani et al., 2012; 78
Press et al., 2003; Sen et al., 2010). The duration of music listening was highly variable
among trials. Based on the data from 63 studies, the mean duration of the music
intervention was 37.8 minutes (SD = 28.5), with a range from one minute to 180 minutes
and mode of 30 minutes.
Robb et al. (2011) urged researchers to specify rationales for their selection and
application of music when reporting music-based interventions. In addition, these authors
stressed the importance of explaining the qualities of the music and delivery method with
the anticipated outcomes in mind. From my review of the included studies, I found that
many studies omitted essential information about the music interventions used. Among
MM studies, 72 trials (82.8%) did not report the specific music they used, 20 studies
(23%) did not indicate the duration of their music intervention, nine studies left out all
information about their music, and six studies did not explain the equipment used to
deliver music (i.e., headphones or speakers).
In order to assess whether included studies provided selection criteria or a
rationale for their choice of music or music intervention, I examined and recorded whether the researchers cited published works or clinical trials as a basis or rationale for their music selection; consulted music therapists, researchers, or professional musicians;
or specified two or more aspects of musical criteria that they considered in terms of
tempo, style, harmony, rhythm, instrumentation, range, and whether or not it had vocal
parts. Upon classification, I found that 26 studies (30%) described the musical criteria
that they adopted, 21 trials (24%) took recommendations from the published literature,
and 13 studies consulted experts in the area. Thirty-seven trials (42.5%) implemented at 79 least one of the three methods when developing their MM intervention, whereas three studies utilized all three (Chiang, 2012; Jafari, Emami Zeydi, Khani, Esmaeili, &
Soleimani, 2012; Schou, 2008). Characteristics of music interventions are tabulated and presented in Appendices G and H.
Even though the scope and nature of practice between MM and MT interventions are very different, MM studies have used a variety of terms in describing their interventions. When I analyzed what MM studies called their interventions, I found that
51 studies (58.6%) used terms such as ‘music,’ ‘music listening’ or ‘music intervention,’ and 12 authors referred to their MM intervention as ‘music therapy.’ The latter group of authors used both terms, MM and MT, interchangeably. As shown on Table 10, I discovered that music medicine was most poorly differentiated from music therapy among studies in Asia.
Table 10. Titles Used to Describe MM in Different Regions Music, listening, Both terms Music Regions Total or intervention interchangeably Therapy Africa 1 1 Asia 11 14 9 34 Europe 12 2 1 15 Middle East 3 3 6 North America 23 5 2 30 South America 1 1 51 24 12 Total 87 (58.6%) (27.6%) (13.8%)
To investigate a potential trend in titles of MM interventions over time, I categorized different terminologies used according to different time frames in Table 11. 80
This table shows that the use of the term, ‘music therapy,’ to describe MM practice has
appeared more frequently in the recent five years among studies conducted in Asian
countries. On the other hand, a trend can be noticed in how researchers in other regions have differentiated MM and MT more accurately as time progressed. Details of intervention characteristics of MM studies are tabulated and included in Appendix G.
Table 11. Titles Used to Describe MM in Different Regions According to Four Time Frames
1995~1999 2000~2004 2005~2009 2010~2014 Regions MI IC MT MI IC MT MI IC MT MI IC MT Africa 1 Asia 1 2 3 3 5 1 5 6 8 Europe 4 1 2 1 6 1 Middle East 1 1 1 1 2 North America 8 1 3 2 2 7 1 5 1 South America 1 Note. MI: music or music interventions; IC: both terms interchangeably; MT: music therapy
Intervention Characteristics of Music Therapy Studies
There were ten music therapy clinical trials included in this meta-analysis. Two
studies conducted by the same researchers (Kim & Kim, 2009; Kim & Kim, 2010) investigated the effect of a single group music therapy session on pain, whereas the others examined the impact of individual MT sessions. In terms of the levels of participants’ music involvement, five studies (Bradt, 2001; Ghetti, 2013; Ghetti, 2011b;
Kim & Kim, 2009; Yinger, 2012) included a more active style of engagement by providing recreative and creative methods, whereas four trials (Clark et al., 2006; 81
Fredenburg & Silverman, 2014; Gutgsell et al., 2013; Schou, 2008) used sessions involving receptive methods with passive participation. One study by Kim and Kim
(2010) compared the two types of approaches by conducting two separate MT groups: one with a receptive approach and the other with a singing-centered recreative approach.
Most studies provided one single MT session, but three studies (Bradt, 2001;
Clark et al., 2006; Schou, 2008) implemented slightly different formats. Bradt (2001) randomized the sequence of two MT and one standard-care session, and reported results from every phase. Only the post-test data from the first MT session was used for this meta-analysis. Clark (2006) offered a 45-60 minute psycho-educational session described as an ‘interview’ wherein the therapist assessed the client’s musical preference, educated participants on relaxation techniques, and provided a personalized music program. The frequency and duration of listening to music after that was different for each individual participant. Schou (2008) facilitated guided relaxation with music and imagery for patients undergoing cardiac surgery once before and 2-4 times after the surgery. For this analysis, I extracted data from the post-test of the first session following heart surgery.
More information about the MT interventions can be found in Appendix H.
Results of Risk of Bias Assessment
Randomization
To determine this, I assessed whether the included studies clearly described the method of random allocation. Upon assessment, I found that 68 trials implemented a proper method, whereas 28 studies (29%) did not.
82
Allocation Concealment
The results of group allocation were properly concealed to the recruiter and participants until all informed consents were obtained in 26 studies (27%), but not in three studies (3.2%). The rest of the studies (69.8%) did not mention allocation concealment procedures.
Blinding Interventionist
Blinding the researcher was not possible and/or not described in most studies
(94.8%), but it was adequately performed in five MM studies (5.2%) (Beaulieu-Boire et al., 2013; Ikonomidou, Rehnstrom, & Naesh, 2004; Migneault et al., 2004; Nguyen,
Nilsson, Hellström, & Bengtson, 2010; Yu et al., 2009).
Blinding Subjective Assessor
Due to the nature of music intervention, most studies could not prevent participants from knowing their group allocation. However, it was achieved among five
MM studies, as four studies (Migneault et al., 2004; Reza, Ali, Saeed, Abul-Qasim, &
Reza, 2007; Simcock et al., 2008; Szmuk et al., 2008) provided music after participants were sedated, and Bechtold and colleagues (2006) did not reveal the independent variable
(i.e., music) to their participants.
Blinding Objective Assessor
Risk of bias for this item was rated as ‘low’ for 67 studies (69.8%), because 37 of them did not use objective assessment tools (38.5%), and 30 trials (31.3%) used proper blinding of their assessors to the allocation information. Among the rest, 16 studies did
83
not blind the outcome assessors, and 22 trials did not describe the process of blinding
assessors.
Intention-to-treat Analysis
Attrition rate was adequately reported and explained in 74 trials (77.1%). On the
other hand, withdrawals were either too high or reported without reasons in five studies
(5.2%), and were not clearly described in 17 studies (17.7%).
Selective Reporting
All outcomes were discussed in 90 studies (93.8%), however there were six studies with missing or unclear information (6.4%).
Other Sources of Bias
Sixty-two studies (64.6%) either declared no conflict of interest or disclosed their funding sources. Thirty-three studies (35.4%) were rated as ‘unclear,’ as the above information was missing. A risk of bias graph and summary for all included studies can be found in Appendix I and J.
R F R t F F i p n h n h l gr . igure 4. unnel Plot: evman soft verted fun ot didnoti e guideline Publi n n w w c c n n s s M el shape. ation bias presented dicate evid are based usic vs.S w w o o t t b b e e andard Ca n datafro as examine y Eggeret nce ofap Assess
m m m m u u r a a e on0-10P blication bi d byvisuall the0-10p ent ofRepo l. (1997). I a a a a a a y r y r in intensity created the s asitdem ting Biases in Intensit inspectin g g y y o o
funnel plot scales (Fig afunnelpl Scales nstrated as u u o o u u y y re 4).Thef t accordin sing the mmetrical,
g g u u to
nnel 84 84 85
Results of Meta-Analysis
Research Question 1: The Effects of Music on Pain
A series of meta-analyses on three primary outcomes was conducted to address
the following research question: How effective is music in reducing pain when compared
to standard care? The primary outcomes of this meta-analysis included results that were
obtained from patients’ own rating of pain intensity on 0-10 scales, those that used other
than 0-10 pain scales, such as objective assessment of pain via observational tools, and
those that measured emotional distress from pain. Table 12 lists overall results of the
meta-analyses and includes analysis numbers that correspond to the forest plots in
Appendix L. Forest plots provide a graphical illustration of the relative strength of
treatment effects, as well as more detailed statistical information about all individual
trials included in meta-analyses.
Pain Intensity According to 0-10 Scales
In this analysis, scores from various types of 0-10 pain intensity scales were analyzed together using the mean difference statistic (MD). A number of studies utilized
100 mm VAS (visual analog scale) which recorded pain levels out of 100, not 10.
Because computation of mean difference statistic requires all data to be in the same format, I simply divided the scores from 100 mm VAS by 10, in order to convert the numbers to a comparable 0-10 format.
A total of 76 studies involving 6,487 participants examined the effect of music interventions on the subjective perception of pain using 0-10 scales. A pooled estimate of the data indicated that the music group showed a significantly lower level of pain than the 86
standard care group by 1.13 units on the 0-10 scales (95% CI -1.44, -0.82, p < .00001).
However, this result was highly inconsistent among the studies analyzed (I² = 95%).
Pain Intensity According to Other Pain Scales
In this analysis, data from various other subjective and objective pain scales were
pooled together using the standardized mean difference statistic (SMD). A total of 15
studies involving 1,278 participants examined the effect of music interventions on pain
using various other types of pain scales. As with the 0-10 pain scales, the music
intervention showed a significant and small to medium effect in decreasing the pain level
(SMD = -0.39, 95% CI -0.68, -0.09, p = 0.01) when compared to standard care.
Distress from Pain
A total of eight studies used the 100 mm visual analog scale to measure emotional
distress from pain. The analysis of the eight studies involving 731 participants showed a
significantly lower distress score in the music group (MD = -10.83, 95% CI -17.12, -4.53,
p = .0008) when compared to the standard care group, but this effect was highly
heterogeneous (I² = 91%).
Table 12. Meta-Analysis of Music Interventions on Pain
Analysis no. & Outcomes k N Effect Size 95% CI p value I² (%)
1.1 Pain Intensity: 0-10 scales 76 6,487 MD -1.13 -1.44, -0.82 < .00001 95
1.2 Pain Intensity: other scales 15 1,278 SMD -0.39 -0.68, -0.09 .010 84
1.3 Distress: 100mmVAS 8 731 MD -10.83 -17.12, -4.53 .0008 91
Note. k: number of studies; N: number of participants; CI: confidence interval; I²: heterogeneity testing; MD: mean difference; SMD: standardized mean difference; VAS: visual analog scale 87
Research Question 2: The Effects of Music on Analgesic Use
Meta-analyses on four secondary outcomes related to analgesic use were conducted to investigate the following question: How effective is music in reducing analgesic use when compared to standard care? A total of 30 studies investigated the effect of music on the amount of various analgesic agents used before, during or after medical procedures or surgery. According to the classification of drugs, these analgesic agents were categorized according to anesthetics; opioids; non-opioids; and sedatives.
Table 13 reports the results from the meta-analyses of music interventions on these four types of analgesics.
Use of Anesthetics
Seven studies examined the impact of music on total consumption of anesthetic agents, such as propofol, isoflurane, or sevoflurane. The pooled estimate of the seven studies involving 382 participants revealed a significant and moderate effect of music on reducing total anesthetic use in the music group when compared to the standard care group (SMD = -0.56, 95% CI -0.88, -0.25, p = .0005); this effect was moderately heterogeneous (I² = 54%).
Use of Opioids
A total of 23 trials recorded the amounts of opioids taken following various medical procedures or surgeries. Commonly taken opioids included morphine, fentanyl and tramadol. An analysis of pooled data from the 23 studies with 1,761 participants indicated a small but significant and homogeneous effect of music in reducing the amount of opioid intake (SMD = -0.24, 95% CI -0.34, -0.14, p < .00001, I² = 8%). 88
Use of Non-opioids
Three studies involving 258 participants examined the effects of music on
reducing non-opioid intake (i.e., acetaminophen and diclofenac). A meta-analysis of
pooled data yielded a moderate and significant effect in reducing the use of non-opioids
in the music group (SMD = -0.54, 95% CI -0.78, -0.29, p < .0001) with no signs of
heterogeneity (I² = 0%).
Use of Sedatives
Sedative agents investigated for this analysis included midazolam and versed. The pooled estimate of seven studies including 544 participants showed that music
interventions had no significant effect on sedative use (SMD = -0.4, 95% CI -0.92, 0.11, p
= 0.12, I² = 88%).
Table 13. Meta-Analysis of Music Interventions on Analgesic Use Effect Size Analysis no. & Outcomes k N 95% CI p value I² (%) (SMD) 1.4 Use of Anesthetics 7 382 -0.56 -0.88, -0.25 .0005 54 1.5 Use of Opioids 22 1,761 -0.24 -0.34, -0.14 < .00001 8 1.6 Use of Non-opioids 3 258 -0.54 -0.78, -0.29 < .0001 0 1.7 Use of Sedatives 7 544 -0.4 -0.92, 0.11 0.12 88 Note. k: number of studies; N: number of participants; SMD: standardized mean difference; CI: confidence interval; I²: heterogeneity testing
Research Question 3: The Effects of Music on Vital Signs
Meta-analyses of five physiological outcomes were carried out to examine the
following research question: How effective is music in alleviating pain as measured by 89 lower vital signs (i.e., heart rate, respiration rate, and systolic and diastolic blood pressure) when compared to standard care? Table 14 lists results of these analyses.
Heart Rate
Twenty eight studies investigated the impact of music on heart rate as a secondary measure of pain. The pooled estimate of data of 2,195 participants indicated that the music group showed a significantly lower heart rate on average than the standard care group by 4.25 bpm (beats per minute) (95% CI -5.92, -2.59, p < .00001). However, this result was highly heterogeneous (I² = 70%).
Systolic Blood Pressure
Systolic blood pressure (SBP) was reported in 21 studies that involved 1,811 participants. The mean difference (MD) of the 21 studies suggested that the music group displayed 3.34 mmHg lower SBP than the standard care group (95% CI -5.23, -1.45, p
= .0005), and this effect was fairly consistent among the studies analyzed (I² = 43%).
Diastolic Blood Pressure
A total of 19 trials examined the diastolic blood pressure (DBP) of 1,693 participants as a secondary measure of pain. A meta-analysis of the 19 studies indicated that music significantly decreased DBP in the music group by 1.18 units (mmHg) when compared to the standard care group (95% CI -2.30, -0.07, p = 0.04); this effect was moderately consistent among trials (I² = 43%).
90
Mean Arterial Pressure
The pooled estimate of five studies that measured mean arterial pressure (MAP)
in 216 participants did not show evidence for an effect of music on MAP (MD = -0.61, 95%
CI -6.91, 5.69, p = 0.85, I² = 74%).
Respiration Rate
Ten trials investigated the effect of music on respiration rate as a secondary measure of pain. The result of the meta-analysis that pooled data from 1,028 participants demonstrated that the music group took 1.46 breaths per minute fewer than the control group (95% CI -2.58, -0.34, p = 0.01), however this result was highly inconsistent among trials (I² = 92%).
Table 14. Meta-Analysis of Music Interventions on Physiological Measures
Effect Size Analysis no. & Outcomes k N 95% CI p value I² (%) (MD) 1.8 Heart rate 28 2,195 -4.25 -5.92, -2.59 < .00001 70
1.9 Systolic blood pressure 21 1,811 -3.34 -5.23, -1.45 .0005 43
1.10 Diastolic blood pressure 19 1,693 -1.18 -2.30, -0.07 0.04 43
1.11 Mean arterial pressure 5 216 -0.61 -6.91, 5.69 0.85 74
1.12 Respiration rate 10 1,028 -1.46 -2.58, -0.34 0.01 92 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing
91
Research Question 4: Music Therapy vs. Music Medicine
As shown in Appendix L, every meta-analysis on all 12 outcomes was
constructed with two subgroups, MT &MM, in order to address the following research question: Is there a difference between the effectiveness of music medicine and music therapy in reducing pain, analgesic use and vital signs when compared to standard care?
The results from the subgroup analyses on reported outcomes are presented in Tables 15 through 17.
Comparison on 0-10 Pain Intensity Scales.
A subgroup analysis between music therapy (MT) and music medicine (MM) demonstrated that participants from the nine MT trials (N = 537) displayed a greater reduction of -1.56 on the 0-10 scales (95% CI -2.24, -0.88, p <.00001) whereas the participants in the 67 MM studies (N = 5,950) showed a reduction of -1.08 (95% CI -1.42,
-0.75, p <.00001) in comparison to standard care. The difference between the two groups was not statistically significant, and substantial heterogeneity still remained for both groups (i.e., 71% for MT, and 96% for MM).
Comparison on Other Pain Scales
A subgroup analysis comparing MM and MT studies comprised of 13 and two studies respectively, showed that the small to medium effect remained significant for the
MM group (SMD = -0.38, 95% CI -0.72, -0.04, p = 003), but not significant for the MT group (SMD = -0.42, 95% CI -1.09, 0.24, p = 0.22), as the confidence interval contained
zero. This is likely due to the small number of studies analyzed for the MT group. The
results, however, were inconsistent for both MM (I² = 86%) and MT (I² = 79%) groups. 92
Comparison on Emotional Distress from Pain.
A subgroup analysis on emotional distress from pain could not be conducted
because none of the MT studies investigated this outcome.
Table 15. Comparison between MT and MM on Pain Analysis no. I² Variables k N Effect Size 95% CI p value & Subgroup (%) Pain intensity: 1.1.1 MT 9 537 MD -1.56 -2.24, -0.88 < .00001 71 0-10 scales 1.1.2 MM 67 5,950 MD -1.08 -1.42, -0.75 < .00001 96 Pain intensity: 1.2.1 MT 2 254 SMD -0.42 -1.09, 0.24 0.22 79 other scales 1.2.2 MM 13 1,024 SMD -0.38 -0.72, -0.04 0.03 86 Distress: 100mmVAS n/a Note. k: number of studies; N: number of participants; CI: confidence interval; I²: heterogeneity testing; MD: mean difference; SMD: standardized mean difference; VAS: visual analog scale
Comparison on Anesthetic Use
A comparison between the two groups on the amount of anesthetic use was not
feasible, because none of the MT studies reported anesthetic use as an outcome.
Comparison on Use of Opioids
Two MT studies were compared with 21 MM studies on opioid use; these
involved 49 and 1,712 participants respectively. A subgroup analysis of separately pooled
data indicated a non-significant effect for the MT group (SMD = -0.05, 95% CI -0.62,
0.51, p = 0.85), but a small yet significant effect for the MM group (SMD = -0.25, 95%CI
-0.35, -0.14, p < .00001). These results were consistent among MT studies (I² = 0%) as
well as among MM studies (I² = 15%). The meta-analytic results from these subgroup
analyses are presented in Table 16.
93
Comparison on Use of Non-opioids
A subgroup analysis between MT and MM groups on the use of non-opioids was
not conducted because no MT studies investigated this outcome.
Comparison on Use of Sedatives
A subgroup analysis on sedative use was carried out although there was only one trial in the MT group (N = 49) and six studies in the MM group (N = 544). The data from both analyses did not indicate an effect for MT (SMD = -0.39, 95% CI -1.28, 0.50, p =
0.39) or MM (SMD = -0.41, 95% CI -0.97, 0.16, p = 0.16) concerning the use of
sedatives.
Table 16. Comparison between MT and MM on Analgesic Use Effect Analysis no. I² Variables k N Size 95% CI p value & Subgroup (%) (SMD) Use of anesthetic n/a Use of opioids 1.5.1 MT 2 49 -0.05 -0.62, 0.51 0.85 0 1.5.2 MM 21 1,712 -0.25 -0.35, -0.14 < .00001 15 Use of non-opioids n/a Use of sedatives 1.7.1 MT 1 20 -0.39 -1.28, 0.50 0.39 n/a 1.7.2 MM 6 544 -0.41 -0.97, 0.16 0.16 90 Note. k: number of studies; N: number of participants; SMD: standardized mean difference; CI: confidence interval; I²: heterogeneity testing; n/a: not available
Comparison on Heart Rate
A subgroup analysis between MM and MT was carried out, although there was
only one RCT in the MT group (Ghetti, 2013). The result from the one MT study
involving 22 participants yielded a non-significant effect on heart rate (MD = -1.5, 95%
CI -16.92, 13.92, p = 0.85). On the other hand, the music group from 27 MM studies of 94
2,173 participants, demonstrated 4.28 less bpm in heart rate (95% CI -5.97, -2.60, p
< .00001) than the standard care group. However, this effect was highly inconsistent
among the included studies (I² = 71%). Data from all subgroup analyses on physiological
measures are presented in Table 17.
Comparison on Systolic Blood Pressure.
Systolic blood pressures (SBP) reported in one MT trial (N = 20) and 20 MM
trials (N = 1,791) were analyzed separately to compare the subgroup differences. The
results indicated a non-significant effect for MT on SBP (MD = 5, 95% CI -13.70, 23.70,
p = 0.6), but a significant effect for the MM group (MD = -3.42, 95% CI -5.32, -1.51, p
= .0004): listening to music decreased SBP by 3.42 mmHg on average in the experimental group when compared to the standard care group. This effect was moderately consistent among included studies (I² = 45%).
Comparison on Diastolic Blood Pressure
Data from one MT study and 18 MM studies involving 20 and 1,673 participants respectively were analyzed to compare their effectiveness on DBP. The analysis suggested a non-significant effect for MT (MD = 5.8, 95% CI -3.05, 14.65, p = 0.2) but a significant and moderately consistent effect for MM (MD = -1.31, 95% CI -2.40, -0.21, p
= 0.02, I² = 42%).
Comparison on Mean Arterial Pressure
Because no MT studies investigated the effect on mean arterial pressure, this comparison was not conducted.
95
Respiration Rate
A subgroup analysis on respiration rates was conducted to examine differences between MT and MM. The analysis did not indicate a significant effect for the MT group
(MD = 2.4, 95% CI -0.91, 5.71, p = 0.16), but suggested a significant yet heterogeneous effect for the MM group (MD = -1.71, 95% CI -2.86, -0.56, p = .004, I² = 92%).
Table 17. Comparison between MT and MM on Physiological Measures Analysis no. Effect Size Variables k N 95% CI p value I² (%) & Subgroup (MD) Heart rate 1.8.1 MT 1 22 -1.5 -16.92, 13.92 0.85 n/a 1.8.2 MM 27 2,173 -4.28 -5.97, -2.60 < .00001 71 Systolic BP 1.9.1 MT 1 20 5 -13.70, 23.70 0.60 n/a 1.9.2 MM 20 1,791 -3.42 -5.32, -1.51 .0004 45 Diastolic BP 1.10.1 MT 1 20 5.8 -3.05, 14.65 0.20 n/a 1.10.2 MM 18 1,673 -1.31 -2.40, -0.21 0.02 42 Mean arterial n/a pressure Respiration rate 1.12.1 MT 1 19 2.4 -0.91, 5.71 0.16 n/a 1.12.2 MM 9 1,009 -1.71 -2.86, -0.56 .004 92 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing; BP: blood pressure; n/a: not available
Research Question 5: Moderator Variables
A number of additional analyses were conducted to address the following research question: As moderator variables, how influential are pain subtypes (i.e., procedural, acute, chronic, cancer pain), patient-characteristics (e.g., age, gender, race, etc.), and intervention-characteristics (e.g., genre, style, choice, dosage, delivery, timing, etc.) on the effectiveness of music in reducing pain, analgesic use, and vital signs when compared to standard care? 96
Even though the number of studies analyzed for this meta-analysis is relatively high compared to previous systematic reviews on music and pain, conducting meta- analyses on all the moderator variables mentioned above was not possible due to limited information available from the included studies. Therefore, analyses on the following moderator variables were conducted: pain types (i.e., acute, chronic/cancer, & procedural), age groups (i.e., children & adults), levels of choice in music selection (i.e., researcher-chosen, participant-preferred, & participant-chosen), and different music experiences provided in music therapy trials. In addition, based on observations made from data synthesis, I added three additional analyses investigating the potential role of selection bias, detection bias and rationale for music selection on selected intervention outcomes.
Moderator Variable: Types of Pain
In order to examine if music interventions showed a consistent impact on different forms of pain, scores from the 0-10 pain intensity scales were reanalyzed according to the following types of pain: acute, chronic/cancer, and procedural. As shown on Table 18, the pooled data indicate that music interventions were significantly effective in decreasing subjective perception of pain measured by 0-10 scales for all three types of pain when compared to standard care. Although the differences in effect estimates of the three types of pain were not statistically different, music interventions showed the greatest decrease in procedural pain (MD = -1.19, 95% CI -1.77, -0.60, p < .0001), followed by acute pain (MD = -1.13, 95% CI -1.53, -0.73, p < .00001), and then chronic/cancer pain (MD = -0.97, 95% CI -1.55, -0.39, p = 0.001). However, the results 97 of heterogeneity I² testing suggested high variance among findings, as the variance was
95% for procedural, 94% for acute, and 94% for chronic/cancer pain.
I took this analysis one step further by looking into the effects of two music interventions separately on the subtypes of pain. Only a small number of MT studies were available for the analysis as there were three studies (N = 109) for acute pain, five studies (N = 405) for chronic/cancer pain, and one study (N = 23) for procedural pain.
The results indicated non-significant effects of MT for acute pain (MD = 1.91, 95% CI -
3.97, 0.16, p = 0.07) and procedural pain (MD = -0.61, 95% CI -1.93, 0.71, p = 0.37), but a significant and moderately consistent effect for chronic/cancer pain (MD = -1.42, 95%
CI -1.99, -0.84, p < .00001, I² = 48%).
There were substantially more studies pooled to estimate the effect of MM on acute pain (k = 33, N = 2,682), chronic/cancer pain (k = 6, N = 449) and procedural pain
(k = 28, N = 2,819). The abbreviation k, refers to the number of studies pooled, and N indicates the number of total participants involved. The analysis showed that MM produced significant pain-reducing but highly inconsistent effects on procedural and acute pain with a slightly larger effect on procedural pain (MD = -1.21, 95% CI -1.80, -
0.61, p < 0.0001, I² = 95%), followed by acute pain (MD = -1.07, 95% CI -1.48, -0.66, p
< .00001, I² = 94%). The six MM studies on chronic/cancer pain did not show evidence for its effect in reducing chronic/cancer pain (MD = -0.6, 95% CI -1.34, 0.15, p = 0.12, I²
= 96%).
98
Table 18. Types of Pain on 0-10 Pain Intensity Scales Analysis no. Effect Size Intervention k N 95% CI p value I² (%) & Moderator (MD) Music 2.1.1 Acute 36 2,791 -1.13 -1.53, -0.73 < .00001 94 Overall 2.1.2 Chronic/Cancer 11 854 -0.97 -1.55, -0.39 = 0.001 94 2.1.3 Procedural 29 2,842 -1.19 -1.77, -0.60 < .0001 95 Music 2.2.1 Acute 3 109 -1.91 -3.97, 0.16 0.07 79 Therapy 2.2.2 Chronic/Cancer 5 405 -1.42 -1.99, -0.84 < .00001 48 2.2.3 Procedural 1 23 -0.61 -1.93, 0.71 0.37 n/a Music 2.3.1 Acute 33 2,682 -1.07 -1.48, -0.66 < .00001 94 Medicine 2.3.2 Chronic/Cancer 6 449 -0.6 -1.34, 0.15 = 0.12 96 2.3.3 Procedural 28 2,819 -1.21 -1.80, -0.61 < .0001 95 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing; n/a: not available
Moderator Variable: Age Groups
To investigate the effects music interventions have on pain in different age groups,
data from 0-10 pain intensity scales and other pain measures were pooled for music
interventions as a whole and then separately according to MM or MT. Table 19 lists the
results of comparisons between the two age groups.
A total of five studies (N = 376) involving 376 children and 71 studies involving
6,111 adults were pooled to compare the effects of music interventions on pain in the two
age groups. The pooled estimate indicated that music decreased pain perception
significantly for both children (MD = -1.65, 95% CI -3.02, -0.28, p = 0.02) and adults
(MD = -1.1, 95% CI -1.42, -0.78, p < .00001) on 0-10 scales when compared to standard
care. The mean difference was greater for children than adults, but not statistically so.
These effects were substantially heterogeneous for both children (I² = 91%) and adults (I²
= 95%). 99
Again, additional analyses on the age groups were conducted for MT and MM
interventions separately. A meta-analysis of one MT study with 64 children and eight MT
trials of 473 adults suggested that MT had significant pain-relieving effects for both
children (MD = -3.45, 95% CI -4.41, -2.50, p < .00001) and adults (MD = -1.26, 95% CI -
1.71, -0.81, p < .00001) with a consistent effect among trials involving adults (I² = 26%).
Because there was only one study involving children, no heterogeneity testing was
conducted. Because the effect size was extremely high for the particular study on children
(Bradt, 2001), there was a statistical difference between the two age groups (p < 0.0001).
However, this result should be interpreted with the utmost caution because there was only
one study of this age group.
To examine potential age group differences among music medicine trials, four
studies with 312 children and 63 trials with a total of 5,638 adults were compared. The
outcome of the pooled estimate also indicated significant effects for both children (MD =
-1.13, 95% CI -2.17, -0.09, p = 0.03) and adults (MD = -1.08, 95% CI -1.42, -0.73, p
< .00001). The magnitude of effect was almost identical, and the effect was highly
inconsistent within both age groups (I² = 80% for children, & I² = 96% for adults).
The sub-analysis on age groups was conducted again using the data from other pain scales. Five studies concerning children and 70 studies involving adults were pooled to compare the effect of combined music interventions on the two age groups. The analysis showed that music had a significant medium to large effect on children (SMD = -
0.62, 95% CI -0.98, -0.25, p < .00001), but non-significant effect on adults (SMD = -0.27,
100
95% CI -0.66, 0.12, p = 0.17) as the confidence interval contained zero. The effect for children was largely heterogeneous (I² = 65%).
Independent analysis of each intervention presented similar results, as MT was
found to have a significant and large effect on children’s pain (SMD = -0.8, 95% CI -1.35,
-0.26, p = .004), but not on pain in adults (SMD = -0.12, 95% CI -0.40, -0.16, p = 0.4) as
measured by scales other than 0-10. In the same way, four MM studies involving children
produced a significant and moderate effect on alleviating pain (SMD = -0.57, 95% CI -
1.02, -0.13, p = 0.01) whereas nine MM studies of adults did not show a meaningful
effect (SMD = -0.29, 95% CI -0.76, 0.18, p = 0.22) on pain levels as measured by non 0-
10 scales.
Table 19. Children vs. Adults on All Pain Intensity Scales Intervention Analysis no. k N Effect Size 95% CI p value I² (%) (outcome) & Moderator Music Overall 3.1.1 Children 5 376 MD -1.65 -3.02, -0.28 0.02 91 (0-10 pain scales) 3.1.2 Adults 71 6,111 MD -1.1 -1.42, -0.78 < .00001 95 MT 3.2.1 Children 1 64 MD -3.45 -4.41, -2.50 < .00001 n/a (0-10 pain scales) 3.2.2 Adults 8 473 MD -1.26 -1.71, -0.81 < .00001 26 MM 3.3.1 Children 4 312 MD -1.13 -2.17, -0.09 0.03 80 (0-10 pain scales) 3.3.2 Adults 63 5,638 MD -1.08 -1.42, -0.73 < .00001 96 Music Overall 3.4.1 Children 5 375 SMD -0.62 -0.98, -0.25 < .00001 65 (other scales) 3.4.2 Adults 10 903 SMD -0.27 -0.66, 0.12 0.17 87 MT 3.5.1 Children 1 56 SMD -0.8 -1.35, -0.26 .004 n/a (other scales) 3.5.2 Adults 1 198 SMD -0.12 -0.40, 0.16 0.40 n/a MM 3.6.1 Children 4 319 SMD -0.57 -1.02, -0.13 0.01 73 (other scales) 3.6.2 Adults 9 705 SMD -0.29 -0.76, 0.18 0.22 88 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing; n/a: not available
101
Moderator Variable: Levels of Choice in Music Selection
To investigate if different levels of choice influence the effect of music on pain,
MM studies were divided into three types according to the levels of choice provided to participants in music selection. The first group listened to researcher-chosen (RC) music with no choice given; the second group listened to participant-preferred (PP) music where participants had some choice over the style or genre of music; and the third group
listened to participant-chosen (PC) music where participants had total freedom in
choosing music from their own personal library.
To test this moderator variable, data from 0-10 pain intensity scales were
analyzed. A pooled estimate of the effects suggested that all three levels of choice had
significant impact on reducing pain perceptions. Although the between group differences
were not statistically significant, the biggest effect was found in the RC (researcher-
chosen) music (MD = -1.32, 95% CI -1.97, -0.67, p < .0001), followed by PP
(participant-preferred) music (MD = -0.95, 95% CI -1.27, -0.64, p < .00001), and then PC
(participant-chosen) music (MD = -0.92, 95% CI -1.85, 0.01, p = 0.05). As shown on
Table 20, these effects were highly inconsistent among studies analyzed for all three
conditions.
Similar comparisons on the levels of choice were conducted using the data on
amount of analgesic use. The analysis showed that neither RC music (SMD = -0.13, 95%
CI -0.69, 0.43, p = 0.65) nor PP music (SMD = -0.44, 95% CI -1.00, 0.13, p = 0.13) had
a meaningful effect on the amount of anesthetics used. On the other hand, PC music was
associated with a significant and substantial effect on the use of anesthetics (SMD = -0.81, 102
95% CI -1.25, -0.38, p = 0.0002). This outcome was fairly consistent among analyzed studies (I² = 0.39).
Table 20. Levels of Choice in Music Selection on 0-10 Pain Intensity Scales
Analysis no. Effect Size k N 95% CI p value I² (%) & Moderator (MD) 4.1.1 Researcher-chosen 17 1,606 -1.32 -1.97, -0.67 < .0001 97
4.1.2 Participant-preferred 46 4,137 -0.95 -1.27, -0.64 < .00001 91
4.1.3 Participant-chosen 5 248 -0.92 -1.85, 0.01 0.05 74 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing
The levels of choice in music selection were also compared on the amount of opioids used. The pooled data from ten studies with 913 participants indicated a small but significant effect of RC music on the use of opioids (SMD = -0.25, 95% CI -0.39, -0.11, p
= 0.0005) which was highly consistent among studies analyzed (I² = 0.1). However, there
was no significant effect found for PP music (SMD = -0.11, 95% CI -0.30, 0.08, p =
0.25). A bigger and significant effect was found for PC music when analyzing four
studies with 320 participants (SMD = -0.42, 95% CI -0.64, -0.20, p = 0.0002), and this
effect was also homogeneous (I² = 0). This difference between RC and PC music was not
statistically significant.
Further analyses on levels of choices were conducted on non-opioid use by
analyzing two studies with RC music (N = 126) and one study with PP music (N = 132).
There were no PC music studies for this outcome. The results suggested a small to
medium effect for RC music on non-opioid use (SMD = -0.39, 95% CI -0.74, -0.04, p = 103
0.03) and a medium to large effect for PP music (SMD = -0.68, 95% CI -1.03, -0.33, p =
0.0001) when compared to standard care. No heterogeneity was found between findings
of the two RC music studies (I² = 0).
Different levels of choice had no impact on the use of sedatives as all the
confidence intervals contained zero. The SMDs for the three conditions were -0.01 for
RC music (95% CI -0.31, 0.30, p = 0.97), -0.66 for PP music (95% CI -1.86, 0.54, p =
0.28), and -0.35 for PC music conditions (95% CI -0.75, 0.04, p = 0.08).
Data from multiple analyses examining different levels of choice on analgesic
usage are tabulated and presented in Table 21.
Table 21. Levels of Choice in Music Selection on the Use of Analgesics Analysis no. Effect Size Outcomes k N 95% CI p value I² (%) & Moderator (SMD) Use of anesthetics 4.2.1 RC music 1 49 -0.13 -0.69, 0.43 0.65 n/a 4.2.2 PP music 3 180 -0.44 -1.00, 0.13 0.13 66 4.2.3 PC music 3 153 -0.81 -1.25, -0.38 0.0002 39 Use of opioids 4.3.1 RC music 10 913 -0.25 -0.39, -0.11 0.0005 10 4.3.2 PP music 7 479 -0.11 -0.30, 0.08 0.25 5 4.3.3 PC music 4 320 -0.42 -0.64, -0.20 0.0002 0 Use of non-opioids 4.4.1 RC music 2 126 -0.39 -0.74, -0.04 0.03 0 4.4.2 PP music 1 132 -0.68 -1.03, -0.33 0.0001 n/a Use of sedatives 4.5.1 RC music 2 246 -0.01 -0.31, 0.30 0.97 24 4.5.2 PP music 3 198 -0.66 -1.86, 0.54 0.28 93 4.5.3 PC music 1 100 -0.35 -0.75, 0.04 0.08 n/a Note. k: number of studies; N: number of participants; SMD: standardized mean difference; CI: confidence interval; I²: heterogeneity testing; RC: researcher-chosen; PP: participant-preferred; PC: participant-chosen
104
As reported in Table 22, the three levels of choice in the selection of music were
further analyzed as a moderator variable on available data from physiological measures.
The pooled estimate indicated that both RC and PP music had significant impact in lowering heart rates, whereas the PC music did not. There was a statistical difference between these variables (p = 0.004), as the PP music displayed the strongest effect of -
5.02 bpm (95% CI -6.87, -3.18, p < .00001), followed by RC music, which showed 4.68 bpm lower heart rate than the standard care counterpart (95% CI -9.34, -0.02, p = 0.05).
The PC music did not show a significant effect on heart rate (MD = 2.61, 95% CI -1.51,
6.73, p = 0.21). These findings were highly consistent for the RC music (I² = 0.8%) but
largely heterogeneous for PP music (I² = 67%).
In terms of systolic blood pressure (SBP), PP music was the only intervention that
led to a significant difference between the music and the standard care group. The mean
difference in SBP was -4.04 for PP music (95% CI -6.55, -1.52, p = 0.002), whereas it
was -3.28 for RC music (95% CI -6.68, 0.11, p = 0.06) and -0.45 for PC music (95% CI -
5.73, 4.84, p = 0.87). The effect of PP music on SBP was moderately heterogeneous
among included studies (I² = 61%).
The analysis on diastolic blood pressure (DBP) yielded similar results, as PP
music was the only music choice that showed a significant effect on DBP (MD = -4.04,
95% CI -6.55, -1.52, p = 0.002) which was fairly consistent (I² = 44%). Neither RC
music (MD = 0.31, 95% CI -4.53, 5.15, p = 0.9) nor PP music (MD = -0.12, 95% CI -
3.68, 3.44, p = 0.95) demonstrated a meaningful effect on DBP when compared to
105 standard care. A comparison on mean arterial pressure (MAP) was not conducted, because all of the studies that used MAP as an outcome provided PP music.
For respiration rate, one study involving RC music was compared to eight studies that provided PP music. The analysis showed that the RC music group showed a slightly greater effect of two fewer breaths per minute than standard care (95% CI -2.64, -
1.36, p < .00001), whereas PP music group showed 1.61 fewer breaths per minute (95%
CI -2.81, -0.42, p = 0.008). However, there was substantial heterogeneity among studies that provided PP music (I² = 91%).
