Psychological Interventions for Needle-Related Procedural Pain and Distress in Children and Adolescents (Review)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review)

Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2013, Issue 10 http://www.thecochranelibrary.com

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER...... 1 ABSTRACT ...... 1 PLAINLANGUAGESUMMARY ...... 2 BACKGROUND ...... 2 OBJECTIVES ...... 4 METHODS ...... 4 RESULTS...... 10 Figure1...... 13 Figure2...... 14 DISCUSSION ...... 17 AUTHORS’CONCLUSIONS ...... 20 ACKNOWLEDGEMENTS ...... 21 REFERENCES ...... 22 CHARACTERISTICSOFSTUDIES ...... 33 DATAANDANALYSES...... 103 Analysis 1.1. Comparison 1 Distraction, Outcome 1 Self-reportedpain...... 105 Analysis 1.2. Comparison 1 Distraction, Outcome 2 Observer-reported pain...... 106 Analysis 1.3. Comparison 1 Distraction, Outcome 3 Self-reported distress...... 107 Analysis 1.4. Comparison 1 Distraction, Outcome 4 Observer-reported distress...... 107 Analysis 1.5. Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain...... 108 Analysis 1.6. Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress...... 109 Analysis 1.7. Comparison 1 Distraction, Outcome 7 Physiological measure - Heart Rate...... 110 Analysis 1.8. Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen Saturation...... 110 Analysis 2.1. Comparison 2 Hypnosis, Outcome 1 Self-reported pain...... 111 Analysis 2.2. Comparison 2 Hypnosis, Outcome 2 Self-reported distress...... 112 Analysis 2.3. Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress...... 113 Analysis 3.1. Comparison 3 Preparation and information, Outcome 1 Self-reported pain...... 114 Analysis 4.1. Comparison 4 Virtual reality, Outcome 1 Self-reported pain...... 114 Analysis 5.1. Comparison 5 CBT-combined, Outcome 1 Self-reportedpain...... 115 Analysis 5.2. Comparison 5 CBT-combined, Outcome 2 Self-reported distress...... 116 Analysis 5.3. Comparison 5 CBT-combined, Outcome 3 Observer-reported distress...... 116 Analysis 5.4. Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress...... 117 Analysis 6.1. Comparison 6 Parent coaching + child distraction, Outcome 1 Self-reported pain...... 118 Analysis 6.2. Comparison 6 Parent coaching + child distraction, Outcome 2 Observer-reported distress...... 118 Analysis 6.3. Comparison 6 Parent coaching + child distraction, Outcome 3 Behavioral measures- Distress. . . . . 119 Analysis 7.1. Comparison 7 Suggestion, Outcome 1 Self-reportedpain...... 120 ADDITIONALTABLES...... 120 APPENDICES ...... 124 WHAT’SNEW...... 133 HISTORY...... 133 CONTRIBUTIONSOFAUTHORS ...... 134 DECLARATIONSOFINTEREST ...... 134 SOURCESOFSUPPORT ...... 134 DIFFERENCES BETWEEN PROTOCOL AND REVIEW ...... 135 NOTES...... 135 INDEXTERMS ...... 135

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) i Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Psychological interventions for needle-related procedural pain and distress in children and adolescents

Lindsay S Uman1, Kathryn A Birnie2, Melanie Noel2, Jennifer A Parker2, Christine T Chambers3, Patrick J McGrath3, Steve R Kisely 4

1IWK Health Centre & Dalhousie University, Halifax, Canada. 2Centre for Pediatric Pain Research, IWK Health Centre, Halifax, Canada. 3Department of Psychology, Dalhousie University, Department of Pediatrics (GI Division), IWK Health Centre, Halifax, Canada. 4School of Population Health, The University of Queensland, Brisbane, Australia

Contact address: Christine T Chambers, Department of Psychology, Dalhousie University, Department of Pediatrics (GI Division), IWK Health Centre, 5850/5980 University Avenue, P.O. Box 9700, Halifax, Noval Scotia, B3K 6R8, Canada. [email protected].

Editorial group: Cochrane Pain, Palliative and Supportive Care Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 10, 2013. Review content assessed as up-to-date: 2 September 2013.

Citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle- related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD005179. DOI: 10.1002/14651858.CD005179.pub3.

ABSTRACT Background This review is an updated version of the original Cochrane review published in Issue 4, 2006. Needle-related procedures are a common source of pain and distress for children. Our previous review on this topic indicated that a number of psychological interventions were efficacious in managing pediatric needle pain, including distraction, hypnosis, and combined cognitive behavioural interventions. Considerable additional research in the area has been published since that time. Objectives To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. Search methods Searches of the following databases were conducted for relevant randomized controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Web of Science. Requests for relevant studies were also posted on various electronic list servers. We ran an updated search in March 2012, and again in March 2013. Selection criteria Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only RCTs with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion. Data collection and analysis Two review authors extracted data and assessed trial quality and a third author helped with data extraction and coding for one non- English study. Included studies were coded for quality using the Cochrane Risk of bias tool. Standardized mean differences with 95% confidence intervals were computed for all analyses using Review Manager 5.2 software.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 1 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results

Thirty-nine trials with 3394 participants were included. The most commonly studied needle procedures were venipuncture, intravenous (IV) line insertion, and immunization. Studies included children aged two to 19 years, with the most evidence available for children under 12 years of age. Consistent with the original review, the most commonly studied psychological interventions for needle procedures were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majority of included studies (19 of 39) examined distraction only. The additional studies from this review update continued to provide strong evidence for the efﬁcacy of distraction and hypnosis. No evidence was available to support the efﬁcacy of preparation and information, combined CBT (at least two or more cognitive or behavioural strategies combined), parent coaching plus distraction, suggestion, or virtual reality for reducing children’s pain and distress. No conclusions could be drawn about interventions of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as evidence was available from single studies only. In addition, the Risk of bias scores indicated several domains with high or unclear bias scores (for example, selection, detection, and performance bias) suggesting that the methodological rigour and reporting of RCTs of psychological interventions continue to have considerable room for improvement.