Table 22. Levels of Choice in Music Selection on Physiological Measures Analysis no. Effect Size I² Outcomes K N 95% CI p value & Moderator (MD) (%) Heart rate 4.6.1 RC music 6 461 -4.68 -9.34, -0.02 0.05 80 4.6.2 PP music 18 1,558 -5.02 -6.87, -3.18 < .00001 67 4.6.3 PC music 3 154 2.61 -1.51, 6.73 0.21 13 Systolic BP 4.7.1 RC music 5 419 -3.28 -6.68, 0.11 0.06 0 4.7.2 PP music 12 1,218 -4.04 -6.55, -1.52 0.002 61 4.7.3 PC music 3 154 -0.45 -5.73, 4.84 0.87 0 Diastolic BP 4.8.1 RC music 4 349 0.31 -4.53, 5.15 0.9 71 4.8.2 PP music 11 1,170 -1.56 -2.73, -0.38 0.009 44 4.8.3 PC music 3 154 -0.12 -3.68, 3.44 0.95 0 Mean arterial n/a pressure Respiration 4.10.1 RC music 1 100 -2 -2.64, -1.36 < .00001 n/a 4.10.2 PP music 8 909 -1.61 -2.81, -0.42 0.008 91 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing; BP: blood pressure; RC: researcher-chosen; PP: participant-preferred; PC: participant-chosen; n/a: not available
106
Rationale for Selection of Music
As pointed out in the characteristics of MM interventions, a number of studies did
not report essential information about their music interventions. In particular, many
studies did not provide a rationale for selecting the particular pieces, genres, or styles of
music that they provided as the intervention for pain management. Therefore, I investigated the ‘rationale for selection of music’ as another moderator variable for MM
studies, in addition to the previously identified variables. Studies were classified as
having a ‘rationale for selection of music’ if they described using one of three identified
methods in developing their music intervention: 1) implemented music used in previously
published literature; 2) selected music after consulting experts; or 3) described at least
two musical criteria which guided their music selection (e.g., tempo, style, harmony,
rhythm, instrumentation, etc.). There were 37 studies (42.5%) that met at least one of the three criteria and 50 studies that did not describe a rationale for their selection of music.
Available outcomes from these two types of studies were pooled to investigate the
potential impact purposeful selection of music has on pain-related outcomes. To simplify the process of reporting, I will refer to the former as the group ‘with rationale’ and the latter as the group ‘without rationale’ in the following section.
Pain intensity scores measured by 0-10 scales were compared between 32 studies
(N = 2,971) that provided a rationale for selection of music and 36 studies (N = 3,020) that did not. The results favored the studies with a rationale and the difference between the two groups was statistically significant (P = 0.008). Participants in the former group
(with rationale) displayed on average 1.4 units lower pain intensity (95% CI -1.81, -0.99, 107 p < .00001) than participants in standard care, whereas participants in the latter group (no rationale) showed 0.70 lower pain scores (95% CI -1.03, -0.37, p < .0001) than their control counterpart. Both groups with rationale (I² = 96%) and without rationale (I² =
85%) showed ‘high’ heterogeneity among studies analyzed.
One study which employed a rationale (N = 49) and six studies that did not (N =
333) were available for a comparison on anesthetic use. The analysis indicated no meaningful effect for the study with the rationale in reducing anesthetic use (SMD = -
0.13, 95% CI -0.69, 0.43, p = 0.65), but a medium to large effect with some heterogeneity among studies without rationales (SMD = -0.64, 95% CI -0.97, -0.31, p
= .0002, I² = 51%).
I also compared eight studies with rationales (N = 626) and thirteen studies without (N = 1,086) on the amount of opioid use. The result showed a consistent and small effect for reducing opioid intake in the former group (SMD = -0.31, 95% CI -0.47, -
0.15, p = .0002, I² = 0%) which was relatively larger than the effect shown in the group with no rationale (SMD = -0.22, 95% CI -0.38, -0.06, p = 0.008, I² = 39%).
A comparison on non-opioid use was performed with one study that used a rationale (N = 132) and two trials that did not (N = 126). Both groups showed a significant effect in reducing non-opioid use in comparison to standard care, but the effect was bigger with the study using a rationale (SMD = -0.68, 95% CI -1.03, -0.33, p
= .0001) than those that did not (SMD = -0.39, 95% CI -0.74, -0.04, p = 0.03, I² = 0%).
The pooled estimates of two trials with (N = 160) and four trials without the use of a rationale (N = 384) on the effect of reducing sedative use did not yield a significant 108
effect for either the group with a rationale (SMD = -0.94, 95% CI -2.29, 0.41, p = 0.17, I²
= 94%) or the group without (SMD = -0.13, 95% CI -0.57, 0.30, p = 0.54, I² = 74%).
Table 23. Rationale for Selection of Music on Pain Intensity and Analgesic Use Analysis no. Outcomes k N Effect Size 95% CI p value I² (%) & Moderator Pain intensity 5.1.1 With rationale 32 2,971 MD -1.40 -1.81, -0.99 <.00001 96 (0-10 scales) 5.1.2 No rationale 36 3,020 MD -0.70 -1.03, -0.37 <.0001 85 Use of anesthetics 5.2.1 With rationale 1 49 SMD -0.13 -0.69, 0.43 0.65 n/a 5.2.2 No rationale 6 333 SMD -0.64 -0.97, -0.31 .0002 51 Use of opioids 5.3.1 With rationale 8 626 SMD -0.31 -0.47, -0.15 .0002 0 5.3.2 No rationale 13 1,086 SMD -0.22 -0.38, -0.06 .008 39 Use of non-opioids 5.4.1 With rationale 1 132 SMD -0.68 -1.03, -0.33 .0001 n/a 5.4.2 No rationale 2 126 SMD -0.39 -0.74, -0.04 0.03 0 Use of sedatives 5.5.1 With rationale 2 160 SMD -0.94 -2.29, 0.41 0.17 94 5.5.2 No rationale 4 384 SMD -0.13 -0.57, 0.30 0.54 74 Note. k: number of studies; N: number of participants; MD: mean difference; SMD: standardized mean difference; CI: confidence interval; I²: heterogeneity testing; n/a: not available
Similar analyses on the role of rationale for selection of music were conducted on
all reported vital signs. The comparison on the heart rate in 11 studies with a rationale
and 16 studies without indicated that the music group with a rationale showed on average
6.19 bpm lower heart rate than standard care (95% CI -8.87, -3.50, p < .0001), whereas
the group without a rationale displayed 3.03 bpm lower heart rate than their control (95%
CI -5.31, -0.76, p = 0.009). This difference between the two groups, however, was not
statistically significant (p = 0.08). In addition, these effects were inconsistent for both
groups as the results of heterogeneity testing were 75% for the former and 69% for the
latter group. 109
The analysis of systolic blood pressure (SBP) between these two groups yielded a significant effect for the group with a rationale (MD = -5.34, 95% CI -7.06, -3.62, p
< .0001) but not for the group without (MD = -2.39, 95% CI -5.18, 0.39, p = 0.09). There was no statistical difference (p = 0.08), however the former group showed high consistency among its results (I² =0%), whereas the group without a rationale showed varying outcomes (I² = 53%).
Likewise, results from the comparison of diastolic blood pressure (DBP) favored the group with a rationale as it showed a significant effect on lowering DBP (MD = -1.35,
95% CI -2.71, 0.02, p = 0.05, I² = 41%). This significance was not found in the group without a rationale (MD = -0.99, 95% CI -2.81, 0.83, p = 0.29, I² = 46%).
The pooled estimate of two studies with a rationale and three studies without on mean arterial pressure (MAP) did not demonstrate significant effects in the group with a rationale (MD = -5.17, 95% CI -19.85, 9.52, p = 0.49) or the one without (MD = 1.83, 95%
CI -5.99, 9.65, p = 0.65), although the noticeable difference between the groups remained.
The last comparison of this series was conducted on respiration rates in six studies
(N = 677) with a rationale and three studies (N = 332) without. The results indicated that participants in the music with a rationale group exhibited 2.92 fewer breaths per minutes than the participants receiving standard care (95% CI -4.71, -1.13, p = 0.001), but this finding was highly inconsistent among studies analyzed (I² = 92%). On the other hand, there was no significant effect found for the group without a rationale (MD = -0.39, 95%
CI -1.79, 1.01, p = 0.58).
110
Table 24. Rationale for Selection of Music on Physiological Measures Analysis no. Effect Size Outcomes k N 95% CI p value I² (%) & Moderator (MD) Heart rate 5.6.1 With rationale 11 1,080 -6.19 -8.87, -3.50 < .0001 75 5.6.2 No rationale 16 1,093 -3.03 -5.31, -0.76 0.009 69 Systolic BP 5.7.1 With rationale 7 828 -5.34 -7.06, -3.62 < .0001 0 5.7.2 No rationale 13 963 -2.39 -5.18, 0.39 0.09 53 Diastolic BP 5.8.1 With rationale 7 828 -1.35 -2.71, 0.02 0.05 41 5.8.2 No rationale 11 845 -0.99 -2.81, 0.83 0.29 46 Mean arterial 5.9.1 With rationale 2 86 -5.17 -19.85, 9.52 0.49 82 pressure 5.9.2 No rationale 3 130 1.83 -5.99, 9.65 0.65 76 5.10.1 With rationale 6 677 -2.92 -4.71, -1.13 0.001 92 Respiration 5.10.2 No rationale 3 332 -0.39 -1.79, 1.01 0.58 90 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing; BP: blood pressure
Moderator Variable: Active vs. Passive Approach in Music Therapy
To investigate if different levels of participation required of participants influence
the impact of music therapy on pain perception, music therapy studies that employed
active musical interactions, such as singing, composing, playing and improvising were
classified as active MT trials. Studies that used a receptive approach, wherein the
therapist provides music and the patients participate mainly by listening, were classified
as passive MT trials. Due to the limited number of MT studies, this comparison was only
feasible with 0-10 pain intensity scales.
There were five trials using an active MT approach (N = 348) and another five studies using a passive MT approach (N = 205). The actual number of trials involved in this analysis was nine, but there were five trials in each arm. Because Kim and Kim
(2010) provided both types of approaches in two separate intervention groups, their data 111
from these groups were entered separately. A meta-analysis on these data indicated that
the active MT approach showed a greater effect on reducing pain perception (MD = -2.15,
95% CI -3.27, -1.03, p = 0.0002) than the passive approach (MD = -1.18, 95% CI -1.67, -
0.68, p < .00001) when compared to standard care. However, the difference between the
two approaches was not statistically significant. In terms of heterogeneity, the passive
approach showed a strong consistency among studies analyzed (I² = 0.23), whereas the
active approach exhibited high inconsistency in its results across studies (I² = 0.71).
Table 25. Music Experiences in Music Therapy on 0-10 Pain Intensity Scales
Analysis no. Effect Size k N 95% CI p value I² (%) & Moderator (MD)
6.1.1 Passive MT 5 348 -1.18 -1.67, -0.68 < .00001 23
6.1.2 Active MT 5 205 -2.15 -3.27, -1.03 0.0002 71 Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing
Methodological Moderators
Because this meta-analysis included a fairly large number of studies, additional analyses were carried out to examine the impact of essential methodological moderator variables on the main outcome. The first analysis was concerned with selection bias and compared studies that fulfilled both randomization and allocation concealment with those studies that overlooked one or more steps for minimizing selection bias. The second analysis investigated the role of blinding on pain outcomes that were based on
112 observational scales conducted by objective assessors. Results from these analyses are presented in Table 26.
Randomization & Allocation Concealment
There were 19 studies with 1,622 participants that met both criteria for minimizing selection bias, whereas there were 57 studies with 4,848 participants that did not fulfill one or more criteria. The pooled estimate of effects on 0-10 pain intensity scales indicated that both groups showed a significant pain-reducing effect, but it was weaker for the group with higher methodological rigor (MD = -0.97, 95% CI -1.57, -0.37, p = .001), than the one without (MD = -1.18, 95% CI -1.51, -0.85, p < .00001). Both cases, however, exhibited substantial heterogeneity.
Blinding Objective Assessors
Six studies that used observational tools to measure pain intensities were divided into three studies (N = 300) that hid the group allocation information from their assessors and three (N = 273) that did not blind the assessors. The trials with blinded assessors produced a small to medium, but significant and fairly consistent pain-reducing effect
(SMD = -0.39, 95% CI -0.72, -0.06, p = 0.02, I² = 38%) when compared to standard care.
On the other hand, trials that did not blind their assessors showed a greater but not significant effect (SMD = -0.72, 95% CI -1.47, 0.02, p = 0.06), in addition to high heterogeneity (I² = 88%).
113
Table 26. Analysis of Moderator Variables: Methodological Qualities
Analysis no. Effect Size Outcomes k N 95% CI p value I² (%) & Moderator (MD) Randomization & Allo- 7.1.1 Both met 19 1,622 -0.97 -1.57, -0.37 .001 92 cation Concealment 7.1.2 Not met 57 4,848 -1.18 -1.51, -0.85 <.00001 95
Blinding Objective 7.2.1 Blinded 3 300 -0.39 -0.72, -0.06 0.02 38 Assessors 7.2.2 Not blinded 3 273 -0.72 -1.47, 0.02 0.06 88
Note. k: number of studies; N: number of participants; MD: mean difference; CI: confidence interval; I²: heterogeneity testing;
114
CHAPTER 5
DISCUSSION
Overview of the Study
Because pain poses numerous physical, psychological, social and economic burdens on the public, the frequently discounted issues of undertreated and poorly managed pain need to be addressed via holistic and patient-centered care. A number of clinical trials have investigated the effect of music on pain for patients experiencing acute, procedural, chronic and/or cancer pain due to various medical issues. The purpose of this study was to systematically review and conduct a meta-analysis of clinical trials investigating the effect of music interventions on pain regardless of the medical diagnosis, settings, age groups, or types of pain investigated.
For a comprehensive inquiry, I conducted electronic searches of 12 databases and a handsearch of music therapy related journals and reference lists of relevant systematic
reviews, with partial restrictions on design (i.e., RCT: randomized controlled trials);
language (i.e., English, German, Korean, and Japanese); year of publication (i.e., 1995 to
2014) and intervention (i.e., music therapy and music medicine). Grey literature was also
sought by searching online resources and contacting PhD music therapy program
directors worldwide. I implemented this priori design with clear inclusion and exclusion
criteria in order to examine and pool studies that were similar in their method, assessment,
and intervention with higher methodological quality.
After fully reviewing 358 potential articles, I included and analyzed 94 studies
reporting 97 clinical trials in this meta-analysis. Analyzed studies included 87 music 115
medicine (MM) and 10 music therapy (MT) trials, conducted in 24 countries on six continents. Studies were mainly research reports in peer-reviewed journals or doctoral dissertations, printed in English or Korean language. Eighty-eight of the included studies involved adults, and eight trials focused on children. In terms of the types of pain, there were 50 trials on acute, 34 on procedural, and 12 on cancer or chronic pain, and they were conducted in over 20 different medical specialty areas.
For the assessment of study quality, I used the risk of bias tool developed by the
Cochrane collaboration. Pooled data from included studies were analyzed using the
Revman 5.3 software according to levels of pain intensity, amount of analgesic use, and changes in vital signs. I reported the results using mean difference (MD) or standardized mean difference (SMD) along with confidence intervals and I² results for estimation of heterogeneity. Additional analyses were conducted to test the following moderator variables: pain types, age groups, levels of choice in music selection, absence/presence of rationale for music selection, types of music therapy approach, and methodological variables.
Results from the 97 trials suggest that music interventions have beneficial effects on pain intensity, emotional distress from pain, use of anesthetic, opioid and non-opioid agents, heart rate, systolic and diastolic blood pressure, and respiration rate. However, large variations found among studies warrant careful interpretation of results. On average, music interventions were associated with a mean pain reduction of 1.13 units on 0-10 scales and 0.39 standardized units on other scales. Music intervention groups showed
10.8 units lower emotional distress from pain on 100 mm visual analog scales, and 116 required less anesthetic (SMD = -0.56), opioid (SMD = -0.24), and non-opioid medications (SMD = -0.54). Moreover, the music group showed decreases in heart rate of
4.25 BPM, systolic blood pressure of 3.34 mmHg, diastolic blood pressure of 1.18 mmHg, and respiration rate of 1.46 breaths per minute. Findings from several analyses of moderator variables suggest various implications for future research and the clinical application of music interventions.
Presentation of Discussion
In the following section, I will discuss the results of this meta-analysis in detail based on the proposed research questions. For interpretation of statistical results, I adopted a significance level of p < 0.05 for all outcomes and comparisons. Effect sizes are presented in MD (mean difference) and/or SMD (standardized mean difference) with
95% confidence intervals. When necessary, I reported both MD and SMD to enable a fuller understanding of the effects under discussion. For interpretation of effect sizes estimated in SMD, I followed Cohen’s guideline for interpreting the magnitude of SMDs in the social sciences; he indicated a small effect for 0.2, medium effect for 0.5, and a large effect for 0.8 (1988). The majority of effect sizes presented in both MD and SMD were negative values; this was an indication of the reduction in pain intensity, analgesic usage and/or vital signs.
117
Discussions on Proposed Research Questions
Research Question 1: The Effects of Music on Pain
Pain Intensity According to 0-10 Scales
The effect sizes found in this study not only support findings from previous studies, but also show stronger magnitude of the effects of music interventions on pain intensity. The meta-analytic result of 76 studies showed that music interventions were associated with 1.13 units lower pain intensity than standard care on 0-10 scales. In other words, it illustrates that participants who received music interventions rated their pain level 1.13 units lower on average than the participants who received standard care. This result is substantially greater than what has been reported in previous meta-analyses, which was -0.46 for overall pain without a specific population (Cepeda et al., 2006), and
-0.54 for cancer pain (Zhang et al., 2012). This comparison with the results from the meta-analysis by Cepeda and colleagues is especially meaningful, both as comprehensive meta-analysis on all types of pain, in that the current finding is based on 72 newly added studies in addition to 17 overlapping studies.
Pain Intensity According to Other Pain Scales
The analysis of 16 trials on pain intensity measured by non 0-10 pain scales indicated that the mean pain intensity in the music group was 0.39 standard deviations lower than the control group. This result indicates that music had a small to medium but significant effect on reducing pain when measured by non 0-10 pain scales. This finding is similar to or weaker than the results from previous meta-analyses, which were -0.39 for pediatric pain (Klassen et al., 2008), and -0.59 to -0.656 for cancer pain (Bradt et al., 118
2011; Tsai et al., 2014). The difference between cancer pain and overall pain can be
explained in several ways. In comparison to the 0-10 scales, there was a relatively small number of studies employing other validated tools that could be pooled for this analysis, which may have weakened the outcome. Moreover, these studies investigated various
types of pain of less intensity than cancer pain. This difference is known as ‘floor effect,’ and it can be observed in studies involving minor medical procedures (MacDonald et al.,
2003). Because cancer pain is greater in its intensity than many other types of pain, the magnitude of decrease often appears larger (Binns-Turner et al., 2011).
Because both the American Psychological Association (2010) and Borenstein et al.
(2009) suggest that presenting effect sizes in both MD and SMD can illustrate the
magnitude of the effect under investigation in an easy and helpful way, I also obtained
the effect size of SMD based on the data from 0-10 scales above for a comparison. In
standardized units, the MD reported above was converted into an SMD of -0.63 with 95%
CI of -0.78 to -0.48, which is greater or similar to that effect reported in the meta-
analyses on cancer pain (Bradt et al., 2011; Tsai et al., 2014). According to Cohen, (1988)
this can be interpreted as a medium to large effect.
Distress from Pain
The emotional distress from pain measured by 100 mm VAS also showed a
significant decrease in the music group when compared to the control group. In terms of
an effect size, this was a medium to large effect. This scale, otherwise known as
‘affective pain scale,’ has been primarily used by a group of researchers in nursing to
gauge the “amount of emotional distress associated with the sensation” (Good et al., 1999, 119 p. 165). The use of both types of pain assessments (sensation and emotional) warrants a brief discussion of pain theories discussed in these studies.
Pain Theories Discussed in Included Trials
The rationale for assessing both sensation and emotional pain intensity in the studies described above was based on the cognitive and emotional components of pain presented in the Gate Control theory (Melzack, 1996). This theory is based on the proposition that cognitive understanding and emotional reaction to pain can activate the descending control of pain inhibitors. The fact that eight studies measuring both physical sensations and emotional distress from pain showed highly analogous results between the measures seems to demonstrate the close relationship between physical and emotional distress. However, the mechanism behind the effect in relation to music is still unclear.
Over 20 studies included in this meta-analysis mentioned the Gate Control theory in their report, but the focus on and connection to music was different from one researcher to the next. In addition to the emotional link explained above, some researchers explained music more as a competing stimulus that masks noxious sensations
(Laurion & Fetzer, 2003; Nilsson, Rawal, Enqvist, & Unosson, 2003); some viewed music as a mental attention device that takes the focus away from pain stimuli (Guerrero et al., 2012; Kristjánsdóttir & Kristjánsdóttir, 2011); whereas others attributed music’s effect to a combination of all these factors (Good et al., 1999; Li et al., 2011). Numerous other theories have been mentioned in individual studies, but the Gate Control theory was the single most frequently cited and used theory as a framework for many of the included studies. However, no matter what the focus of mechanism was in each study, the findings 120
in this meta-analysis seem to support the Gate Control theory and its close relationship
with music. Needless to say, more research is needed to investigate the mechanisms and
theories behind the pain-relieving effect of music.
Issues of Heterogeneity
Despite the effort to minimize heterogeneity by limiting study designs to: RCTs,
interventions to MM and MT, participants to medical patients, and assessments to 0-10
scales, highly inconsistent effects still remained. The results of I² were 95% for 0-10
scales, 84% for other scales and 91% for emotional distress. There are many factors that
could contribute to this high level of heterogeneity, such as population, medical diagnosis,
procedure, research setting, study design, and sampling error. Above all, as can be seen in
Appendices G and H, the music intervention itself was one of the biggest sources of the
heterogeneity. The duration, frequency, style, genre, preparation, choice, rationale, personnel, equipment, and approach in the delivery of music interventions were vastly
different. When visually inspecting the forest plots in Appendix L, however, it can be
observed that the direction of effect is in agreement in at least 90% of the studies. The
heterogeneity appears to be influenced more by several studies with either highly effective or ineffective results. Thus, a further investigation of these studies may lead to
the discovery of factors that contribute to the high variance in meta-analytic results.
The results from the meta-analyses on pain intensity and emotional distress from
pain indicate a moderately significant but inconsistent effect of music on reducing pain
intensity. One important issue to consider, however, is the clinical relevance of this effect.
Gallagher, Liebman, and Bijur (2001) reported that a minimum change in visual analog 121 scale required for a clinically meaningful effect is 1.3 units out of 0-10 scales. Because the mean difference found in this study was 1.13 for 0-10 scales, the clinical relevance of the current findings should be interpreted with great caution.
Research Question 2: The Effects of Music on Analgesic Use
Use of Anesthetics
Music appears to be effective in reducing the use of anesthetics during medical procedures, although the effect shows variability. According to the pooled results of seven studies, music demonstrated a moderate effect in reducing the amount of anesthetics, such as propofol or isoflurane, required during surgery or medical procedures.
This finding may be clinically meaningful because anesthetics can cause side effects, such as respiratory depression, kidney failure, cardiac dysfunction or low blood pressure
(Drugs.com, n.d.). However, this outcome was moderately inconsistent among included studies (I² = 54%).
In looking at the types of anesthesia given, two studies (Migneault et al., 2004;
Szmuk et al., 2008) involved general anesthesia, whereas the others involved local sedation. A subgroup analysis of the five studies involving procedural sedation with propofol, revealed an even stronger effect (SMD = -0.69, 95% CI, -1.03, -0.36, p <
0.0001) with slightly less heterogeneity (I² = 49%). I could not compare this result with other meta-analyses due to lack of data.
Use of Opioids
Music interventions may be effective in reducing the amount of morphine or similar opioid intake as the pooled data showed a small but consistent and significant 122 effect. Based on an inspection of the forest plot, I found one outlier (Vanderboom et al.,
2012) that showed contradictory findings. A secondary analysis excluding this study resulted in only a fraction of change in the effect size, but the heterogeneity testing yielded zero.
Cepeda and colleagues (2006) also reported a significant reduction in morphine intake in music groups in three studies (MD = -1.08, 95% CI -1.95 to -0.21). In order to directly compare the result of this study with their findings, I conducted a second analysis on 11 studies that compared morphine consumption only, and found an almost identical result (MD = -1.11, 95% CI -1.63, -0.60, p <.0001) with homogeneous results (I² = 0%).
This means that patients who received music interventions consumed 1.11 mg less morphine than the patients in standard care, and this result was highly consistent among studies.
Use of Non-opioids
Music seems to have a moderate effect in reducing the use of non-opioid pain killers following medical procedures or surgery. This effect was consistent among the three studies that were analyzed. However, its effect on non-opioid medications should be interpreted carefully because the sample size was relatively small compared to other analyses.
Use of Sedatives
Music does not appear to have an effect on the amount of sedatives use. Seven studies were examined to investigate if music has an effect on the amount of midazolam or versed required to keep patients sedated, and found no significant effect. The 95% 123
confidence interval of the effect ranged from -0.92 to 0.11 including a zero, showing that this effect was highly inconsistent. This result was largely due to two studies (Bechtold et al., 2006; Vanderboom et al., 2012) that showed contradictory results with five other studies. I could not locate possible explanations for the differences between these studies.
On the other hand, a meta-analysis by Tam et al. (2008) showed different results.
Based on their analysis of six studies that provided music during colonoscopy, they reported that the music group used on average 0.46 mg less (0.91 to 0.01 less) midazolam than their control counterparts. Due to the differences in inclusion and exclusion criteria,
there were only two studies that overlapped with the current study.
The evidence suggests that music interventions have a small to moderate effect in
reducing the amount of anesthetic, opioid and non-opioid usage during or after medical
procedures. This effect was highly consistent for opioid and non-opioid intake, but
moderately heterogeneous for the use of anesthetics. On the other hand, no evidence was
found to support the use of music in reducing the amount of sedatives. Nevertheless,
considering the potential side effects that accompany these analgesic agents, the overall
evidence seems to support the use of music for reducing analgesia use.
Research Question 3: The Effects of Music on Vital Signs
Heart Rate
Music appears to have a significant effect in reducing heart rate, although the
effect is variable among different trials. This effect corresponds to the result of a meta-
analysis on patients with cancer (Bradt et al., 2011) that found that patients in the music group exhibited 3.78 bpm lower (6.50 to 1.06 lower) heart rates than their controls. While 124
the effect estimate seems similar, the result of their heterogeneity testing was 0%,
whereas the current study found 70% variability among the included studies.
Nevertheless, this finding is meaningful in that data from Bradt et al.’s meta-analysis came from five trials with 235 participants, whereas the data in this study were pooled from 28 studies involving 2,195 participants.
As Bradt et al. (2011) indicate, a mean heart rate difference of 4 bpm may not be clinically meaningful. When converted, the mean difference of 4.2 bpm found in this study yields SMD of -0.40 (-0.56 to -0.24). This can be interpreted as a small to medium effect, which certainly is not substantial. However, a meta-analysis investigating heart rate reduction in patients with heart failure reported that every 5 bpm reduction in heart
rate was associated with an 18% reduction in risk of death (McAlister, Wiebe, Ezekowitz,
Leung, & Armstrong, 2009). From this perspective, for medical patients who are suffering from acute, chronic, cancer, or procedural pain, a reduction in heart rate may have a greater clinical significance than for healthy population.
Systolic Blood Pressure
The results from 21 studies suggest that music interventions may lower systolic blood pressure, as the music group showed 3.34 mmHg lower SBP than the control. This effect, however, is smaller than what Bradt et al. (2011) found in cancer patients; which was 5.95 mmHg lower SBP in the music group than control group. Once again, the differences in the study populations and the number of participants involved may explain the smaller effect found in this study.
125
In terms of its clinical significance, results from another large scale meta-analysis
seem to suggest that small changes in blood pressure may make a critical difference for
certain populations. According to Law, Morris and Wald (2009), every 10 mmHg
decrease in systolic and 5 mmHg reduction in diastolic blood pressure has been found to
be associated with a 22% decrease in risk for developing coronary heart disease and a 41%
reduction in risk of stroke.
Diastolic Blood Pressure
The result of this analysis seems to indicate a modest effect of music on diastolic
blood pressure. The pooled data of 19 studies demonstrated that music decreased on
average 1.18 mmHg in DBP in comparison to standard care. This finding was moderately
variable among included studies (I² = 43%), and the effect was smaller than the 4.28
mmHg decrease reported by Bradt et al. (2011).
Mean Arterial Pressure
The analysis of five studies did not show an effect of music on mean arterial pressure. The 95% confidence interval was extremely wide from -6.91 to 5.69, showing a
very inconsistent effect. This finding was consistent with the results from a meta-analysis
on patients with coronary heart disease, in which they also found a wide confidence
interval ranging from -4.08 to 2.26 (Bradt et al., 2013).
Respiration Rate
The result suggests that music may be effective in decreasing respiration rate
although the outcomes were highly variable among studies (I² = 92%). The analysis of
ten studies showed that participants in the music group took 1.46 fewer breaths per 126 minute than participants in the standard care group. However, I could not locate similar findings from other meta-analyses. In SMD, music appears to have a moderate effect on respiration (SMD = -0.45, 95% CI -0.87, -0.03, p = 0.04).
The results of these meta-analyses suggest a moderate effect of music on lowering heart rate, systolic blood pressure and respiration rate. There was no support found for the effect of music on mean arterial pressure, but a small but significant effect was observed for diastolic blood pressure. However, findings on the effect of music on vital signs have been extremely inconsistent, and these results need to be interpreted with great caution.
Research Question 4: Music Therapy vs. Music Medicine
Comparison on 0-10 Pain Intensity Scales
The comparison between nine MT and 67 MM trials shows that music therapy is more effective in lowering participants’ own rating of pain intensity. On the 0-10 scale, participants in the MT group rated their pain level 0.48 units lower than participants in the MM group. However, this difference was not statistically significant (p = 0.22), and high heterogeneity remained in each subgroup analysis (I²: 71% for MT & 96% for MM).
On the other hand, an inspection of the forest plot revealed that the heterogeneity in the MT group was due to one study with highly significant results (Bradt, 2001). A second heterogeneity testing excluding this trial revealed a homogeneous result for the
MT group (I² = 26%).
Dileo and Bradt (2005) also found more favorable results for music therapy than for music medicine in their meta-analysis of five MT and 43 MM studies. The effect size for MT was r = 0.62 (95% CI 0.41, 0.77) and for MM was r = 0.18 (95% CI 0.11, 0.25); 127 this difference was significant (p = 0.00). Although the current study did not find a statistical difference, this finding is meaningful in that all the analyzed trials are relatively high quality randomized controlled trials, and there are substantially more studies pooled for this analysis.
Moreover, this difference leads to a contrasting interpretation in terms of their clinical significance. As discussed earlier, Gallagher et al. (2001) reported that the minimum change required for achieving a clinically meaningful change is 1.3 on 0-10
VAS scales. Based on that recommendation, MT is found to be clinically significant, whereas MM is not on self-rated pain intensity on 0-10 scales.
Comparison on Other Pain Intensity Scales
When studies compared MT and MM on non 0-10 scales, no effect was found for
MT, whereas MM displayed a small to moderate but substantially inconsistent effect in relieving pain. The non-significant effect found for MT was likely due to the small sample size and highly variable data from one study (Gutgsell et al., 2013). This study used two types of non 0-10 scales: Face, Legs, Activity, Cry, Consolability (FLACC) scale and Functional Pain Scale (FPS). The posttest outcome of FLACC for the MT group, which was used for this analysis, had a standard deviation twice the size of the mean for the music group. Consequently, this outcome was the cause for the inconclusive result for music therapy. When I replaced the FLACC data with FPS, the outcome was significant with a moderate effect for the music therapy group (SMD = -0.54, 95% CI, -
0.89, -0.19, p = 0.003) with a robust consistency (I² = 34%). This moderate effect was
128
larger than what was found for the MM group (SMD = -0.38), however no conclusive
conclusion can be drawn at this point due to the small number of MT studies.
Comparison on Emotional Distress from Pain.
There were no music therapy studies that utilized this tool measuring emotional
distress from pain, thus no comparison could be made. MT trials utilized different types
of tools in the psychological domain targeting anxiety, depression, distress, affect, mood,
coping, and sense of control, none of which could be pooled for the current analysis.
Comparisons on Use of Analgesic Agents.
There were no music therapy studies that included anesthetic or non-opioid intake
as treatment outcomes. Hence, I could not conduct a comparison on these variables. In terms of opioid or sedative usage, music therapy did not show a meaningful effect. On the other hand, music medicine showed a small but highly significant and consistent effect in reducing the amount of opioid use, but no significant effect was found for sedative usage. Because there were very few MT studies that measured use of analgesic agents as outcomes, I did not make direct comparisons between MT and MM.
One obvious difference between MT and MM is the general setting where these interventions usually take place. Most MM studies that measured the amount of anesthetics or sedatives were conducted during a medical or surgical procedure. For example, a number of these studies were conducted with patients undergoing surgery under general anesthesia or patients receiving a medical procedure such as colonoscopy under sedation. Obviously, patients can easily listen to music before, during or after these medical interventions, whereas music therapists usually work with the patients before 129
such procedures, not during or right after. Consequently, it appears that a direct comparison between MT and MM using these variables is not possible. Further differences between MT and MM that are relevant to these comparisons will be discussed later in this section.
Comparison on Physiological Measures
There was only one MT study (Ghetti, 2013) that assessed vital signs, and it did not show any meaningful effect across all physiological measures. On the other hand,
MM demonstrated a significant effect in reducing all physiological measures except
mean arterial pressure.
One explanation offered by the researcher (Ghetti, 2013) on the contradictory
results found on vital signs was that the MT intervention utilized in her study involved
active engagement, which appeared to increase autonomic nervous system arousal,
instead of calming it down. From that perspective, it is self-explanatory how one’s body
might react differently to receptive and passive experiences versus active musical
experiences, such as singing, playing instruments, or creating one’s own music. As a
matter of fact, the outcomes in blood pressure and respiration rates all increased in the
MT group within the normal range (Ghetti, 2013). Consequently, further comparisons
between the MM and MT interventions with only one MT study using a fundamentally
different approach seem irrelevant.
On the other hand, excluding the MT study discussed above, the effect of MM on
physiological variables becomes even more prominent. When looking at MM alone, the
mean difference in heart rate improves from -4.25 bpm to -4.28 bpm. The MD of systolic 130
blood pressure changes from -3.34 to -3.42, and diastolic blood pressures changes from -
1.18 to -1.31. Moreover, the decrease in respiration rate changes from -1.46 to -1.71
breaths per minutes. These results are meaningful in that they suggest how music can be effective in influencing physiological functions, and also possibly play an exhilaratory
function when needed with active engagements.
More Discussion on the Differences Between MT and MM
Results from the current analyses suggest that music therapy is more effective in
decreasing patients’ own perception of pain intensity, whereas music medicine is more
effective in decreasing analgesic use and lowering vital signs. This overview of effects
found in this meta-analysis seems to reflect the fundamental differences between music
therapy and music medicine.
In essence, both music therapy and music medicine “rely on the inherent
therapeutic possibilities of music,” (Dileo, 1999, p. 4) but the process and ways in which
music is used are immensely different. In music medicine, patients mainly listen to pre-
recorded music for specific purposes. Thus, good quality music, proper equipment and
appropriate music selections are the most important factors in MM. The goal of music
medicine is narrower in that music is generally used to distract, alleviate tension, and/or
promote relaxation. On the other hand, music therapy “always involves a therapeutic
process, a music therapist, and a relationship that develops through the music and process”
(Dileo, 1999, p. 4). Based on clinical assessment, music therapists employ a wide array of
music experiences to promote individualized goals. Thus, music therapists do not
approach a client only to reduce stress or alleviate pain, because the therapeutic focus is 131
“broader, involving the whole of the patient on many levels” (Dileo, 1999, p. 5). As established in the introduction, pain is a ‘multidimensional and complex phenomenon,’ thus music therapists approach pain from a biopsychosocial perspective. This opens up many possibilities in working with patients who are in pain, because there is no predetermined protocol. Some of the ways music therapists might work with patients who are experiencing pain include emotional expression, cognitive reframing, exploration of fears and worries, enhancement of social support, anxiety and stress management, relaxation, and entrainment of pain (Allen, 2013a; Dileo & Bradt, 1999; Magill, 2001). In summary, what makes music therapy different from music medicine is the role and presence of a therapist, extensive use of live music, utilization of various music experiences, an individually tailored therapeutic process, and a holistic approach.
The purpose of this comparison between MT and MM is not to determine which is better; rather, it is to establish that both interventions have therapeutic value and can benefit patients in different ways. A recent systematic review comparing the role of MT and MM in the pediatric medical setting reported that MM and MT addressed different groups with different medical needs and severity of conditions. Even in the pain studies, all but one MM study reviewed focused on brief and minor procedural pain, such as venipuncture or immunization, whereas MT studies involved patients undergoing painful procedures, such as donor site dressing changes or post-op recovery from orthopedic surgeries (Lee, 2013).
Consequently, Dileo suggests “Both music medicine and music therapy approaches are considered important and necessary for the medical patient, and collaborative approaches
132 between medical personnel and music therapists often provide valuable and rich opportunities for research and clinical practice” (1999, p. 5).
The comparison between MM and MT did not yield a statistically different result, but MT appears to have a stronger effect in reducing self-rated pain intensity. More MT studies are needed in order to compare MM and MT on all other variables. Such comparisons should be made to achieve a fuller understanding of their clinical implications so that more individually tailored and beneficial options can be offered to patients who are in pain.
Discussion on Moderator Variables
Moderator Variable: Types of Pain
Effects of Music Interventions on Different Types of Pain
Music interventions, as a whole, showed the strongest impact on procedural pain, followed by acute pain, then chronic/cancer pain. However, these differences were marginal and far from reaching statistical significance (p = 0.86).
For music therapy, a comparison between the three types of pain was not possible because MT studies did not show significant effects on acute or procedural pain. For acute pain, one of the three MT studies analyzed for acute pain, showed a standard deviation that was bigger than the mean (Schou, 2008); this variability led to an insignificant result (p = 0.07). A sub-analysis of the other two studies (Bradt, 2001;
Ghetti, 2011), however, showed an extremely favorable effect for MT on acute pain (MD
= -2.70, 95% CI -4.65, -0.75, p = 0.007).
133
MM showed significant effects on all three types of pain. Although the difference
was not significant, MM showed the biggest effect on procedural, followed by acute and
chronic/cancer.
An interesting observation can be made from examining these effects in
conjunction with the number of studies conducted on each type. For MT, the order of
meaningful impact seems to be chronic/cancer pain, followed by acute pain, then
procedural pain. For MM, the order is procedural pain, followed by acute pain, then
chronic/cancer pain. These patterns are consistent with the observation made in the
systematic review discussed earlier, which reported that MT addresses more severe types
of pain, whereas MM targets briefer or more minor types of pain (Lee, 2013). On a
similar note, in a meta-analysis of music therapy trials, Standley and Whipple (2003)
reported that music therapy was more effective for patients who were exposed to more invasive and painful conditions.
In terms of pain types, music therapy appears to be more effective in reducing
chronic/cancer pain, whereas music medicine seems to be more effective in managing
procedural pain. The data seem to suggest that the relative benefit of each type of
intervention depends on the type of pain being addressed.
Moderator Variable: Age Groups
Music Interventions Overall on Age Groups
Results from 0-10 pain intensity scales indicate that music interventions are
effective for both adults and children. However, a fairly large difference exists between
their effect estimates (children: MD = -1.65; & adults: MD = -1.1). This difference is not 134 statistically significant, but according to Gallagher et al. (2001), the mean difference in children is clinically significant, whereas the adults’ score is not. Thus, it can be said that children benefit more from the pain-reducing effect of music.
This difference between children and adults was also found in the scores from non
0-10 pain scales. The effect size for children was moderate to strong with some heterogeneity, but it was not significant for adults, and the difference between the groups was significant (p = 0.03). However, there was only one study in each age group, thus this result should be interpreted carefully and considered more as a compliment to what was found previously.
An interesting comparison can be made with the results from other meta-analyses
(Dileo & Bradt, 2005; Tsai et al., 2014). In their analyses of moderators, Tsai et al. found that adults benefited more than children on anxiety and depression measures, however, children benefited more on pain measures (SMD = -0.835 for children vs. SMD = 0.579 for adults). Likewise, Dileo and Bradt also reported discovering a greater overall effect size in studies conducted in the pediatric population (r = 0.39) compared to other (r =
0.12 to r = 0.38) except fetal (r = 0.57) and Alzheimer’s (r = 0.56), although the effect was not based on pain specific outcomes.
Music Interventions Separately on Age Groups
When MT and MM were analyzed separately with age groups as moderators, the difference between children and adults became statistically significant for music therapy
(0-10 scales: p < .0001; other scales: p < 0.03). Because only a few studies were available for this analysis, one should be careful when interpreting the results. Nonetheless, these 135
outcomes seem to suggest that music therapy is highly effective in relieving children’s
self-rated levels of pain intensity.
There was no notable difference between the age groups for MM on 0-10 scales.
For other scales, MM did not show a meaningful effect for adults, whereas it showed a
moderate effect for children, but the difference was not statistically significant (p = 0.39).
As a result, it can be inferred that music therapy is more effective then music medicine
when working with children who are experiencing pain; the between group difference
found in the overall analysis originated from the MT studies.
One of the biggest differences between MT and MM is the different levels of involvement and engagement used in their approaches. The most active engagement one can experience in a MM intervention is talking about and selecting music that the patient likes, which is not enough to address the needs of most children. Froehlich emphasizes that children are “people of action” (1996, p. 17) and that this “action” should be continued in the hospital. Bradt also stressed that music therapists need to provide ample opportunities for active participation when working with children (2013b). In music therapy, children choose music, sing songs, learn and play instruments, record, conduct, perform, interact and play with others, improvise and compose their own music, and move to rhythm and beats. In passive music experiences, children can be engaged by talking, listening, sharing, writing, rewriting and imagining to music. Once again, because pain is a multidimensional phenomenon, data from these analyses appear to support the effectiveness of the active, multisensory and multidimensional approach utilized in music therapy. A further analysis on active versus passive approach in music 136 therapy will be conducted later in this section for all age groups, and will re-illuminate this issue of active engagement in MT intervention.
Data suggest that both music medicine and music therapy have the potential to help adult and pediatric patients suffering from pain. A closer look at the data shows that in general, children benefit more from music than adults do, and more from music therapy than music medicine. However, more studies are needed to confirm these findings, and until then, these data should be interpreted with caution.
Moderator Variable for MM: Levels of Choice in Music Selection
Levels of Choice on Pain Intensity Measured by 0-10 Scales
The result of this moderator analysis suggests that all three types of music selection are effective in reducing the perceived level of pain. However, a comparison between the sub-types reveals that the researcher-chosen (RC) music brings a greater reduction in pain than the other types of music. The difference is significant clinically but not statistically (p = 0.60).
This outcome is partially consistent with the result from another meta-analysis
(Cepeda et al., 2006), which found that participants who listened to RC music exhibited a significant reduction in pain whereas participants who had a choice did not. It is very interesting to see that RC music has been found to be more effective than PP music in both meta-analyses using the same 0-10 scales. One may explain this difference by pointing out that RC music improves the methodological consistency in the intervention and minimizes heterogeneity arising from musical variations. However, in this study, RC music showed a greater variability (I² = 97%) than other types (I² = 74-91%). Another 137
interesting result to consider is that PP music has been found to be more effective than
RC music in reducing anxiety in two different meta-analyses (Bradt et al., 2013; Tsai et
al., 2014). These findings seem to suggest that consistency in the intervention may not
explain this result; otherwise, RC music would have been more effective in reducing
anxiety as well.
Levels of Choice on Analgesic Use
According to these analyses, PC music seems more effective in reducing the amount of anesthetics and opioids than RC or PP music. In terms of non-opioid intake, excluding PC music due to lack of data, PP music shows a greater effect than RC music.
No significant effects were found for the use of sedatives. However, based on a
preliminary overview of the confidence intervals and average effect sizes for comparative
purposes, it can be inferred that PP music is more effective than RC music in reducing
the amount of sedative use. Prior meta-analytic results suggest that PP music is more
effective in relieving state anxiety (Bradt et al., 2013; Tsai et al., 2014); this result for
sedatives seems to coincide with that finding, because lower levels of state and trait
anxiety have been reported to be associated with a lower amount of propofol use (Kil et
al., 2012).
Levels of Choice on Physiological Measures
PP music shows a greater effect in lowering heart rate, systolic blood pressure
(SBP) and diastolic blood pressure (DBP). Interestingly, PC music, which was associated
with the reduction of anesthetic and opioid use, seems least effective in lowering vital
signs. In this analysis, PC music raised heart rate by 2.6 bpm, whereas PP music 138
decreased it by 5.02 bpm. The increase was not significant, but was consistent among the
three studies analyzed (I² = 13%). This hyperarousal of the autonomic nervous system
appears to be due to the use of stimulative music, because it has been reported that
participants are likely to select popular music when asked to bring their own music
(MacDonald et al., 2003).
PC or RC music had no influence on either type of blood pressure, whereas PP
music showed moderately strong effectiveness in lowering both types of blood pressure.
No conclusion could be drawn on respiration rate because there were too few studies
analyzed.
More Discussion on the Levels of Choice as Moderators
In summary, RC music is found to be most effective in lowering the perceived
level of pain, whereas PC music is more influential in the use of anesthetics and opioids.
On the other hand, PP music is most effective in lowering heart rate, systolic blood
pressure and diastolic blood pressure. Such unexpected, even-split results bring many
questions about the mechanisms underlying these effects. However, most theories are still
unproven, and the mechanisms involved are poorly understood (Bradt, 2010; Burns, 2012;
Dileo, 1999).
In examining the reasons for these differences, it seems helpful to lay out first the
essential differences between the three types of music. The main difference between RC,
PP and PC music is that RC and PP music are supposedly selected carefully with a therapeutic intent (i.e., pain or anxiety reduction). I used the word ‘supposedly,’ because I
have found that this was not practiced in almost half of the included studies. Anyhow, in 139 the case of PC music, it is generally selected based on the personal tastes of the individual patient, not necessarily with a therapeutic intent or based on specific guidelines. Hence, the RC and PP music are likely to have qualities that are within specific musical parameters in terms of their therapeutic effect.
On the other hand, PC music is mainly selected based on the individual patient’s preference and familiarity with the music. In that sense, participants are likely to choose pieces that are interesting, evocative or meaningful to them. Due to this personal relationship with PC music, it may be the most enjoyable and attention grabbing of all.
PP music is a remedial option that partially meets the essential qualities of both RC and
PC music. Because PP music is likely to be chosen based on a therapeutic rationale, this could be the driving force behind therapeutic change. Offering choices that are closer to patients’ tastes in terms of genre, styles, instruments and/or artists, PP music may create opportunities to ‘meet them where they are’ by offering familiar music. This concept is very important in therapeutic work, however, it has been pointed out that many researchers provide too few choices leading participants to choose the ‘least disliked’ music instead of preferred music (Dileo & Bradt, 2005).
In looking at all the relationships found between the use of analgesia and PC music, and the autonomic nervous system and PP music, I have made informal observations based on what has been postulated by theorists and these outcomes. My intent is to make inferences about these connections based on the available information, not to examine or test the theories.
140
Based on my observations, the principles of iso and entrainment (Dileo & Bradt,
1999) may be playing a role in the relationship found between PP music and the
autonomic nervous system. Perhaps, offering music that matches the patient’s taste
creates a point of matching and connection, which then enables the music to entrain and
regulate physiological responses through the musical qualities intended for therapeutic
change.
PC music and its relationship with decreased opioid and anesthetic use may be explained by the bottom up the Gate Control theory where strong aural and vibrational stimulations mask noxious sensations. Also, researchers in neuroscience have discovered that music activates certain neural pathways in the brain which alters and generates endorphin and endogenous opiates (Lin et al., 2011). Interestingly, in one study, the production of B-endorphin was associated with listening to techno music, not classical music, among high school students (Gerra et al., 1998). Thus, considering that a majority of participants have chosen a stimulative type of music for PC music, their choice of music might have produced more natural pain-reducing agents, leading to a reduction in anesthetic and opioid use.
The relationship between the perception of pain intensity and RC music seems more complicated, and therefore I could not make an inference based on one particular theory. It could be due to experimenter bias, response bias, or participants’ raised expectation of the presented music intervention. Undoubtedly, more in-depth investigations are needed.
141
Providing choices in MM has been confirmed as a moderator variable. RC music
may be more effective in reducing the perceived level of pain intensity, but PC music
seems more influential in the amount of anesthetic and opioid use. On the other hand, PP music is more effective in regulating nervous system hyperarousal. More research is
needed in order to identify mechanisms behind these effects for better clinical and
research practice.
Moderator Variable for MM: Rationale for Selection of Music
Rationale for Selection of Music on Pain Intensity
The difference between MM studies that have a clear rationale for selection of
music and those without is remarkably large as they are both clinically and significantly
different (p = 0.008). Because this finding is based on the pooled data of 68 studies
involving 5,991 participants, the role of a rationale for selection of music seems extremely meaningful. Thus, it can be stated that careful selection of music based on prior research, expert opinion and musical parameters of clinically effective music can significantly increase the internal validity of music medicine.
Rationale for Selection of Music on the Amount of Analgesic Use
Due to limited data, no evidence was found that music selected according to a rationale is more effective in reducing the use of anesthetics. However, carefully selected music with a rationale is found to be more effective in reducing opioid and non-opioid intake than music without a rationale, and the outcome on opioids shows a greater consistency as well. Although the effect size itself was not significant due to a large confidence interval, the music group with a rationale showed a greater effect in reducing 142
the amount of sedative use. Consequently, it can be postulated that MM developed with a
rationale is more effective in reducing the amount of overall analgesic use.
Rationale for Selection of Music on Physiological Measures
Data suggest that music selected with a rationale is more effective in lowering
vital signs. The difference is statistically significant for respiration (p = 0.03), and highly
consistent for systolic blood pressure (I² = 0%). The group with a rationale showed, on
average, a 3.16 bpm lower heart rate, 2.95 mmHg lower SBP, 0.36 mmHg lower DBP, 7
mmHg lower MAP, and 2.53 fewer breaths per minutes on respiration than the group without a rationale. As a result, it can be concluded that music selected according to a rationale can increase the effectiveness of music in relieving physiological hyperarousal.
More Discussion on a Rationale for Selection of Music as Moderators
Burns (2012) emphasized the importance of providing a rationale or theoretical framework for the selection of music, delivery method, role of music, and mechanisms for outcomes. In her review of 22 music medicine studies investigating the effect of music on cancer patients, she found that almost none of the studies provided a rationale or theoretical framework for their music intervention, and only nine of the 22 studies provided a theoretical background for the targeted outcome. In addition, she reported that studies with a theoretical framework were more likely to produce statistically meaningful results (75%). Although the current study did not investigate whether studies provided a theoretical framework for intended outcomes, these results are consistent in that the
establishment of a rationale for the therapeutic process improves the treatment outcome.
143
Another important matter for music medicine and music therapy researchers relates to following the comprehensive guidelines for reporting developed by Robb et al. (2011).
Using a rationale for the selection of music has been established as a significant moderator in MM practice. Hence, it is highly important to make a clinically- and theoretically-informed decision when preparing music for MM interventions. In addition, it is important to fully report essential components of clinical trials and music interventions by following available guidelines.
Moderator Variable for MT: Active vs. Passive Approach
Active vs. Passive MT Approach on Pain Intensity
A comparison of the two MT approaches suggests that the active approach is more effective than the passive approach in reducing the perceived level of pain.
Although the difference between the two approaches was not statistically significant, the mean difference in the active approach was clinically meaningful, whereas the MD of the passive approach was not. The difference between the two approaches was 0.97 units.
Considering the fact that the confidence interval of the 0-10 scales was -0.82 to -1.44, this difference seems large. Moreover, the mean difference of -2.15 in the active MT group is the largest mean difference of all analyses in this study. Therefore, it can be concluded that an active MT approach is the most effective intervention of all.
An additional analysis was conducted excluding one exceptionally effective study involving children (Bradt, 2001), leaving studies of adults only to see if the difference persists. The result also favors the effectiveness of an active approach, and indicates that the change score remains clinically significant (MD = -1.73, 95% CI -2.74, -0.72). The 144
importance of an active approach has been discussed previously in the analysis of age
groups as a moderator. The result from the second test also supports that an active
approach may be more effective for adults as well.
Previous meta-analyses have also compared active interventions with passive
interventions, but they were not limited to music therapy, meaning that MM studies were
included in the passive approach group. Nevertheless, the directions found were all identical, favoring the effectiveness of an active approach over a passive approach (Dileo
& Bradt, 2005; Standley & Whipple, 2003; Tsai et al., 2014).
As previous meta-analyses have suggested, the results of the current study suggests that an active approach, such as recreative experience, is more effective in
relieving the perceived level of pain intensity. Because this result is based solely on MT
studies, this may have an important clinical implication for music therapists working with
patients who are experiencing pain.
Methodological Moderators
Randomization & Allocation Concealment on 0-10 Pain Intensity Scales
Studies using proper methods of randomization and allocation concealment for
minimizing selection bias display a more robust effect estimate (MD = -0.97) for
reduction in pain intensity than those studies that do not fulfill one or more proper methods (MD = -1.18). This result is consistent with other meta-analyses that found a smaller effect size for studies with higher methodological integrity (Bradt, Dileo, Grocke,
& Magill, 2011; Dileo & Bradt, 2005).
145
Because high heterogeneity still remained even after grouping the studies with
higher methodological standards, I conducted a sensitivity analysis using the studies that
properly implemented six or more items on the risk of bias including randomization and
allocation concealment. There were 12 studies that implemented six or more of the eight
items below that assessed the risk of bias: (1) randomization; (2) allocation concealment;
(3) blinding of researchers; (4) blinding of participants; (5) blinding of objective
assessors; (6) intention-to-treat analysis; (7) selective reporting; and (8) other biases. The
results of these 12 studies did not indicate a lower level of heterogeneity (I² = 95%), but showed a stronger pain-reducing effect (MD = -1.32, 95% CI -2.30, -0.35, p = 0.008), and this outcome was clinically meaningful. There were four studies (Nguyen, Nilsson,
Hellström, & Bengtson, 2010; Simcock et al., 2008; Szmuk et al., 2008; Yu, Liu, Li, &
Ma, 2009) that implemented seven or more items of the assessment, indicating even higher methodological rigor, and the result of this analysis yielded the strongest effect size and consistency (MD = -1.94, 95% CI -2.66, -1.23, p < .0001, I² = 0%). This was an
interesting finding, as the studies with lower selection bias showed a more robust effect
estimate, yet implementation of blinding increased the effect size and consistency. It
seems to indicate that methodological quality may be responsible for amplifying and causing inconsistent results.
Blinding Objective Assessors on Observational Pain Measures
The outcome of this analysis seems to suggest that there is a potential detection bias in play as the effect size of the studies that didn’t used blinding is medium to large,
whereas it is small to medium for the blinded group. Of the six studies analyzed, all of 146
them focused on children except for one study by Gutgsell et al. (2013). Thus, an
additional analysis was conducted excluding this study. In this analysis, the difference
between the studies that used proper blinding (SMD = -0.62, 95% CI -1.01, -0.22, p =
0.002) and studies that did not blind assessors (SMD = -0.72, 95% CI-1.47, 0.02, p = 0.06)
became negligible. Thus, according to this outcome, it appears that blinding outcome
assessors may produce unbiased outcomes, but does not impact effect sizes to any great
degree.
The results of these analyses of methodological moderators suggest that selection
or detection bias may be present and may skew clinical outcomes; however the actual
impact on effect estimates is minimal. On the other hand, a sub-analysis indicated that
studies with the highest methodological qualities yielded the strongest evidence with zero
heterogeneity. Nevertheless, it is important to continue to conduct risk of bias assessment,
and interpret results accordingly.
Limitations of the Study
Despite numerous efforts to uncover consistent pain reducing effects of music, a great portion of the findings yielded highly heterogeneous outcomes. Moreover, a few sub-analyses particularly some involving MT included only a few studies, thus weakening the external validity of the results. Thus, it is essential to interpret the results from this study with caution.
Because no comprehensive meta-analysis on music and pain has been conducted on studies published on or after 2005, I invested extra time searching many databases
with wide search parameters without restrictions. In addition I also conducted extensive 147
hand and online searches and contacted experts in the field. Thus, this study became one
of the largest meta-analyses focusing on a particular outcome in MM and MT research.
However, due to the inevitable language restrictions, there were a good number of studies
that could not be included. In addition, because I could not access foreign databases in
languages other than English and Korean, there may be undiscovered clinical trials that meet the inclusion criteria of this study in other languages.
One of the criteria for evaluating methodological quality of systematic reviews is the implementation of ‘double extraction.’ Because this study was conducted for my doctoral dissertation, I could not collaborate with other researchers in extracting and comparing data.
There were multiple studies that did not report essential information, which prevented them from being included in this meta-analysis. Initially, I attempted to contact a few researchers regarding missing data, but more than half did not respond or took many weeks to respond. Due to the time constraints and timelines for completing extraction and analysis, obtaining missing data from those studies became impossible.
Hence, I could not include studies with missing data in this study.
Implications for MM and MT Practice
Referrals for MM and MT
The results of this meta-analysis present numerous suggestions for current MM and MT practice. In general, the results demonstrate that MT is more effective in reducing severe pain as opposed to less severe pain, whereas MM is more beneficial in
reducing briefer and milder forms of pain and lowering the use of analgesic agents and 148
vital signs. Hence, these findings may be useful to medical professionals who make
referrals for music therapy. MT may be recommended to patients who are suffering from
moderate to severe levels of acute or cancer/chronic pain. On the other hand, MM can be
provided to patients who are experiencing mild to moderate levels of acute or procedural
pain due to medical or surgical procedures. Because MT is highly effective for children,
priority needs to be given to pediatric patients when working with limited time and resources.
Implications for MT Intervention
Active engagement in MT is found to be more effective in reducing pain intensity.
On the other hand, an active approach seems to be associated with hyperarousal of the autonomic nervous system. Therefore, music therapists need to collaborate with the treatment team even more closely when determining clinical goals, and continue to implement individually-tailored approaches and music experiences. Because MM is also beneficial for patients, music therapists need to offer MM and provide equipment to all of their patients, so that patients can utilize music whenever they need it.
Implications for MM Intervention
Research has demonstrated that music selected based on a clinical rationale improves the effect of MM on pain intensity, opioid, non-opioid intake, and overall vital signs. In order to provide a more effective MM intervention, one must select music based on a clear rationale and therapeutic intent. This means that it is imperative to study the existing literature, consult experts in the field, and select music based on certain musical parameters set forth by clinicians and researchers in the field. 149
If music is selected carefully based on the above mentioned criteria, music chosen by medical personnel can be beneficial in reducing the perceived level of pain. However, offering choices to patients in terms of their preferred genre, style or instrument can lead to greater range of benefits in terms of psychological (i.e., anxiety, distress, & depression), physiological (i.e., vital signs), and sensation (i.e., pain intensity) aspects of pain.
Selecting music based on specific requests made by patients or music brought from their personal collection may have a small to moderate effect in reducing the perception of pain. However research shows that such personally chosen music has a greater impact on reducing the amount of anesthetic and opioid use. Consequently, it may be ideal to provide patient-preferred music prior to medical procedures or surgeries then switch to patient-chosen music during or after procedures.
Recommendations for Future Research
Recommendations for All Types of Research Studies
The effect of music on pain intensity is one of the few areas that has been investigated quite extensively in the medical setting. However, there seems to be a disproportionate number of studies in certain areas. Specifically, there are numerous MM studies conducted in the areas of procedural and acute pain, but very few in the areas of chronic and cancer pain. In terms of medical specialty, more studies are needed in pediatrics, neonatology, oncology, hospice, and intensive care. For MT research, more clinical trials are needed in all areas and settings.
150
The survey of general characteristics of the included studies revealed that MM
and MT are generally differentiated more accurately in the West than in Asia. The fact
that music therapy as a health profession is much newer in Asia may explain why the
confusion over terminology is more localized to this area. Also, it may be due to
translation. I found several articles from Korea that referred to their interventions as
‘music therapy’ only when translated into English. Consequently, future studies in MM
and MT need to educate the public, medical community and researchers regarding the
distinction between MM and MT in order to promote research and clinical advancement
of both valuable and important music interventions in the medical setting.
Specific Recommendations for Future Meta-Analyses
First, prospective meta-analyses on music and pain will need to address some of
the methodological limitations of this study by employing double extraction; including
studies reported in all languages; and obtaining missing data by contacting authors.
Second, additional moderator analyses or sub-analyses may lead to the discovery
of other sources of heterogeneity. Regarding the research method, it may be necessary to
compare studies by following potential moderators: medical populations; areas of
medical specialty; timing of outcome measurement; severity of pain levels; levels of
consciousness/sedation during MM for procedural pain by levels of choice (i.e., RC, PP,
PC music) or styles of music (i.e., sedative vs. stimulative); randomization level (i.e., including qRCT); and presence of sample size calculation.
In terms of music medicine interventions, additional analyses on the following variables may be informative: frequency and duration of interventions; delivery method 151
(i.e., headphones or speakers); time point of music listening in surgical setting (i.e., before, during, after or all throughout surgery); theoretical framework for intervention; and rationale for selection of music.
Due to the limited number of currently available randomized trials in music therapy, further analyses in MT may not be feasible. The differences between MM and
MT illustrate why there are substantially fewer MT studies than MM trials. In order to successfully complete more RCTs in MT, music therapists need to develop ways to standardize or streamline its practice in order to minimize individual variances;
collaborate more closely with other medical staff, so blinding and independent data
collection can be achieved; utilize wait-list control groups or crossover design, so patients
in control conditions receive equal care; and educate medical staff and seek active
cooperation, so research sessions can be conducted without frequent interruptions.
Nevertheless, if more studies become available, meta-analytic comparisons on the
following variables may be considered: single therapist vs. more than one therapist;
duration and frequency of sessions; timing of interventions; types of active engagement
in music (i.e., playing, singing, composing, improvising, etc.); and therapeutic theoretical
framework.
Finally, systematic reviews need to be conducted and reported in accordance with
generally accepted assessment and reporting guidelines, such as AMSTAR (Shea et al.,
2007) and PRISMA(Moher, Liberati, Tetzlaff, Altman, & PRISMA Group, 2009).
152
Specific Recommendations for Future MM and MT Clinical Trials
During my inspection of over 350 full-text articles, I came across many different
styles of reporting and numerous articles with missing information. This resulted in much confusion and the exclusion of several eligible studies. Hence, researchers need to fully report essential information about the demographic, methodological; statistical and clinical aspects of their investigations. For that, it is helpful to follow reporting guidelines for RCTs (Schulz, Altman, Moher, & CONSORT Group, 2010) and guidelines for clinical trials based on music interventions (Robb, Burns, & Carpenter, 2011).
As observed in this meta-analysis, the efficacy of music interventions on pain has been extensively investigated using the 0-10 pain intensity scales. These rating scales have been widely implemented because they are simple and easy to use. However, they are quite limited in terms of assessing the multidimensional aspects of pain because they only measure pain intensity. In order to provide more clinically relevant information, researchers need to develop and/or administer additional measures in order to approach pain from a more comprehensive and multidimensional perspective (McGuire, 1992).
This incorporation of more comprehensive measurements encompassing emotional and psychosocial pain is especially important for patients suffering from chronic and cancer pain (Hølen et al., 2006; McGuire, 1992).
The results of this study suggest that higher methodological standards for clinical trials not only yield unbiased outcomes, but also can increase the effect estimates.
Consequently, it is essential to improve the methodological rigor by adopting proper methods of randomization, allocation concealment, and blinding of researchers and data 153
assessors. Blinding of participants is not possible in MT, but can be achieved for MM studies, if music is provided when patients are sedated or under general anesthesia.
Blinding of interventionists is not easy, but MM researchers can provide headphones to both groups and use blank CDs or silent tracks on MP3 players. Blinding outcome
assessors can be achieved by implementing outcome assessment at a different time point
by an independent assessor; video-recording sessions and either masking sound or
inserting sound to all conditions; or using physiological markers measured by
independent blinded assessors.
The fact that there are numerous studies with high standard deviations indicates
that there are individual variances among participants. This does not rule out incidences
where certain music interventions are contraindicated for certain individuals. It is
possible that one may become overly stimulated, emotional or somehow disturbed by the
experiences. Consequently, researchers need to keep a record of such incidences and
report whether there were any adverse effects found during their investigation.
Considering how many variables exist within the music intervention alone, researchers
need to be receptive to all types of individual variances. One should keep in mind that
patients experiencing excruciating pain may respond in unusual way to certain sounds,
instruments, movements, volume, duration of exposure, equipment, relaxation techniques,
and/or imagery.
More research is needed in order to identify the specific types of music or music
experiences that lead to the particular therapeutic outcomes found in this study. Such an
154
investigation can be conducted by comparing various types of music, intervention strategies and/or music therapy experiences on particular treatment outcomes.
One of the factors that contributes to largely heterogeneous findings is the lack of theoretical framework or poorly understood mechanisms of action regarding music’s effects. Thus, more research is needed in developing theories and identifying the therapeutic mechanisms involved in MM and MT practice.
Lastly, in order to better understand the effect of music on the multidimensional aspects of pain, qualitative and mixed method research studies are needed to fill the gaps and to identify further areas that need to be investigated.
155
REFERENCES
* indicates studies included in the review of systematic reviews †indicates studies included in the meta-analysis
ABC News, USA Today, & Stanford Medical Center. (2005). Poll: Broad experience with pain sparks a search for relief ABC News. Available from http://paincenter.stanford.edu/press/external/2005-05usatodaypollpressrelease.pdf.
†Abraham, A., & Drory, V. E. (2014). Listening to music during electromyography does not influence the examinee's anxiety and pain levels. Muscle & Nerve, 50(3), 445-447.
Adler, R. H. (2009). Engel's biopsychosocial model is still relevant today. Journal of Psychosomatic Research, 67(6), 607-611. doi:10.1016/j.jpsychores.2009.08.008
†Ajorpaz, N. M., Mohammadi, A., Najaran, H., & Khazaei, S. (2014). Effect of music on postoperative pain in patients under open heart surgery. Nursing and Midwifery Studies, 3(3), 1-6. doi:10.5812/nms.20213
Akobeng, A. K. (2005). Understanding systematic reviews and meta-analysis. Archives of Disease in Childhood, 90(8), 845-848. doi:10.1136/adc.2004.058230
Allen, J. (2013a). Pain management with adults. In J. Allen (Ed.), Guidelines for music therapy practice in adult medical care (pp. 35-61). University Park, IL: Barcelona Publishers.
Allen, J. (2013b). Guidelines for music therapy practice in adult medical care. University Park, IL: Barcelona Publishers.
†Allred, K. (2007). The impact of music on postoperative pain and anxiety . (2009982573).
†Allred, K. D., Byers, J. F., & Sole, M. L. (2010). The effect of music on postoperative pain and anxiety. Pain Management Nursing, 11(1), 15-25.
American Pain Society. (2006). Pain control in the primary care setting. Glenview, IL: American Pain Society.
American Psychological Association. (2010). Publication manual of the american psychological association. Washington, DC: American Psychological Association.
Anderson, K. O., Green, C. R., & Payne, R. (2009). Racial and ethnic disparities in pain: Causes and consequences of Unequal care. Journal of Pain, 10(12), 1187-1204. doi:10.1016/j.jpain.2009.10.002
Anderson, K. O., Richman, S. P., Hurley, J., Palos, G., Valero, V., Mendoza, T. R., . . . Cleeland, C. S. (2002). Cancer pain management among underserved minority outpatients. Cancer, 94(8), 2295-2304. doi:10.1002/cncr.10414 156
†Angioli, R., De, C. N., Plotti, F., Cafà, E. V., Dugo, N., Damiani, P., . . . Terranova, C. (2014). Use of music to reduce anxiety during office hysteroscopy: Prospective randomized trial. Journal of Minimally Invasive Gynecology, 21(3), 454-459. doi:10.1016/j.jmig.2013.07.020
Archie, P., Bruera, E., & Cohen, L. (2013). Music-based interventions in palliative cancer care: A review of quantitative studies and neurobiological literature. Supportive Care in Cancer, 21(9), 2609-2624. doi:10.1007/s00520-013-1841-4
ASPMN. (2010). Optimizing the treatment of pain in patients with acute presentations (position paper). Olathe, KS: American Society for Pain Management Nursing. Available from http://www.aspmn.org/documents/OptimizingPositionPaper.pdf
†Ayoub, C. M., Rizk, L. B., Yaacoub, C. I., Gaal, D., & Kain, Z. N. (2005). Music and ambient operating room noise in patients undergoing spinal anesthesia. Anesthesia and Analgesia, 100(5), 1316-1319. doi:10.1213/01.ANE.0000153014.46893.9B
†Bally, K., Campbell, D., Chesnick, K., & Tranmer, J. E. (2003). Effects of patient-controlled music therapy during coronary angiography on procedural pain and anxiety distress syndrome. Critical Care Nurse, 23(2), 50-58.
†Bansal, P., Kharod, U., Patel, P., Sanwatsarkar, S., Patel, H., & Kama, T. H. (2010). The effect of music therapy on sedative requirements and haemodynamic parameters in patients under spinal anaesthesia; A prospective study. Journal of Clinical and Diagnostic Research, 4(4), 2782-2787.
Bao, Y., Kong, X., Yang, L., Liu, R., Shi, Z., Li, W., . . . Hou, W. (2014). Complementary and alternative medicine for cancer pain: An overview of systematic reviews. Evidence-Based Complementary and Alternative Medicine, 2014, 170396.
*Bardia, A., Barton, D. L., Prokop, L. J., Bauer, B. A., & Moynihan, T. J. (2006). Efficacy of complementary and alternative medicine therapies in relieving cancer pain: A systematic review. Journal of Clinical Oncology, 24(34), 5457-5464.
Bardiau, F. M., Braeckman, M. M., Seidel, L., Albert, A., & Boogaerts, J. G. (1999). Effectiveness of an acute pain service inception in a general hospital. Journal of Clinical Anesthesia, 11(7), 583-589. doi:10.1016/S0952-8180(99)00101-4
†Beaulieu-Boire, G., Bourque, S., Chagnon, F., Chouinard, L., Gallo-Payet, N., & Lesur, O. (2013). Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward-a prospective interventional randomized crossover trial. Journal of Critical Care, 28(4), 442-450.
†Bechtold, M. L., Perez, R. A., Puli, S. R., & Marshall, J. B. (2006). Effect of music on patients undergoing outpatient colonoscopy. World Journal of Gastroenterology, 12(45), 7309-7312.
*Bechtold, M. L., Puli, S. R., Othman, M. O., Bartalos, C. R., Marshall, J. B., & Roy, P. K. (2009). Effect of music on patients undergoing colonoscopy: A meta-analysis of randomized controlled trials. Digestive Diseases and Sciences, 54(1), 19-24. doi:10.1007/s10620-008- 0312-0 157
Beck, C. T. (1995). The effects of postpartum depression on maternal-infant interaction: A meta- analysis. Nursing Research, 44(5), 298-305. doi:10.1097/00006199-199509000-00007
†Bellieni, C. V., Cioncoloni, D., Mazzanti, S., Bianchi, M. E., Morrone, I., Becattelli, R., . . . Buonocore, G. (2013). Music provided through a portable media player (iPod) blunts pain during physical therapy. Pain Management Nursing, 14(4), e151-e155.
†Binns-Turner, P. (2008). Perioperative music and its effects on anxiety, hemodynamics, and pain in women undergoing mastectomy . (2010155023).
†Binns-Turner, P., Wilson, L. L., Pryor, E. R., Boyd, G. L., & Prickett, C. A. (2011). Perioperative music and its effects on anxiety, hemodynamics, and pain in women undergoing mastectomy. AANA Journal, 79(4), S21-S27.
†Blankfield, R. P., Zyzanski, S. J., Flocke, S. A., Alemagno, S., & Scheurman, K. (1995). Taped therapeutic suggestions and taped music as adjuncts in the care of coronary-artery-bypass patients. American Journal of Clinical Hypnosis, 37(3), 32-42.
Borenstein, M., Hedges, L. V., Higgins, J. P. T., & Rothstein, H. R. (2009). Introduction to meta- analysis. Hoboken, NJ: Wiley.
†Bradt, J. (2001). The effects of music entrainment on postoperative pain perception in pediatric patients. (Unpublished Temple University, (2003084882)
Bradt, J. (2010). The effects of music entrainment on postoperative pain perception in pediatric patients. Music and Medicine: An Interdisciplinary Journal, 2(3), 150-157.
Bradt, J. (2013a). Guidelines for music therapy practice in pediatric care. University Park, IL: Barcelona Publishers.
Bradt, J. (2013b). Pain management with children. In J. Bradt (Ed.), Guidelines for music therapy practice in pediatric care (pp. 15-65). University Park, IL: Barcelona Publishers.
*Bradt, J., Dileo, C., & Potvin, N. (2013). Music for stress and anxiety reduction in coronary heart disease patients. The Cochrane Database of Systematic Reviews, 12, CD006577.
*Bradt, J., Dileo, C., Grocke, D., & Magill, L. (2011). Music interventions for improving psychological and physical outcomes in cancer patients. The Cochrane Database of Systematic Reviews, (8), CD006911.
Bradt, J., Magee, W., Dileo, C., Wheeler, B., & McGilloway, E. (2010). Music therapy for acquired brain injury. Cochrane Database of Systematic Reviews, (7) doi:10.1002/14651858.CD006787.pub2
Brennan, F., Carr, D. B., & Cousins, M. (2007). Pain management: A fundamental human right. Anesthesia and Analgesia, 105(1), 205-221. doi:10.1213/01.ane.0000268145.52345.55
†Broscious, S. K. (1997). Music: An intervention for pain during chest tube removal after open heart surgery (D.S.N.). Available from ProQuest Dissertations & Theses A&I. (304351898). 158
†Broscious, S. K. (1999). Music: An intervention for pain during chest tube removal after open heart surgery. American Journal of Critical Care, 8(6), 410-415.
Bruscia, K. E. (1998). Defining music therapy. Gilsum, NH: Barcelona Publishers.
Burns, D. S. (2012). Theoretical rationale for music selection in oncology intervention research: An integrative review. Journal of Music Therapy, 49(1), 7-22. doi:10.1093/jmt/49.1.7
*Cepeda, M. S., Carr, D. B., Lau, J., & Alvarez, H. (2006). Music for pain relief. The Cochrane Database of Systematic Reviews, (2), CD004843.
†Cepeda, M. S., Diaz, J. E., Hernandez, V., Daza, E., & Carr, D. B. (1998). Music does not reduce alfentanil requirement during patient-controlled analgesia (PCA) use in extracorporeal shock wave lithotripsy for renal stones. Journal of Pain & Symptom Management, 16(6), 382-387.
†Chan, M. F. (2007). Effects of music on patients undergoing a C-clamp procedure after percutaneous coronary interventions: A randomized controlled trial. Heart & Lung, 36(6), 431-439.
†Chan, M. F., Wong, O. C., Chan, H. L., Fong, M. C., Lai, S. Y., Lo, C. W., . . . Leung, S. K. (2006). Effects of music on patients undergoing a C-clamp procedure after percutaneous coronary interventions. Journal of Advanced Nursing, 53(6), 669-679. doi:10.1111/j.1365- 2648.2006.03773.x
Chang, C. (2012). Dynamic pain assessment: An application of clinical infometrics to personalized pain treatment and management. In R. J. Moore (Ed.), Handbook of pain and palliative care: Biobehavioral approaches for the life course (pp. 121-130). New York, NY: Springer New York. doi:10.1007/978-1-4419-1651-8_17
†Chiang, L. (2012). The effects of music and nature sounds on cancer pain and anxiety in hospice cancer patients
†Chlan, L., Evans, D., Greenleaf, M., & Walker, J. (2000). Effects of a single music therapy intervention on anxiety, discomfort, satisfaction, and compliance with screening guidelines in outpatients undergoing flexible sigmoidoscopy. Gastroenterology Nursing, 23(4), 148- 156.
Chronister, J. A., Chan, F., Cardoso, E. d. S., Lynch, R. T., & Rosenthal, D. A. (2008). The evidence-based practice movement in healthcare: Implications for rehabilitation. Journal of Rehabilitation, 74(2), 6.
†Clark, M., Isaacks-Downton, G., Wells, N., Redlin-Frazier, S., Eck, C., Hepworth, J. T., & Chakravarthy, B. (2006). Use of preferred music to reduce emotional distress and symptom activity during radiation therapy. Journal of Music Therapy, 43(3), 247-265.
Cliff, B. (2012). The evolution of patient-centered care. Journal of Healthcare Management, 57(2), 86. 159
Cohen, J. (1988). Statistical power analysis for the behavioral sciences. Hillsdale, N.J: L. Erlbaum Associates.
†Costa, A., Montalbano, L. M., Orlando, A., Ingoglia, C., Linea, C., Giunta, M., . . . D'Amico, G. (2010). Music for colonoscopy: A single-blind randomized controlled trial. Digestive & Liver Disease, 42(12), 871-876.
Coulling, S. (2007). Fundamentals of pain management in wound care. British Journal of Nursing, 16(11), S4-6, S8, S10 passim.
†Danhauer, S. C., Marler, B., Rutherford, C. A., Lovato, J. F., Asbury, D. Y., McQuellon, R. P., & Miller, B. E. (2007). Music or guided imagery for women undergoing colposcopy: A randomized controlled study of effects on anxiety, perceived pain, and patient satisfaction. Journal of Lower Genital Tract Disease, 11(1), 39-45.
†Danhauer, S. C., Vishnevsky, T., Campbell, C. R., McCoy, T. P., Tooze, J. A., Kanipe, K. N., . . . Cruz, J. (2010). Music for patients with hematological malignancies undergoing bone marrow biopsy: A randomized controlled study of anxiety, perceived pain, and patient satisfaction. Journal of the Society for Integrative Oncology, 8(4), 140-147.
Davies, J., & McVicar, A. (2000). Issues in effective pain control. 1: Assessment and education. International Journal of Palliative Nursing, 6(2), 58-65.
Davis, W. B., Gfeller, K. E., & Thaut, M. H. (2008). An introduction to music therapy: Theory and practice. Silver Spring, Md: American Music Therapy Association.
Dileo, C. (1997). Reflections on medical music therapy: Biopsychosocial perspectives of the treatment process. In J. Loewy (Ed.), Music therapy and pediatric pain (pp. 125-144). Cherry Hill, NJ: Jeffrey Books.
Dileo, C. (1999). Music therapy and medicine: Theoretical and clinical applications. Silver Spring, MD: American Music Therapy Association.
Dileo, C. (2006). Effects of music and music therapy on medical patients: A meta-analysis of the research and implications for the future. Journal of the Society for Integrative Oncology, 4(2), 67-70.
Dileo, C., & Bradt, J. (1999). Entrainment, resonance, and pain-related suffering. In C. Dileo (Ed.), Music therapy and medicine: Theoretical and clinical applications (pp. 181-188). Silver Spring, MD: American Music Therapy Association.