Authors’ conclusions

Overall, there is strong evidence supporting the efﬁcacy of distraction and hypnosis for needle-related pain and distress in children and adolescents, with no evidence currently available for preparation and information or both, combined CBT, parent coaching plus distraction, suggestion, or virtual reality. Additional research is needed to further assess interventions that have only been investigated in one RCT to date (that is, memory alteration, parent positioning plus distraction, blowing out air, and distraction plus suggestion). There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress.

PLAIN LANGUAGE SUMMARY

Psychological interventions for needle-related procedural pain and distress in children and adolescents

Psychological interventions (for example, distraction, hypnosis, coping skills training) are treatments used to reduce pain and distress (anxiety and fear, or both) that children and adolescents experience while undergoing medical procedures involving needles. There is strong evidence that distraction and hypnosis are effective in reducing the pain and distress that children and adolescents experience during needle procedures. Distraction techniques can often be quite simple, such as reading the child stories, watching television, listening to music, or talking about something other than the needle. Sometimes parents or nurses are involved in helping to distract the child, although that is not always necessary. Interventions such as hypnosis may require some teaching by a trained professional for a child to learn. Other psychological treatments, such as explaining what is going to happen before or during the procedure (labelled ’providing information or preparation or both’), using virtual reality (for example, interactive video equipment, goggles, computers showing images, games, stories), or a combination of various strategies have been tested. More research is needed to know whether they are effective for reducing children’s pain and distress during needles.

BACKGROUND throughout childhood. The Advisory Committee on Immuniza- tion Practices (ACIP 2004), the American Academy of Pediatrics This review is an update of a previously published review in the (AAP 2004), the American Academy of Family Physicians (AAFP Cochrane Database of Systematic Reviews (2006, Issue 4) on ’Psy- 2004), and the Canadian Paediatric Society (CPS 2004) all recom- chological interventions for needle-related procedural pain and mend over 20 various immunizations before age 18 years. Children distress in children and adolescents’. with chronic illnesses experience an even greater number of painful procedures, as part of the diagnosis, treatment, and monitoring of Description of the condition their condition. In a hospital setting, children often experience un- Medical procedures are a common source of pain and distress predictable and severe procedure-related pain (Cummings 1996) for children. Healthy children undergo immunizations repeatedly that can be associated with negative emotional and psychological

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 2 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. implications (Kazak 2001). Despite the prevalence of pain stem- or maladaptive behaviours to help replace them with more positive ming from medical procedures and the distress associated with and adaptive behaviours (for example, watching a funny movie this, research indicates that pain management continues to be sub- instead of talking about how much the needle will hurt). Cog- optimal. For example, a recent investigation of the epidemiology nitive behavioural therapy (CBT) uses a combination or varia- and management of painful procedures in children in Canadian tion of cognitive or behavioural, or both, strategies targeting both hospitals found that 78% of patients admitted to inpatient units thoughts and behaviours (Barlow 1999). CBT for pain manage- had undergone a painful procedure; however, less than a third of ment aims to help individuals develop and use coping skills to the painful procedures had documented pain management inter- manage their pain and distress, and can include various techniques ventions (Stevens 2011). such as distraction, relaxation training, deep breathing, hypnosis, Evidence-based clinical guidelines for reducing the pain of child- preparing for and rehearsing the procedure in advance, using pos- hood vaccinations do exist (Taddio 2010). These guidelines pro- itive reinforcement for adaptive behaviours, making positive cop- mote a ’3-P’ approach to pain management, which includes phar- ing statements, and receiving coaching to use adaptive strategies macological, physical, and psychological factors. In terms of psy- (Chen 2000a; Christophersen 2001; Keefe 1992). While it can chological approaches, the guidelines recommend various cogni- be challenging to identify the exact processes or mechanisms that tive and behavioural techniques that are effective at reducing vac- each of the interventions target, efficacy is in part a function of cination pain (for example, deep breathing) as well as various tech- many dimensions such as intervention novelty, engagement, and niques that are ineffective for vaccination pain (for example telling developmental appropriateness. children reassuring comments like ’it won’t hurt’). As noted above, although CBT-based interventions are often described as ’psychological’ in nature, this does not mean they are limited to use or direction by psychologists. On the contrary, most Description of the intervention of these techniques are quite straightforward (for example, distraction, deep breathing), require no intensive training to use, Medical procedures, particularly needles, are among the most and can be delivered by various healthcare workers (for exam- feared experiences of children (Broome 1990). It is important to ple, nurses, child life specialists) as well as family members, such note that identifying positive adaptive or negative maladaptive as parents. However, certain techniques do require some training intervention strategies should be based on evidence. While intu- and knowledge for maximum effectiveness (for example, diaphrag- itively it might appear that reassurance (for example, saying ’don’t matic breathing is more involved than taking a few deep breaths). worry’ or ’it’s going to be ok’) would help to decrease pain and Operational definitions of specific cognitive or behavioural inter- distress during needle procedures, there is a large body of evi- ventions (for example, hypnosis, memory alteration, distraction) dence to indicate that it is actually distress-promoting (for exam- are available by request from the authors. ple, Manimala 2000). Various mechanisms have been proposed to explain this, including reassurance indicating to the child that the parent is worried, reinforcement of child distress behaviours by attention, or permission to the child to freely express his or her How the intervention might work distress (McMurtry 2006; McMurtry 2010). Cognitive interventions include techniques that target negative A number of psychological interventions for managing pain and or unrealistic thoughts to help replace them with more positive distress in children are available, of which the majority are cog- beliefs and attitudes (for example, saying positive self-statements nitive behavioural in nature. Although non-pharmacological in- such as ’I can get through this’ instead of ’this is going to hurt’). terventions for pain that are not cognitive behavioural exist (for Behavioural interventions include techniques that target negative example, acupuncture, heat or cold), these interventions were not or maladaptive behaviours to help replace them with more positive included in the present review. The borderline between psycholog- and adaptive behaviours (for example, watching a funny movie ical and non-psychological interventions is difficult to define, of- instead of talking about how much the needle will hurt). CBT ten because some interventions could arguably fit into more than uses a combination or variation of cognitive or behavioural, or one category. For example, coughing and deep breathing could both, strategies targeting both thoughts and behaviours (Barlow both arguably fall under the categories of psychological (for exam- 1999). For the purpose of this review, all of the cognitive, be- ple, distraction) or physical interventions. We would argue that havioural, and cognitive behavioural strategies described above fall the classification of interventions into distinct mutually exclusive under the overarching category of ‘psychological’ interventions. As categories would misrepresent the processes involved. a whole, psychological interventions for pain management aim to Cognitive interventions include techniques that target negative help individuals develop and use coping skills to manage their pain or unrealistic thoughts to help replace them with more positive and distress, and can include various techniques such as distrac- beliefs and attitudes (for example, saying positive self-statements tion, relaxation training, deep breathing, hypnosis, preparing for such as ’I can get through this’ instead of ’this is going to hurt’). and rehearsing the procedure in advance, using positive reinforce- Behavioural interventions include techniques that target negative ment for adaptive behaviours, making positive coping statements,