Dileo, C., & Bradt, J. (2005). Medical music therapy: A meta-analysis & agenda for future research. Cherry Hill, N.J: Jeffrey Books.
Dolin, S. J., Cashman, J. N., & Bland, J. M. (2002). Effectiveness of acute postoperative pain
management: I. evidence from published data. British Journal of Anaesthesia, 89(3), 409- 423. doi:10.1093/bja/aef207 160
Drugs.com. (n.d.). Propofol. Auckland, New Zealand: Drugs.com. Available from http://www.drugs.com/pro/propofol.html.
Durlak, J. A., Meerston, I., & Foster, C. (2003). Meta-analysis. In J. Thomas, & M. Hersen (Eds.), Role of systematic reviews and meta-analysis in evidence-based medicine (pp. 243-270). Mahwah, NJ: Lawrence Erlbaum Associates.
Ebneshahidi, A., & Mohseni, M. (2008). The effect of patient-selected music on early postoperative pain, anxiety, and hemodynamic profile in cesarean section surgery. Journal of Alternative & Complementary Medicine, 14(7), 827-831. doi:10.1089/acm.2007.0752
†Ebneshahidi, A., & Mohseni, M. (2008). The effect of patient-selected music on early postoperative pain, anxiety, and hemodynamic profile in cesarean section surgery. Journal of Alternative & Complementary Medicine, 14(7), 827-831. doi:10.1089/acm.2007.0752
Elliott, C. H., Jay, S. M., & Woody, P. (1987). An observation scale for measuring children's distress during medical procedures. Journal of Pediatric Psychology, 12(4), 543-551. doi:10.1093/jpepsy/12.4.543
Engel, G. L. (1977). The need for a new medical model: A challenge for biomedicine. Science, 196(4286), 129-136. doi:10.1126/science.847460
*Engwall, M., & Duppils, G. S. (2009). Music as a nursing intervention for postoperative pain: A systematic review. Journal of PeriAnesthesia Nursing, 24(6), 370-383. doi:http://dx.doi.org.libproxy.temple.edu/10.1016/j.jopan.2009.10.013
European Federation of IASP Chapters. (n.d.). Unrelieved pain is a major global healthcare problem. Diegem, Belgium: International Association for the Study of Pain. Available from http://www.efic.org/userfiles/Pain%20Global%20Healthcare%20Problem.pdf.
Fishman, S. M. (2006). Commentary in response to paulozzi et al.: Prescription drug abuse and safe pain management. Pharmacoepidemiology and Drug Safety, 15(9), 628-631. doi:10.1002/pds.1292
Fishman, S. M. (2007). Recognizing pain management as a human right: A first step. Anesthesia and Analgesia, 105(1), 8-9. doi:10.1213/01.ane.0000267526.37663.41
†Fredenburg, H. A., & Silverman, M. J. (2014). Effects of music therapy on positive and negative affect and pain with hospitalized patients recovering from a blood and marrow transplant: A randomized effectiveness study. Arts in Psychotherapy, 41(2), 174-180. doi:10.1016/j.aip.2014.01.007
Froehlich, M. A. (1996). Music therapy with hospitalized children: A creative arts child life approach. Cherry Hill, NJ: Jeffrey Books.
Gallagher, E. J., Liebman, M., & Bijur, P. E. (2001). Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Annals of Emergency Medicine, 38(6), 633-638. doi:10.1067/mem.2001.118863 161
Gatchel, R. J., Haggard, R., Thomas, C., & Howard, K. J. (2012). Biopsychosocial approaches to understanding chronic pain and disability. In R. J. Moore (Ed.), Handbook of pain and palliative care: Biobehavioral approaches for the life course (pp. 1-16). New York, NY: Springer New York. doi:10.1007/978-1-4419-1651-8_17
Gatchel, R. J., Peng, Y. B., Peters, M. L., Fuchs, P. N., & Turk, D. C. (2007). The biopsychosocial approach to chronic pain: Scientific advances and future directions. Psychological Bulletin, 133(4), 581-624.
Gerra, G., Zaimovic, A., Franchini, D., Palladino, M., Giucastro, G., Reali, N., . . . Brambilla, F. (1998). Neuroendocrine responses of healthy volunteers to `techno-music': Relationships with personality traits and emotional state. International Journal of Psychophysiology, 28(1), 99-111. doi:10.1016/S0167-8760(97)00071-8
†Ghetti, C. M. (2011). Active music engagement with emotional-approach coping to improve well-being in liver and kidney transplant recipients. Journal of Music Therapy, 48(4), 463- 485.
†Ghetti, C. M. (2011). Effect of music therapy with emotional-approach coping on pre- procedural anxiety in cardiac catheterization. (Unpublished doctoral dissertation). University of Kansas, (889930637)
†Ghetti, C. M. (2013). Effect of music therapy with emotional-approach coping on preprocedural anxiety in cardiac catheterization: A randomized controlled trial. Journal of Music Therapy, 50(2), 93-122.
†Good, M. (1995). A comparison of the effects of jaw relaxation and music on postoperative pain. Nursing Research, 44(1), 52-57.
†Good, M., & Chin, C. C. (1998). The effects of western music on postoperative pain in taiwan. Kaohsiung Journal of Medical Sciences, 14(2), 94-103.
†Good, M., Stanton-Hicks, M., Grass, J. A., Cranston Anderson, G., Choi, C., Schoolmeesters, L. J., & Salman, A. (1999). Relief of postoperative pain with jaw relaxation, music and their combination. Pain, 81(1-2), 163-172.
Groenewald, C. B., Rabbitts, J. A., Schroeder, D. R., & Harrison, T. E. (2012). Prevalence of moderate–severe pain in hospitalized children. Pediatric Anesthesia, 22(7), 661-668. doi:10.1111/j.1460-9592.2012.03807.x
†Guerrero, J. M., Castano, P. M., Schmidt, E. O., Rosario, L., & Westhoff, C. L. (2012). Music as an auxiliary analgesic during first trimester surgical abortion: A randomized controlled trial. Contraception, 86(2), 157-162.
Gureje, O., Von Korff, M., Simon, G. E., & Gater, R. (1998). Persistent pain and well-being: A
world health organization study in primary care. JAMA, 280(2), 147-151. doi:10.1001/jama.280.2.147 162
†Gutgsell, K. J., Schluchter, M., Margevicius, S., DeGolia, P. A., McLaughlin, B., Harris, M., . . . Wiencek, C. (2013). Music therapy reduces pain in palliative care patients: A randomized controlled trial. Journal of Pain & Symptom Management, 45(5), 822-831.
†Hartling, L., Newton, A. S., Liang, Y., Jou, H., Hewson, K., Klassen, T. P., & Curtis, S. (2013). Music to reduce pain and distress in the pediatric emergency department: A randomized clinical trial. JAMA Pediatrics, 167(9), 826-835.
*Hartling, L., Shaik, M. S., Tjosvold, L., Leicht, R., Liang, Y., & Kumar, M. (2009). Music for medical indications in the neonatal period: A systematic review of randomised controlled trials. Archives of Disease in Childhood - Fetal & Neonatal Edition, 94(5), F349-F354. doi:10.1136/adc.2008.148411
*Haslbeck, F. B. (2012). Music therapy for premature infants and their parents: An integrative review. Nordic Journal of Music Therapy, 21(3), 203-226. doi:10.1080/08098131.2011.648653
Higgins, J. P., & Green, S. (Eds.). (2011). Cochrane handbook for systematic reviews of interventions, version 5.1.0 [updated march 2011]. Oxford, UK: The Cochrane Collaboration. Available from www.cochrane–handbook.org.
Higgins, J. P., & Thompson, S. G. (2002). Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine, 21(11), 1539-1558. doi:10.1002/sim.1186
Hølen, J. C., Hjermstad, M. J., Loge, J. H., Fayers, P. M., Caraceni, A., De Conno, F., . . . Kaasa, S. (2006). Pain assessment tools: Is the content appropriate for use in palliative care? Journal of Pain and Symptom Management, 32(6), 567-580. doi:10.1016/j.jpainsymman.2006.05.025
†Hook, L., Sonwathana, P., & Petpichetchian, W. (2008). Music therapy with female surgical patients: Effect on anxiety and pain. Thai Journal of Nursing Research, 12(4), 259-271.
†Huang, S. (2006). The effects of music on cancer pain . (2009718445).
†Huang, S., Good, M., & Zauszniewski, J. A. (2010). The effectiveness of music in relieving pain in cancer patients: A randomized controlled trial. International Journal of Nursing Studies, 47(11), 1354-1362. doi:10.1016/j.ijnurstu.2010.03.008
†Hyun, S. S., Kim, E. K., Kim, E. J., Chae, H. J., Ko, Y. H., & Lee, M. Y. (2004). The effect of music therapy on pain and anxiety after CPM exercise in surgical patient of skeletal and muscle wound. Journal of Korean Clinical Nursing Research, 9(2), 93-106.
IASP. (1994). Pain terms, A current list with definitions and notes on usage. In H. Merskey, & N. Bogduk (Eds.), Classification of chronic pain (2nd ed., pp. 209-214). Seattle, WA.: International Association for the Study of Pain Press. Available from http://www.iasp-
pain.org/Education/Content.aspx?ItemNumber=1381. 163
IASP. (2009). Guidelines for pain treatment services. Washington, DC.: International Association for the Study of Pain. Available from http://www.iasp- pain.org/Education/Content.aspx?ItemNumber=1381.
†Ikonomidou, E., Rehnstrom, A., & Naesh, O. (2004). Effect of music on vital signs and postoperative pain. AORN Journal, 80(2), 269-274.
Im, E., Guevara, E., & Chee, W. (2007). The pain experience of hispanic patients with cancer in the united states. Oncology Nursing Forum, 34(4), 861-868. doi:10.1188/07.ONF.861-868
Im, E., Lim, H., Clark, M., & Chee, W. (2008). African american cancer patients' pain experience. Cancer Nursing, 31(1), 38-46. doi:10.1097/01.NCC.0000305685.59507.9e
†Jacobson, A. (1995). Effect of intradermal normal saline, listening to music, and insertion difficulty on pain of IV insertion . (1999030668).
†Jacobson, A. F. (1999). Intradermal normal saline solution, self-selected music, and insertion difficulty effects on intravenous insertion pain. Heart & Lung: The Journal of Critical Care, 28(2), 114-122.
Jadad, A. R., Moore, R. A., Carroll, D., Jenkinson, C., Reynolds, D. J., Gavaghan, D. J., & McQuay, H. J. (1996). Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Controlled Clinical Trials, 17(1), 1-12. doi:10.1016/0197- 2456(95)00134-4
†Jafari, H., Emami Zeydi, A., Khani, S., Esmaeili, R., & Soleimani, A. (2012). The effects of listening to preferred music on pain intensity after open heart surgery. Iranian Journal of Nursing and Midwifery Research, 17(1), 1-6.
†Jeon, Y. S. (2004). The effect of music listening on anxiety and pain reduction of dental treatment. Korean Journal of Music Therapy, 6(1), 35-47.
†Jose, J., Verma, M., & Arora, S. (2012). An experimental study to assess the effectiveness of music therapy on the post operative pain perception of patients following cardiac surgery in a selected hospital of New Delhi. International Journal of Nursing Education, 4(2), 198-201.
Kagawa-Singer, M., Valdez Dadia, A., Yu, M. C., & Surbone, A. (2010). Cancer, culture, and health disparities: Time to chart a new course? CA: A Cancer Journal for Clinicians, 60(1), 12-39. doi:10.3322/caac.20051
Kassirer, J. P. (1994). Incorporating patients' preferences into medical decisions. The New England Journal of Medicine, 330(26), 1895.
Kikuchi, S. (2008). New concept for backache: Biopsychosocial pain syndrome. European Spine Journal, 17 Suppl 4(S4), 421-427. doi:10.1007/s00586-008-0747-1
Kil, H. K., Kim, W. O., Chung, W. Y., Kim, G. H., Seo, H., & Hong, J. -. (2012). Preoperative anxiety and pain sensitivity are independent predictors of propofol and sevoflurane 164
requirements in general anaesthesia. British Journal of Anaesthesia, 108(1), 119-125. doi:10.1093/bja/aer305
†Kim, J. Y., & Kim, Y. S. (2009). The effects of single-session music therapy intervention on pain, anxiety, and depression of the gynecologic cancer patients receiving chemotherapy. Korean Journal of Music Therapy, 11(2), 21-35.
†Kim, J. Y., & Kim, Y. S. (2010). The effects of listening-centered and singing-centered single- session music therapy intervention on pain, anxiety, and depression of the gynecologic cancer patients receiving chemotherapy. Korean Journal of Music Therapy, 12(3), 1-18.
†Kim, M. S., Kim, J. H., Lee, D. J., Han, M. A., Ha, K. H., Kim, M. C., & Cho, K. H. (2004). Effect of intra- and postoperative music on patients of regional anesthesia. Inje Medical Journal, 25(1), 61-66.
†Kim, Y. K., Kim, S. M., & Myoung, H. (2011). Musical intervention reduces patients' anxiety in surgical extraction of an impacted mandibular third molar. Journal of Oral & Maxillofacial Surgery, 69(4), 1036-1045.
King, N. B., & Fraser, V. (2013). Untreated pain, narcotics regulation, and global health ideologies. PLoS Medicine, 10(4), e1001411. doi:10.1371/journal.pmed.1001411
*Klassen, T. P., Klassen, J. A., Liang, Y., Tjosvold, L., & Hartling, L. (2008). Music for pain and anxiety in children undergoing medical procedures: A systematic review of randomized controlled trials. Acute Pain, 10(2), 106-106. doi:10.1016/j.acpain.2008.05.038
†Koca Kutlu, A., & Eren, A. G. (2014). Effects of music on complications during hemodialysis for chronic renal failure patients. Hemodialysis International, 18, 777-784. doi:10.1111/hdi.12161
†Koch, M. E., Kain, Z. N., Ayoub, C., & Rosenbaum, S. H. (1998). The sedative and analgesic sparing effect of music. Anesthesiology, 89(2), 300-306.
Kreps, G. (2012). Communication and palliative care: E-health interventions and pain management. In R. J. Moore (Ed.), Handbook of pain and palliative care: Biobehavioral approaches for the life course (pp. 43-52). New York, NY: Springer New York. doi:10.1007/978-1-4419-1651-8_17
†Kristjánsdóttir, Ó., & Kristjánsdóttir, G. (2011). Randomized clinical trial of musical distraction with and without headphones for adolescents' immunization pain. Scandinavian Journal of Caring Sciences, 25(1), 19-26. doi:10.1111/j.1471-6712.2010.00784.x
†Kulkarni, S., Johnson, P. C., Kettles, S., & Kasthuri, R. S. (2012). Music during interventional radiological procedures, effect on sedation, pain and anxiety: A randomised controlled trial. British Journal of Radiology, 85(1016), 1059-1063.
Kung, J., Chiappelli, F., Cajulis, O. O., Avezova, R., Kossan, G., Chew, L., & Maida, C. A. (2010). From systematic reviews to clinical recommendations for evidence-based health care: Validation of revised assessment of multiple systematic reviews (R-AMSTAR) for grading 165
of clinical relevance. The Open Dentistry Journal, 4(1), 84-91. doi:10.2174/1874210601004010084
†Kwekkeboom, K. L. (2003). Music versus distraction for procedural pain and anxiety in patients with cancer. Oncology Nursing Forum, 30(3), 433-440. doi:10.1188/03.ONF.433-440
Lasserson, T. J. (2012). What should be done with quasi-randomised trials?. Oxford, UK: Cochrane Editorial Unit. Available from http://www.editorial-unit.cochrane.org/blog/guest- blog-peter-herbison-what-should-be-done-quasi-randomised-trials.
Lau, J., Antman, E. M., Jimenez-Silva, J., Kupelnick, B., Mosteller, F., & Chalmers, T. C. (1992). Cumulative meta-analysis of therapeutic trials for myocardial infarction. The New England Journal of Medicine, 327(4), 248-254. doi:10.1056/NEJM199207233270406
†Laurion, S., & Fetzer, S. J. (2003). The effect of two nursing interventions on the postoperative outcomes of gynecologic laparoscopic patients. Journal of PeriAnesthesia Nursing, 18(4), 254-261.
Law, M. R., Morris, J. K., & Wald, N. J. (2009). Use of blood pressure lowering drugs in the prevention of cardiovascular disease: Meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ: British Medical Journal, 338(7705), 1245-1253. doi:10.1136/bmj.b1665
*Lee, J. H. (2013). Music for pediatric patients in medical settings: A systematic review of randomized controlled trials. Journal of Music and Human Behavior, 10(2), 1-33.
†Lepage, C., Drolet, P., Girard, M., Grenier, Y., & DeGagne, R. (2001). Music decreases sedative requirements during spinal anesthesia. Anesthesia & Analgesia, 93(4), 912-916.
Li, X. M., Yan, H., Zhou, K. N., Dang, S. N., Wang, D. L., & Zhang, Y. P. (2011). Effects of music therapy on pain among female breast cancer patients after radical mastectomy: Results from a randomized controlled trial. Breast Cancer Research & Treatment, 128(2), 411-419.
†Li, X. M., Yan, H., Zhou, K. N., Dang, S. N., Wang, D. L., & Zhang, Y. P. (2011). Effects of music therapy on pain among female breast cancer patients after radical mastectomy: Results from a randomized controlled trial. Breast Cancer Research & Treatment, 128(2), 411-419.
†Li, Y., & Dong, Y. (2012). Preoperative music intervention for patients undergoing cesarean delivery. International Journal of Gynaecology & Obstetrics, 119(1), 81-83.
Lin, S., Yang, P., Lai, C., Su, Y., Yeh, Y., Huang, M., & Chen, C. (2011). Mental health implications of music: Insight from neuroscientific and clinical studies. Harvard Review of Psychiatry, 19(1), 34-46. doi:10.3109/10673229.2011.549769
Lipman, A. G. (2005). Pain as a human right: The 2004 global day against pain. Journal of Pain & Palliative Care Pharmacotherapy, 19(3), 85-100. 166
Littell, J. H., Corcoran, J., & Pillai, V. K. (2008). Systematic reviews and meta-analysis. New York; Oxford: Oxford University Press. doi:10.1093/acprof:oso/9780195326543.001.0001
Lohman, D., Schleifer, R., & Amon, J. J. (2010). Access to pain treatment as a human right. BMC Medicine, 8(1), 8-8. doi:10.1186/1741-7015-8-8
†MacDonald, R., Mitchell, L. A., Serpell, M., Davies, J., & Ashley, E. (2003). An empirical investigation of the anxiolytic and pain reducing effects of music. Psychology of Music, 31(2), 187-203. doi:http://dx.doi.org.libproxy.temple.edu/10.1177/0305735603031002294
Magill, L. (2001). Use of music therapy to address the suffering in advanced cancer pain. Journal of Palliative Care, 17, 167-172.
Maly, R. C., Umezawa, Y., Ratliff, C. T., & Leake, B. (2006). Racial/ethnic group differences in treatment decision-making and treatment received among older breast carcinoma patients. Cancer, 106(4), 957-965. doi:10.1002/cncr.21680
Marsac, M. L., & Funk, J. B. (2008). Relationships among psychological functioning, dental anxiety, pain perception, and coping in children and adolescents. Journal of Dentistry for Children, 75(3), 243-251.
†Masuda, T., Miyamoto, K., & Shimizu, K. (2005). Effects of music listening on elderly orthopaedic patients during postoperative bed rest. Nordic Journal of Music Therapy, 14(1), 4-14.
Mathews, L. (2011). Pain in children: Neglected, unaddressed and mismanaged. Indian Journal of Palliative Care, 17(Suppl), S70-S73. doi:10.4103/0973-1075.76247
Mazanec, P. M., Daly, B. J., & Townsend, A. (2010). Hospice utilization and end-of-life care decision making of african americans. American Journal of Hospice and Palliative Medicine, 27(8), 560-566. doi:10.1177/1049909110372087
McAlister, F. A., Wiebe, N., Ezekowitz, J. A., Leung, A. A., & Armstrong, P. W. (2009). Meta- analysis: Beta-blocker dose, heart rate reduction, and death in patients with heart failure. Annals of Internal Medicine, 150(11), 784.
McGuire, D. B. (1992). Comprehensive and multidimensional assessment and measurement of pain. Journal of Pain and Symptom Management, 7(5), 312-319. doi:10.1016/0885- 3924(92)90064-O
Melzack, R. (1996). Gate control theory. Pain Forum, 5(2), 128-138. doi:10.1016/S1082- 3174(96)80050-X
Melzack, R. (1999). From the gate to the neuromatrix. Pain, Suppl 6, S121-S126. doi:10.1016/S0304-3959(99)00145-1
Melzack, R. (2001). Pain and the neuromatrix in the brain. Journal of Dental Education, 65(12), 1378. 167
Melzack, R. (2010). Pain theories. In I. B. Weiner, & W. E. Craighead (Eds.), The corsini encyclopedia of psychology (4th ed., ). Hoboken, NJ: John Wiley & Sons, Inc. doi:10.1002/9780470479216.corpsy0630
†Migneault, B., Girard, F., Albert, C., Chouinard, P., Boudreault, D., Provencher, D., . . . Girard, D. C. (2004). The effect of music on the neurohormonal stress response to surgery under general anesthesia. Anesthesia & Analgesia, 98(2), 527-532.
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & PRISMA Group. (2009). Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Medicine, 6(7), e1000097. doi:10.1371/journal.pmed.1000097
Montori, V. M., Murad, M. H., & Brito, J. P. (2013). The optimal practice of evidence-based medicine. JAMA, 310(23), 2503.
†Nagata, K., Iida, N., Kanazawa, H., Fujiwara, M., Mogi, T., Mitsushima, T., . . . Sugimoto, H. (2014). Effect of listening to music and essential oil inhalation on patients undergoing screening CT colonography: A randomized controlled trial. European Journal of Radiology, 83(12), 2172-2176.
†Nguyen, T. N., Nilsson, S., Hellström, A., & Bengtson, A. (2010). Music therapy to reduce pain and anxiety in children with cancer undergoing lumbar puncture: A randomized clinical trial. Journal of Pediatric Oncology Nursing, 27(3), 146-155. doi:10.1177/1043454209355983
*Nilsson, U., Hälsoakademin, & Örebro universitet. (2008). The anxiety- and pain-reducing effects of music interventions: A systematic review. AORN Journal, 87(4), 780- 780,782,794,807. doi:10.1016/j.aorn.2007.09.013
†Nilsson, U., Rawal, N., & Unosson, M. (2003). A comparison of intra-operative or postoperative exposure to music--a controlled trial of the effects on postoperative pain. Anaesthesia, 58(7), 699-703. doi:10.1046/j.1365-2044.2003.03189
†Nilsson, U., Rawal, N., Enqvist, B., & Unosson, M. (2003). Analgesia following music and therapeutic suggestions in the PACU in ambulatory surgery; a randomized controlled trial. Acta Anaesthesiologica Scandinavica, 47(3), 278-283.
†Nilsson, U., Unosson, M., & Rawal, N. (2005). Stress reduction and analgesia in patients exposed to calming music postoperatively: A randomized controlled trial. European Journal of Anaesthesiology, 22(2), 96-102.
†Ottaviani, S., Bernard, J. L., Bardin, T., & Richette, P. (2012). Effect of music on anxiety and pain during joint lavage for knee osteoarthritis. Clinical Rheumatology, 31(3), 531-534.
†Ovayolu, N., Ucan, O., Pehlivan, S., Pehlivan, Y., Buyukhatipoglu, H., Savas, M. C., & Gulsen, M. T. (2006). Listening to turkish classical music decreases patients' anxiety, pain,
dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: A prospective randomized controlled trial. World Journal of Gastroenterology, 12(46), 7532- 7536. 168
†Parlar Kilic, S., Karadag, G., Oyucu, S., Kale, O., Zengin, S., Ozdemir, E., & Korhan, E. A. (2014). Effect of music on pain, anxiety, and patient satisfaction in patients who present to the emergency department in turkey. Japan Journal of Nursing Science, , 1-10. doi:10.1111/jjns.12047
Pelletier, C. L. (2004). The effect of music on decreasing arousal due to stress: A meta-analysis. Journal of Music Therapy, 41(3), 192-214. doi:10.1093/jmt/41.3.192
†Phipps, M. A., Carroll, D. L., & Tsiantoulas, A. (2010). Music as a therapeutic intervention on an inpatient neuroscience unit. Complementary Therapies in Clinical Practice, 16(3), 138- 142.
†Phumdoung, S. (2002). The effect of music on labor pain . (2004157699).
Phumdoung, S., & Good, M. (2003). Music reduces sensation and distress of labor pain. Pain Management Nursing, 4(2), 54-61. doi:10.1016/S1524-9042(02)54202-8
†Phumdoung, S., & Good, M. (2003). Music reduces sensation and distress of labor pain. Pain Management Nursing, 4(2), 54-61.
Polit, D. F., & Beck, C. T. (2004). Nursing research: Generating and assessing evidence for nursing practice. Philadelphia, PA: Lippincott Williams & Wilkins.
Polit, D. F., & Beck, C. T. (2008). Nursing research: Generating and assessing evidence for nursing practice. Philadelphia, PA: Lippincott Williams & Wilkins.
†Pothoulaki, M., Macdonald, R. A., Flowers, P., Stamataki, E., Filiopoulos, V., Stamatiadis, D., & Stathakis, C. (2008). An investigation of the effects of music on anxiety and pain perception in patients undergoing haemodialysis treatment. Journal of Health Psychology, 13(7), 912-920.
†Press, J., Gidron, Y., Maimon, M., Gonen, A., Goldman, V., & Buskila, D. (2003). Effects of active distraction on pain of children undergoing venipuncture: Who benefits from it? The Pain Clinic, 15(3), 261-269.
Ransom, S., Pearman, T., Philip, E., & Anwa, D. (2012). Adult cancer-related pain. In R. J. Moore (Ed.), Handbook of pain and palliative care: Biobehavioral approaches for the life course (pp. 247-270). New York, NY: Springer New York. doi:10.1007/978-1-4419-1651- 8_17
Rennick, J. E., Johnston, C. C., Dougherty, G., Platt, R., & Ritchie, J. A. (2002). Children's psychological responses after critical illness and exposure to invasive technology. Journal of Developmental and Behavioral Pediatrics, 23(3), 133-144. doi:10.1097/00004703- 200206000-00002
Reyes-Gibby, C. C., Aday, L., & Cleeland, C. (2002). Impact of pain on self-rated health in the community-dwelling older adults. Pain, 95(1), 75-82. doi:10.1016/S0304-3959(01)00375-X 169
†Reza, N., Ali, S. M., Saeed, K., Abul-Qasim, A., & Reza, T. H. (2007). The impact of music on postoperative pain and anxiety following cesarean section. Middle East Journal of Anesthesiology, 19(3), 573-586.
Robb, S. L., Burns, D. S., & Carpenter, J. S. (2011). Reporting guidelines for music-based interventions. Music & Medicine, 3(4), 271-279. doi:10.1177/1943862111420539
Rubin, G. J., & Hotopf, M. (2002). Systematic review and meta-analysis of interventions for postoperative fatigue. The British Journal of Surgery, 89(8), 971-984. doi:10.1046/j.1365- 2168.2002.02138.x
Running, A., & Seright, T. (2012). Integrative oncology: Managing cancer pain with complementary and alternative therapies. Current Pain and Headache Reports, 16(4), 325- 331. doi:10.1007/s11916-012-0275-x
Sackett, D. L., Rosenberg, W. M. C., Gray, J. A. M., Haynes, R. B., & Richardson, W. S. (1996). Evidence based medicine: What it is and what it isn't: It's about integrating individual clinical expertise and the best external evidence. BMJ: British Medical Journal, 312(7023), 71-72.
†Salem, S. G. (2004). The effect of music on pain during the first stage of labor in egypt . (2005109760).
Sauerland, S., & Seiler, C. M. (2005). Role of systematic reviews and meta-analysis in evidence- based medicine. World Journal of Surgery, 29(5), 582-587. doi:10.1007/s00268-005-7917-7
†Schou, K. (2008). Music therapy for post operative cardiac patients: A randomized controlled trial evaluating guided relaxation with music and music listening on anxiety, pain, and mood. (Unpublished Aalborg University, Denmark.
Schulz, K. F., Altman, D. G., Moher, D., & CONSORT Group. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine, 152(11), 726.
Schulz, K. F., Chalmers, I., Hayes, R. J., & Altman, D. G. (1995). Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 273(5), 408-412. doi:10.1001/jama.1995.03520290060030
†Şen, H., Ateş, F., Sizlan, A., Yanarateş, Ö., Dere, K., Teksöz, E., . . . Dağli, G. (2009). Effect of music on sedation during local urological surgeries. Anatolian Journal of Clinical Investigation, 3(2), 131-135.
†Şen, H., Sizlan, A., Yanarateş, Ö., Kul, M., Kılıç, E., Özkan, S., & Dağlı, G. (2009). The effect of musical therapy on postoperative pain after caesarean section. TAF Preventive Medicine Bulletin, 8(2), 107-112.
†Sen, H., Yanarates, O., Sizlan, A., Kilic, E., Ozkan, S., & Dagli, G. (2010). The efficiency and duration of the analgesic effects of musical therapy on postoperative pain. Agri Dergisi, 22(4), 145-150. 170
†Seo, B. R., & Hong, H. S. (2010). Effects of music therapy on pain and depression in terminal cancer patients. Journal of Korean Biological Nursing Science, 12(1), 48-57.
Shea, B., Grimshaw, J., Wells, G., Boers, M., Andersson, N., Hamel, C., . . . Bouter, L. (2007). Development of AMSTAR: A measurement tool to assess the methodological quality of systematic reviews. BMC Medical Research Methodology, 7(1), 10-10. doi:10.1186/1471- 2288-7-10
†Siedlecki, S. L. (2005). The effect of music on power, pain, depression, and disability: A clinical trial. (Unpublished Case Western Reserve University, Cleveland, OH.
†Siedlecki, S. L., & Good, M. (2006). Effect of music on power, pain, depression and disability. Journal of Advanced Nursing, 54(5), 553-562. doi:10.1111/j.1365-2648.2006.03860.x
†Simavli, S., Gumus, I., Kaygusuz, I., Yildirim, M., Usluogullari, B., & Kafali, H. (2014). Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: A randomized controlled clinical trial. Gynecologic and Obstetric Investigation, 78(4), 244- 250. doi:10.1159/000365085
†Simavli, S., Kaygusuz, I., Gumus, I., Usluogullari, B., Yildirim, M., & Kafali, H. (2014). Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. Journal of Affective Disorders, 156, 194-199.
†Simcock, X. C., Yoon, R. S., Chalmers, P., Geller, J. A., Kiernan, H. A., & Macaulay, W. (2008). Intraoperative music reduces perceived pain after total knee arthroplasty: A blinded, prospective, randomized, placebo-controlled clinical trial. The Journal of Knee Surgery, 21(4), 275-278.
Standley, J. M., & Whipple, J. (2003). Music therapy with pediatric patients: A meta-analysis. In S. L. Robb (Ed.), Music therapy in pediatric healthcare: Research and evidence-based practice (pp. 1-18). Silver Spring, Md: American Music Therapy Association.
Standley, J., & Walworth, D. (2005). Cost/benefit analysis of the total program. In J. Standley, D. Gregory, D. Whipple, D. Walworth, J. Nguyen, J. Jared, . . . A. Cevasco (Eds.), Medical music therapy: A model program for clinical practice, education, training, and research (pp. 31-40). Silver Spring, MD: American Music Therapy Association.
Stephens, J., Laskin, B., Pashos, C., Peña, B., & Wong, J. (2003). The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors. Rheumatology, 42 Suppl 3(4), iii40.
Stewart, W. F., Ricci, J. A., Chee, E., & Morganstein, D. (2003). Lost productive work time costs from health conditions in the united states: Results from the american productivity audit. Journal of Occupational and Environmental Medicine, 45(12), 1234-1246. doi:10.1097/01.jom.0000099999.27348.78
SUNY Downstate Medical Center. (n.d.). The evidence pyramid. Retrieved from http://library.downstate.edu/EBM2/2100.htm 171
†Szmuk, P., Aroyo, N., Ezri, T., Muzikant, G., Weisenberg, M., & Sessler, D. I. (2008). Listening to music during anesthesia does not reduce the sevoflurane concentration needed to maintain a constant bispectral index. Anesthesia and Analgesia, 107(1), 77-80. doi:10.1213/ane.0b013e3181733e16
Taddio, A., Shah, V., Gilbert-MacLeod, C., & Katz, J. (2002). Conditioning and hyperalgesia in newborns exposed to repeated heel lances. JAMA, 288(7), 857-861. doi:10.1001/jama.288.7.857
*Tam, W. W. (2008). Effect of music on procedure time and sedation during colonoscopy: A meta-analysis. World Journal of Gastroenterology, 14(34), 5336-5343. doi:10.3748/wjg.14.5336
Todd, K. H., Deaton, C., D'Adamo, A. P., & Goe, L. (2000). Ethnicity and analgesic practice. Annals of Emergency Medicine, 35(1), 11-16. doi:10.1016/S0196-0644(00)70099-0
*Tsai, H. F., Chen, Y. R., Chung, M. H., Liao, Y. M., Chi, M. J., Chang, C. C., & Chou, K. R. (2014). Effectiveness of music intervention in ameliorating cancer patients’ anxiety, depression, pain, and fatigue: A meta-analysis. Cancer Nursing, , 1. doi:10.1097/NCC.0000000000000116
†Vaajoki, A., Pietila, A. M., Kankkunen, P., & Vehvilainen-Julkunen, K. (2012). Effects of listening to music on pain intensity and pain distress after surgery: An intervention. Journal of Clinical Nursing, 21(5-6), 708-717.
†Vanderboom, T. L., Arcari, P. M., Duffy, M. E., Somarouthu, B., Rabinov, J. D., Yoo, A. J., & Hirsch, J. A. (2012). Effects of a music intervention on patients undergoing cerebral angiography: A pilot study. Journal of Neurointerventional Surgery, 4(3), 229-233. doi:10.1136/neurintsurg-2011-010052
†Voss, J. A., Good, M., Yates, B., Baun, M. M., Thompson, A., & Hertzog, M. (2004). Sedative music reduces anxiety and pain during chair rest after open-heart surgery. Pain, 112(1-2), 197-203.
Waldstein, S. R., Neumann, S. A., Drossman, D. A., & Novack, D. H. (2001). Teaching psychosomatic (biopsychosocial) medicine in united states medical schools: Survey findings. Psychosomatic Medicine, 63(3), 335-343. doi:10.1097/00006842-200105000-00001
Walworth, D. (2005). Procedural-support music therapy in the healthcare setting: A Cost– Effectiveness analysis. Journal of Pediatric Nursing, 20(4), 276-284. doi:10.1016/j.pedn.2005.02.016
Whipple, B., & Glynn, N. J. (1992). Quantification of the effects of listening to music as a noninvasive method of pain control... including commentary by McCaffery M. Scholarly Inquiry for Nursing Practice, 6(1), 43-62.
Wood, B. L. (2012). Biopsychosocial. (pp. 169-186). New York, NY: Springer New York. doi:10.1007/978-1-4614-0914-4_9 172
†Yeo, J. K., Cho, D. Y., Oh, M. M., Park, S. S., & Park, M. G. (2013). Listening to music during cystoscopy decreases anxiety, pain, and dissatisfaction in patients: A pilot randomized controlled trial. Journal of Endourology, 27(4), 459-462.
†Yinger, O. S. (2012). Music therapy as procedural support for young children undergoing immunizations: A randomized controlled study (Ph.D.). Available from ProQuest Dissertations & Theses A&I. (1095642435).
†Yu, H., Liu, Y., Li, S., & Ma, X. (2009). Effects of music on anxiety and pain in children with cerebral palsy receiving acupuncture: A randomized controlled trial. International Journal of Nursing Studies, 46(11), 1423-1430. doi:10.1016/j.ijnurstu.2009.05.007
†Zengin, S., Kabul, S., Al, B., Sarcan, E., Dogan, M., & Yildirim, C. (2013). Effects of music therapy on pain and anxiety in patients undergoing port catheter placement procedure. Complementary Therapies in Medicine, 21(6), 689-696.
†Zhang, X., Fan, Y., Manyande, A., Tian, Y., & Yin, P. (2005). Effects of music on target- controlled infusion of propofol requirements during combined spinal-epidural anaesthesia. Anaesthesia, 60(10), 990-994. doi:10.1111/j.1365-2044.2005.04299.x
†Zhang, Z. S., Wang, X. L., Xu, C. L., Zhang, C., Cao, Z., Xu, W. D., . . . Sun, Y. H. (2014). Music reduces panic: An initial study of listening to preferred music improves male patient discomfort and anxiety during flexible cystoscopy. Journal of Endourology, 28(6), 739-744.
*Zhang, J. M., Wang, P., Yao, J. X., Zhao, L., Davis, M. P., Walsh, D., & Yue, G. H. (2012). Music interventions for psychological and physical outcomes in cancer: A systematic review and meta-analysis. Supportive Care in Cancer, 20(12), 3043-3053. doi:10.1007/s00520-012- 1606-5
†Zhu, J., Hong-Gu, H., Zhou, X., Wei, H., Gao, Y., Ye, B., . . . Chan, S. W. (2014). Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in china: A randomized controlled trial. Midwifery,
†Zimmerman, L., Nieveen, J., Barnason, S., & Schmaderer, M. (1996). The effects of music interventions on postoperative pain and sleep in coronary artery bypass graft (CABG) patients... including commentary by miaskowski C. Scholarly Inquiry for Nursing Practice, 10(2), 153-174.
173
REFERENCES
Excluded Studies from Review of Systematic Reviews
Archie, P., Bruera, E., & Cohen, L. (2013). Music-based interventions in palliative cancer care: A review of quantitative studies and neurobiological literature. Supportive Care in Cancer, 21(9), 2609-2624. doi:10.1007/s00520-013-1841-4
Austin, D. (2010). The psychophysiological effects of music therapy in intensive care units. Paediatric Nursing, 22(3), 14-20.
Bailey, L. (2010). Strategies for decreasing patient anxiety in the perioperative setting. AORN Journal, 92(4), 445-460. doi:10.1016/j.aorn.2010.04.017
Bao, Y., Kong, X., Yang, L., Liu, R., Shi, Z., Li, W., . . . Hou, W. (2014). Complementary and alternative medicine for cancer pain: An overview of systematic reviews. Evidence-Based Complementary and Alternative Medicine, 2014, 170396.
Bowers, T., A., & Wetsel, M., A. (2014). Utilization of music therapy in palliative and hospice care. Journal of Hospice & Palliative Nursing, 16(4), 231-239. doi:10.1097/NJH.0000000000000060
Bradt, J., Magee, W., Dileo, C., Wheeler, B., & McGilloway, E. (2010). Music therapy for acquired brain injury. Cochrane Database of Systematic Reviews, (7) doi:10.1002/14651858.CD006787.pub2
Bradt, J., & Dileo, C. (2010). Music therapy for end-of-life care. The Cochrane Database of Systematic Reviews, (1), CD007169. doi:10.1002/14651858.CD007169.pub2
Brady-Fryer, B., Wiebe, N., & Lander, J. A. (2004). Pain relief for neonatal circumcision. The Cochrane Database of Systematic Reviews, (4), CD004217.
Chi, G. C., & Young, A. (2011). Selection of music for inducing relaxation and alleviating pain: Literature review. Holistic Nursing Practice, 25(3), 127-135. doi:10.1097/HNP.0b013e3182157c64
Chlan, L., & Halm, M. A. (2013). Does music ease pain and anxiety in the critically ill? American Journal of Critical Care, 22(6), 528-532. doi:10.4037/ajcc2013998
Cignacco, E., Hamers, J. P. H., Stoffel, L., van Lingen, R.,A., Gessler, P., McDougall, J., & Nelle, M. (2007). The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. European Journal of Pain, 11(2), 139-152.