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 3 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. and receiving coaching to use adaptive strategies (Chen 2000a; review but acknowledge the importance of these areas of inquiry Christophersen 2001; Keefe 1992). for future research.

Why it is important to do this review Several narrative, non-systematic reviews and book chapters on OBJECTIVES psychological interventions for the management of procedural To provide an update to our 2006 review assessing the efficacy pain and distress in children are available (for example, Alvarez of psychological interventions for needle-related procedural pain 1997; Blount 2003; Chen 2000a; Christophersen 2001; Devine and distress in children and adolescents. 2004; Kazak 2001; Powers 1999; Young 2005). These reviews have typically concluded that psychological interventions are beneficial; however, the lack of a systematic and pooled approach to integrating the literature is problematic and can mean that only lim- METHODS ited conclusions regarding the efficacy of these interventions are made. Although there have been a few examples of more systematic approaches to integrating this literature (for example, Broome Criteria for considering studies for this review 1989; Kleiber 1999; Luebbert 2001; Saile 1988), these reviews have tended to adopt a more limited focus (for example, examining the effects of only one type of intervention such as distraction) Types of studies and many are out of date given the rapid growth of research in this area in recent years. Only randomized controlled trials (RCTs) with at least five partic- We conducted and published our original Cochrane Review ipants in each study arm were included. In contrast to our original (Uman 2006; Uman 2008) to provide a comprehensive, systematic review in which we included quasi-randomized trials (for example, review of the efficacy of different psychological interventions for alternative assignment) in a sensitivity analysis, for this updated managing procedure-related pain and distress in children. Based review we included only true RCT designs and excluded all quasi- on that original review, we established the efficacy of several in- randomized trials. A study was deemed to be a true RCT if the terventions (namely distraction, hypnosis, and CBT) and made authors explicitly stated that participants were randomly assigned several clinical and research recommendations, including identify- to groups (for example, assignment was determined using a table ing interventions requiring further research. We also made recom- of random numbers) and did not indicate using quasi-randomiza- mendations for improving the quality of trials in the area, which tion methods (for example, alternating assignment) at any point were explored in more depth and outlined in a subsequent paper in the paper. For example, some authors may describe the study (Uman 2010). At the time of our initial review only 28 RCTs met as an RCT in the title or abstract but later report quasi-random- our inclusion criteria and provided the necessary data for inclusion ization techniques in the methods sections. A true RCT is one in our meta-analysis. Since the publication of our initial review, that is described as such throughout the entire paper. While we considerable additional research in the area has been published. were more lenient in the original review and included a few stud- Therefore, this updated review was meant to expand upon our ies reporting quasi-randomization procedures, these studies were original review by identifying and including the more recent RCTs excluded from the present review in order to be more consistent and synthesizing the results of these more contemporary studies and stringent in our approach. In addition, unlike in our original with our prior work to make stronger conclusions about the effi- review, we included only published trials and therefore excluded cacy of these interventions. We also used a risk of bias measure in any non-published trials (for example, dissertations). No language this update to evaluate the risk of bias for all of the included stud- restrictions were used during the search and translations were ob- ies. The current updated review combines findings across a larger tained when necessary. sample, which strengthens and expands our conclusions regarding the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. Types of participants Although we wished to conduct sensitivity analyses to examine Studies involving children and adolescents aged two to 19 years more specific age ranges or developmental periods, the broadness undergoing needle-related medical procedures were included. For and variability in the study sample age ranges limited these anal- the purposes of this review, a needle-related medical procedure yses. In addition, the majority of RCTs in this area assessed single was defined as any procedure performed as part of a medical diag- event needle procedures rather than repeated or multiple needle nosis, prevention, or treatment. This included dental procedures procedures, thereby precluding the ability to assess this area fur- (excluding dental surgery) but did not include procedures such ther. As such, we did not include these analyses in this updated as body piercings or tattoos, which involve needles but are not