Cole, L. C., & LoBiondo-Wood, G. (2014). Music as an adjuvant therapy in control of pain and symptoms in hospitalized adults: A systematic review. Pain Management Nursing, 15(1),
406-425. doi:10.1016/j.pmn.2012.08.010 174
Crowe, L., Chang, A., Fraser, J. A., Gaskill, D., Nash, R., & Wallace, K. (2008). Systematic review of the effectiveness of nursing interventions in reducing or relieving post-operative pain. International Journal of Evidence-Based Healthcare, 6(3), 396-430.
Dileo, C., & Bradt, J. (2008). Music therapy for end-of-life care. The Cochrane Database of Systematic Reviews, CD007169(2), CD007169. doi:10.1002/14651858.CD007169
Dileo, C., & Bradt, J. (2005). Medical music therapy: A meta-analysis & agenda for future research. Cherry Hill, N.J: Jeffrey Books.
Dunn, K. (2004). Music and the reduction of post-operative pain. Nursing Standard, 18(36), 33- 39. doi:10.7748/ns2004.05.18.36.33.c3612
Economidou, E., Klimi, A., Vivilaki, V. G., & Lykeridou, K. (2012). Does music reduce postoperative pain? A review. Health Science Journal, 6(3), 365.
Evans, D. (2002). The effectiveness of music as an intervention for hospital patients: A systematic review. Journal of Advanced Nursing, 37(1), 8-18. doi:10.1046/j.1365- 2648.2002.02052.x
Galaal, K., Bryant, A., Deane, K. H., Al-Khaduri, M., & Lopes, A. D. (2011). Interventions for reducing anxiety in women undergoing colposcopy. The Cochrane Database of Systematic Reviews, (12), CD006013.
Good, M. (1996). Effects of relaxation and music on postoperative pain: A review. Journal of Advanced Nursing, 24(5), 905-914. doi:10.1111/j.1365-2648.1996.tb02925.x
Hokka, M., Kaakinen, P., & Polkki, T. (2014). A systematic review: Non-pharmacological interventions in treating pain in patients with advanced cancer. Journal of Advanced Nursing, 70(9), 1954-1969. doi:10.1111/jan.12424
Koenig, J., Warth, M., Oelkers-Ax, R., Wormit, A., Bardenheuer, H. J., Resch, F., . . . Hillecke, T. K. (2013). I need to hear some sounds that recognize the pain in me: An integrative review of a decade of research in the development of active music therapy outpatient treatment in patients with recurrent or chronic pain. Music & Medicine, 5(3), 150-161. doi:10.1177/1943862113490739
Koller, D., & Goldman, R. D. (2012). Distraction techniques for children undergoing procedures: A critical review of pediatric research. Journal of Pediatric Nursing, 27(6), 652-681. doi:10.1016/j.pedn.2011.08.001
Laopaiboon, M., Lumbiganon, P., Martis, R., Vatanasapt, P., & Somjaivong, B. (2009). Music during caesarean section under regional anaesthesia for improving maternal and infant outcomes. The Cochrane Database of Systematic Reviews,(2), CD006914.
Leow, M. Q. (2011). Music therapy in the palliative setting: A systematic review. Singapore Nursing Journal, 38(4), 14-21. 175
Ma, L., & Yu, L. (2008). Critical examination of nursing research on music therapy for pain relief in china. Asian Journal of Nursing, 11(2), 97-106.
Matsota, P., Christodoulopoulou, T., Smyrnioti, M. E., Pandazi, A., Kanellopoulos, I., Koursoumi, E., . . . Kostopanagiotou, G. (2013). Music's use for anesthesia and analgesia. Journal of Alternative and Complementary Medicine, 19(4), 298-307. doi:10.1089/acm.2010.0235
Moris, D. N., & Linos, D. (2013). Music meets surgery: Two sides to the art of "healing". Surgical Endoscopy, 27(3), 719-723. doi:10.1007/s00464-012-2525-8
Ngee-Ming, G., Tamsin, D., Rai, B. P., & Somani, B. K. (2014). Complementary approaches to decreasing discomfort during shockwave lithotripsy (SWL). Urolithiasis, 42(3), 189-193. doi:10.1007/s00240-014-0655-2
Pan, C. X., Morrison, R. S., Ness, J., Fugh-Berman, A., & Leipzig, R. M. (2000). Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of life: A systematic review. Journal of Pain & Symptom Management, 20(5), 374- 387.
Park, J., & Hughes, A. K. (2012). Nonpharmacological approaches to the management of chronic pain in community-dwelling older adults: A review of empirical evidence. Journal of the American Geriatrics Society, 60(3), 555-568. doi:10.1111/j.1532-5415.2011.03846.x
Pillai Riddell, R. R., Gerwitz-Stern, A., Racine, N. M., Turcotte, K., Uman, L. S., Horton, R. E., . . . Stevens, B. (2011). Non-pharmacological management of infant and young child procedural pain. The Cochrane Database of Systematic Reviews, (10), CD006275.
Pothoulaki, M., MacDonald, R., & Flowers, P. (2005). Music interventions in oncology settings: A systematic literature review. British Journal of Music Therapy, 19(2), 75-84.
Pyati, S., & Gan, T. J. (2007). Perioperative pain management. CNS Drugs, 21(3), 185-211. doi:2132 [pii]
Renner, R. M., Jensen, J. T., Nichols, M. D., & Edelman, A. B. (2010). Pain control in first- trimester surgical abortion: A systematic review of randomized controlled trials. Contraception, 81(5), 372-388. doi:10.1016/j.contraception.2009.12.008
Renner, R., Jensen, J. T. J., Nichols, M. D. N., & Edelman, A. (2009). Pain control in first trimester surgical abortion. The Cochrane Database of Systematic Reviews, (2), CD006712.
Rheingans, J. I. (2007). A systematic review of nonpharmacologic adjunctive therapies for symptom management in children with cancer. Journal of Pediatric Oncology Nursing, 24(2), 81-94.
Richards, T., Johnson, J., Sparks, A., & Emerson, H. (2007). The effect of music therapy on
patients' perception and manifestation of pain, anxiety, and patient satisfaction. MedSurg Nursing, 16(1), 7-14. 176
Rudin, D., Kiss, A., Wetz, R. V., & Sottile, V. M. (2007). Music in the endoscopy suite: A meta- analysis of randomized controlled studies. Endoscopy, 39(6), 507-510.
Simkin, P., & Bolding, A. (2004). Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. Journal of Midwifery and Women's Health, 49, 489-504.
Skingley, A., & Vella-Burrows, T. (2010). Therapeutic effects of music and singing for older people. Nursing Standard, 24(19), 35-41. doi:10.7748/ns2010.01.24.19.35.c7446
Smith, C. A., Levett, K. M., Collins, C. T., & Jones, L. (2012). Massage, reflexology and other manual methods for pain management in labour. Cochrane Database of Systematic Reviews, (2) doi:10.1002/14651858.CD009290.pub2
Smith, C. A., Collins, C. T., Cyna, A. M., & Crowther, C. A. (2003). Complementary and alternative therapies for pain management in labour. The Cochrane Database of Systematic Reviews, (2), CD003521.
Smith, C. A., Collins, C. T., Cyna, A. M., & Crowther, C. A. (2006). Complementary and alternative therapies for pain management in labour. The Cochrane Database of Systematic Reviews, (4), CD003521.
Somrarnyart, M., Sukonthasarn, A., Sucamvang, K., & Wonghongkul, T. (2007). Effectiveness of music on pain experience: A systematic review. Thai Journal of Nursing Research, 11(1), 15-25.
Thrane, S. (2013). Effectiveness of integrative modalities for pain and anxiety in children and adolescents with cancer: A systematic review. Journal of Pediatric Oncology Nursing: Official Journal of the Association of Pediatric Oncology Nurses, 30(6), 320-332. doi:10.1177/1043454213511538
Treurnicht Naylor, K., Kingsnorth, S., Lamont, A., McKeever, P., & Macarthur, C. (2011). The effectiveness of music in pediatric healthcare: A systematic review of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine, 2011, 464759-18. doi:10.1155/2011/464759
Uman, L. S., Birnie, K. A., Noel, M., Parker, J. A., Chambers, C. T., McGrath, P. J., & Kisely, S. R. (2013). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews, (10) doi:10.1002/14651858.CD005179
Weller, C. M., & Baker, F. A. (2011). The role of music therapy in physical rehabilitation: A systematic literature review. Nordic Journal of Music Therapy, 20(1), 43-61. doi:10.1080/08098131.2010.485785
177
REFERENCES
Excluded Studies from Meta-Analysis
Ahn, M. N., & Ahn, H. Y. (2013). The effects of music intervention on pain among critically ill patients with ventilatory support. Journal of Korean Biological Nursing Science, 15(4), 247- 256.
Aitken, J., & Wilson, S. (2001). Audio distraction as a behavior management technique for pediatric dental patients. Pediatric Dentistry, 23(2), 166-167.
Aitken, J. C., Wilson, S., Coury, D., & Moursi, A. M. (2002). The effect of music distraction on pain, anxiety and behavior in pediatric dental patients. Pediatric Dentistry, 24(2), 114-118.
Akmese, Z., Baykal, & Oran, N., Tuna. (2014). Effects of progressive muscle relaxation exercises accompanied by music on low back pain and quality of life during pregnancy. Journal of Midwifery & Women's Health, 59(5), 503-509. doi:10.1111/jmwh.12176
Akombo, D. O. (2006). Effects of listening to music as an intervention for pain and anxiety in bone marrow transplant patients (Unpublished doctoral dissertation). University of Florida, Gainesville.
Albert, R. E. (2001). The effect of guided imagery and music on pain and anxiety during laceration repair. (Unpublished doctoral dissertation). Case Western Reserve University, Cleveland.
Anderson, C. (2014). Is Music therapy an Effective way to reduce distress and increase coping skills in pediatric oncology patients during their first radiation therapy treatment? Journal of Medical Imaging and Radiation Sciences, 45, 178-179.
Aragon, D., Farris, C., & Byers, J. F. (2002). The effects of harp music in vascular and thoracic surgical patients. Alternative Therapies in Health & Medicine, 8(5), 52-54.
Baby, R., & Badu, D. (2014). Effectiveness of music therapy vs foot reflexology on pain among postoperative patients in selected hospitals at Mangalore. International Journal of Nursing Education, 6(1), 226-228. doi:10.5958/j.0974-9357.6.1.046
Bae, I., Lim, H. M., Hur, M., & Lee, M. (2014). Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complementary Therapies in Medicine, 22(2), 251. doi:10.1016/j.ctim.2014.02.002
Baghdadi, Z. D. (2000). Evaluation of audio analgesia for restorative care in children treated using electronic dental anesthesia. Journal of Clinical Pediatric Dentistry, 25(1), 9-12.
Baker, S. L. (1998). The effects of audiostimulation on plasma beta-endorphin levels of persons experiencing pain (Unpublished doctoral dissertation). Indiana University.
Balan, R., Bavdekar, S. B., & Jadhav, S. (2009). Can Indian classical instrumental music reduce pain felt during venepuncture?. Indian Journal of Pediatrics, 76(5), 469-473. 178
Barnason, S., Zimmerman, L., & Nieveen, J. (1995). The effects of music interventions on anxiety in the patient after coronary artery bypass grafting. Heart & Lung: The Journal of Acute and Critical Care, 24(2), 124-132. doi:10.1016/S0147-9563(05)80007-X
Barrera, M. E., Rykov, M. H., & Doyle, S. L. (2002). The effects of interactive music therapy on hospitalized children with cancer: A pilot study. Psycho-Oncology, 11(5), 379-388.
Beckett, R. (2011). The use of music during labour and for the birth. MIDIRS Midwifery Digest, 21(4), 471-474.
Bekhuis, T. (2009). Music therapy may reduce pain and anxiety in children undergoing medical and dental procedures. The Journal of Evidence-Based Dental Practice, 9(4), 213-214. doi:10.1016/j.jebdp.2009.03.002
Bertling, R., Lemmer, W., & Klieser, E. (2003). Effectiveness of music therapy on pain reduction and psychopharmacotherapy. Pharmacopsychiatry, 36(5), 215-215.
Binek, J., Sagmeister, M., Borovicka, J., Knierim, M., Magdeburg, B., & Meyenberger, C. (2003). Perception of gastrointestinal endoscopy by patients and examiners with and without background music. Digestion, 68(1), 5-8.
Binson, B., Lertmaharit, S., Satayaprakop, P., Chongthanakorn, K., Boonyakrai, C., Klinphaetkit, S., . . . Boonpob, C. (2013). Effects of music intervention on patients undergoing hemodialysis in the Bangkok metropolitan administration hospitals. Music and Medicine: An Interdisciplinary Journal, 5(3), 188-193. doi:http://dx.doi.org.libproxy.temple.edu/10.1177/1943862113495700
Björkman, I., Karlsson, F., Lundberg, A., & Frisman, G. H. (2013). Gender differences when using sedative music during colonoscopy. Gastroenterology Nursing: The Official Journal of the Society of Gastroenterology Nurses and Associates, 36(1), 14-20. doi:10.1097/SGA.0b013e31827c4c80
Bo, L. K., MN, B., & Callaghan, P. (2000). Soothing pain-elicited distress in Chinese neonates. Pediatrics, 105(4), e49-e49. doi:10.1542/peds.105.4.e49
Bradshaw, D. H., Chapman, C. R., Jacobson, R. C., & Donaldson, G. W. (2012). Effects of music engagement on responses to painful stimulation. Clinical Journal of Pain, 28(5), 418-427.
Bradshaw, D. H., Donaldson, G. W., Jacobson, R. C., Nakamura, Y., & Chapman, C. R. (2011). Individual differences in the effects of music engagement on responses to painful stimulation. Journal of Pain, 12(12), 1262-1273.
Bradt, J., Potvin, N., Kesslick, A., Shim, M., Radl, D., Schriver, E., . . . Komarnicky-Kocher, L. (2014). The impact of music therapy versus music medicine on psychological outcomes and pain in cancer patients: A mixed methods study. Supportive Care in Cancer.
doi:10.1007/s00520-014-2478-7 179
Bringman, H., Giesecke, K., Thorne, A., & Bringman, S. (2009). Relaxing music as pre- medication before surgery: A randomised controlled trial. Acta Anaesthesiologica Scandinavica, 53(6), 759-764. doi:10.1111/j.1399-6576.2009.01969.x
Browning, C. A. (2000). Using music during childbirth. Birth: Issues in Perinatal Care, 27(4), 272-276.
Burrai, F., Micheluzzi, V., Zito, M. P., Pietro, G., & Sisti, D. (2014). Effects of live saxophone music on physiological parameters, pain, mood and itching levels in patients undergoing haemodialysis. Journal of Renal Care, 40(4), 249-256. doi:10.1111/jorc.12078
Butt, M. L., & Kisilevsky, B. S. (2000). Music modulates behaviour of premature infants following heel lance. Canadian Journal of Nursing Research, 31(4), 17-39.
Cadigan, M. E., Caruso, N. A., Haldeman, S. M., McNamara, M. E., Noyes, D. A., Spadafora, M. A., & Carroll, D. L. (2001). The effects of music on cardiac patients on bed rest. Progress in Cardiovascular Nursing, 16(1), 5-13.
Calcaterra, V., Ostuni, S., Bonomelli, I., Mencherini, S., Brunero, M., Zambaiti, E., . . . Pelizzo, G. (2014). Music benefits on postoperative distress and pain in pediatric day care surgery. Pediatric Reports, 6(3), 5534. doi:10.4081/pr.2014.5534
Caprilli, S., Anastasi, F., Grotto, R. P., Scollo Abeti, M., & Messeri, A. (2007). Interactive music as a treatment for pain and stress in children during venipuncture: A randomized prospective study. Journal of Developmental & Behavioral Pediatrics, 28(5), 399-403.
Cardoso,Maria Vera Lúcia Moreira Leitão, Farias, L. M., & Melo, G. M. d. (2014). Music and 25% glucose pain relief for the premature infant: A randomized clinical trial. Revista Latino- Americana De Enfermagem, 22(5), 810-818.
Chae, S. J., Park, H. R., & Yang, S. (2007). The effects of music therapy on anxiety and pain in patients with retrograde ureteral stenting under local anesthesia. The Korean Journal of Fundamentals of Nursing, 14(2), 173-180.
Chaput-McGovern, J., & Silverman, M. J. (2012). Effects of music therapy with patients on a post-surgical oncology unit: A pilot study determining maintenance of immediate gains. The Arts in Psychotherapy, 39, 417.
Chen, X., Seth, R. K., Rao, V. S., Huang, J. J., & Adelman, R. A. (2012). Effects of music therapy on intravitreal injections: A randomized clinical trial. Journal of Ocular Pharmacology & Therapeutics, 28(4), 414-419.
Chesky, K. S., Russell, I. J., Lopez, Y., & Kondraske, G. V. (1997). Fibromyalgia tender point pain: A double-blind, placebo-controlled pilot study of music vibration using the music vibration table. Journal of Musculoskeletal Pain, 5(3), 33-52.
Chiasson, A. M., Baldwin, A. L., Mclaughlin, C., Cook, P., & Sethi, G. (2013). The effect of live spontaneous harp music on patients in the intensive care unit. Evidence-Based Complementary & Alternative Medicine (eCAM), , 1-6. doi:10.1155/2013/428731 180
Choi, S. E. (2009). The effects of therapeutic music listening on the pain relief for the patients with burn. Korean Journal of Interdisciplinary Therapy, 1(1), 35-51.
Chou, Y., Yip, W., Chang, L., & Lin, C. (2012). Reducing neonatal vaccination pain: The effectiveness of behavioral interventions [Chinese]. Journal of Nursing & Healthcare Research, 8(1), 3-13.
Chuang, C. Y., Han, W. R., Li, P. C., & Young, S. T. (2010). Effects of music therapy on subjective sensations and heart rate variability in treated cancer survivors: A pilot study. Complementary Therapies in Medicine, 18(5), 224-226. doi:10.1016/j.ctim.2010.08.003
Cigerci, Y., & Ozbayir, T. (2013). The effects of music therapy on patients having coronary artery bypass graft operation in terms of pain, anxiety and the duration of the stay in hospital. International Journal of Cardiology, 163, S10-S10.
Cohen, B. E. (2001). Use of aromatherapy and music therapy to reduce anxiety and pain perception in dental hygiene. Access, 15(6), 34.
Colwell, C. M., Edwards, R., Hernandez, E., & Brees, K. (2013). Impact of music therapy interventions (listening, composition, orff-based) on the physiological and psychosocial behaviors of hospitalized children: A feasibility study. Journal of Pediatric Nursing, 28(3), 249-257.
Comeaux, T., & Comeaux, T. (2013). The effect of complementary music therapy on the patient's postoperative state anxiety, pain control, and environmental noise satisfaction. MEDSURG Nursing, 22(5), 313-318.
Cooke, M., Chaboyer, W., Schluter, P., Foster, M., Harris, D., & Teakle, R. (2010). The effect of music on discomfort experienced by intensive care unit patients during turning: A randomized cross-over study. International Journal of Nursing Practice, 16(2), 125-131. doi:10.1111/j.1440-172X.2010.01819.x
Cutshall, S. M., Anderson, P. G., Prinsen, S. K., Wentworth, L. J., Olney, T. L., Messner, P. K., . . . Bauer, B. A. (2011). Effect of the combination of music and nature sounds on pain and anxiety in cardiac surgical patients: A randomized study. Alternative Therapies in Health & Medicine, 17(4), 16-23.
Dixon, L., Coscione, A. I. L., & Winkler, M. (2014). The impact of music on pain and anxiety experienced in patients undergoing flexible cystoscopy: A prospective randomized controlled trial. BJU International, 113, 64-64.
Dobek, C. E., Beynon, M. E., Bosma, R. L., & Stroman, P. W. (2014). Music modulation of pain perception and pain-related activity in the brain, brain stem, and spinal cord: A functional magnetic resonance imaging study. The Journal of Pain, 15(10), 1057-1068. doi:10.1016/j.jpain.2014.07.006
Dobek, C. E. (2013). Effects of music on the pain response in the central nervous system using functional magnetic resonance imaging (M.Sc.). Available from ProQuest Dissertations & Theses A&I. (1511031998). 181 dos, S. A., Oliveira, d. N., Lyra, S., Tayná, Soares, F. T., & Zeviani Brêda, M. (2012). The effects of music on aged alzheimer patients in a long-term care facility [Portuguese]. Revista Eletronica De Enfermagem, 14(2), 404-413.
Dunbar, R. I., Kaskatis, K., MacDonald, I., & Barra, V. (2012). Performance of music elevates pain threshold and positive affect: Implications for the evolutionary function of music. Evolutionary Psychology, 10(4), 688-702.
Dvorak, A. L. (2012). Music therapy support groups for cancer patients and caregivers (Unpublished doctoral dissertation). University of Iowa, Iowa City.
Easter, B., DeBoer, L., Settlemyre, G., Starnes, C., Marlowe, V., & Tart, R. C. (2010). The impact of music on the PACU patient's perception of discomfort. Journal of PeriAnesthesia Nursing, 25(2), 79-87.
Eells, K. (2014). The use of music and singing to help manage anxiety in older adults. Mental Health Practice, 17(5), 10-17.
El Rakshy, M., & Weston, C. (1997). An investigation into the possible additive effects of acupuncture and autogenic relaxation in the management of chronic pain. Acupuncture in Medicine, 15(2), 74-75.
Ernst, E. (2006). [Vivaldi reduces pain]. MMW Fortschritte Der Medizin, 148(31-32), 19.
Ferguson, S. L., & Voll, K. V. (2004). Burn pain and anxiety: The use of music relaxation during rehabilitation. Journal of Burn Care & Rehabilitation, 25(1), 8-14.
Finlay, K. A. (2014). Music-induced analgesia in chronic pain: Efficacy and assessment through a primary-task paradigm. Psychology of Music, 42(3), 325-346. doi:http://dx.doi.org.libproxy.temple.edu/10.1177/0305735612471236
Flaugher, M. (2002). The intervention of music on perceptions of chronic pain, depression, and anxiety in ambulatory individuals with cancer (Unpublished doctoral dissertation). University of Alabama, Birmingham.
Franco, M., & Rodrigues, A. B. (2009). Music therapy in relief of pain in oncology patients. Einstein, 7, 147-151.
Fratianne, R. B., Prensner, J. D., Huston, M. J., Super, D. M., Yowler, C. J., & Standley, J. M. (2001). The effect of music-based imagery and musical alternate engagement on the burn debridement process. Journal of Burn Care & Rehabilitation, 22(1), 47-53.
Garza-Villarreal, E., Wilson, A. D., Vase, L., Brattico, E., Barrios, F. A., Jensen, T. S., . . . Vuust, P. (2014). Music reduces pain and increases functional mobility in fibromyalgia. Frontiers in Psychology, 5, 90-90. doi:10.3389/fpsyg.2014.00090
Gawronska-Skorkowska, J., Zienkiewicz, J., Majkowicz, M., Szwed, E., Kiewlicz, W., & Soroka, A. (2002). Music therapy before and during oral surgeries as a positive relaxing influence on the young patients. Annales Academiae Medicae Gedanensis, 32, 161-172. 182
Ghaffaripour, S., Mahmoudi, H., Sahmeddini, M. A., Alipour, A., & Chohedri, A. (2013). Music can effectively reduce pain perception in women rather than men. Pakistan Journal of Medical Sciences, 29(1), 128-131. doi:10.12669/pjms.291.2947
Giaquinto, S., Cacciato, A., Minasi, S., Sostero, E., & Amanda, S. (2006). Effects of music-based therapy on distress following knee arthroplasty. British Journal of Nursing, 15(10), 576-579.
Goff, L. C., Pratt, R. R., & Madrigal, J. L. (1997). Music listening and S-IgA levels in patients undergoing a dental procedure. International Journal of Arts Medicine (IJAM), 5(2), 22-26.
Good, M., & Ahn, S. (2008). Korean and American music reduces pain in Korean women after gynecologic surgery. Pain Management Nursing, 9(3), 96-103.
Good, M., Albert, J. M., Anderson, G. C., Wotman, S., Cong, X., Lane, D., & Ahn, S. (2010). Supplementing relaxation and music for pain after surgery. Nursing Research, 59(4), 259- 269. doi:10.1097/NNR.0b013e3181dbb2b3
Good, M., Albert, J. M., Arafah, B., Anderson, G. C., Wotman, S., Cong, X., . . . Ahn, S. (2013). Effects on postoperative salivary cortisol of relaxation/music and patient teaching about pain management. Biological Research for Nursing, 15(3), 318-329.
Good, M., Anderson, G. C., Ahn, S., Cong, X., & Stanton-Hicks, M. (2005). Relaxation and music reduce pain following intestinal surgery. Research in Nursing & Health, 28(3), 240- 251.
Good, M., Anderson, G. C., Stanton-Hicks, M., Grass, J. A., & Makii, M. (2002). Relaxation and music reduce pain after gynecologic surgery. Pain Management Nursing, 3(2), 61-70.
Good, M., Picot, B. L., Salem, S. G., Chin, C., Picot, S. F., & Lane, D. (2000). Cultural differences in music chosen for pain relief... five pain studies. Journal of Holistic Nursing, 18(3), 245-260.
Good, M., Stanton-Hicks, M., Grass, J. A., Anderson, G. C., Lai, H., Roykulcharoen, V., & Adler, P. A. (2001). Relaxation and music to reduce postsurgical pain. Journal of Advanced Nursing, 33(2), 208-215. doi:10.1111/j.1365-2648.2001.01655.x10.1046/j.1365- 2648.2001.01655.x
Guétin, S., Goudeau, S., Pelletier, E., Bonté, F., Bussy, C., Touchon, J., & Hérisson, C. (2014). Usefulness of music therapy among patients hospitalized in convalescent and rehabilitation units for the elderly. Annals of Physical & Rehabilitation Medicine, 57, e249-e250. doi:10.1016/j.rehab.2014.03.908
Guétin, S., Giniès, P., Siou, D. K. A., Picot, M., Pommié, C., Guldner, E., . . . Touchon, J. (2012). The effects of music intervention in the management of chronic pain: A single-blind, randomized, controlled trial. The Clinical Journal of Pain, 28(4), 329-337.
Han, L., Li, J. P., Sit, J. W. H., Chung, L., Jiao, Z. Y., & Ma, W. G. (2010). Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated 183
patients in china: A randomised controlled trial. Journal of Clinical Nursing, 19(7-8), 978- 987. doi:10.1111/j.1365-2702.2009.02845.x
Harikumar, R., Raj, M., Paul, A., Harish, K., Kumar, S. K., Sandesh, K., . . . Thomas, V. (2006). Listening to music decreases need for sedative medication during colonoscopy: A randomized, controlled trial. Indian Journal of Gastroenterology, 25(1), 3-5.
Hasenbring, M., Schulz-Kindermann, F., Hennings, U., Florian, M., Linhart, D., Ramm, G., & Zander, A. (1999). The efficacy of relaxation/imagery, music therapy and psychological support for pain relief and quality of life: First results from a randomized controlled clinical trial. Bone Marrow Transplantation, 23, S166-S166.
Hatem, T. P., Lira, P. I., & Mattos, S. S. (2006). The therapeutic effects of music in children following cardiac surgery. Jornal De Pediatria, 82(3), 186-192.
Hauck, M., Metzner, S., Rohlffs, F., Lorenz, J., & Engel, A. K. (2013). The influence of music and music therapy on pain-induced neuronal oscillations measured by magnetencephalography. Pain, 154(4), 539-547.
Haythronthwaite, J. A., Lawrence, J. W., & Fauerbach, J. A. (2001). Brief cognitive interventions for burn pain. Annals of Behavioral Medicine, 23(1), 42-49. doi:10.1207/S15324796ABM2301_7
Heiser, R. M., Chiles, K., Fudge, M., & Gray, S. E. (1997). The use of music during the immediate postoperative recovery period. AORN Journal, 65(4), 777. doi:10.1016/S0001- 2092(06)62999-2
Hilliard, R. E. (2003). The effects of music therapy on the quality and length of life of people diagnosed with terminal cancer. Journal of Music Therapy, 40(2), 113-137.
Hong, M. S., & Cho, M. J. (2010). The effects of music therapy on pain, depression and anxiety in terminal cancer patients. Asian Oncology Nursing, 10(1), 112-118.
Hong, M. (1996). The effects of attention enhancement during music listening on chronic pain attenuation (M.M.). Available from ProQuest Dissertations & Theses A&I. (304252240).
Horne-Thompson, A., & Grocke, D. (2008). The effect of music therapy on anxiety in patients who are terminally ill. Journal of Palliative Medicine, 11(4), 582-590.
Hosseini, S. E., Bagheri, M., & Honarparvaran, N. (2013). Investigating the effect of music on labor pain and progress in the active stage of first labor. European Review for Medical & Pharmacological Sciences, 17(11), 1479-1487.
Hsieh, C., Kong, J., Kirsch, I., Edwards, R. R., Jensen, K. B., Kaptchuk, T. J., & Gollub, R. L. (2014). Well-loved music robustly relieves pain: A randomized, controlled trial. Plos One,
9(9), e107390-e107390. doi:10.1371/journal.pone.0107390
Huth, M. M. (1999). Children's responses to immunizations: Lullabies as distraction. Journal of Child & Family Nursing, 2(6), 432-433. 184
Ignacio, J., Chan, M. F., Teo, S. H., Tsen, L. M., & Goy, R. (2012). Research in brief - the effect of music on pain, anxiety, and analgesic use on adults undergoing an orthopaedic surgery: A pilot study. Singapore Nursing Journal, 39(4), 49-53.
Ilkkaya, N. K., Ustun, F. E., Sener, E. B., Kaya, C., Ustun, Y. B., Koksal, E., . . . Ozkan, F. (2014). The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. Journal of Perianesthesia Nursing, 29(5), 418-426. doi:10.1016/j.jopan.2014.05.008
Jaber, S., Bahloul, H., Guetin, S., Chanques, G., Sebbane, M., & Eledjam, J. J. (2007). [Effects of music therapy in intensive care unit without sedation in weaning patients versus non- ventilated patients]. Annales Francaises d Anesthesie Et De Reanimation, 26(1), 30-38.
Jacobi, E. M., & Eisenberg, G. M. (2001). The efficacy of guided imagery and music (GIM) in the treatment of rheumatoid arthritis. Journal of the Association for Music and Imagery, 8, 57-74.
Jacobi, E. M. (1995). The efficacy of the bonny method of guided imagery and music as experiential therapy in the primary care of persons with rheumatoid arthritis (Unpublished doctoral dissertation). Union Institute, Los Angeles.
Jeaun, H. S., Chun, K. H., Lee, S. Y., Lee, J. K., & Song, H. C. (2008). The effect of music therapy at surgical extraction of mandibular impacted 3rd molars. Journal of the Korean Association of Oral and Maxillofacial Surgeons, 34(3), 266-275.
Jeffs, D. A. (2007). A pilot study of distraction for adolescents during allergy testing. Journal for Specialists in Pediatric Nursing: JSPN, 12(3), 170-185.
Joyce, B. A., Keck, J. F., & Gerkensmeyer, J. (2001). Evaluation of pain management interventions for neonatal circumcision pain. Journal of Pediatric Healthcare, 15(3), 105- 114.
Kaluza, G., Margraf-Stiksrud, J., & Wnuk, P. (2002). Original Studies–does the use of music or audio books reduce anxiety in children and adolescents?– A randomized clinical intervention trial. Dtsch Zahnarztl Z, 57, 406-410.
Kane, F. M. A., Brodie, E. E., Coull, A., Coyne, L., Howd, A., Milne, A., . . . Robbins, R. (2004). The analgesic effect of odour and music upon dressing change. British Journal of Nursing (Mark Allen Publishing), 13(19), S4-S12.
Kang, H. Y. (1998). The effect of music therapy on the state anxiety, pain in dental patients. The Journal of Korean Academic Society of Nursing Education, 4(2), 147-158.
Kang, J. G., Lee, J. J., Kim da, M., Kim, J. A., Kim, C. S., Hahm, T. S., & Lee, B. D. (2008). Blocking noise but not music lowers bispectral index scores during sedation in noisy
operating rooms. Journal of Clinical Anesthesia, 20(1), 12-16. doi:10.1016/j.jclinane.2007.06.005 185
Kankkunen, P., & Vaajoki, A. (2014). Songs for silent suffering: Could music help with postsurgical pain? Pain Management, 4(1), 1-3. doi:10.2217/pmt.13.65
Karimi, R., Shabani, F., Dehghan Nayeri, N., Zareii, K., Khalili, G., & Chehrazi, M. (2012). Effect of music therapy on physiological pain responses of blood sampling in premature infants. Hayat, 18(2), 11-11.
Kenntner-Mabiala, R., Gorges, S., Alpers, G. W., Lehmann, A. C., & Pauli, P. (2007). Musically induced arousal affects pain perception in females but not in males: A psychophysiological examination. Biological Psychology, 75(1), 19-23.
Kenny, D. T., & Faunce, G. (2004). The impact of group singing on mood, coping, and perceived pain in chronic pain patients attending a multidisciplinary pain clinic. Journal of Music Therapy, 41(3), 241-258.
Kim, H. S., Lee, C. G., Jung, H., & Kim, K. S. (2002). The effect of music therapy on recovery of anesthesia, vital sign and pain of post operative patients in obstetrics and gynecology. The Medical Journal of Chosun University, 27(1), 105-112.
Kim, M. Y., Kim, A. R., Choi, H. O., Whang, M. S., & Kwon, I. G. (2007). Effects of music therapy on level of pain and ambulation of patients with abdominal surgery. Journal of Korean Clinical Nursing Research, 13(3), 81-91.
Kim, S. H. (2007). The effects of music therapy on pain, anxiety, and discomfort behavior during burn dressing change. Journal of Korean Clinical Nursing Research, 13(1), 143-155.
Kim, S. J., & Koh, I. (2005). The effects of music on pain perception of stroke patients during upper extremity joint exercises. Journal of Music Therapy, 42(1), 81-92.
Kimber, L., McNabb, M., Mc Court, C., Haines, A., & Brocklehurst, P. (2008). Massage or music for pain relief in labour: A pilot randomised placebo controlled trial. European Journal of Pain, 12(8), 961-969.
Kleiber, C., & Adamek, M., S. (2012). Adolescents' perceptions of music therapy following spinal fusion surgery. Journal of Clinical Nursing, 22(3), 414-422. doi:10.1111/j.1365- 2702.2012.04248.x
Kliempt, P., Ruta, D., Ogston, S., Landeck, A., & Martay, K. (1999). Hemispheric- synchronisation during anaesthesia: A double-blind randomised trial using audiotapes for intra-operative nociception control. Anaesthesia, 54(8), 769-773. doi:10.1046/j.1365- 2044.1999.00958.x
Koenig, J., Kaess, M., Oelkers-Ax, R., Parzer, P., Lenzen, C., Hillecke, T. K., & Resch, F. (2013). Recurrent primary headache in adolescence. pilot study on music therapeutic interventions. Psychotherapeut, 58(3), 285-291. doi:10.1007/s00278-012-0941-9
Korhan, E. A., & Uyar, M. (2011). The effect of music therapy on pain and anxiety in intensive care patients/ yogun bakim hastalarinda muzik terapinin agri ve anksiyete uzerine etkisi. Agri, 23, 139. 186
Korhan, E. A., Uyar, M., Eyigör, C., Hakverdioğlu Yönt, G., Çelik, S., & Khorshıd, L. (2014). The effects of music therapy on pain in patients with neuropathic pain. Pain Management Nursing, 15(1), 306-314.
Kotwal, M. R., Rinchhen, C. Z., & Ringe, V. V. (1998). Stress reduction through listening to Indian classical music during gastroscopy. Diagnostic and Therapeutic Endoscopy, 4(4), 191-197. doi:10.1155/DTE.4.191
Krout, R. E. (2001). The effects of single-session music therapy interventions on the observed and self-reported levels of pain control, physical comfort, and relaxation of hospice patients. American Journal of Hospice & Palliative Care, 18(6), 383-90, 432, 1p-383-90, 432, 1p.
Kullich, W., Bernatzky, G., Hesse, H. P., Wendtner, F., Likar, R., & Klein, G. (2003). [Music therapy-effect on pain, sleep and quality of life in low back pain]. Wiener Medizinische Wochenschrift, 153(9-10), 217-221.
Kwan, M., & Seah, A. S. T. (2013). Music therapy as a non-pharmacological adjunct to pain management: Experiences at an acute hospital in Singapore. Progress in Palliative Care, 21(3), 151-157. doi:10.1179/1743291X12Y.0000000042
Kwon, I. S., Kim, J., & Park, K. M. (2006). Effects of music therapy on pain, discomfort, and depression for patients with leg fractures. Daehan Ganho Haghoeji, 36(4), 630-636.
Lai, H., & Good, M. (2005). Music improves sleep quality in older adults. Journal of Advanced Nursing, 49(3), 234-244. doi:10.1111/j.1365-2648.2004.03281.x
Le Roux, F. (1998). Music: A new integrated model in physiotherapy. South African Journal of Physiotherapy, 54, 2-11.
Leao, E. R., & da Silva, M. J. (2005). The relationship between music and musculoskeletal chronic pain. Online Brazilian Journal of Nursing, 4(1), 1-16.
Leão, E. R., & da Silva, M.,Julia Paes. (2004). [Music and chronic muscular-skeletal pain: The evocative potential of mental images]. Revista Latino-Americana De Enfermagem, 12(2), 235-241.
Leardi, S., Pietroletti, R., Angeloni, G., Necozione, S., Ranalletta, G., & Del Gusto, B. (2007). Randomized clinical trial examining the effect of music therapy in stress response to day surgery. The British Journal of Surgery, 94(8), 943-947.
Lee, B., Ko, C. H., Park, M. S., Park, S. H., & Kim, S. H. (2003). The effects of information provision and musical treatment on relieving discomfort and anxiety for gastric endoscopy patients. Journal of Korean Clinical Nursing Research, 8(2), 33-48.
Lee, D. W., Chan, K. W., Poon, C. M., Ko, C. W., Chan, K. H., Sin, K. S., . . . Chan, A. C. (2002).
Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: A prospective randomized controlled trial. Gastrointestinal Endoscopy, 55(1), 33-36. 187
Lee, D. Y., & Lee, J. Y. (2010). The influence of music listening, vocalization with music listening on pain, mood, and autonomic nervous system of pain patients. Korean Journal of Music Therapy, 12(2), 61-82.
Lee, E. H., & Choi, S. E. (2012). The effects of music therapy by self-selected music listening on terminal cancer patients' affect and stress by pain level. Korean Journal of Hospice and Palliative Care, 15(2), 77-87.
Lee, E. J., Bhattacharya, J., Sohn, C., & Verres, R. (2012). Monochord sounds and progressive muscle relaxation reduce anxiety and improve relaxation during chemotherapy: A pilot EEG study. Complementary Therapies in Medicine, 20(6), 409-416. doi:10.1016/j.ctim.2012.07.002
Lee, J. M., & Hong, H. S. (2011). The effect of a preference music therapy on anxiety and pain of cystoscopy. Journal of Korean Biological Nursing Science, 13(1), 44-42.
Lin, P., Lin, M., Huang, L., Hsu, H., & Lin, C. (2011). Music therapy for patients receiving spine surgery. Journal of Clinical Nursing, 20(7), 960-968. doi:10.1111/j.1365- 2702.2010.03452.x
Liu, Y., Chang, M., & Chen, C. (2010). Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. Journal of Clinical Nursing, 19(7-8), 1065-1072. doi:10.1111/j.1365-2702.2009.03028.x
Loewy, J., Stewart, K., Dassler, A., Telsey, A., & Homel, P. (2013). The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics, 131(5), 902-918. doi:10.1542/peds.2012-1367
Lopes da Silva, R. (2012). Humor and music to reduce the stress and pain related to invasive diagnostic and therapeutical procedures in patients with hematological malignancies. Annals of Hematology, 91(1), 133-134.
López-Cepero Andrada, J. M., Amaya Vidal, A., Castro Aguilar-Tablada, T., García Reina, I., Silva, L., Ruiz Guinaldo, A., . . . Benítez Roldán, A. (2004). Anxiety during the performance of colonoscopies: Modification using music therapy. European Journal of Gastroenterology & Hepatology, 16(12), 1381-1386. doi:10.1097/00042737-200412000-00024
Lukas, L. K. (2004). Orthopedic outpatients' perception of perioperative music listening as therapy. Journal of Theory Construction & Testing, 8(1), 7-12.
Luna, M. P., & Nosek, L. J. (2011). Can music provide pain relief during vascular access cannulation for hemodialysis? Nephrology Nursing Journal, 38(2), 197.
Madden, J. R., Mowry, P., Gao, D., Cullen, P. M., & Foreman, N. K. (2010). Creative arts therapy improves quality of life for pediatric brain tumor patients receiving outpatient
chemotherapy. Journal of Pediatric Oncology Nursing, 27(3), 133-145. 188
Madson, A. T., & Silverman, M. J. (2010). The effect of music therapy on relaxation, anxiety, pain perception, and nausea in adult solid organ transplant patients. Journal of Music Therapy, 47(3), 220-232.
Magill, L. (2001). The use of music therapy to address the suffering in advanced cancer pain. Journal of Palliative Care, 17(3), 167-172.
Malone, A. B. (1996). The effects of live music on the distress of pediatric patients receiving intravenous starts, venipunctures, injections, and heel sticks. Journal of Music Therapy, 33(1), 19-33.
Mandel, S. E., Davis, B. A., & Secic, M. (2014). Effects of music therapy on patient satisfaction and health-related quality of life of hospital inpatients. Hospital Topics, 92(2), 28-35.
Mandel, S. E., Hanser, S. B., Secic, M., & Davis, B. A. (2007). Effects of music therapy on health-related outcomes in cardiac rehabilitation: A randomized controlled trial. Journal of Music Therapy, 44(3), 176.
Mariauzouls, C., Michel, D., & Schiftan, Y. (1999). Vibration supported music therapy reduces pain and enhances relaxation in persons with paraplegia or tetraplegia - a pilot study of the psychological and autonomic effects of simultaneous acoustic and somatosensory music stimulation to manage pain [German]. Rehabilitation, 38(4), 245-248.
Martindale, F., Mikocka-Walus, A., Walus, B. P., Keage, H., & Andrews, J. M. (2014). The effects of a designer music intervention on patients' anxiety, pain, and experience of colonoscopy: A short report on a pilot study. Gastroenterology Nursing, 37(5), 338-342. doi:10.1097/SGA.0000000000000066
McCaffrey, R., & Freeman, E. (2003). Effect of music on chronic osteoarthritis pain in older people. Journal of Advanced Nursing, 44(5), 517-524. doi:10.1046/j.0309- 2402.2003.02835.x
McCaffrey, R., & Locsin, R. (2006). The effect of music on pain and acute confusion in older adults undergoing hip and knee surgery. Holistic Nursing Practice, 20(5), 218-226.
McDaniel, C., Burkett, A. M., Cormier, M., Duvall, J., Davis, S., Gabriel, L., . . . Conaway, M. (2009). PICC, the music and travel to the port of relaxation: The effects of music on perceived pain and anxiety in patients receiving PICCs and port-a-caths. Journal of Radiology Nursing, 28(1), 32-34.
McNair, C., Campbell Yeo, M., Johnston, C., & Taddio, A. (2013). Nonpharmacological management of pain during common needle puncture procedures in infants: Current research evidence and practical considerations. Clinics in Perinatology, 40(3), 493-508. doi:10.1016/j.clp.2013.05.003
McRee, L. D., Noble, S., & Pasvogel, A. (2003). Using massage and music therapy to improve postoperative outcomes. AORN Journal, 78(3), 433. doi:10.1016/S0001-2092(06)60754-0 189
Meeuse, J. J., Koornstra, J. J., & Reyners, A. (2010). Listening to music does not reduce pain during sigmoidoscopy. European Journal of Gastroenterology & Hepatology, 22(8), 942- 945. doi:10.1097/MEG.0b013e328336ec6e
Megel, M. E., Houser, C. W., & Gleaves, L. S. (1998). Children's responses to immunizations: Lullabies as a distraction. Issues in Comprehensive Pediatric Nursing, 21(3), 129-145.
Mitchell, L. A., & MacDonald, R. A. (2006). An experimental investigation of the effects of preferred and relaxing music listening on pain perception. Journal of Music Therapy, 43(4), 295-316.
Mitchell, L. A., MacDonald, R. A., & Brodie, E. E. (2006). A comparison of the effects of preferred music, arithmetic and humour on cold pressor pain. European Journal of Pain, 10(4), 343-351.
Mitchell, L. A., MacDonald, R. A. R., & Knussen, C. (2008). An investigation of the effects of music and art on pain perception. Psychology of Aesthetics, Creativity & the Arts, 2(3), 162- 170. doi:10.1037/1931-3896.2.3.162
Moser, L. (2007). The effects of music therapy on pain. Kentucky Nurse, 55(3), 10-10.
Müller-Busch, H. C., & Hoffmann, P. (1997). [Active music therapy for chronic pain: A prospective study]. Germany: Springer-Verlag.
Na Cholburi, J., Hanucharurnkul, S., & Waikakul, W. (2004). Effects of music therapy on anxiety and pain in cancer patients. Thai Journal of Nursing Research, 8(3), 173-181.
Najafi, M., Motamed, F., Kiani, M., Sabbagh, M., Attaei, P., Mobarhan, M. G., . . . Javan, A. (2014). The effect of music on pain, anxiety and vital signs of children during colonoscopy. International Journal of Pediatrics, 2, 26-26.
Nickel, A., Hillecke, T., Oelkers-Ax, R., Parzer, P., Resch, F., & Bolay, H. (2005). Effectiveness of music therapy in the treatment of children with migraine headache. Cephalalgia, 25(8), 659-659.
Nikandish, R., Sahm Aldini, M. A., & Khademi, S. (2006). Effect of exposure to music on postoperative pain and anxiety after cesarean section under general anesthesia: A double blind randomized placebo - controlled trial. Journal of Iranian Society Anaesthesiology and Intensive Care, 28(55), 44-53.
Nilsson, S., Kokinsky, E., Nilsson, U., Sidenvall, B., & Enskar, K. (2009). School-aged children's experiences of postoperative music medicine on pain, distress, and anxiety. Paediatric Anaesthesia, 19(12), 1184-1190.
Nilsson, U. (2009). The effect of music intervention in stress response to cardiac surgery in a
randomized clinical trial. Heart & Lung, 38(3), 201-207. 190
Nilsson, U. (2009). Soothing music can increase oxytocin levels during bed rest after open-heart surgery: A randomised control trial. Journal of Clinical Nursing, 18(15), 2153-2161. doi:10.1111/j.1365-2702.2008.02718.x
Nilsson, U. (2012). Effectiveness of music interventions for women with high anxiety during coronary angiographic procedures: A randomized controlled. European Journal of Cardiovascular Nursing, 11(2), 150-153.
Nilsson, U., Lindell, L., Eriksson, A., & Kellerth, T. (2009). The effect of music intervention in relation to gender during coronary angiographic procedures: A randomized clinical trial. European Journal of Cardiovascular Nursing, 8(3), 200-206. doi:10.1016/j.ejcnurse.2009.01.001
Nilsson, U. (2012). Effectiveness of music interventions for women with high anxiety during coronary angiographic procedures: A randomized controlled. European Journal of Cardiovascular Nursing, 11(2), 150-153.
Noguchi, L. K. (2006). The effect of music versus nonmusic on behavioral signs of distress and self-report of pain in pediatric injection patients. Journal of Music Therapy, 43(1), 16-38.
Noh, G. O., Hwang, M. S., Cho, K. S., Lim, J. A., Kang, M. K., Kim, H. J., & Kim, J. Y. (2011). Effect of music therapy as intervention on peripheral neuropathic pain and anxiety of gynecologic cancer patients undergoing paclitaxel chemotherapy. Korean Journal of Women Health Nursing, 17(3), 215-224. doi:10.4069/kjwhn.2011.17.3.215
Oelkers-Ax, R., Leins, A., Parzer, P., Hillecke, T., Bolay, H. V., Fischer, J., . . . Resch, F. (2008). Butterbur root extract and music therapy in the prevention of childhood migraine: An explorative study. European Journal of Pain, 12(3), 301-313.
Onieva-Zafra, M., Castro-Sánchez, A., María, Matarán-Peñarrocha, G., A., & Moreno-Lorenzo, C. (2013). Effect of music as nursing intervention for people diagnosed with fibromyalgia. Pain Management Nursing, 14(2), e39-46. doi:10.1016/j.pmn.2010.09.004
Ozer, N., Karaman Ozlu, Z., Arslan, S., & Gunes, N. (2013). Effect of music on postoperative pain and physiologic parameters of patients after open heart surgery. Pain Management Nursing, 14(1), 20-28.
Park, H. (2010). Effect of music on pain for home-dwelling persons with dementia. Pain Management Nursing, 11(3), 141-147. doi:10.1016/j.pmn.2009.05.004
Park, H., & Pringle Specht, J. K. (2009). Effect of individualized music on agitation in individuals with dementia who live at home. Journal of Gerontological Nursing, 35(8), 47- 55. doi:10.3928/00989134-20090706-01
Park, J. S., Yeom, J. H., & Shin, H. J. (2006). The effect of music therapy on postoperative pain
in patients with total hip replacement. The Journal of Korean Academic Society of Adult Nursing, 18(2), 183-193. 191
Park, M. G., Kang, K. S., Yeo, J. K., Cho, D. Y., & Park, S. S. (2012). Listening to music decreases patient's anxiety, pain and dissatisfaction during cystoscopy: A prospective randomized controlled trial. Journal of Urology, 187(4), E612-E612.
Pellino, T. A., Gordon, D. B., Engelke, Z. K., Busse, K. L., Collins, M. A., Silver, C. E., & Norcross, N. J. (2005). Use of nonpharmacologic interventions for pain and anxiety after total hip and total knee arthroplasty. Orthopaedic Nursing, 24(3), 182-192.
Perlini, A. H., & Viita, K. A. (1996). Audioanalgesia in the control of experimental pain. Canadian Journal of Behavioural Science/Revue Canadienne Des Sciences Du Comportement, 28(4), 292-301.
Phumdoung, S., Youngvanichsate, S., Jongpaiboonpatana, W., & Leetanaporn, R. (2007). The effects of the PSU cat position and music on length of time in the active phase of labor and labor pain. Thai Journal of Nursing Research, 11(2), 96-105.
Phumdoung, S., Youngwanichsetha, S., Mahattanan, S., Payakkamas, T., Maneechot, K., Chanudom, B., & Ajasariyasing, T. (2014). Prince of Songkla university cat and upright positions together with music reduces the duration of active phase of labour and labour pain in primiparous women compared to oxytocin. Focus on Alternative & Complementary Therapies, 19(2), 70-77. doi:10.1111/fct.12113
Picard, L. M., Bartel, L. R., Gordon, A. S., Cepo, D., Wu, Q., & Pink, L. R. (2014). Music as a sleep aid in fibromyalgia. Pain Research & Management, 19(2), 97-101.
Podder, L. (2007). Effects of music therapy on anxiety levels and pain perception. Nursing Journal of India, 98(7), 161-161.
Prasertcharoensuk, W., & Thinkhamrop, J. (2004). Non-pharmacologic labour pain relief. Journal of the Medical Association of Thailand, 87(Suppl 3), S203-S206.
Prensner, J. D., Yowler, C. J., Smith, L. F., Steele, A. L., & Fratianne, R. B. (2001). Music therapy for assistance with pain and anxiety management in burn treatment. Journal of Burn Care & Rehabilitation, 22(1), 83-88.
Protacio, J. (2010). Patient-directed music therapy as an adjunct during burn wound care. Critical Care Nurse, 30(2), 74-76. doi:10.4037/ccn2010250
Reilly, M. P. (1999). Music, a cognitive behavioral intervention for anxiety and acute pain control in the elderly cataract patient (Unpublished doctoral dissertation). University of Texas, San Antonio.
Ribeiro, A. S., Ramos, A., Bermejo, E., Casero, M., Corrales, J. M., & Grantham, S. (2014). Effects of different musical stimuli in vital signs and facial expressions in patients with cerebral damage: A pilot study. Journal of Neuroscience Nursing, 46(2), 117-124.
Ripley, L., Christopoulos, G., Michael, T. T., Alomar, M., Rangan, B. V., Roesle, M., . . . Brilakis, E. S. (2014). Randomized controlled trial on the impact of music therapy during cardiac catheterization on reactive hyperemia index and patient satisfaction: The functional 192
change in endothelium after cardiac catheterization, with and without music therapy (FEAT) study. The Journal of Invasive Cardiology, 26(9), 437.
Risch, M., Scherg, H., & Verres, R. (2001). [Music therapy for chronic headaches. evaluation of music therapeutic groups for patients suffering from chronic headaches]. Der Schmerz, 15(2), 116-125.
Risos-Rio, G. (2009). The effects of a structured live music and arts program on depression, pain control and mood/behavior patterns among nursing home residents. UPNAAI Nursing Journal, 5(1), 9-15.
Rosenow, S. C., & Silverman, M. J. (2014). Effects of single session music therapy on hospitalized patients recovering from a bone marrow transplant: Two studies. The Arts in Psychotherapy, 41(1), 65-70.
Rossetti, A., Chadha, M., Lucido, D., Hylton, D., Loewy, J., & Harrison, L. (2014). The impact of music therapy on anxiety and distress in patients undergoing simulation for radiation therapy (RT). International Journal of Radiation Oncology Biology Physics, 90, S708-S709.
Ruscheweyh, R., Kreusch, A., Albers, C., Sommer, J., & Marziniak, M. (2011). The effect of distraction strategies on pain perception and the nociceptive flexor reflex (RIII reflex). Pain, 152(11), 2662-2671.
Sahler, O. J., Hunter, B. C., & Liesveld, J. L. (2003). The effect of using music therapy with relaxation imagery in the management of patients undergoing bone marrow transplantation: A pilot feasibility study. Alternative Therapies in Health & Medicine, 9(6), 70-74.
Salmore, R. G., & Nelson, J. P. (2000). The effect of preprocedure teaching, relaxation instruction, and music on anxiety as measured by blood pressures in an outpatient gastrointestinal endoscopy laboratory. Gastroenterology Nursing, 23(3), 102-110.
Sand-Jecklin, K., & Emerson, H. (2010). The impact of a live therapeutic music intervention on patients' experience of pain, anxiety, and muscle tension. Holistic Nursing Practice, 24(1), 7.
Schiemann, U., Gross, M., Reuter, R., & Kellner, H. (2002). Improved procedure of colonoscopy under accompanying music therapy. European Journal of Medical Research, 7(3), 131-134.
Schroter, T. (2014). [Medicine needs music! music therapy for chronic pain]. Revue Medicale Suisse, 10(415), 286.
Sendelbach, S. E., Halm, M. A., Doran, K. A., Miller, E. H., & Gaillard, P. (2006). Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. Journal of Cardiovascular Nursing, 21(3), 194-200.
Shabanloei, R., Golchin, M., Esfahani, A., Dolatkhah, R., & Rasoulian, M. (2010). Effects of
music therapy on pain and anxiety in patients undergoing bone marrow biopsy and aspiration. AORN Journal, 91(6), 746-751. doi:10.1016/j.aorn.2010.04.001 193
Shahabi, M., Tehrani, K. D., Eghbal, M., Majd, A. H., & Saidi, A. J. (2007). Comparing the effects of EMLA ointment with a diversionary activity (music) on vein puncture pain at school-age children [Farsi]. Journal of Nursing & Midwifery, 16(56), 18-18.
Shertzer, K. E., & Keck, J. F. (2001). Music and the PACU environment. Journal of PeriAnesthesia Nursing, 16(2), 90-102.
Siedlecki, S. L. (2009). Racial variation in response to music in a sample of African-American and Caucasian chronic pain patients. Pain Management Nursing, 10(1), 14-21. doi:10.1016/j.pmn.2008.08.003
Silvestrini, N., Piguet, V., Cedraschi, C., & Zentner, M. R. (2011). Music and auditory distraction reduce pain: Emotional or attentional effects? Music and Medicine, 3(4), 264-270.
Singh, P. (2012). Effect of distraction techniques in behaviour responses to pain among toddlers receiving immunisation. The Nursing Journal of India, 103(4), 176-179.
Smith, G. R., & Jawed, S. (2003). Effect of music on reducing patient perceived pain whilst undergoing soft tissue and intraarticular injections. Rheumatology, 42, 122-123.
Smolen, D., Topp, R., & Singer, L. (2002). The effect of self-selected music during colonoscopy on anxiety, heart rate, and blood pressure. Applied Nursing Research, 15(3), 126-136. doi:10.1053/apnr.2002.34140
Sohi, B. K. (1998). Differential effectiveness of music-mediated relaxation and guided imagery on post-surgical pain and wound healing (Unpublished doctoral dissertation). University of Wisconsin, Madison.
Son, J. T., & Kim, S. H. (2006). [The effects of self-selected music on anxiety and pain during burn dressing changes]. Daehan Ganho Haghoeji, 36(1), 159-168.
Son, J. T., Lee, E. J., & Kim, S. H. (2009). Effect of music listening on pain, anxiety, and vital signs of burn patients. Korean Journal of Music Therapy, 11(1), 124-141.
Son, M. R., Yun, H. S., Lee, S. J., & Lee, H. N. (2012). Effects of musical therapy on pain and mood states of patients in complex regional pain syndroms(CRPS). Journal of Military Nursing Research, 30(1), 43-59.
Spintge, R. (2000). Music in anesthesia and pain therapy. Anasthesiologie Intensivmedizin Notfallmedizin Schmerztherapie, 35(4), 254-261.
Stein, T. R., Olivo, E. L., Grand, S. H., Namerow, P. B., Costa, J., & Oz, M. C. (2010). A pilot study to assess the effects of a guided imagery audiotape intervention on psychological outcomes in patients undergoing coronary artery bypass graft surgery. Holistic Nursing Practice, 24(4), 213-222. doi:10.1097/HNP.0b013e3181e90303
Stephens, L. G., Gargiulo, R. J., Daniels, J. C., Nezat, G. G., & Pellegrini, J. E. (2008). The effect of music and therapeutic suggestion on postoperative pain in the general anesthesia patient. AANA Journal, 76(5), 390-390. 194
Sunitha Suresh, B. S., De Oliveira, G. S.,Jr, & Suresh, S. (2015). The effect of audio therapy to treat postoperative pain in children undergoing major surgery: A randomized controlled trial. Pediatric Surgery International, doi:10.1007/s00383-014-3649-9
Tabrizi, E. M., Sahraei, H., Rad, S. M., Hajizadeh, E., & Lak, M. (2012). The effect of music on the level of cortisol, blood glucose and physiological variables in patients undergoing spinal anesthesia. Excli Journal, 11, 556-565.
Tachdjian, R., Henry, L., & Babikian, T. (2012). Music therapy as a complementary and alternative medicine (CAM) technique used in patients with chronic and life-altering illness experiencing pain and anxiety. Haemophilia, 18, 145-145.
Tadic, D., & Kostiov, A. (2013). Effect of music on patients undergoing mammography screening. Bilten, 31(Suppl 1), 64.
Taghinejad, H., Delpisheh, A., & Suhrabi, Z. (2010). Comparison between massage and music therapies to relieve the severity of labor pain. Women's Health (London, England), 6(3), 377-381. doi:10.2217/whe.10.15
Tan, X., Yowler, C. J., Super, D. M., & Fratianne, R. B. (2008). Music therapy significantly reduces pain, anxiety, and muscle tension involved with burn debridement... proceedings of the American burn association: 40th annual meeting, April 29 - May 2, 2008, Chicago, Illinois. Journal of Burn Care & Research, 29(2), S83-S83.
Tan, X., Yowler, C. J., Super, D. M., & Fratianne, R. B. (2010). The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: A prospective randomized crossover trial. Journal of Burn Care & Research, 31(4), 590-597. doi:10.1097/BCR.0b013e3181e4d71b
Tanabe, P., Thomas, R., Paice, J., Spiller, M., & Marcantonio, R. (2001). The effect of standard care, ibuprofen, and music on pain relief and patient satisfaction in adults with musculoskeletal trauma. JEN: Journal of Emergency Nursing, 27(2), 124.
Tanamura, M., Nagata, K., Hasegawa, T., & Ohtsuki, C. (2005). Music therapy of fibromyalgia syndrome. Journal of Psychosomatic Research, 58(6), S20-S20.
Taylor, L. K., Kuttler, K. L., Parks, T. A., & Milton, D. (1998). The effect of music in the postanesthesia care unit on pain levels in women who have had abdominal hysterectomies. Journal of PeriAnesthesia Nursing, 13(2), 88-94.
Thoma, M. V., Scholz, U., Ehlert, U., & Nater, U. M. (2012). Listening to music and physiological and psychological functioning: The mediating role of emotion regulation and stress reactivity. Psychology & Health, 27(2), 227-241.
Tondel, S., S. (2010). Use of guided imagery and music: For pain management satisfaction in the
total joint replacement patient (Unpublished doctoral dissertation). Fairleigh Dickinson University, Hackensack. 195
Tramo, M. J., Lense, M., Van Ness, C., Kagan, J., Doyle Settle, M., & Cronin, J. H. (2011). Effects of music on physiological and behavioral indices of acute pain and stress in premature infants: Clinical trial and literature review. Music and Medicine, 3(2), 72-83.
Tse, M. M., Chan, M. F., & Benzie, I. F. (2005). The effect of music therapy on postoperative pain, heart rate, systolic blood pressures and analgesic use following nasal surgery. Journal of Pain & Palliative Care Pharmacotherapy, 19(3), 21-29.
Tsivian, M., Qi, P., Kimura, M., Chen, V. H., Chen, S. H., Gan, T. J., & Polascik, T. J. (2012). The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology, 79(1), 32-36.
Uedo, N., Ishikawa, H., Morimoto, K., Ishihara, R., Narahara, H., Akedo, I., . . . Fukuda, S. (2004). Reduction in salivary cortisol level by music therapy during colonoscopic examination. Hepato-Gastroenterology, 51(56), 451-453.
Umeda, Y., & Tsuji, M. (2006). The role of music therapy during day surgery at a Children’s hospital. Japanese Music Therapy Association Journal, 6(1), 3-16.
Vaajoki, A., Kankkunen, P., Pietila, A. M., Kokki, H., & Vehvilainen-Julkunen, K. (2012). The impact of listening to music on analgesic use and length of hospital stay while recovering from laparotomy. Gastroenterology Nursing, 35(4), 279-284.
Vaajoki, A., Kankkunen, P., Pietila, A. M., & Vehvilainen-Julkunen, K. (2011). Music as a nursing intervention: Effects of music listening on blood pressure, heart rate, and respiratory rate in abdominal surgery patients. Nursing & Health Sciences, 13(4), 412-418.
Vaajoki, A., Pietila, A. M., Kankkunen, P., & Vehvilainen-Julkunen, K. (2013). Music intervention study in abdominal surgery patients: Challenges of an intervention study in clinical practice. International Journal of Nursing Practice, 19(2), 206-213.
Vaajoki, A., Pietilä, A., Kankkunen, P., & Vehviläinen-Julkunen, K. (2012). Quasi-experimental intervention study in nursing: Example of music intervention in adult gastroenterology patients' pain management. Hoitotiede, 24(4), 313-324.
Villarreal, E. A. G., Brattico, E., LenêVase, Østergaard, L., & Vuust, P. (2012). Superior analgesic effect of an active distraction versus pleasant unfamiliar sounds and music: The influence of emotion and cognitive style. Plos One, 7(1), 1-8. doi:10.1371/journal.pone.0029397
Voss, J. A. (2003). Effect of sedative music and scheduled rest on anxiety, pain, and myocardial oxygen demand during chair rest in adult postoperative open-heart patients (Unpublished doctoral dissertation). University of Nebraska Medical Center, Omaha.
Walworth, D., Rumana, C. S., Nguyen, J., & Jarred, J. (2008). Effects of live music therapy
sessions on quality of life indicators, medications administered and hospital length of stay for patients undergoing elective surgical procedures for brain. Journal of Music Therapy, 45(3), 349-359. 196
Wang, Y., Dong, Y., & Li, Y. (2014). Perioperative psychological and music interventions in elderly patients undergoing spinal anesthesia: Effect on anxiety, heart rate variability, and postoperative pain. Yonsei Medical Journal, 55(4), 1101-1105. doi:10.3349/ymj.2014.55.4.1101
Weber, S., Nuessler, V., & Wilmanns, W. (1997). A pilot study on the influence of receptive music listening on cancer patients during chemotherapy. International Journal of Arts Medicine, 5(2), 27-35.
Weeks, B. P., & Nilsson, U. (2011). Music interventions in patients during coronary angiographic procedures: A randomized controlled study of the effect on patients' anxiety and well-being. European Journal of Cardiovascular Nursing, 10(2), 88-93. doi:10.1016/j.ejcnurse.2010.07.002
Werner, S. (2014). [The pain management challenge. alleviating pain with music]. Pflege Zeitschrift, 67(9), 570-571.
Whipple, J. (2008). The effect of music-reinforced nonnutritive sucking on state of preterm, low birthweight infants experiencing heelstick. Journal of Music Therapy, 45(3), 227-272. doi:10.1093/jmt/45.3.227
Whipple, J. (2004). The effect of music-reinforced nonnutritive sucking on state of preterm, low birthweight infants experiencing heelstick (Unpublished doctoral dissertation). Florida State University, Tallahassee.
Whitaker, M. H. (2010). Controlling pain. sounds soothing: Music therapy for postoperative pain. Nursing, 40(12), 53-54. doi:10.1097/01.NURSE.0000390680.80395.cd
Whitehead-Pleaux, A. M., Zebrowski, N., Baryza, M. J., & Sheridan, R. L. (2007). Exploring the effects of music therapy on pediatric pain: Phase 1. Journal of Music Therapy, 44(3), 217- 241.
Wong, A., Pei, Y., Chou, S., Chao, M., Chen, K., & Tang, S. (2002). Investigation of effects of background music on pain and anxiety during electrodiagnostic examination. Journal of the Neurological Sciences, 199, S41-S41.
Wood, A. H. (2008). Effects of music therapy on preterm infants in the neonatal intensive care unit (Unpublished doctoral dissertation). University of Alabama at Birmingham.
Wu, J., Chaplin, W., Amico, J., Butler, M., Ojie, M. J., Hennedy, D., & Clemow, L. (2012). Music for surgical abortion care study: A randomized controlled pilot study. Contraception, 85(5), 496-502.
Yilmaz, E., Ozcan, S., Basar, M., Basar, H., Batislam, E., & Ferhat, M. (2003). Music decreases anxiety and provides sedation in extracorporeal shock wave lithotripsy. Urology, 61(2), 282-
286.
Yi-yueh, L., Xin, G., Shi-Hao, W., Hui-Ling, W., & Gao-Hua, W. (2014). Comparative study of auxiliary effect on dental anxiety, pain and compliance during adult dental root canal 197
treatment under therapeutic chinese music or western classic music. Physikalische Medizin Rehabilitationsmedizin Kurortmedizin, 24(3), 149-154. doi:10.1055/s-0034-1374592
Young, T., Griffin, E., Phillips, E., & Stanley, E. (2010). Music as distraction in a pediatric emergency department. JEN: Journal of Emergency Nursing, 36(5), 472-473. doi:10.1016/j.jen.2010.05.014
Zavotsky, K. E. (2004). The effect of music on pain, anxiety, and cardiac reactivity in ED patients. Journal of Emergency Nursing, 30(5), 404-404. doi:10.1016/j.jen.2004.07.010
Zavotsky, K. E., Banavage, A., James, P., Easter, K., Pontieri-Lewis, V., & Lutwin, L. (2014). The effects of music on pain and anxiety during screening mammography. Clinical Journal of Oncology Nursing, 18(3), E45-E49. doi:10.1188/14.CJON.E45-E49
Zhao, H., & Chen, A. C. N. (2009). Both happy and sad melodies modulate tonic human heat pain. The Journal of Pain, 10(9), 953-960. doi:10.1016/j.jpain.2009.03.006
198
APPENDIX A
LIST OF EXCLUDED STUDIES FROM REVIEW OF SYSTEMATIC REVIEWS
1st Author & Year Reason for exclusion Archie al., 2013 Not a systematic review Austin, 2010 Not a systematic review Bailey, 2010 Did not investigate pain Bao al., 2014 Not a systematic review Bowers & Wetsel, 2014 Not a systematic review Bradt et al., 2010a Insufficient number of studies on pain or music Bradt et al., 2010b Insufficient number of studies on pain or music Brady-Fryer et al., 2004 Insufficient number of studies on pain or music Chi & Young, 2011 Not a systematic review Chlan & Halm, 2013 Incomplete systematic review Cignacco et al., 2007 Insufficient number of studies on pain or music Cole & LoBiondo-Wood, 2014 Did not conduct quality appraisal Crowe et al., 2008 Investigated combined intervention only Dileo & Bradt, 2005 Did not conduct quality appraisal Dileo & Bradt, 2008 Updated Cochrane review exists Dunn, 2004 Did not conduct quality appraisal Economidou et al., 2012 Did not conduct quality appraisal Evans, 2002 Insufficient number of studies on pain or music Galaal et al., 2011 Insufficient number of studies on pain or music Good, 1996 Out of date range specified Hokka al., 2014 Did not involve music intervention Koenig et al., 2013 Not a systematic review Koller & Goldman, 2012 Included uncontrolled studies Laopaiboon al., 2009 Did not investigate pain Leow, 2011 Included uncontrolled studies Ma & Yu, 2008 Not a systematic review Matsota et al., 2013 Not a systematic review Moris & Linos, 2013 Included uncontrolled studies Ngee-Ming et al., 2014 Did not conduct quality appraisal Pan et al., 2000 Insufficient number of studies on pain or music
199
LIST OF EXCLUDED STUDIES FROM REVIEW OF SYSTEMATIC REVIEWS (cont.)