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 4 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. performed for medical purposes. The search was limited to nee- in this review. dle-related pain, which is among the most commonly occurring and feared procedures for both healthy and chronically-ill children (Broome 1990). Our justification for not including children Types of interventions less than two years of age is that the majority of psychological Studies were included if at least one trial arm consisted of a psy- interventions examined in this review are either not appropriate chological intervention, and there was a comparator control arm, for use with infants or are qualitatively different when applied to other active treatment, treatment as usual, or waiting list control. infants. The efficacy of psychological interventions for procedural We excluded studies in which the psychological intervention(s) pain and distress in infants has been addressed in another review was combined with a non-psychological intervention (for exam- (Pillai-Riddell 2011a; Pillai-Riddell 2011b). For both the original ple, pharmacological intervention) when the unique effects of the review and this review update, we included studies with partic- psychological intervention could not be evaluated. ipants ranging from two to 19 years of age. A maximum age of 19 years was chosen to ensure that our search was limited to chil- Types of outcome measures dren and adolescents only, and is also consistent with the World Health Organization (WHO) definition of adolescence, which de- The two measured outcomes of interest were pain and distress, fines it as ranging from 10 to 19 years (http://www.searo.who.int/ assessed using scales or measures with established reliability and en/Section13/Section1245_4980.htm). The age range was kept validity (that is, as evidenced in at least one prior study published broad so as to not exclude any relevant studies; however, studies in a peer-reviewed journal). For this review, pain was operational- that included any participants falling outside of this age range were ized using the definition proposed by the International Associa- excluded unless authors were able to provide data for only the age tion for the Study of Pain (IASP), describing pain as: “an unpleas- range specified for this review while also continuing to meet the ant sensory and emotional experience associated with actual or minimum criterion of five participants per group. potential tissue damage, or described in terms of such damage” We included studies examining medical procedures from the same (IASP 2004). In addition, distress was broadly defined as any type list of procedures identified in our prior review (please see Table of negative affect associated with the procedure (for example, anx- 1 for the list of medical procedures and their definitions). Def- iety, stress, fear). Because the main focus of this review was the initions were derived from online medical dictionaries (for ex- data pooling component (that is, the meta-analysis), as with the ample, MedlinePlus Medical Encyclopedia, MedLine 2004; On- original review, RCTs were excluded if the data necessary for data Line Medical Dictionary, OLMD 2004) and by consulting with pooling (for example, means, SDs, cell sizes) were not available in medical professionals in the area of pediatric pain. Participants the published study, could not be identified through contact with included healthy children and children with chronic or transitory the study authors, or could not be calculated based on other data illnesses from both inpatient and outpatient settings. Studies in- provided (for example, confidence intervals). cluding patients with known needle phobias (that is, diagnosed by a qualified professional such as a psychologist) were excluded. Primary outcomes While we acknowledge that needle fears are quite prevalent and some youth included in the reviewed studies may have had undi- agnosed phobias, this criterion was established in an attempt to 1) Self-report distinguish between typical needle fears or ones that are extreme enough to have warranted assessment and diagnosis prior to the Measures of pain and distress may include various versions of the study. Furthermore, children undergoing surgery were excluded following (Champion 1998): because numerous factors specific to surgery or being in inten- • Visual Analogue Scales (VAS); sive care units can complicate and interfere with the accuracy of • Numerical Rating Scales (NRS); self-reported accounts of pain and distress. These factors may in- • Verbal Rating Scales (VRS); clude sedation, inability to verbalize because of intubation, more • faces Scales designed to assess level of pain or distress (for example, intensive pharmacological interventions, long-term hospital stays, anxiety or fear, or both). inability or difficulty attributing pain or distress to one specific medical procedure, and difficulty distinguishing between the pain 2) Observer Global Reports and distress caused by the procedure versus the medical condition Observer versions of the self-report measures for pain and distress requiring the surgery (Puntillo 2004). The exception to this was listed above (completed by parents, caregivers, nurses, doctors, or for studies that assessed the efficacy of a psychological intervention other hospital staff present) were also included. It is important to for a pre-surgical needle procedure such as an intravenous (IV) note that there are various factors affecting the degree to which insertion. The outcome measures of interest had to be completed observer reports are positively correlated with self-reports of pain prior to surgery or sedation in order for the study to be included and distress, such as the person completing the report (that is,

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 5 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. mother, nurse, or doctor) and the age of the child (Champion in some studies of parental and staff proxy ratings whereby more 1998). Despite these caveats, observer reports of pain and distress weight is given to certain scales or raters (for example, giving more can provide valuable information, particularly for younger chil- weight to parent reports and less weight to child reports). For these dren. reasons, it can be helpful for studies to incorporate various measures of pain and distress by different raters (for example, child, parent, staff) and this is the reason we chose to evaluate these out- 3) Behavioural Measures comes separately in this review. These include behavioural observation measures, typically com- However, is it worth noting that there is also variability among ob- pleted by trained researchers or medical staff. They may in- servational assessments of pain and distress. In another systematic clude but are not limited to the following commonly used scales review of observational (behavioural) measures of pain for youth (McGrath 1998). three to 18 years old, it was noted that pain intensity measures are not generally age-normed and there are often no separated versions of observational scales for different ages. Rather, although most observational scales were originally developed for speciﬁc Pain Scales ages ranges, they have been applied or expanded to a broader age • The Children’s Hospital of Eastern Ontario Pain Scales range. However, despite this important issue, which warrants fur- (CHEOPS) (McGrath 1985) ther research, the results of the systematic review did recommend • The Faces Legs Activity Cry Consolability Scale (FLACC) ( using certain observational scales (that is, FLACC and CHEOPS) Merkel 1997) based on their sound psychometric properties for youth in this age range undergoing painful medical procedures (von Baeyer 2007).

Distress Scales • The Observational Scale of Behavioral Distress (OSBD) (Jay Secondary outcomes 1983) • The Child-Adult Medical Procedure Interaction Scale (CAMPIS) (Blount 1989), the CAMPIS-revised (Blount 1990; Blount 1997), and the CAMPIS-short form (Blount 2001) 4) Physiological Measures While developmental and age factors are important considerations when selecting appropriate outcome measures, there is still con- Measures of pain and distress that are practical to quantify in siderable variability in selecting outcome measures and many are clinical setting may include (Sweet 1998): used for a broad range of ages. However, systematic reviews of self- • heart rate (generally increases with pain); report of pain intensity in youth aged zero to 18 years note that • respiratory rate (may increase or decrease with pain and distress no scale is uniformly appropriate across development and there or both); continues to be debate about the choice of scale to use (Stinson • blood pressure (generally increases with pain and distress or 2006; Tomlinson 2010). The more recent Tomlinson 2010 re- both); view suggests that faces scales are frequently used; the most widely • oxygen saturation (generally decreases with pain and distress or used with the best validity are currently the Faces Pain Scale-Re- both); vised (FPS-R) (Hicks 2001), the Oucher pain scale (Beyer 1992), • cortisol levels (generally increase with pain and distress or both); and the Wong-Baker Faces Pain Rating Scale (WBFPRS) (Wong • transcutaneous oxygen tension (tcPO2) (generally decreases with 1988). However, it is important to note that several studies have pain and distress or both); found that faces scales starting with smiling no-pain anchors, such • transcutaneous carbon dioxide tension (tcPCO2) (may increase as the WBFPRS, tend to result in greater pain ratings compared or decrease with pain and distress or both). to scales starting with neutral non-smiling pain anchors because Despite concerns regarding the tendency of physiological measures they may confound affective states with pain ratings (for exam- to habituate in response to pain and distress, as well as a lack of ple, Chambers 1998). In addition, although many faces scales are data supporting the speciﬁcity of these measures to pain (McGrath validated and used with younger children (three to ﬁve years), it 1998; Sweet 1998), physiological measures have frequently been has been found that children this young often demonstrate re- assessed as outcomes in pain studies, and were therefore included sponse biases, such as choosing only the lowest or highest anchors as outcomes in this review. However, it is important to note that (for example, von Baeyer 2009). Thus, self-reports of pain from all self- and observer-rated measures of pain and distress are sub- preschoolers should be interpreted with caution and complemen- jective, given that pain is a subjective experience based on a variety tary observational assessments (for example, by parents) are also of factors (for example, pain threshold, previous experiences with recommended. However, there are systematic discounting biases pain, etc).

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 6 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Search methods for identification of studies 1. Selection of studies Published studies were identified by conducting electronic searches Two review authors (LU and CC) independently screened titles and by contacting researchers using various electronic mailing lists and abstracts of trials from literature searches for inclusion in the and list servers. original review, and two additional review authors (MN and KB) independently screened titles and abstracts for the review update. For all abstracts that were relevant, potentially relevant, or where Electronic searches relevance to the current review was unclear, the full articles were Through consultation with a reference librarian and with assis- obtained and read by one of the study authors. Using the full tance from the Cochrane Pain, Palliative and Supportive Care (Pa- articles, two review authors (LU and CC for the original review, PaS) Group, detailed search strategies were developed to search and MN and KB for the updated review) decided which studies the following six electronic databases for relevant trials: did and did not meet the inclusion criteria. Review authors were • Cochrane Central Register of Controlled Trials not blind to the authors, institutions, journals, or results. A third (CENTRAL) (The Cochrane Library 2013, Issue 2); review author (PM for the original review, and LU for the updated • MEDLINE (1966 to March 2013) ; review) was brought in to help resolve any issues or selection dis- • EMBASE (1989 to March 2013); crepancies that arose. • PsycINFO (March 2013); As noted above, to increase the methodological quality of the stud- • Cumulative Index to Nursing and Allied Health Literature ies included in this updated review, we imposed more stringent (CINAHL) (March 2013); inclusion criteria for this review update as compared to the orig- • Web of Science (IBI Web of Knowledge) (March 2013). inal review. Specifically, for this review update we omitted any non-published studies (for example, unpublished dissertations) For this updated review, the same database search terms were used and quasi-randomized trials (that is, anything other than report- as in the original review; however, we extended the search date to ing true random assignment, as described above). In our original cover the period from when the last update ended (2005) to March review, contact with some study authors clarified that the assign- 2013. Thus, altogether, the database searches covered the period ment they used was indeed random assignment although it was from their inception to March 2013. Because we opted to include not described as such in the paper (for example, described in the only published studies for this current review update, we excluded abstract as an RCT but described in the methods as using alter- one additional database searched in the original review (that is, nating assignment). Thus, to be consistent across all studies, those Dissertation Abstracts International). A similar search strategy was reporting quasi-randomized procedures in the published studies adapted for each of the databases but additional related keywords were excluded from this update even if they were included in the and MeSH terms were included as appropriate for each specific original review. database. Please see the appendices for the search strategies and A total of 28 RCTs were retrieved and included in the original terms used for each of the databases: MEDLINE (Appendix 1), review, although for the current update we excluded seven of these PsycINFO (Appendix 2), CENTRAL (Appendix 3), EMBASE studies because they were unpublished dissertations or reported (Appendix 4), IBI Web of Knowledge (Appendix 5), and CINAHL quasi-randomized methods (that is, alternating assignment). In (Appendix 6). March 2012, our updated search strategy identified 18 additional RCTs meeting the inclusion criteria and having the necessary data to be included in this update. An additional search in March 2013 Searching other resources did not identify any further studies. Thus, a total of 39 RCTs In addition to the electronic search strategy, we also put out a call (retrieved from the original and updated searches) were included for relevant studies to four e-mail list serves including: 1) Pain in in this updated review; all of these included RCTs were coded in Child Health (PICH), 2) Pediatric Pain, 3) the American Psycho- full. The references for these studies are all provided below in the logical Association’s Society of Pediatric Psychology Division 54, ’Description of studies’ section. and 4) the American Psychological Association’s Health Psychol- ogy Division 38. Requests to these list serves were sent out for both the original review and, again, for the present review update. 2. Data extraction and management Any other relevant studies identified and included in the original Two review authors (LU and CC) extracted data using a data ex- review (for example, from reference or citation lists) were included traction form designed for the original review, and two additional in this update. review authors (MN and KB) performed data extraction for additional studies identified in the review update. In addition, another researcher who was fluent in Farsi confirmed inclusion eligibility Data collection and analysis and conducted data extraction for one non-English study identified from our updated search. Data were extracted on various