1st Author & Year Reason for exclusion Park & Hughes, 2012 Not a systematic review Pillai Riddell al., 2011 Did not involve music intervention Pothoulaki et al., 2005 Did not conduct quality appraisal Pyati & Gan, 2007 Not a systematic review Renner et al., 2009 Insufficient number of studies on pain or music Renner et al., 2010 Insufficient number of studies on pain or music Rheingans, 2007 Included uncontrolled studies Richards et a., 2007 Did not conduct quality appraisal Rudin et al., 2007 Did not conduct quality appraisal Simkin & Bolding, 2004 Not a systematic review Skingley & Vella-Burrows, 2010 Included uncontrolled studies Smith al., 2003 Did not involve music intervention Smith al., 2006 Did not involve music intervention Smith al., 2012 Did not involve music intervention Thrane, 2013 Insufficient number of studies on pain or music Treurnicht Naylor et al., 2011 Insufficient number of studies on pain or music Uman al., 2013 Did not involve music intervention Weller & Baker, 2011 Did not investigate pain
200
APPENDIX B
R-AMSTAR ASSESSMENT ITEMS
1. Was an ‘a priori’ (A) ‘a priori’ design design provided? (B) statement of inclusion criteria (C) PICO/PIPO research question (population, intervention, comparison, prediction, outcome) 2. Was there duplicate (A) There should be at least two independent data extractors as stated or data extraction? implied. (B) Statement of recognition or awareness of consensus procedure for disagreements. (C) Disagreements among extractors resolved properly as stated or implied 3. Was a comprehensive (A) At least two electronic sources should be searched. literature search (B) The report must include years and databases used (e.g. Central, EMBASE, performed? and MEDLINE). (C) Key words and/or MESH terms must be stated AND where feasible the search strategy outline should be provided such that one can trace the filtering process of the included articles. (D) In addition to the electronic databases (PubMed, EMBASE, Medline), all searches should be supplemented by consulting current contents, reviews, textbooks, specialized registers, or experts in the particular field of study, and by reviewing the references in the studies found. (E) Journals were “hand-searched” or “manual searched” (i.e. identifying highly relevant journals and conducting a manual, page-by-page search of their entire contents looking for potentially eligible studies) 4. Was the status of (A) The authors should state that they searched for reports regardless of their publication (i.e. grey publication type. literature) used as an (B) The authors should state whether or not they excluded any reports based on inclusion criterion? their publication status, language etc. (C) “Non-English papers were translated” or readers sufficiently trained in foreign language (D) No language restriction or recognition of non-English articles 5. Was a list of studies (A) Table/list/or figure of included studies, a reference list does not suffice. (included and (B) Table/list/figure of excluded studies1 either in the article or in a excluded) provided? supplemental source (i.e. online). (Excluded studies refers to those studies seriously considered on the basis of title and/or abstract, but rejected after reading the body of the text) (C) Author satisfactorily/sufficiently stated the reason for exclusion of the seriously considered studies. (D) Reader is able to retrace the included and the excluded studies anywhere in the article bibliography, reference, or supplemental source 6. Were the (A) In an aggregated form such as a table, data from the original studies should characteristics of the be provided on the participants, interventions AND outcomes. included studies provided? (B) Provide the ranges of relevant characteristics in the studies analyzed (e.g. age, race, sex, relevant socioeconomic data, disease status, duration, severity, or other diseases should be reported.) (C) The information provided appears to be complete and accurate (i.e. there is a tolerable range of subjectivity here. Is the reader left wondering? If so, state the needed information and the reasoning). 201
7. Was the scientific (A) ‘A priori’ methods of assessment should be provided (e.g., for quality of the effectiveness studies if the author(s) chose to include only randomized, included studies double-blind, placebo controlled studies, or allocation concealment as assessed and inclusion criteria); for other types of studies alternative items will be documented? relevant. (B) The scientific quality of the included studies appears to be meaningful. (C) Discussion/recognition/awareness of level of evidence (D) Quality of evidence should be rated/ranked based on characterized instruments. (Characterized instrument is a created instrument that ranks the level of evidence) 8. Was the scientific (A) The results of the methodological rigor and scientific quality should be quality of the considered in the analysis and the conclusions of the review included studies used appropriately in (B) The results of the methodological rigor and scientific quality are explicitly formulating stated in formulating recommendations. conclusions? (C) To have conclusions integrated/drives towards a clinical consensus statement (D) This clinical consensus statement drives toward revision or confirmation of clinical practice guidelines
9. Were the methods (A) Statement of criteria that were used to decide that the studies analyzed used to combine the were similar enough to be pooled? findings of studies appropriate? (B) For the pooled results, a test should be done to ensure the studies were combinable, to assess their homogeneity (i.e. Chi-squared test for homogeneity, I2). (C) Is there a recognition of heterogeneity or lack of thereof (D) If heterogeneity exists “random effects model” should be used &/or the rationale (i.e. clinical appropriateness) of combining should be taken into consideration (i.e. sensible to combine?), or stated explicitly (E) If homogeneity exists, author should state a rationale or a statistical test 10. Was the likelihood of (A) Recognition of publication bias or file-drawer effect publication bias (i.e., (B) An assessment of publication bias should include graphical aids “file drawer” effect) (e.g., funnel plot, other available tests) assessed? (C) Statistical tests (e.g., Egger regression test). 11. Was the conflict of (A) Statement of sources of support interest stated? (B) No conflict of interest. This is subjective and may require some deduction or searching. (C) An awareness/statement of support or conflict of interest in the primary inclusion studies Reprinted with permission (Kung et al., 2010, pp 89-91)
202
APPENDIX C
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS 1st Author & Year Reason for exclusion Ahn, 2013 Not a randomized controlled trial Aitken, 2001 Not a randomized controlled trial Aitken, 2002 Not a randomized controlled trial Akmese, 2014 Atypical intervention - progressive muscle relaxation Akombo, 2006 No standard care group Albert, 2001 Atypical intervention - guided Imagery Albuquerque, 2012 Not a randomized controlled trial; foreign language - Portuguese Anderson, 2014 No standard care group; outcome not relevant Andrada, 2004 Outcome not relevant Aragon, 2002 Not a randomized controlled trial; atypical intervention - live music (harp) Baby, 2014 No standard care group; insufficient data Bae, 2014 Not properly randomized (qRCT); outcome not relevant Baghdadi, 2000 No standard care group Baker, 1998 Investigation of experimental pain Balan, 2009 Insufficient data Barnason, 1995 Outcome not relevant Barrera, 2002 Outcome not relevant Beckett, 2011 Not a randomized controlled trial Bekhuis, 2009 Not a randomized controlled trial Bertling, 2003 Full text unavailable Binek, 2003 Not properly randomized (qRCT); insufficient data Binson, 2013 No standard care group Björkman, 2013 Insufficient data Bo & Callaghan Insufficient data Bradshaw, 2011 Investigation of experimental pain Bradshaw, 2012 Investigation of experimental pain Bradt, 2014 No standard care group Bringman, 2009 No standard care group; outcome not relevant Browning, 2000 Not a randomized controlled trial Burrai, 2014 Atypical intervention - live music (saxophone) Butt, 2000 Not a randomized controlled trial Cadigan, 2001 Atypical intervention - combined with nature sound Calceterra, 2014 Insufficient data - mean & SD not reported Caprilli, 2007 Atypical intervention - live intervention by non-music therapist Cardoso, 2014 No standard care group Chae, 2007 Not properly randomized (qRCT) Chaput-McGovern, 2012 No standard care group Chen, 2012 Not properly randomized (qRCT)
203
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Chesky, 1997 Atypical intervention - vibroacoustic Chiasson, 2013 Atypical intervention - live music (harp) Choi, 2009 Not a randomized controlled trial Chou, 2012 Foreign language - Chinese Chuang, 2010 Outcome not relevant Ci ̆gerci, 2013 Not a randomized controlled trial Cohen, 2001 Not a randomized controlled trial Colwell, 2013 No standard care group Comeaux, 2013 Not properly randomized (qRCT) Cooke, 2010 Insufficient data - first phase data unavailable Cutshall, 2011 Atypical intervention - combined with nature sound da Silva, 2012 Not a randomized controlled trial Dixon, 2014 Not a randomized controlled trial Dobek, 2013 Outcome not relevant Dobek, 2014 Investigation of experimental pain Dunbar, 2012 Investigation of experimental pain Dvorak, 2011 Insufficient data - Mean & SD not reported Easter, 2010 Insufficient data - Mean & SD not reported Eells, 2014 Not a randomized controlled trial El Rakshy, 1997 Atypical intervention - combined with autogenic relaxation Ernst, 2006 Not a randomized controlled trial Ferguson, 2004 Insufficient data - Mean & SD not reported Finlay, 2014 Not a randomized controlled trial Flaugher, 2002 Insufficient data - Mean & SD not reported Franco, 2009 Not a randomized controlled trial Fratianne, 2001 Insufficient data - Mean & SD not reported Garza-Villarreal, 2014 Not a randomized controlled trial Gawronska-Skorkowska, 2002 Outcome not relevant Ghaffaripour, 2013 Investigation of experimental pain Giaquinto, 2006 Outcome not relevant Goff, 1997 Outcome not relevant Good, 2000 Not a randomized controlled trial Good, 2001 Secondary analysis of existing study Good, 2002 Secondary analysis of existing study Good, 2005 Secondary analysis of existing study Good, 2008 Not properly randomized (qRCT) Good, 2010 Atypical intervention - combined with jaw relaxation Good, 2013 Atypical intervention - combined with jaw relaxation Guétin, 2012 Atypical intervention - "U sequence" program Guétin, 2014 Atypical intervention - "U sequence" program
204
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Han, 2010 Outcome not relevant Harikumar, 2006 Insufficient data - Mean & SD not reported Hasenbring, 1999 No standard care group Hatem, 2006 Not properly randomized (qRCT) Hauck, 2013 Investigation of experimental pain Haythronthwaite, 2001 Atypical intervention - instruction for focusing with no music Heiser, 1997 Insufficient data - Mean & SD not reported Hilliard , 2003 Outcome not relevant Hong, 1996 No standard care group Hong, 2010 Not a randomized controlled trial Horne-Thompson, 2008 Insufficient data - Mean & SD not reported Hosseini, 2013 Not a randomized controlled trial Hsieh, 2014 Investigation of experimental pain Huth, 1999 Not a randomized controlled trial Ignacio, 2012 Insufficient data - Mean & SD not reported Iikkaya, 2014 Outcome not relevant Jaber, 2007 Foreign language - French Jacobi, 1995 Not a randomized controlled trial Jacobi, 2001 Not a randomized controlled trial Jeaun, 2008 Not properly randomized (qRCT) Jeffs, 2007 No standard care group Joyce, 2001 No standard care group Kaluza, 2002 Atypical intervention - combined audiobooks Kane, 2004 Not a randomized controlled trial Kang, 1998 Not a randomized controlled trial Kang, 2008 Insufficient data - Mean & SD not reported Kankkunen, 2014 Not a randomized controlled trial Karimi, 2012 Foreign language - Persian Kenntner-Mabiala, 2007 Investigation of experimental pain Kenny, 2004 No standard care group Kim, 2002 Not properly randomized (qRCT) Kim, 2005 Not a randomized controlled trial Kim, 2007A Not a randomized controlled trial Kim, 2007B Not a randomized controlled trial Kimber, 2008 Atypical intervention - combined with relaxation Kleiber, 2012 Not a randomized controlled trial Kliempt, 1999 No standard care group; atypical intervention - music offered as placebo Koenig, 20013a No standard care group Korhan, 2011 Foreign language - Turkish Korhan, 2014 Not a randomized controlled trial
205
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Kotwal, 1998 Insufficient data - Mean & SD not reported Krout, 2001 Not a randomized controlled trial Kullich, 2003 Atypical intervention - combined with guided imagery Kwan, 2013 Not a randomized controlled trial Kwon, 2006 Not a randomized controlled trial Lai, 2005 Outcome not relevant Le Roux, 1998 Insufficient data - Mean & SD not reported Leao, 2004 No standard care group; foreign language - Portuguese Leao, 2005 No standard care group Leardi, 2007 Insufficient data - Mean & SD not reported Lee, 2002 No standard care group Lee, 2003 Not properly randomized (qRCT) Lee, 2010 Not a randomized controlled trial Lee, 2011 Not a randomized controlled trial Lee, 2012a Outcome not relevant Lee, 2012b No standard care group Lin, 2011 Not properly randomized (qRCT) Liu, 2010 Insufficient data - Mean & SD not reported Loewy, 2013 Outcome not relevant Lukas, 2004 Not a randomized controlled trial Luna, 2011 Not a randomized controlled trial Madden, 2010 Atypical intervention - creative arts therapy Madson, 2010 Not a randomized controlled trial Magill, 2001 Not a randomized controlled trial Malone, 1996 Not a randomized controlled trial Mandel, 2007 Measurement Mandel, 2014 Not a randomized controlled trial Mariauzouls, 1999 Atypical intervention - combined with vibration Martindale, 2014 Not properly randomized (qRCT) McCaffrey, 2003 Insufficient data - Mean & SD not reported McCaffrey, 2006 Not properly randomized (qRCT) McDaniel, 2009 Insufficient data - Mean & SD not reported McNair, 2013 Not a randomized controlled trial McRee, 2003 Outcome not relevant Meeuse, 2010 Not a randomized controlled trial Megel, 1998 Insufficient data - Mean & SD not reported Mitchell, 2006a Investigation of experimental pain Mitchell, 2006b Investigation of experimental pain Mitchell, 2008 Investigation of experimental pain Moser, 2007 Not a randomized controlled trial
206
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Müller-Busch, 1997 Not a randomized controlled trial Na Cholburi, 2004 Full text unavailable Najafi, 2014 Not a randomized controlled trial Nickel, 2005 Not a randomized controlled trial Nikandish, 2006 Full text unavailable Nilsson, 2001 Atypical intervention - combined with nature sound Nilsson, 2009a Insufficient data - SD not reported Nilsson, 2009b Outcome not relevant Nilsson, 2009c Insufficient data - SD not reported Nilsson, 2009d Insufficient data - Mean & SD not reported Nilsson, 2012 Outcome not relevant Noguchi, 2006 Atypical intervention - song story Noh, 2011 Not properly randomized (qRCT) Oelkers-Ax, 2008 Outcome not relevant Onieva-Zafra, 2013 Atypical intervention - live intervention by non-music therapist Ozer, 2013 Insufficient data Park, 2006 Not properly randomized (qRCT) Park, 2009 Outcome not relevant Park, 2010 Not a randomized controlled trial Park, 2012 Not a randomized controlled trial Pellino, 2005 Atypical intervention - non-pharmacoloic kit Perlini, 1996 Investigation of experimental pain Phumdoung, 2007 Atypical intervention - combined with PSU Cat position Phumdoung, 2014 Atypical intervention - combined with PSU Cat position Picard, 2014 Atypical intervention - Delta-embedded music Podder, 2007 Not a randomized controlled trial Prasertcharoensuk, 2004 Not a randomized controlled trial Prensner, 2001 Not a randomized controlled trial Protacio, 2010 Not a randomized controlled trial Reilly, 1999 Insufficient data - missing pain results Ribeiro, 2014 Outcome not relevant Ripley, 2014 Outcome not relevant Risch, 2001 Atypical intervention - live intervention by non-music therapist Risos-Rio, 2009 Atypical intervention - live intervention by non-music therapist Rosenow & Silverman, 2014 Not a randomized controlled trial Rossetti, 2014 Not a randomized controlled trial Ruscheweyh, 2011 Investigation of experimental pain Sahler, 2003 Not a randomized controlled trial Salmore, 2000 Atypical intervention - combined with guided imagery Sand-Jeckin & Emerson, 2010 Atypical intervention - live intervention by non-music therapist
207
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Schiemann, 2002 Atypical intervention - played radio station Schroter, 2014 Not a randomized controlled trial Sendelbach, 2006 Atypical intervention - combined with guided relaxation Shabanloei, 2010 Insufficient data Shahabi, 2007 Foreign language - Persian Shertzer, 2001 Not properly randomized (qRCT) Siedliecki, 2009 Secondary analysis of existing study Silvestrini, 2011 Investigation of experimental pain Singh, 2012 Not properly randomized (qRCT) Smith & Jawed, 2003 Not a randomized controlled trial Smolen, 2002 Outcome not relevant Sohi, 1998 Atypical intervention - combined with guided imagery Son & Kim, 2006 Not a randomized controlled trial Son, Lee, & Kim, 2009 Not a randomized controlled trial Son, Yun, Lee, & Lee, 2012 Not a randomized controlled trial Spintge, 2000 Not a randomized controlled trial Stein et al, 2010 Outcome not relevant Stephens, 2008 Atypical intervention - combined with therapeutic suggestion Suresh, 2015 Insufficient data - Mean & SD not reported Tabrizi, 2012 Outcome not relevant Tachdjian, 2012 Not a randomized controlled trial Tadic & Kostiov, 2013 Full text unavailable Taghinejad, 2010 No standard care group Tan, 2008 Insufficient data - Mean & SD not reported Tan, 2010 Insufficient data - Mean & SD not reported Tanabe, 2001 Not properly randomized (qRCT) Tanamura, 2005 Atypical intervention - live music (piano) Taylor, 1998 Insufficient data Thoma, 2012 Not a randomized controlled trial Tondel, 2010 Atypical intervention - combined with guided imagery Tramo, 2011 Not properly randomized (qRCT) Tse, 2005 Not properly randomized (qRCT) Tsivian, 2012 Insufficient data - SD not reported Uedo, 2004 Insufficient data - SD not reported Umeda, 2006 Insufficient data; outcome not relevant Vaajoki, 2011 Not properly randomized (qRCT) Vaajoki, 2012 Not a randomized controlled trial Vaajoki, 2012b Not properly randomized (qRCT) Vaajoki, 2013 Not properly randomized (qRCT) Villarreal, 2012 Investigation of experimental pain
208
LIST OF EXCLUDED STUDIES FROM META-ANALYSIS (cont.) 1st Author & Year Reason for exclusion Voss, 2003 Full text unavailable Walworth, 2008 Insufficient data - SD not reported Wang, 2014 Atypical intervention - combined with psychological treatment Weber, 1997 Outcome not relevant Weeks, 2011 Insufficient data - Mean & SD not reported; outcome not relevant Werner, 2014 Not a randomized controlled trial Whipple, 2004 Atypical intervention - music-reinforced nonnutritive sucking (NNS) Whipple, 2008 Atypical intervention - music-reinforced nonnutritive sucking (NNS) Whitaker, 2010 Not a randomized controlled trial Whitehead-Pleaux, 2007 Not a randomized controlled trial Wong, 2002 Not a randomized controlled trial Wood, 2008 Outcome not relevant Wu, 2012 Insufficient data - SD not reported Yilmaz, 2003 No standard care group Yi-yueh, 2014 Insufficient data - Mean & SD not reported Young, 2010 Not a randomized controlled trial Zavotsky, 2004 Not a randomized controlled trial Zavotsky, 2014 Not properly randomized (qRCT) Zhao & Chen, 2009 Investigation of experimental pain
APPENDIX D
CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES
Age Authors & year Country Design N Male% Female% White% Other% (mean or range) Abraham & Dvory, 2014 Israel 2-arm 60 49.5 48.3 51.7 Ajorpaz et al., 2014 Iran 2-arm 60 20-65 48.3 51.7 Allred, K., 2007 USA 2-arm 56 63.9 87.5 Angioli et al., 2014 Italy 2-arm 372 56 0 100 Ayoub et al., 2005 USA 3-arm 90 56 87 13 Bally et al., 2003 Canada 2-arm 113 58.5 57 43 Bansal et al., 2010 India 2-arm 100 33 72 28 Beaulieu-Boire et al., 2013 Canada Crossover 49 62 65.3 34.7 Bechtold et al., 2006 USA 2-arm 166 56 50.1 49.9 Bellieni et al., 2013 Italy Crossover 25 42.3 40 60 Binns-Turner, 2008 USA 2-arm 30 42-70 80.0 Blankfield et al., 1995 USA 3-arm 95 59 72.5 27.5 Bradt, 2001 USA Crossover 32 14.2 56 44 40.6 Brouscious, 1999 USA 3-arm 156 66 70.8 29.2 98.0 Cepeda et al., 1998 Colombia 2-arm 193 40.85 49.2 50.8 Chan et al., 2003 China 2-arm 220 39.25 69.4 Chan et al., 2006 Hong Kong 2-arm 43 35-75 72.1 27.9 Chan, 2007 Hong Kong 2-arm 66 35-75 72.7 27.3 Chiang, 2012 Taiwan 4-arm 117 60.5 61.7 38.3
209
CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES (cont.)
Age Authors & year Country Design N Male% Female% White% Other% (mean or range) Chlan et al., 2000 USA 2-arm 64 54.6 96.8 Clark et al., 2006 USA 2-arm 66 57.66 61.9 38.1 85.3 Costa et al., 2010 Italy 2-arm 109 51 65.5 34.5 Danhauer et al., 2007 USA 3-arm 170 27.95 51.2 Danhauer et al., 2010 USA 2-arm 59 50.9 40.5 59.5 78.0 Ebneshahidi & Mohseni, 2008 Iran 2-arm 77 25.2 0 100 Fredenburg & Silverman, 2014 USA 2-arm 32 53.5 46.9 53.1 85.2 Ghetti, 2011 USA 3-arm 29 50.1 Ghetti, 2013 USA 3-arm 37 63.6 Good & Chin, 1998 Taiwan 2-arm 44 40.5 11.4 88.6 Good et al., 1999 USA 4-arm 617 45.3 81.0 Good, 1995 USA 4-arm 84 46 29.2 73.8 83.0 Guerrero et al., 2012 USA 2-arm 101 25.1 Hispanic 85.6 Gutgsell et al., 2013 USA 2-arm 200 55.4 31 69 67.5 Hartling et al., 2013 Canada 2-arm 42 5.9 67.1 32.9 71.4 Hook et al., 2008 Malaysia 2-arm 102 40.3 Huang et al., 2010 Taiwan 2-arm 126 54 Hyun et al., 2004 S. Korea 2-arm 40 33.5 66.5 Ikonomidou et al., 2004 Sweden 2-arm 60 34 0 100
210
CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES (cont.)
Age Authors & year Country Design N Male% Female% White% Other% (mean or range) Jacobson, 1995 USA 3-arm 94 52.4 67.0 Jacobson, 1999 USA 3-arm 110 Jafari et al., 2012 Iran 2-arm 60 57.8 Jeon, 2004 S. Korea 2-arm 80 Jose et al., 2012 India 2-arm 60 60.1 39.9 Kim & Kim, 2009 S. Korea 2-arm 67 Kim & Kim, 2010 S. Korea 3-arm 45 40-49 Kim et al., 2004 S. Korea 2-arm 62 51 Kim et al., 2011 S. Korea 2-arm 219 55.7 44.3 Koca Kutlu & Eren, 2014 Turkey 2-arm 60 52.99 61.7 38.3 Koch et al., 1998 USA 2-arm 34 53.5 86 14 Koch et al., 1998 USA 2-arm 43 53.5 62 38 Kristjánsdóttir & Iceland 3-arm 118 14 Kristjánsdóttir, 2011 Kulkarni et al., 2012 UK 2-arm 100 58 58 42 Kwekkeboom, 2003 USA 3-arm 58 53 Laurion & Fetzer, 2003 USA 3-arm 84 34 Lepage et al., 2001 Canada 2-arm 50 38.35 62 38 Li & Dong, 2012 China 2-arm 60 0 100 Li et al., 2011 China 2-arm 120 44.95 0 100
211
CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES (cont.)
Age Authors & year Country Design N Male% Female% White% Other% (mean or range) Macdonald et al., 2003 Scotland 2-arm 40 39.2 37.5 62.5 Macdonald et al., 2003 Scotland 2-arm 58 45.6 Masuda et al., 2005 Japan 2-arm 44 68.95 40.9 59.1 Migneault et al., 2004 Canada 2-arm 30 49.25 Nagata et al., 2014 Japan 4-arm 224 52 62.5 37.5 Nguyen et al., 2010 Vietnam 2-arm 40 9.1 62.5 37.5 Nilsson et al., 2003 Sweden 3-arm 182 37 73.6 26.4 Nilsson et al., 2003 Sweden 3-arm 151 54 72 28 Nilsson et al., 2005 Sweden 3-arm 75 56 96 4 Ottaviani et al., 2012 France 2-arm 62 68.8 27.5 72.5 Ovayolu et al., 2006 Turkey 2-arm 60 46.7 53.3 Parlar Kilic et al., 2014 Turkey 2-arm 200 32.43 53 47 Phipps et al., 2010 USA 2-arm 53 55.35 30.2 69.8 73.6 Phumdoung & Good, 2003 Thailand 2-arm 110 24 Pothoulaki et al., 2008 Greece 2-arm 60 52.9 70 30 Press et al., 2003 Israel 2-arm 94 10.7 60.5 39.5 Reza et al., 2007 Iran 2-arm 100 25.5 Salem, 2004 Egypt 2-arm 74 24.3 Schou, 2008 Denmark 2-arm 63 65
212
CHARACTERISTICS OF PARTICIPANTS IN INCLUDED STUDIES (cont.)
Age Authors & year Country Design N Male% Female% White% Other% (mean or range) Sen et al, 2010 Turkey 2-arm 70 29.5 Sen et al., 2009 Turkey 2-arm 60 22.55 Sen et al., 2009 Turkey 2-arm 100 29.5 Seo & Hong, 2010 S. Korea 2-arm 44 53.5 70.5 29.5 Siedliecki & Good, 2006 USA 3-arm 60 50.75 28.9 71.1 40.0 Simavli et al, 2014 Turkey 2-arm 156 25 Simavli et al, 2014 Turkey 2-arm 161 23.78 0 100 African Americans Simcock et al., 2008 USA 2-arm 30 67.2 40 60 70 Szmuk, 2008 USA 2-arm 40 51.5 47.5 52.5 Vaajoki et al, 2012 Finland 2-arm 168 61.5 53.6 46.4 Vanderboom et al., 2012 USA 2-arm 48 49 18.75 81.25 89.6 Voss et al, 2004 USA 3-arm 61 63 87.0 Yeo et al, 2013 Korea 2-arm 70 48.2 100 0 Yinger, 2012 USA 2-arm 58 46.5 53.5 Yu et al., 2009 China 2-arm 60 8.1 60 40 Zengin et al., 2013 Turkey 2-arm 100 49.5 52 48 Zhang et al., 2005 China 2-arm 110 41 Zhang et al., 2014 China 2-arm 124 63.4 Zhu et al., 2014 China 4-arm 250 3.24 51.5 48.5 Zimmerman et al., 1996 USA 3-arm 96 67 100
213
APPENDIX E
GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES
Authors & year Pain Age Specialization Setting 0-10 Other Physiological Analgesic Types Group scale scales measures requirements Abraham & Dvory, PP Adults Neurology Out VAS 2014 (unclear) Ajorpaz et al., 2014 AP Adults Cardiology In VAS Allred, K., 2007 AP Adults Orthopaedic In VAS MPQ-SF HR,RR,MAP Angioli et al., 2014 PP Adults OBGYN Out VAS HR,RR,SBP,DBP Ayoub et al., 2005 AP Adults Urology In AN-Propofol Bally et al., 2003 PP Adults Cardiology Out VAS Bansal et al., 2010 AP Adults Urology In SD-Midazolam Beaulieu-Boire et al., AP Adults Intensive care In OP-Fentanyl & AN-Propofol 2013 Bechtold et al., 2006 PP Adults Gastroenterology Out VAS OP-Meperidine & SD-Midazolam Bellieni et al., 2013 PP Adults Physical therapy Out VAS Binns-Turner, 2008 AP Adults Oncology In VAS HR,MAP OP-Morphine eqv. Blankfield et al., 1995 AP Adults Cardiology In OP-Morphine Brouscious, 1999 PP Adults Cardiology In NRS Cepeda et al., 1998 PP Adults Urology Out VRS OP-Alfentanil Chan, 2007 PP Adults & Cardiology In VAS HR,RR,SBP,DBP seniors Chan et al., 2003 PP Adults OBGYN Out VAS Chan et al., 2006 PP Adults & Cardiology In VAS HR,RR,SBP,DBP seniors Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain, Out: outpatient; In: inpatient; VAS: visual analogue scale, NRS: numeric rating scale, MPQ- SF: Magill pain questionnaire-short form; HR: heart rate; RR: respiration rate; MAP: mean arterial pressure; SBP: systolic blood pressure; DBP: diastolic blood pressure; AN: anesthetic; SD: sedative; OP: opioid 214
GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES (cont.)
Authors & year Pain Age Specialization Setting 0-10 Other Physiological Analgesic Types Group scale scales measures requirements Chiang, 2012 CP Adults Hospice/Oncology In VAS Chlan et al., 2000 PP Adults Gastroenterology Out NRS Costa et al., 2010 PP Adults Gastroenterology Out VAS Danhauer et al., 2007 PP Adults OBGYN Out VAS Danhauer et al., 2010 CP Adults Oncology Out VAS Ebneshahidi AP Adults OBGYN In VAS HR,SBP,DBP OP-Morphine & Mohseni, 2008 Good, 1995 AP Adults General Surgery In NRS OP-Morphine Good & Chin, 1998 AP Adults OBGYN In VAS Good et al., 1999 AP Adults General Surgery In VAS Guerrero et al., 2012 AP Adults OBGYN Out VAS HR,SBP,DBP Hartling et al., 2013 PP Children Emergency Out OSBD-R HR Medicine Hook et al., 2008 AP Adults OBGYN In VAS VAS-D OP-Morphine eqv. Huang et al., 2010 CP Adults Oncology In VAS, VAS-D VRS Hyun et al., 2004 AP Adults Orthopaedic In VAS HR,SBP,DBP Ikonomidou et al., 2004 AP Adults OBGYN In VAS Jacobson, 1995 PP Adults General Medicine In VAS VAS-D Jacobson, 1999 PP Adults General Medicine In VAS VAS-D Jafari et al., 2012 AP Adults Cardiology In NRS Jeon, 2004 PP Adults Dentistry Out VAS Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain; Out: outpatient; In: inpatient; VAS: visual analogue scale; NRS: numeric rating scale; VRS: verbal rating scale; VAS-D: visual analogue scale of emotional distress from pain; OSBD-R: observational scale of behavioral distress–revised; HR: heart rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; OP: opioid 215
GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES (cont.)
Authors & year Pain Age Specialization Setting 0-10 Other Physiological Analgesic Types Group scale scales measures requirements Jose et al., 2012 AP Adolescents Cardiology In NRS HR,SBP,DBP & Adults (unclear) Kim et al., 2004 AP Adults Orthopaedic In NRS Kim et al., 2011 PP Adults Dentistry Out VAS HR,RR,SBP,DBP (0-5) Koca Kutlu PP Adults Nephrology Out VAS & Eren, 2014 Koch et al., 1998 AP Adults Urology In HR,SBP,DBP AN-Propofol Koch et al., 1998 PP Adults Urology Out VAS HR,SBP,DBP OP-Alfentanil Kristjánsdóttir & PP Adolescents General Medicine Out VAS Kristjánsdóttir, 2011 Kulkarni et al., 2012 AP Adults Radiology In OP-Fentanyl & SD-Midazolam Kwekkeboom, 2003 CP Adults Oncology In NRS
Laurion & Fetzer, 2003 AP Adults OBGYN Out VRS OP-Morphine eqv. & NOP-Acetaminophen Lepage et al., 2001 AP Adults General Surgery Out SD-Midazolam Li & Dong, 2012 AP Adults OBGYN In VAS Li et al., 2011 CP Adults Oncology In VAS MPQ Macdonald et al., 2003 AP Adults General Surgery In VAS MPQ Macdonald et al., 2003 AP Adults OBGYN In VAS Masuda, Miyamoto & AP Seniors Orthopaedic In VAS, FS HR,SBP,DBP Shimizu, 2005 Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain, Out: outpatient; In: inpatient; VAS: visual analogue scale, NRS: numeric rating scale, MPQ-SF: Magill pain questionnaire-short form; HR: heart rate; RR: respiration rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; AN: anesthetic; SD: sedative; OP: opioid; NOP: none-opioid medication; eqv: equivalent 216
GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES (cont.)
Authors & year Pain Age Specialization Setting 0-10 Other Physiological Analgesic Types Group scale scales measures requirements Migneault et al., 2004 AP Adults OBGYN In HR,MAP OP-Fentanyl & AN-isoflurane Nagata et al., 2014 PP Adults Gastroenterology Out VAS HR,SBP,DBP Nguyen et al., 2010 PP Children Oncology In NRS HR,RR,SBP,DBP
Nilsson et al., 2003 AP Adults General Surgery Out VAS OP-Morphine
Nilsson et al., 2003 AP Adults General Surgery In VAS OP-Morphine
Nilsson et al., 2005 AP Adults General Surgery In NRS HR,SBP,DBP OP-Morphine
Ottaviani et al., 2012 PP Older adults Orthopaedic Out VAS HR,SBP,DBP
Ovayolu et al., 2006 PP Adults Gastroenterology Out VAS OP-Meperidine & SD-Midazolam Parlar Kilic et al., 2014 AP Adults Emergency medicine Out VAS
Phipps et al., 2010 AP Adults Neurology In VAS HR,RR,SBP,DBP
Phumdoung AP Adults OBGYN In VAS VAS-D & Good, 2003 Pothoulaki et al., 2008 PP Adults Nephrology Out VAS
Press et al., 2003 PP Children Emergency Medicine Out FS VAS (Observer) Reza et al., 2007 AP Adults OBGYN In VAS OP-Morphine
Salem, 2004 AP Adults OBGYN In VAS VAS-D
Sen et al, 2010 AP Adults OBGYN In OP-Tramadol & NOP-Diclofenac Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain; Out: outpatient; In: inpatient; VAS: visual analogue scale; NRS: numeric rating scale; FS: faces scale; VAS-D: visual analogue scale of emotional distress from pain; HR: heart rate; RR: respiration rate; MAP: mean arterial pressure; SBP: systolic blood pressure; DBP: diastolic blood pressure; AN: anesthetic; SD: sedative; OP: opioid; NOP: NOP: none-opioid medication 217
GENERAL CHARACTERISTICS – MUSIC MEDICINE STUDIES (cont.)
Authors & year Pain Age Specialization Setting 0-10 Other Physiological Analgesic Types Group scale scales measures requirements Sen et al., 2009 AP Adults Urology Out AN-Propofol Sen et al., 2009 AP Adults OBGYN In OP-Tramadol Seo & Hong, 2010 CP Adults Hospice/Oncology In BPI-K Siedliecki & Good, 2006 CP Adults Pain clinic Out VAS MPQ-SF Simavli et al, 2014 AP Adults OBGYN In VAS HR,SBP,DBP NOP-Diclofenac Simavli et al, 2014 AP Adults OBGYN In VAS Simcock et al., 2008 AP Adults Orthopaedic In VAS, FS Szmuk, 2008 AP Adults General Surgery In VAS HR,MAP AN-sevoflurane Vaajoki et al, 2012 AP Adults General Surgery In VAS VAS-D Vanderboom et al., 2012 AP Adults Neurology Out HR, SBP OP-Fentanyl & SD-Midazolam Voss et al, 2004 AP Adults Cardiology In VAS VAS-D Yeo et al, 2013 PP Adults Urology Out VAS HR,SBP Yu et al., 2009 PP Children Oriental Medicine Out FS CHEOPS HR,RR,MAP Zengin et al., 2013 PP Adults Oncology Out VAS HR,RR,SBP,DBP Zhang et al., 2005 AP Adults OBGYN In AN-Propofol Zhang et al., 2014 PP Adults Urology Out VAS HR Zhu et al., 2014 PP Neonates Neonatology In NIPS Zimmerman et al., 1996 AP Adults Cardiology In VRS MPQ Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain, Out: outpatient; In: inpatient; VAS: visual analogue scale, VRS: verbal rating scale, FS: faces scale; BPI-K: Brief pain inventory – Korean; VAS-D: visual analogue scale of emotional distress from pain; CHEOPS: Children's Hospital of Eastern Ontario Pain Scale; NIPS: Neonatal infant pain scale; MPQ-SF: Magill pain questionnaire-short form; HR: heart rate; RR: respiration rate; MAP: mean arterial pressure; SBP: systolic blood pressure; DBP: diastolic blood pressure; AN: anesthetic; SD: sedative; OP: opioid; NOP: None-opioid medication 218
APPENDIX F
GENERAL CHARACTERISTICS – MUSIC THERAPY STUDIES
Pain Age 0-10 Other Physiological Analgesic Authors & year Specialization Setting Types Group scale scales measures requirements Bradt, 2001 AP Children Orthopaedic In VAS Clark et al., 2006 CP Adults Radiology Out NRS
Fredenburg CP Adults Oncology In NRS & Silverman, 2014
Ghetti, 2011 AP Adults General Surgery In NRS Ghetti, 2013 PP Adults Cardiology Out NRS HR,RR,SBP,DBP OP-Fentanyl & SD-Versed Gutgsell et al., 2013 CP Adults Hospice/Oncology In NRS FLACC Kim & Kim, 2009 CP Adults Oncology In VAS Kim & Kim, 2010 CP Adults Oncology In VAS Yinger, 2012 PP Children Pediatric Out CAMPIS-R Schou, 2008 AP Adults Cardiology In VAS OP-Morphine Note. PP: procedural pain; AP: acute pain; CP: cancer/chronic pain, Out: outpatient; In: inpatient; VAS: visual analogue scale, NRS: numeric rating scale, FLACC: Face, Legs, Activity, Cry, Consolability Scale; CAMPIS-R: Child-adult medical procedure interaction scale-Revised; HR: heart rate; RR: respiration rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; OP: opioid; SD: sedative
219
APPENDIX G INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES
Authors & year Duration Selection Rationale Title of IX Equip Types / Genres / Titles of Music Abraham & Dvory, 2014 30 PP MI SPK classical, instrumental, rock Ajorpaz et al., 2014 30 SC EC,MC IC HDP Allred, K., 2007 20 PP MC,PL MI HDP easy-listening Angioli et al., 2014 PP MC MI SPK pop, jazz, classical, rock Ayoub et al., 2005 PC MI HDP personal library Bally et al., 2003 30 PP MT HDP classical, soft rock, relaxation, country Bansal et al., 2010 PP MC MT HDP classical, folk or religious category Beaulieu-Boire et al., 2013 60 SC EC,MC MI HDP classical - provided lists of titles Bechtold et al., 2006 SC MI SPK new age - “Watermark” by Enya Bellieni et al., 2013 PP MI ERP classic, rock, disco Binns-Turner, 2008 PP MC MI ERP classical, easy listening, inspirational, new age Blankfield et al., 1995 30 SC MI HDP new age - "Dream Flight II” by Herb Ernst Brouscious, 1999 35 PP EC MI ERP various - provided lists of titles Cepeda et al., 1998 45 PP MI HDP classical, Caribbean, Soft rock, Jazz Chan et al., 2003 PP IC SPK instrumental ballad Chan et al., 2006 45 PP MC,PL IC ERP Chinese and Western Chan, 2007 45 PP MC IC ERP Chinese classical music (eg, bamboo flute), religious music (eg, Buddha Bar IV–Tibet), and western classical music (eg, Mozart piano concerto no. 26) Note. PP: participant preferred; SC: staff chosen; PC: participant chosen; EC: expert consultation; MC: musical criteria; PL: published literature; IX: intervention; MI: referred own IX as music or music intervention; MT: referred to own IX as music therapy; IC: referred to own IX as music, music intervention and/or music therapy interchangeably; SPK: speaker; HDP: headphone; ERP: earphones. 220
INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES (cont.)
Authors & year Duration Selection Rationale Title of IX Equip Types / Genres / Titles of Music Chiang, 2012 20 PP EC,MC,PL MI Choice classical, piano, harp, religious, easy listening, Chinese, and Taiwanese - provided lists of titles Chlan et al., 2000 PP EC MT HDP classical, country-western, new-age, easy listening, pop, rock, religious, era-specific, motion-picture soundtracks, jazz Costa et al., 2010 25 PP MI HDP blues, swing, classic, country, jazz, glam-rock, 50-60-70 s rock, instrumental, new age, Celtic, reggae, relaxing, Spanish music, classic Italian pop, modern Italian pop, classic American pop, motion picture sound, native American. Danhauer et al., 2007 10 PP IC HDP classical, harp, general instrumental, nature sounds Danhauer et al., 2010 20 PP MI HDP classical, harp, general instrumental, nature sounds, country, gospel, and jazz Ebneshahidi & 30 PC IC HDP Personal library Mohseni, 2008 Good & Chin, 1998 15 PP MC MI ERP Western music: piano, harp, synthesizer, orchestral, slow jazz Good et al., 1999 15 PP MI ERP synthesizer, harp, piano, orchestral, slow jazz Good, 1995 PP MI ERP synthesizer, harp, piano, orchestral, slow jazz music Guerrero et al., 2012 PP MI HDP rock, pop, hip-hop, rap, classical, jazz, Spanish, alternative, easy listening and reggae. Hartling et al., 2013 SC EC,MC MI SPK "The Planets Op. 32 Jupiter, Storms in Africa, Disco Beat, and Sunny Days" Hook et al., 2008 30 PP EC,MC MT HDP Western, Malay, Chinese Huang et al., 2010 30 PP MC,PL IC ERP folk songs, Buddhist hymns (Taiwanese), harp, piano - provided lists of titles Hyun et al., 2004 60 PP IC HDP Ikonomidou et al., 2004 30 SC IC HDP pan flute music Jacobson, 1995 & 1999 PP MI HDP provided lists of titles Note. PP: participant preferred; SC: staff chosen; PC: participant chosen; EC: expert consultation; MC: musical criteria; PL: published literature; IX: intervention; MI: referred own IX as music or music intervention; MT: referred to own IX as music therapy; IC: referred to own IX as music, music intervention and/or music therapy interchangeably; SPK: speaker; HDP: headphone; ERP: earphones. 221
INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES (cont.)
Authors & year Duration Selection Rationale Title of IX Equip Types / Genres / Titles of Music Jafari et al., 2012 30 PP EC,MC,PL IC HDP Jeon, 2004 PP MC MI HDP classical, new age, popular, Korean popular Jose et al, 2012 20 PP MT HDP old Hindi, devotional songs, Instrumental, Cazab. Kim et al., 2004 120 PP MC,PL IC classical, meditative, or nature music - provided lists of titles Kim et al., 2011 20 PP IC HDP classical, pop, folk, hymns, and Korean-style country Koca Kutlu & Eren, 2014 30 SC IC HDP instrumental (violin and piano) Turkish art music Koch et al., 1998 a & b 67 PC MI HDP Personal library Kristjánsdóttir & 3 PP MI HDP top 10 charts music and classical Kristjánsdóttir, 2011 vs SPK Kulkarni et al., 2012 60 PC MI HDP Personal library Kwekkeboom, 2003 10 PP IC HDP Laurion & Fetzer, 2003 SC IC Lepage et al., 2001 45 PP MI HDP pop, jazz, classical, new age Li & Dong, 2012 30 SC MC MI Chinese classical Li et al., 2011 30 PP EC,MC MT HDP Chinese classical & folk, popular world music, and Chinese relaxation music Macdonald et al., 2003: choice PC MI Personal library T1 & T2 Masuda et al., 2005 20 PP MI HDP Western classical, Gagaku, Noh songs, or Enka (Japanese) Migneault et al., 2004 PP MI HDP classical, jazz, new-age, and popular piano music Nagata et al., 2014 SC MI SPK New-age - “The Best of Enya–Paint the Sky with Stars” Note. PP: participant preferred; SC: staff chosen; PC: participant chosen; EC: expert consultation; MC: musical criteria; PL: published literature; IX: intervention; MI: referred own IX as music or music intervention; MT: referred to own IX as music therapy; IC: referred to own IX as music, music intervention and/or music therapy interchangeably; SPK: speaker; HDP: headphone; ERP: earphones. 222
INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES (cont.)
Authors & year Duration Selection Rationale Title of IX Equip Types / Genres / Titles of Music Nguyen et al., 2010 23 PP MC IC ERP traditional Vietnamese and children’s songs. Nilsson et al., 2003 40 SC MC,PL MI HDP new-age Nilsson et al., 2003 110 SC MC MI HDP classical Nilsson et al., 2005 40 SC MC,PL MI HDP new-age, synthesizer Ottaviani et al., 2012 20 SC IC SPK Ovayolu et al., 2006 30 SC EC,MC IC SPK Turkish classical played on ney (reed flute) Parlar Kilic et al., 2014 SC EC,MC IC SPK Turkish classical (Acemasiran) Phipps et al., 2010 30 PP IC SPK light classical Phumdoung & Good, 2003 180 PP MC MI ERP synthesizer, harp, piano, orchestra, and jazz - provided lists of titles Pothoulaki et al., 2008 PP MI HDP popular, Greek folk, jazz, classical, soundtracks, new-age Press et al., 2003 SC MI HDP Reza et al., 2007 24 SC MI HDP soft instrumental, Spanish style guitar Salem, 2004 50+ PP PL MI HDP soft synthesizer, harp, piano, orchestra, jazz Schou, 2008 35 PP EC,MC,PL MT SPK Easy listening, classical, Musicure, jazz - provided lists of titles Sen et al, 2010 60 SC MT HDP Sen et al., 2009 60 PC IC HDP Personal library Sen et al., 2009 49 PC MI ERP Personal library Seo & Hong, 2010 35 PP EC,MC IC ERP gospel, hymnal, Buddhist hymnal, K-pop (Ballad, Trot), popular, Korean art song, classical, instrumental Note. PP: participant preferred; SC: staff chosen; PC: participant chosen; EC: expert consultation; MC: musical criteria; PL: published literature; IX: intervention; MI: referred own IX as music or music intervention; MT: referred to own IX as music therapy; IC: referred to own IX as music, music intervention and/or music therapy interchangeably; SPK: speaker; HDP: headphone; ERP: earphones.
223
INTERVENTION CHARACTERISTICS OF MUSIC MEDICINE STUDIES (cont.)