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 7 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. details relating to study design, participant demographics, diagno- (for example, pain). We proposed that when sufficient data were sis (when applicable), needle procedure, type of intervention and available from various studies using the same measurement instru- control conditions, outcomes, as well as other related variables. ments, a weighted mean difference (WMD) with 95% CI would A third review author (PM for the original review, and LU for also be conducted. However, given the wide range of different the updated review) was available to help resolve any coding dis- assessment measures used, this was not feasible. Thus, all mean crepancies. Data from the studies were extracted using paper data differences presented in the tables and plots of the results section extraction sheets developed for this review and were also entered represent SMDs. into electronic spreadsheets to differentiate between included ver- Each psychological intervention was assessed separately in a meta- sus excluded studies. Attempts were made to obtain missing data analysis because the interventions were considered too different (for example, means, SDs, cell sizes) from the authors, whenever to combine. However, within each intervention we analysed each feasible, to include in the meta-analysis. All data for the included outcome measure separately. Thus, for each intervention the fol- studies were first recorded on paper data extraction forms by re- lowing seven outcomes were separately assessed. view authors (LU for the original review, and MN and KB for the a) Pain: self-reports. updated review) and reviewed for errors by a trained research as- b) Pain: observer global reports. sistant. All data suitable for pooling were analysed using RevMan c) Pain: behavioural measures. 5.1 software (RevMan 2011). d) Distress: self-reports. e) Distress: observer global reports. f) Distress: behavioural measures. 3. Assessment of risk of bias in included studies g) Physiological measures: each physiological outcome (e.g. heart In the original review, each included study was scored indepen- rate, blood pressure) was assessed separately. dently for quality by two review authors using the Oxford Quality Scale created by Jadad 1996. We also completed a more extensive quality analysis of the included studies (Uman 2010) given that 5. Unit of analysis issues the Oxford Quality Rating Scale is more appropriate for double- In this context, unit of analysis issues refer to the level at which blind studies (for example, pharmacological interventions); and randomization occurs. For example, in most situations the num- psychological interventions, unlike placebo studies, typically can- ber of observations analysed should match the number of ’units’ not be truly double-blind. For the purpose of this updated re- that were randomized. In a simple, parallel two-group RCT (in- view, we used the Cochrane ’Risk of bias’ tool as a measure of tervention versus control), participants would be randomized to trial quality. The Cochrane Handbook for Systematic Reviews of In- one of the two groups and a single measurement for each outcome terventions (www.cochrane-handbook.org/) distinguishes between would be collected and analysed. For the current review, we in- methodological quality assessment and risk of bias, and recom- cluded and analysed parallel two-group RCTs as well as cluster- mends a focus on the latter (please refer to the Cochrane Hand- randomized trials (that is, groups of individuals randomized to- book for a detailed account of reasons why). The Risk of bias tool gether to the same intervention). In addition, we also included is a two-part tool assessing seven areas: adequate sequence gener- cross-over trials (that is, participants undergo more than one inter- ation, allocation concealment, blinding of participants and study vention); however, we only included these studies if the data were personnel, blinding of outcome assessment, incomplete outcome available separately for each group following the first treatment data addressed, free of selective reporting, and other biases. All arm. For example, in a treatment (n = 50) versus control (n = 50) included studies from the original review and those identified in two-group design we required the data for the first treatment arm this update were independently coded by two review authors (MN (treatment group versus control) before the groups crossed over and KB) who then compared responses to reach consensus. This and the conditions were reversed rather than the overall combined procedure was verified with, and endorsed by, the Cochrane PaPaS values for all treatment values compared to all control values. The Review Group. rationale for this decision was based on the belief that once a psychological intervention (for example, distraction, hypnosis) has been introduced and taught to participants, it is difficult to prevent 4. Measures of treatment effect participants from using these strategies themselves (for example, Given the nature of the outcome measures in this review, all of the cognitive distraction techniques) even if they are then switched outcome data for the included studies were continuous (for exam- to a control condition. Lastly, we also included studies using re- ple, rating scales). Consistent with the analytical approach used in peated measures designs (for example, pain and distress outcomes the original review, and as is recommended by The Cochrane Col- assessed at various time points); however, in these situations we laboration, we computed standardized mean differences (SMD) only included outcomes occurring during the needle procedure with 95% confidence intervals (CI), which allowed us to com- (pre-needle outcomes were not included). If outcomes during the bine the results from different scales measuring the same construct needle procedure were not evaluated, we then selected the next