Authors & year Duration Selection Rationale Title of IX Equip Types / Genres / Titles of Music Siedliecki & Good, 2006 60 PP PL MI HDP piano, jazz, orchestra, harp, synthesizer Simavli et al, 2014 40+ PP PL MT HDP Classic, Turkish music (art, folk, classic), popular Simavli et al, 2014 40+ PP PL MT Choice Classic, Turkish music (art, folk, classic), popular Simcock et al., 2008 PC MI HDP Personal library Szmuk, 2008 75 PP MI HDP classical, pop-rock, Israeli music Vaajoki et al, 2012 30 PP MI HDP domestic or foreign hit songs, dance, pop, rock, soul, blues, spiritual or classical Vanderboom et al., 2012 PP MI SPK classical, jazz, new age, country, pop, rock, folk, acoustic, meditative trance. Voss et al, 2004 30 PP MC,PL MI HDP synthesizer, harp, piano orchestra, slow jazz, flute Yeo et al, 2013 8 SC MI HDP classical Yu et al., 2009 30 PP IC HDP popular & traditional children's, Christmas, folk songs Zengin et al., 2013 30 SC MC,PL MT SPK Turkish classical (Acemisiran) Zhang et al., 2005 6 PP MI HDP Zhang et al., 2014 7 PP MC,PL MI classical, Chinese folk, popular, western Zhu et al., 2014 5 SC PL MT SPK Easy listening - "Souvenirs D'enfance, A Comme Amour, & Ballade Pour Adeline by Richard Oayderman"
Zimmerman et al., 1996 30 PP IC HDP Country Western Instrumental by Country Pops; Fresh Aire by Mannheim Steamroller; Winter into Spring by George Winston; Prelude and Comfort Zone, by Steven Halpern Note. PP: participant preferred; SC: staff chosen; PC: participant chosen; EC: expert consultation; MC: musical criteria; PL: published literature; IX: intervention; MI: referred own IX as music or music intervention; MT: referred to own IX as music therapy; IC: referred to own IX as music, music intervention and/or music therapy interchangeably; SPK: speaker; HDP: headphone; ERP: earphones. 224
APPENDIX H
INTERVENTION CHARACTERISTICS OF MUSIC THERAPY STUDIES
Age Session Music Length (minutes) Authors & year Setting Specific MT Approach Group Style Format / Frequency Bradt, 2001 Children Active Ind Live 30-45 / 1 Entrainment session
Clark et al., 2006 Adults Passive Ind Recorded 45-60 / 1 + Provided 1 psycho-educational session to develop IML (2-4 week) individualized music list and teach relaxation techniques, participants used music & relaxation individually Fredenburg Adults Passive Ind Live 30 / 1 Receptive approach with therapist’s live singing & & Silverman, 2014 playing of patient’s preferred music Ghetti, 2011 Adults Active Ind Live 30-40 / 1 Active music engagement (recreative)
Ghetti, 2013 Adults Active Ind Live 30-40 / 1 Emotional approach coping coupled with active music engagement (recreative) Gutgsell et al., 2013 Adults Passive Ind Live 20 / 1 Receptive approach with therapist’s guided relaxation with live harp music
Kim & Kim, 2009 Adults Active Group Live 60 / 1 Various (recreative, compositional Improvisational, 3-6 receptive) Kim & Kim, 2010 Adults Active vs. Group Live & 50 / 1 Compared two MT conditions: receptive group vs. Passive 3-6 Recorded recreative/singing-centered group
Schou, 2008 Adults Passive Ind Recorded 35 / 3-5 Therapist provided guided relaxation and imagery with music Yinger, 2012 Children Active Ind Live before/during/after Recreative immunization / 1 Note. Ind: individual; IL: individual music listening; MT: music therapy 225 226 APPENDIX I
RISK OF BIAS GRAPH: RISK OF BIAS ACROSS ALL INCLUDED STUDIES
227 APPENDIX J
RISK OF BIAS SUMMARY TABBLE
228 RISK OF BIAS SUMMARY TABLE (cont.)
229 RISK OF BIAS SUMMARY TABLE (cont.)
230 APPENDIX K
ASSESSMENT OF RISK OF BIAS WITH SUPPORT FOR JUDGMENT
Abraham & Dvory, 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "subjects were randomized into 2 groups by choosing 1 of 2 identically appearing cards" (p. 3). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "music was transmitted by nearby loudspeakers" (p.4) 4. Blinding subjective assessor High Blinding of participants was not possible 5. Blinding objective assessor High Assessor was not blinded. Quote: "music that was transmitted by nearby loudspeakers" (p.4) 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "Study funding: None" (p. 1)
Ajorpaz, Mohammadi, Najaran, & Khazaei, 2014 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests
Allred, K., 2007 Bias Judgment Support for judgment 1. Randomization Low Quote: "Randomization into either the comparative rest group or the experimental group was determined by a sealed envelope system" (p. 52). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat High More than 25% attrition rate (19/75); specific reasons not provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests
231 Angioli et al., 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "the patients were randomly assigned to either a music or no-music group by the research nurse, using a computer-generated random number series." (p. 455) 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low Less than 5% attrition rate (16/372); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests
Ayoub et al., 2005 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "nonblinded researcher placed the CD player in an opaque box specially constructed to assure the blindness of the outcome assessor" (p. 1317). 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor Low Quote: "The research team consisted of… a blinded member who assessed outcomes only" (p. 1317). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Funded by "National Institutes of Health grants NICHD, R01HD37007–02"
Bally et al., 2003 Bias Judgment Support for judgment 1. Randomization Low Quote: "randomized to a control or experimental group by selecting a randomly generated group number sealed in an opaque envelope." (p. 53) 2. Allocation concealment Low See above 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low Quote: "Six patients (4 control, 2 experimental) were not included because the procedure was canceled after their enrollment or they could not complete all the questionnaires because of complications" (p. 54) 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "Funding provided by the 1998 American Association of Critical-Care Nurses Sigma Theta lau critical care grant and the Kingston Hospital research development grant" (p.58).
232 Bansal et al., 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: "patients who would listen to music were randomly allocated by using the lottery method." (p. 2783) 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "requests of the patients to change the music album, track or volume adjustments, draws the attention of all the operating room staff and so, the study was single- blinded" (P. 2784). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Beaulieu-Boire et al., 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "computer-generated block randomization list was prepared by the investigators" (p. 443). 2. Allocation concealment Low Quote: "Randomization was concealed using numbered, opaque sealed envelopes and was revealed by an ICU staff member not involved in the direct care of the randomized patient" (p. 443). 3. Blinding interventionist Low Quote: "headphones connected to a MP3 player were chosen and installed by staff not involved in the project for music listening" (p. 444). 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor Low Quote: "Each apparatus was blinded such that the nurse committed in sedative drug tapering, was unable to perceive in which group the patient belonged to" (p. 444). 6. Intention-to-treat Low Quote: "6 patients did not complete all of the requirements, and their data were excluded" (p. 445). 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "authors declare no conflict of interest and they were neither funded to select specific MP3 devices nor to select special music pieces" (p. 442).
Bechtold et al., 2006 Bias Judgment Support for judgment 1. Randomization Low Quote: "Randomization was carried out by the use of opaque envelopes" (p. 7310). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "The study was single-blinded (patients)" (p. 7310). 4. Blinding subjective assessor Low Quote: "They were not told that they were participating in a study to assess the beneficial effects of music" (p. 7309). 5. Blinding objective assessor High Quote: "The study was single-blinded (from the standpoint of patients)" (p. 7310). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
233 Bellieni et al., 2013 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Quote: "Three patients refused to accept to enter the study; they gave no reason for their refusal" (p. e153). 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Binns-Turner, 2008 Bias Judgment Support for judgment 1. Randomization Low Quote: "participants were then assigned randomly to the intervention or control group by drawing numbers from a re-closable plastic bag" (p. s22). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "Women in both groups were asked not to mention the absence or presence of music" (p. s23). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "This research was supported in part by a grant from Sigma Theta Tau, Nu Chapter."
Blankfield et al., 1995 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Surgeon was blinded but did not discuss if the interventionist was blinded. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "A randomized. single-blinded, placebo-controlled trial examined…" (p. 32). 6. Intention-to-treat Low 5% attrition rate (5/100); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "supported by a grant from the American Academy of Family Physicians, along with financial assistance from Fairview General Hospital" (p. 32).
234 Bradt, 2001 Bias Judgment Support for judgment 1. Randomization Low Quote: "Participants were randomly assigned to these treatment sequences using a draw of lots" (p. 152). 2. Allocation concealment Low Quote: "Lots were drawn in the presence of the study participants, ensuring allocation concealment" (p.152). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Quote: "Blinding of the research participants in this study was not possible since the participants were actively involved in the music-making" (p. 152). 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "No financial support was received for this study" (p.155).
Brouscious, 1999 Bias Judgment Support for judgment 1. Randomization Low Quote: "Just before CTR, subjects were randomly assigned to groups by the primary investigator or research assistant, who blindly drew a chip from a box containing 3 chips" (p. 411). 2. Allocation concealment Low Quote: "Just before CTR, subjects were randomly assigned to groups by the primary investigator or research assistant, who blindly drew a chip from a box containing 3 chips" (p. 411). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "An experimental, single-blind, pretest-posttest group design was used for the study" (p. 411). 6. Intention-to-treat Low Less than 18% attrition rate (33/189); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Cepeda et al., 1998 Bias Judgment Support for judgment 1. Randomization Low Quote: "patients were randomly allocated by the nurse to two groups using a computer-generated list" (p. 383). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "blinded the anesthesiologist as to whether music was playing" (p. 393). 6. Intention-to-treat Low Quote: "All patients who were randomized were included in the analysis" (p. 384). 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported in part by a Colciencias grant and the Richard Saltonstall Charitable Foundation (p. 386).
235 Chan et al., 2003 Bias Judgment Support for judgment 1. Randomization Low Quote: "subjects were randomly assigned to either a music or no-music group by the research nurse using a computer- generated random number series" (p. 214). 2. Allocation concealment Low Quote: "computer-generated random number series contained within closed opaque envelopes" (p. 214). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Quote: "220 women were entered into the trial and all of them completed the study" (p. 214) 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Chan et al., 2006 Bias Judgment Support for judgment 1. Randomization Low Quote: "Forty-six participants were included... using a random digit generated by research randomizer" (p. 673). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "The same person administered the intervention and collected the data and so there was a possibility of the results being biased" (p. 677). 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Quote: "The same person administered the intervention and collected the data and so there was a possibility of the results being biased" (p. 677). 6. Intention-to-treat Low Less than 7% attrition rate (3/46); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Chan, 2007 Bias Judgment Support for judgment 1. Randomization Low Quote: "Seventy participants were randomized… using a random digit randomizer" (p.433). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "All of the data collection, including administering the intervention and collecting the data, was carried out by the same researcher." (p. 434). 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Quote: "All of the data collection, including administering the intervention and collecting the data, was carried out by the same researcher." (p. 434). 6. Intention-to-treat Low Less than 6% attrition rate (4/70); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
236 Chiang, 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "The investigator used an online randomization program (Randomization.com) with a block size of four for ten blocks" (p. 59). 2. Allocation concealment High The researcher was aware of the allocation factor. Quote: "she would approach them about the study. Patients would not be told the treatment condition before consent" (p. 60). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 5% attrition rate (6/123); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Chlan et al., 2000 Bias Judgment Support for judgment 1. Randomization Low Quote: "Subjects who consented to participate in the study were randomized by a coin-flip to either an experimental condition or control condition" (p. 4). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Unclear Withdrawal was not described 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
Clark et al., 2006 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomized using a minimization procedure in which the first subject is assigned to a group with a coin toss. Subsequent subjects were assigned based upon covariates (tumor site, gender and pain) and assignment of previous subjects using a computer program" (p. 251) 2. Allocation concealment Low Refer to the minimization steps above. 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 8% attrition rate (5/68); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by The Arthur Flagler Fultz Fund of the American Music Therapy Association, Sigma Theta Tau Iota Chapter, and with support from the Vanderbilt Ingram Cancer Center and the Joint Center for Nursing
237 Costa et al., 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: "The randomization list was generated by a computer software on a 1:1 basis with blocks of 20" (p. 872). 2. Allocation concealment Low Quote: "Allocation concealment was obtained by sealed opaque envelopes consecutively numbered and containing a label reporting the assigned treatment." (p. 872). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "Physicians performing colonoscopies and nurses caring for patients during the colonoscopy and collecting and recording information on treatment outcome measures were blinded to whether patients were listening music" (p. 872). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Unfunded research
Danhauer et al., 2007 Bias Judgment Support for judgment 1. Randomization Low Quote: "Study participants were randomized using simple randomization with an equal probability to 1 of the 3 study groups; this was operationalized by having each participant select a random assignment slip" (p. 40). 2. Allocation concealment Low Above randomization method took place upon recruitment and completion of pre-test. 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low 9.4% attrition rate (16/170); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the North Carolina Academic Alliance for Integrative Medicine.
Danhauer et al., 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: "Study participants were randomly assigned to one of the two groups (music, usual care), stratified by practitioner (3 practitioners/strata)" (p. 3). 2. Allocation concealment Low Above randomization method took place upon recruitment and completion of pre-test. 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 7% attrition rate (4/63); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
238 Ebneshahidi & Mohseni, 2008 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "An attending nurse who was unaware of assignments measured heart rate and noninvasive blood pressure" (p. 828). 6. Intention-to-treat Low Less than 4% attrition rate (3/80); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Fredenburg & Silverman, 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "Participants were randomly assigned via a computer program to either the experimental group (n = 12) or wait- list control group (p. 176). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Ghetti, 2011 Bias Judgment Support for judgment 1. Randomization Low Quote: "Using a table of random numbers, participants were randomly assigned to one of three groups" (p. 471). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "This study used a randomized, single-blind (outcome assessor), pretest/posttest control group design" (p. 471). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
239 Ghetti, 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "Consented participants were randomly assigned... using a computer-generated random number list" (p. 99). 2. Allocation concealment Low Quote: "during the informed consent process, the researcher had no way of knowing to which group the participant would subsequently be assigned" (p. 100). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Quote: "Due to the pardcipants' awareness of receiving or not receiving music intervention, it was not possible to fully blind the pardcipants" (p. 100). 5. Blinding objective assessor Low Quote: ""Assignment to experimental groups was concealed from… medical staff until the commencement of treatment condition 6. Intention-to-treat Low 27% (15/54) excluded as PTs were taken away before completion fo the trial, 3.7% (2/54) withdrew; foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Good, 1995 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low Less than 18% attrition rate (18/102); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Good & Chin, 1998 Bias Judgment Support for judgment 1. Randomization Low Quote: "Subjects were randomly assigned to a music group (n=2 1, 1 male) or the control condition (n=23, 4 males) using permuted blocks of sealed envelopes" (p. 95) 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat High 22.7% attrition rate (10/44)/ foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the National lpstitue of Nursing Research, NIH, Grant Number ROl NR3933-01
240 Good et al., 1999 Bias Judgment Support for judgment 1. Randomization Low Quote: "computerized minimization program was used to randomly assign them" (p. 164). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low 19% attrition rate (117 / 617); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low supported by the National Institute of Nursing Research, NIH, Grant Number RO1 NR-03933
Guerrero et al., 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "The research assistant opened sequentially- numbered, sealed, opaque envelopes after participants completed the baseline enrollment questionnaire and all preoperative assessments" (p. 158). 2. Allocation concealment Low See above randomization method. 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low 19.2% attrition rate (24/125); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Anonymous foundation
Gutgsell et al., 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "The investigator immediately thereafter opened a serially numbered, sealed, opaque envelope to obtain the patient’s assigned group" (p. 825). 2. Allocation concealment Low Above step took place after informed consent was obtained. 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "The investigator opened the sealed envelope containing group assignment in the presence of the patient but not the CNS to ensure blinding of the CNS" (p. 825). 6. Intention-to-treat Low Less than 1% attrition rate (2/200); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Quote: "supported by a grant from the Kulas Foundation in Cleveland, Ohio. The authors declare no conflicts of interest" (p. 830).
241 Hartling et al., 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "The child was then assigned to one of the intervention arms using consecutively labeled, sealed, opaque envelopes (p. 827). 2. Allocation concealment Low Quote: "Allocation was concealed from the research nurse, ED staff, and child and parent until consent was obtained" (p. 827). 3. Blinding interventionist High Quote: "it was not possible to blind the children, parents, researchers, and ED staff" (p. 827). 4. Blinding subjective assessor High See above 5. Blinding objective assessor Low Quote: "Using advanced technological dubbing techniques, the same music heard by the intervention group was added to the video recordings of the control group so that the research assistants were blinded" (p. 828). 6. Intention-to-treat Low No withdrawal, but six missing data; foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by New Investigator Salary Awards from the Canadian Institutes of Health Research (p. 835).
Hook et al., 2008 Bias Judgment Support for judgment 1. Randomization Low Quote: "subjects were randomly assigned, using the “envelope method,” to either the music therapy group or the control group" (p. 261). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Less than 6% attrition rate (6/108), explanations unclear. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low supported by Prince of Songkla University, Hat Yai, Songkhla, Thailand
Huang et al., 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: "A computerized minimization program was used to randomize and conceal the allocation until after assignment and to stratify the groups" (p. 1355). 2. Allocation concealment Unclear Above statement does not explain how and to whom the allocation was concealed. 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 2.5% attrition rate (3/129); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low No known conflict of interests.
242 Hyun et al., 2004 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Ikonomidou, Rehnstrom, & Naesh, 2004 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Low Quote: "the investigators were to remain blinded as to which CD was used" (p. 271). 3. Blinding interventionist Low Quote: "The CDs were unmarked, and the content was unknown to the nurse starting the CD player" (p. 270). 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "Before and after the session, HR, noninvasive BP, and RR were measured by an attending nurse who was unaware of the CDs content" (p. 271). 6. Intention-to-treat Low Less than 8.5% attrition rate (5/60); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Jacobson, 1995 Bias Judgment Support for judgment 1. Randomization Low Quote: "Subjects were randomly assigned to one of the three treatment groups by use of a table of random numbers" (p. 51). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High The researcher also performed and rated IV insertion. 6. Intention-to-treat High More than 35% attrition rate (34/94); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
243 Jacobson, 1999 Bias Judgment Support for judgment 1. Randomization Low Quote: "Subjects wishing to participate were assigned to 1 of the 3 treatment groups by a table of random numbers" (p. 117). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High The researcher also performed and rated IV insertion. 6. Intention-to-treat Low 0% attrition rate. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported in part by funding from Sigma Theta Tau International, Delta Theta Chapter, and Circuit City Foundation.
Jafari et al., 2012 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "Evaluation of pain intensity was done by nurses with sufficient knowledge in this context who were blinded to the study groupings" (p. 3). 6. Intention-to-treat Low Quote: "All randomized patients were included in the analysis and there were no drop outs" (p.3). 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Research Deputy and Student Research Committee of Mazandaran University of Medical Sciences
Jeon, 2004 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting High Not all outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
244 Jose, Verma, & Arora, 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "The sixty four patients, were randomly allocated... by using a computer generated table of random number" (p. 199). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 6.5% attrition rate (4/64); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Declared no conflict of interest
Kim et al., 2004 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Kim & Kim, 2009 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 11% attrition rate (8/75); provided foreseeable explanations for withdrawal. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Sookmyung Women's University
Kim & Kim, 2010 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat High 23% attrition rate (15/60); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
245 Kim et al., 2011 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible (control group did not wear headphone). 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Blinding of assessors was not possible (control group did not wear headphone). 6. Intention-to-treat Low Less than 6% attrition rate (13/232); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Funded by the Ministry of Education, Science and Technology (2009-0075293)
Koca Kutlu & Eren, 2014 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Unclear All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Koch et al., 1998 - T1 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomized into either a control or a music group using a table of random numbers" (p. 301). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor High Quote: "observer was not blinded to group assignment" (p. 301). 6. Intention-to-treat Low Less than 6% attrition rate (2/36); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
246 Koch et al., 1998 - T2 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Kristjánsdóttir & Kristjánsdóttir, 2011 Bias Judgment Support for judgment 1. Randomization Low Quote: "A table of random numbers was used to randomize into groups, providing each participant with the equal probability of being assigned to either the control or the experimental groups" (p. 20). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Quote: "The adolescents were informed to which research group they were assigned" (p. 20). 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Kulkarni et al., 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomized in blocks to either the study group or the control group" (p. 1060). 2. Allocation concealment Low Quote: "This was a computer-generated randomization process, with the sequencing concealed by sealed and consecutively numbered envelopes" (p. 1060). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
247 Kwekkeboom, 2003 Bias Judgment Support for judgment 1. Randomization Low Quote from secondary source: "Computer-generated number list" (Bradt et al., 2011, p.53). 2. Allocation concealment Low Quote: "Opaque sealed envelopes" (from secondary source: Bradt et al., 2011, p.53). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 4% attrition rate (2/60); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Funded by a 2001 grant from the University of Iowa
Laurion & Fetzer, 2003 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "Both the GI and MU audiotapes were coded to blind the perioperative nurse and anesthesia provider caring for the subject" (p. 258). 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Unclear Not all outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Lepage et al., 2001 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Assessor was not blinded 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
248 Li et al., 2011 Bias Judgment Support for judgment 1. Randomization Low Quote: "patients were randomly allocated to two groups using a randomization code generated by computer software" (p. 412). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals for posttest 1; less than 13% attrition rate (15/120) for posttest 2 and 3; foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Dreyfus Health Foundation, New York. No known conflict of interests.
Li & Dong, 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "Randomization was performed using a computer- generated random number table" (p. 81). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Liaoning Province Education Department Scientific Research Plan (grant L2010700) and Liaoning Province Natural Science Foundation (grant 20102272), no known conflicts of interest.
Macdonald et al., 2003 - T1 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Partially supported by the Chief Scientist’s Office of the Scottish Executive.
249 Macdonald et al., 2003 - T2 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting High Not all outcome measures discussed 8. Other sources of bias Low Partially supported by the Chief Scientist’s Office of the Scottish Executive.
Masuda, Miyamoto & Shimizu, 2005 Bias Judgment Support for judgment 1. Randomization Low Quote: "They were randomly assigned to 2 groups of 22 patients… using a table of random numbers" (p. 6). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Sound Technology Promotion Foundation
Migneault et al., 2004 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Low Quote: "Headphones were placed on the patient’s ears in both groups. The CD was then played in the music group by an anesthesiologist not involved in the study" (p. 528). 4. Blinding subjective assessor Low Quote: "Patients of both groups were asked to choose music that was relaxing to them… both groups were asked to adjust the sound volume…" (p. 528). 5. Blinding objective assessor Unclear Above quote in #3 indicates that the anesthesiologist was aware of the group allocation. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
250 Nagata et al., 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "Randomization was carried out by the use ofopaque envelopes" (p. 2173). 2. Allocation concealment Low Quote: "Randomization was carried out by the use ofopaque envelopes" (p. 2173). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Declared no conflict of interest
Nguyen et al., 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: “Randomization was carried out using opaque envelopes, half of which contained a paper that said “music” and half a paper that said “no music” (p. 147). 2. Allocation concealment Low See above 3. Blinding interventionist Low Quote: "The researcher and the physician did not know to which group the patient belonged" (p. 148). 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: “The researcher and the physician did not know to which group the patient belonged. Heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2) were recorded, and the respiratory rate (RR) was measured manually by the researcher" (p. 148). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Unfunded study & declared no conflict of interest
Nilsson et al., 2003a Bias Judgment Support for judgment 1. Randomization Low Quote: "A computer generated the randomization list" (p. 279). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "The anesthetist, nurse anesthetist, surgeon and operating room (OR) nurses and PACU personal were blinded to the CD selection." (p. 701). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Swedish Foundation for Health Care Science and Allergy Research (project V2000 328) and the Swedish Association of Nurse Anesthetists and Intensive Care Nurses.
251 Nilsson et al., 2003b Bias Judgment Support for judgment 1. Randomization Low Quote: "patients were randomly allocated to three groups... using a computer-generated randomization list" (p. 700). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "The anaesthetist, nurse anaesthetist, surgeon and operating room (OR) nurses and PACU personal were blinded to the CD selection." (p. 701). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Swedish Fouodation for Health Care Scieoce and Allergy Research
Nilsson, Unosson, & Rawal, 2005 Bias Judgment Support for judgment 1. Randomization Low Quote: "A computer generated the randomization list. A block randomization was used to keep the numbers of subjects in the different groups closely balanced at all times" (p. 97). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "The anaesthesiologist, nurse anaesthetists, surgeon, physicians and nurses in the operating theatre and the PACU were blinded to the CD selection" (p. 97). 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Swedish Foundation for Health Care Science and Allergy Research (Project V2000 328, V2002 094)
Ottaviani et al., 2012 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Use of speakers reveled group allocation 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Hospital Lariboisière association
252 Ovayolu et al., 2006 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomized into two groups... using computer-generated random numbers" (p. 7533). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Use of speakers reveled group allocation 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Parlar Kilic et al., 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "Therefore, using the random numbers table, the authors determined on what days the music would be played and not played" (p. 3). 2. Allocation concealment High Randomization by day revealed the allocation factor to the researcher prior to recruitment. 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Declared no conflict of interest
Phipps, Carroll & Tsiantoulas, 2010 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Use of speakers reveled group allocation 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Yvonne L. Munn Research Award, Massachusetts General Hospital. Declared no conflict of interest
253 Phumdoung & Good, 2003 Bias Judgment Support for judgment 1. Randomization Low Quote: "Women who met the criteria were randomly assigned to groups using a computerized minimization program" (p. 56). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat High More than than 23% attrition rate (33/110); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Pothoulaki, Macdonald & Flowers, 2008 Bias Judgment Support for judgment 1. Randomization Low Quote: "Participants were randomly assigned... using block randomization" (pp. 913-914). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Declared no conflict of interest
Press et al., 2003 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Assessor was not blinded 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
254 Reza et al., 2007 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomly allocated into two groups of fifty using computer generated random numbers" (p. 575). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Quote: "An unblind investigator obtained demographic data and initial consent after random allocation of patients in the preoperative holding area" (p. 576). 4. Blinding subjective assessor Low Quote: "The patient, anesthetists, surgeon and nurses were blinded to the CD selection… CD-player was started immediately after induction of anesthesia and continued to the time of wound dressing." (p. 576). 5. Blinding objective assessor Low See above 6. Intention-to-treat Low Less than 5% attrition rate (5/105); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Research Committee of Fasa Medical College
Salem, 2004 Bias Judgment Support for judgment 1. Randomization Low Quote: "Participants were randomly assigned to either the experimental or control group by pulling one folded paper out of seventy-four folded papers in a box" (p. 43). 2. Allocation concealment Low Above step took place after informed consent was obtained. 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 12% attrition rate (10/84); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Schou, 2008b Bias Judgment Support for judgment 1. Randomization Low Quote: "The participants were proportionally matched by gender and age, and were randomly assigned to one of three research conditions by block allocation" (p. 321). 2. Allocation concealment Low Quote: "Use of codes as group labels, recruiters did not know what group the codes identified" (Bradt et al., 2013, p. 58). 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 6% attrition rate (4/68); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
255 Sen et al., 2009a Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were divided randomly (generated by a computer)…" (p. 132). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Unclear Not enough information provided 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Sen et al., 2009b Bias Judgment Support for judgment 1. Randomization Low Quote: "The patients were randomly allocated into two groups according to computer-generated randomization" (p. 108). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "All staff in the operating room were unaware of the randomization" (p. 108). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Sen et al, 2010 Bias Judgment Support for judgment 1. Randomization Low Quote: "The patients were randomly allocated into two groups (with 35 patients in each) according to computer- generated randomization" (p.146) 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Quote: "All measurements were recorded by an anesthesiologist that was blinded to the study groups" (p. 147) 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Unclear Not enough information provided 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
256 Seo & Hong, 2010 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low 12% attrition rate (6/50); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Siedliecki & Good, 2006 Bias Judgment Support for judgment 1. Randomization Low Quote: "stratified random assignment using the Min-8 program was used to assign participants randomly to one of three study groups" (p. 555). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 7% attrition rate (4/64); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Frances Payne Bolton Alumni Association, Case Western Reserve University; Sigma Theta Tau, Delta Omega Research Grant; National Institute of Health fellowship Grant for Dissertation research NIH #1F31 NRO 7565
Simavli et al, 2014a Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were randomly assigned to the music (n = 77) or control (n = 79) group using a computer-generated randomization list" (p. 245) 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Blinding of personnel was not possible. 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor Low Quote: "Paper recordings were analyzed manually offline by one of the authors (S.S.), who had no knowledge of the women’s group and maternal pain or anxiety scores" (p. 245). 6. Intention-to-treat Low Less than 7% attrition rate (4/64); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
257 Simavli et al, 2014b Bias Judgment Support for judgment 1. Randomization Low Quote: "Randomization was completed using a computerized minimization program" (p. 195). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low Less than 13% attrition rate (20/161); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unknown Not funded & declared no conflict of interest.
Simcock et al., 2008 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patient was then randomized to either the music or placebo study group by a third-party research assistant via pre-assigned sealed, opaque nontransilluminatable randomization envelopes" (p. 276). 2. Allocation concealment Low See above 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor Low Quote: "All patients were kept blinded of their randomization, which was made possible because of the level of sedation provided before application of the headphones" (p. 276). 5. Blinding objective assessor Low Quote: "All surgeons, anesthetists, and operating room staff were blinded to the patient's randomized group assignment" (p. 276). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the NIH Summer Studmt Fellowship and the Arthritis Foundation Student Fellowship
Szmuk, 2008 Bias Judgment Support for judgment 1. Randomization Low Quote: "Allocation was based on computer-generated codes that were maintained in sequentially numbered opaque envelopes until after induction of anesthesia" (p. 78). 2. Allocation concealment Low See above 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor Low Quote: "Designated sounds (music or no music) started 5 min after induction of anesthesia and continued until sevoflurane administration was stopped" (p. 78). 5. Blinding objective assessor Low Quote: "All operating room personnel, including the anesthesiologist, were blinded to group allocation" (p. 78). 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the NIH Grant GM 061655 and the Joseph Drown Foundation (Los Angeles, CA)
258 Vaajoki et al, 2012 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment High Quote: "The researcher interviewed and informed patients and told them whether they belonged to the music group or the control group prior to the day of surgery" (p. 711). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low Less than 17% attrition rate (34/202); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Kuopio University Hospital EVO funding, Finnish Association of Caring Sciences and Foundation of Nurse Education. Authors declared no conflict of interest.
Vanderboom et al., 2012 Bias Judgment Support for judgment 1. Randomization Low Quote: "Participants were randomized to a control group or experimental group by selecting a group number in an opaque envelope" (p. 230). 2. Allocation concealment Low Quote: "Once these data were collected, participants were randomized…" (p. 230). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Loud speaker revealed group allocation information. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Yvonne L Munn Center for Nursing Research, and Theta Alpha Chapter of the Sigma Theta Tau International Honor Society of Nursing.
Voss et al, 2004 Bias Judgment Support for judgment 1. Randomization Low Quote: "participants were randomly assigned to the sedative music, scheduled rest, or control group using sealed envelopes with a varied block size prepared by the statistician" (p. 198). 2. Allocation concealment Low Quote: "The investigator was blind to the block size and could not anticipate group assignment" (p. 198). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Unclear Less than 2% attrition rate (1/62); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by Sigma Theta Tau Phi Chapter Research Grant, 2001–2002, to J. Vos (p. 197).
259 Yeo et al, 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "(Patients) were selected for this study and were block-randomized into two groups" (p. 460). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Inje University (2011).
Yinger, 2012 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist High Researcher was either video-recording or conducting sessions. 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low Less than 5% attrition rate (3/61); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Yu et al., 2009 Bias Judgment Support for judgment 1. Randomization Low Quote: "A random computer-generated sequence was prepared by a statistician" (p. 1425). 2. Allocation concealment Low Quote: "Group assignment was written on cards which were placed in sequentially numbered, sealed envelopes" (p. 1425). 3. Blinding interventionist Low Quote: "The nurse, parents, and other researchers were blinded to the group assignments, but no blinding of the patients was possible because of the nature of the intervention. 4. Blinding subjective assessor High See above 5. Blinding objective assessor Low See item #3 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the Shenzhen City Foundation for Science and Technology (health care science, project 200703258).
260 Zengin et al., 2013 Bias Judgment Support for judgment 1. Randomization Low Quote: "The patients were randomly allocated to two groups, an MI group or a control group, using computer- generated random numbers" (p. 691). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the science investigation project officeof Gaziantep University. Authors declared no conflict of interest.
Zhang et al., 2005 Bias Judgment Support for judgment 1. Randomization Low Quote: "Patients were... randomly allocated to either the music group or the control group using a computer- generated randomization list" (pp. 990-991). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor High Quote: "The assessors of sedation score were not blinded" (p. 993). 6. Intention-to-treat Unclear Not enough information provided 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Unclear Statements on funding or conflict of interest not found
Zhang et al., 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "A research nurse had a random number list to ensure an equal number in two groups" (p. 740). 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Unclear Blinding of assessors was not described. 6. Intention-to-treat Low No withdrawals reported 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Declared no conflict of interest
261 Zhu et al., 2014 Bias Judgment Support for judgment 1. Randomization Low Quote: "main researcher (ZJM) used the online Research Randomizer (2013) to randomly generate 72 sets of numbers; each set containing four numbers ranging from 1 to 4 with random order" (p. 3). 2. Allocation concealment Low Quote: "After consent taking, the main researcher randomly picked one code for each neonate to ensure the 288 neonates were equally allocated" (p. 3). 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor Low Subjective measures were not used. 5. Blinding objective assessor High Quote: "The observers conducting the recording were not blinded to the allocation" (p. 6). 6. Intention-to-treat Low Less than 12% attrition rate (33/288); foreseeable explanations provided. 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Not funded & declared no conflict of interest.
Zimmerman et al., 1996 Bias Judgment Support for judgment 1. Randomization Unclear Randomization method was not described 2. Allocation concealment Unclear Allocation concealment was not described 3. Blinding interventionist Unclear Blinding of personnel was not described 4. Blinding subjective assessor High Blinding of participants was not possible. 5. Blinding objective assessor Low Objective measures were not used 6. Intention-to-treat Low No withdrawals reported. Quote: "All subjects enrolled in the study participated in both sessions" (p. 158). 7. Selective reporting Low All outcomes discussed 8. Other sources of bias Low Supported by the American Heart Association
262 APPENDIX L
FOREST PLOTS OF META-ANALYSES
1.1 Analysis of Pain Intensity on 0-10 Scales
263 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.1 Analysis of Pain Intensity on 0-10 Scales (cont.)
264 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.2 Analysis of Pain Intensity on Other Scales
1.3 Analysis of Emotional Distress on 100mm VAS
265 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.4 Analysis on Use of Anesthetics
1.5 Analysis on Use of Opioids
FOREST PLOTS OF METAA-ANALYSES (cont.) 266 1.6 Analysis on Use of Non-opioids
1.7 Analysis on Use of Sedatives
267 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.8 Analysis of Heart Rate
268 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.9 Analysis of Systolic Blood Pressure
269 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.10 Analysis of Diastolic Blood Pressure
270 FOREST PLOTS OF METAA-ANALYSES (cont.)
1.11 Analysis of Mean Arterial Pressure
1.12 Analysis of Respiration Rate
271 FOREST PLOTS OF METAA-ANALYSES (cont.)
2.1 Moderator Analysis: Pain Types on 0-10 Pain Intensity Scales (MM+MT)
272 FOREST PLOTS OF METAA-ANALYSES (cont.)
2.1 Moderator Analysis: Pain Types on 0-10 Pain Intensity Scales (MM+MT)(cont.)
273 FOREST PLOTS OF METAA-ANALYSES (cont.)
2.2 Moderator Analysis: Pain Types on 0-10 Pain Intensity Scales (MT)
274 FOREST PLOTS OF METAA-ANALYSES (cont.)
2.3 Moderator Analysis: Pain Types on 0-10 Pain Intensity Scales (MM)
275 FOREST PLOTS OF METAA-ANALYSES (cont.)
2.3 Moderator Analysis: Pain Types on 0-10 Pain Intensity Scales (MM)(cont.)
276 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.1 Moderator Analysis: Age Groups on 0-10 Pain Intensityty Scales (MM+MT)
277 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.1 Moderator Analysis: Age Groups on 0-10 Pain Intensityty Scales (MM+MT)(cont.)
278 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.2 Moderator Analysis: Age Groups on 0-10 Pain Intensityty Scales (MT)
279 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.3 Moderator Analysis: Age Groups on 0-10 Pain Intensityty Scales (MM)
280 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.3 Moderator Analysis: Age Groups on 0-10 Pain Intensityty Scales (MM)
281 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.4 Moderator Analysis: Age Groups on Other Pain Intenssity Scales (MM+MT)
3.5 Moderator Analysis: Age Groups on Other Pain Intenssity Scales (MT)T)
282 FOREST PLOTS OF METAA-ANALYSES (cont.)
3.6 Moderator Analysis: Age Groups on Other Pain Intenssity Scales (MM)
283 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.1 Moderator Analysis: Levels of Choice on 0-10 Pain Intensity Scales
284 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.1 Moderator Analysis: Levels of Choice on 0-10 Pain Intensity Scales (cont.)
285 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.2 Moderator Analysis: Levels of Choice on Use of Anesthetics
286 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.3 Moderator Analysis: Levels of Choice on Use of Opioids
287 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.4 Moderator Analysis: Levels of Choice on Use of Non-ooppioids
4.5 Moderator Analysis: Levels of Choice on Use of Sedatives
288 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.6 Moderator Analysis: Levels of Choice on Heart Rate
289 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.7 Moderator Analysis: Levels of Choice on Systolic Blood Pressure
290 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.8 Moderator Analysis: Levels of Choice on Diastolic Blood Pressure
4.9 Moderator Analysis: Levels of Choice on Mean Arterial Pressure (not discussed)
291 FOREST PLOTS OF METAA-ANALYSES (cont.)
4.10 Moderator Analysis: Levels of Choice on Respiration Rate
292 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.1 Moderator Analysis: Rationale for Selection of Music on 0-10 Pain Scales
293 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.1 Moderator Analysis: Rationale for Selection of Music on 0-10 Pain Scales (cont.)
294 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.2 Moderator Analysis: Rationale for Selection of Music on Use of Anesthetics
5.3 Moderator Analysis: Rationale for Selection of Music on Use of Opioids
295 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.4 Moderator Analysis: Rationale for Selection of Music on Use of Non-opioids
5.5 Moderator Analysis: Rationale for Selection of Music on Use of Sedatives
296 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.6 Moderator Analysis: Rationale for Selection of Music on Heart Rate
297 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.7 Moderator Analysis: Rationale for Selection of Music on Systolic Bloood Pressure
298 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.8 Moderator Analysis: Rationale for Selection of Music on Diastolic Blood Pressure
5.9 Moderator Analysis: Rationale for Selection of Music on Mean Arterial Pressure
299 FOREST PLOTS OF METAA-ANALYSES (cont.)
5.10 Moderator Analysis: Rationale for Selection of Music on Respiration Rate
6.1 Moderator Analysis: Music Experiences in Music Therraapy on 0-10 Pain Intensity Scale
300 FOREST PLOTS OF METAA-ANALYSES (cont.)
7.1 Moderator Analysis: Randomization & Allocation Conccealment on 0-10 Pain Intensity Scales
301 FOREST PLOTS OF METAA-ANALYSES (cont.)
7.1 Moderator Analysis: Randomization & Allocation Conccealment on 0-10 Pain Intensity Scales (cont.)
7.2 Moderator Analysis: Blinding Objective Assessors on 0-10 Pain Intensity Scales
302 APPENDIX M
ELECTRONIC SEARCH STRATEGIES
Databases: CINAHL; PsycINFO; Academic Search Premier; Medline
No. Query S1 (MH "Pain+") OR "pain" S2 (MH "Symptom Distress") OR (MH "Suffering") OR "distress" S3 "discomfort" S4 (MH "Suffering") OR "suffering" (MH "Analgesics, Opioid+") OR (MH "Analgesics, Nonnarcotic+") OR (MH "Analgesics+") OR (MH "Narcotics+") OR "analgesic" OR (MH "Patient Controlled S5 Analgesia Assistance (Iowa NIC)") OR (MH "Opium+") OR (MH "Morphine+") OR (MH "Fentanyl+") OR (MH "Codeine+") OR (MH "Anesthesia Adjuvants+") (MH "Music") OR "music" OR (MH "Music Therapy (Iowa NIC)") OR (MH "Music S6 Therapy") OR (MH "Performing Artists") OR (MH "Singing") S7 S1 OR S2 OR S3 OR S4 OR S5 S8 S6 AND S7
Databases: Global Health; HealthStar
No. Query (pain or distress or discomfort or ache or headache or fibromyalgia or migrane or S1 analgesic or Analgesia or opioid or pain relief or pain medication).mp. [mp=abstract, title, original title, broad terms, heading words, identifiers, cabicodes] (music or music therapy or lullaby or sing or Song or listening or harp).mp. S2 [mp=abstract, title, original title, broad terms, heading words, identifiers, cabicodes] S3 exp Pain Perception/ or exp Pain/ or exp Pain Management/ S4 exp Analgesia/ or Analgesia, Patient-Controlled/ or Analgesia, Epidural/ S5 1 or 3 or 4 S6 2 and 5 S7 1 or 3 or 4 S8 2 and 5
303 Database: Academic OneFile
Keyword (pain Or distress Or discomfort Or ache Or headache Or fibromyalgia Or migrane Or analgesic Or Analgesia Or opioid Or pain relief Or pain medication) And Keyword (music Or music therapy Or lullaby Or sing Or Song Or listening Or harp) LIMITS: Date (119950101-120150531)
Databases: RILM Abstracts of Music Literature; ProQuest Dissertations & Theses A&I
((all(pain) OR all((distress OR discomfort)) OR all((suffering OR ache)) OR all((neuralgia OR myalgia)) OR all((headache OR fibromyalgia))) OR (all(analgesic) OR all((analgesia OR opioid)) OR all((relief OR pain medication)))) AND (all(music) OR all((music therapy OR sing)) OR all((lullaby OR song)) OR all((listening OR harp))) AND yr(1995-2015)
Database: Web of Science
(pain Or distress Or discomfort Or ache Or headache Or fibromyalgia Or migrane Or analgesic Or Analgesia Or opioid Or pain relief Or pain medication) AND Subject: (music Or music therapy Or lullaby Or sing Or Song Or listening Or harp)