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 8 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. proximal time point occurring closest to the completion of the Handbook for Systematic Reviews of Interventions suggests the fol- procedure. If outcomes that assessed both during and following lowing rough interpretation guide: 0 to 40%, might not be impor- the needle-related procedure were reported, outcomes during the tant; 30% to 60%, may represent moderate heterogeneity; 50% to needle procedure were selected for inclusion. 90%, may represent substantial heterogeneity; and 75% to 100% represents considerable heterogeneity. The reason for some of the overlap in ranges is because the importance of I2 depends on sev- 6. Dealing with missing data eral other factors such as the magnitude and direction of effects, as All included RCTs were reviewed to determine if the authors re- well as the strength of evidence for the heterogeneity (for example, 2 2 ported any missing data. We had originally proposed that data the P value for the Chi test or the confidence interval for the I would not be presented for studies if more than 20% of the orig- statistic). In cases where statistically significant heterogeneity was inally randomized participants withdrew; however this was not detected, the data were still pooled; however, these results should applicable to any of the retrieved studies. be interpreted with caution. Given that there was significant het- In all situations where data necessary for data pooling were omit- erogeneity for several of the analyses, results were analysed using ted from the published RCT (for example, means, standard devia- a random-effects model. When possible, attempts were made to tions (SDs), groups sizes, CIs), attempts were made to contact the explore the reasons for the heterogeneity. We chose only to report 2 2 study authors to obtain these data. If that was not possible, statis- I values in the text of the results section but both the I statistics 2 tical formulae identified in the Cochrane Handbook for Systematic and Chi tests are depicted in the forest plot figures. reviews of Interventions for calculating missing data using other reported measures of variation were used (for example, obtaining standard deviations from standard errors, confidence intervals, t 8. Assessment of reporting biases values, and P values). In situations in which the authors could not In order to help overcome publication bias in both the original be contacted, did not respond to contact attempts, did not have and updated review, we: (1) imposed no language barriers in our these data available, or there were insufficient data available to search, (2) contacted several list serves and researchers in the field compute the necessary calculations, these studies or the outcomes of pediatric health and pain to request any published, unpub- with the missing data were excluded from this review. lished, and in-progress studies, and (3) contacted the authors of To be consistent with authors’ reporting, we included the number all the studies with missing means, standard deviations, and cell of participants per group identified in the study results sections. sizes in attempts to retrieve these data. Of note, many studies When not otherwise specified by the authors, we assumed that included several outcome measures; however, in some situations there were no study dropouts and used the reported group sizes authors only reported means and standard deviations when the in the meta-analyses. Initially we intended to conduct all analyses group differences with respect to the intervention were significant, using intention-to-treat (ITT) analyses. ITT analyses include all but not when group differences were not significant. We included participants enrolled in the study including those who were lost to any studies in the meta-analysis that provided completed results follow-up or dropped out. Given that the majority of RCTsdid not (that is, means, SDs, and cell sizes for both treatment and control specifically identify whether ITT analyses were used and did not groups) for at least one outcome measure. Information related to consistently report whether there were any participant dropouts, reporting biases is also captured in the Risk of bias tool used to code ITT analyses could not be performed. all of the included studies reported in this update (studies included from the original review were also coded for this update using this tool). Nine of the studies included in this review had authors who 7. Assessment of heterogeneity responded to our requests and provided clarification or missing For each outcome combining the effects of two or more studies, data (Balan 2009; Bisignano 2006; Caprilli 2007; Cavender 2004; we calculated heterogeneity using both the Chi2 test and the I2 Gupta 2006; Kleiber 2001; Liossi 1999; McCarthy 2010; Sinha statistic. Given that Chi2 tests often have low statistical power, a 2006; Wint 2002). type 1 error level of 0.10 was employed for rejecting the null hy- pothesis of homogeneity as opposed to the more traditional type 1 error level of 0.05. While Chi2 tests are useful for identifying 9. Data synthesis whether heterogeneity is present, it has been argued that there SMDs using a random-effects model for each of the above subcat- will always be some level of heterogeneity in meta-analyses given egories were calculated when the necessary data were available. In- the clinical and methodological diversity (Higgins 2011). The I2 terventions were considered efficacious when the SMD and both statistic shifts the focus away from whether heterogeneity is present anchors of the CI fell in the negative range. In the original review, and provides a measure of inconsistency across studies to assess we limited the main analyses to only RCTs but included quasi- the impact of heterogeneity on the meta-analysis (Higgins 2011). randomized trials in sensitivity analyses. Due to the limitations I2 is expressed as a percentage from 0 to 100, and the Cochrane of quasi-randomized trials, we limited the analyses to only true

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 9 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. RCTs for this review update and did not include the additional heterogeneity sensitivity analyses for quasi-randomized trials. As with the original review, subgroup analyses were limited to In situations where studies included more than one type of con- analysing each category of psychological intervention separately trol condition, we selected the condition that was most similar to (for example, distraction RCTs, hypnosis RCTs, etc) as the in- the intervention condition, with the only difference being non- terventions were considered too qualitatively distinct to combine, administration of the specific intervention. Thus, if a study had and overall analyses including all RCTs would not be as mean- three conditions comparing: (1) music with headphones, (2) head- ingful. In addition, as mentioned above, within each intervention phones without music, and (3) no headphones or music, we would category analyses were broken down by outcome category (pain select the headphones without music condition as the appropriate versus distress outcomes) and within each of those categories they control condition because it was most similar to the intervention were further broken down by outcome measure (that is, self-re- but just did not include the active ingredient (that is, music). In port, observer-report, behavioural rating scales, and physiologi- addition, it was important to note that some control or standard cal interventions). Physiological outcomes were further analysed care groups included some cognitive or behavioural techniques, or separately as they represented distinct functions or processes (for both. However, we decided a priori to continue to classify these example, heart rate versus blood pressure). For all outcomes, the as control conditions since they were determined to be part of Chi2 test and I2 statistic of heterogeneity were carried out as pre- standard care and were conceptualized as control conditions by viously described. the study authors. In addition, and as noted above, if the control condition included a pharmacological component (for example, lidocaine and prilocaine eutectic mixture (EMLA), a cream used 11. Sensitivity analysis for local anaesthesia), this was still conceptualized as a control In our original review, we were unable to conduct all of the sensi- condition provided that the intervention group also received the tivity analyses that we proposed due to insufficient data reported same pharmacological component plus a psychological interven- within and across studies, as well as the small number of studies tion. The implications of these types of control conditions are fur- within each intervention category. The main sensitivity analyses ther explored in the discussion section of this review. we conducted in the original review involved comparing the study Consistent with the original review, when a single study provided results when quasi-randomized trials were added to the analyses. more than one observer rating of the same construct (for exam- However, in order to strengthen the methodological quality of the ple, both parent and nurse VAS ratings of child pain) or more findings for this updated review, we limited the included trials than one behavioural measure for the same construct (for exam- to only true RCTs that explicitly stated that true random assign- ple, CAMPIS and OSBD measures to assess distress), these mea- ment was conducted. As a result, the four studies with alternat- sures were pooled using statistical formulae recommended by The ing assignment included in the sensitivity analyses of the original Cochrane Collaboration for combining means and SDs. This was review were omitted from this updated review (Christiano 1996; done in order to be able to summarize the large amount of data MacLaren 2005; Manne 1990; Sparks 2001). reported in these studies. The formulae we used to pool means and SDs were the following: pooled mean = [(mean1 x N1) + (mean2 x N2) / (N1 + N2)] and pooled SD = square root of [SD12 (N1 - 1) + SD22 (N2 - 1)] / N1 + N2 -2. As previously indicated, for studies that included outcomes for nu- RESULTS merous time points we restricted our analyses to the measurement occurring during the procedure or, if that was not provided, we used the first post-procedure measurement. For example, if a study Description of studies included procedural measures (taken during the needle) and post- procedural measures (taken after the needle), we included only the former in our analyses. For studies that included only post-needle Results of the search measures but provided them at several time points (for example, Three electronic database searches were conducted: one for the immediately after needle, one minute later, five minutes later), original review (February 2005) and three for the updated review we included the first measure or the outcome assessed as soon as (December 2010, March 2012, March 2013). In the original re- possible following the needle. Pre-procedural measures of pain or view (Uman 2006; Uman 2008), 29 papers representing 28 sepa- distress were not analysed as the focus of this review was on pain rate studies were included. Of these, four were excluded from this and distress reduction during needle procedures. review update because they did not report adequate randomization procedures in the paper (Cohen 1997; Cohen 2001; Cohen 2002; French 1994) and three were excluded because they were 10. Subgroup analysis and investigation of unpublished dissertation theses (Krauss 1996; Posner 1998; Zabin

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 10 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1982). Of note, the Cohen 2001 (Cohen 2001) study was listed Kuttner 1987; Liossi 1999; Liossi 2003; Liossi 2006; Press 2003; in the original review as Cohen 1999 (Cohen 1999) because both Tak 2006; Tyc 1997; Vessey 1994; Wint 2002) in addition to 18 studies reported on the same sample; however, it was only counted studies from the updated searches from December 2010, March as one study. Thus, a total of 21 studies from the original review 2012, and March 2013 (Balan 2009; Bellieni 2006; Bisignano were included in this update. 2006; Caprilli 2007; Gold 2006; Gupta 2006; Huet 2011; Inal We initiated an updated search of the six databases from 2005 2012; Jeffs 2007; Kristjansdottir 2010; Liossi 2009; McCarthy (inclusive) onwards in December 2010, yielding a total of 1338 2010; Nguyen 2010; Noguchi 2006; Sinha 2006; Vosoghi 2010; abstracts which were reviewed. To account for the time taken to Wang 2008; Windich-Biermeier 2007) for a total of 39 studies (N review these abstracts and work on other components of this re- = 3584 participants) reported in this updated review and meta- view, we also conducted searches of the databases in March 2012 analysis. and March 2013 to identify any new studies published since De- Of the 39 included studies, most had intervention arms examin- cember 2010. These latter two searches yielded an additional 639 ing distraction only (n = 20), followed by hypnosis (n = 7), CBT- abstracts. A total of 1977 abstracts were reviewed for this review combined (n = 4), parent coaching plus child distraction (n = update. Of these abstracts, 90 studies were identified as poten- 3), suggestion only (n = 3), preparation and information (n = 2), tially meeting the inclusion criteria; however two of these stud- virtual reality (n = 2); and memory alteration, parent position- ies were previously identified and included in our original review ing plus child distraction, blowing out air, and distraction plus (Liossi 2006; Tak 2006) and one study was not identified in the suggestion (n = 1 each). Needle procedures varied and included original review search (Klingman 1985). Not accounting for the venipuncture (n = 13), IV insertion (n = 7), immunization (n = 6), two studies already included in our original review (Liossi 2006; lumbar puncture (n = 5), bone marrow aspiration (n = 2); and in- Tak 2006), this resulted in 88 studies identified in these updated tramuscular injection, local dental anesthetic, injection for allergy searches that were reviewed in full based on their abstracts. testing, laceration repair (n = 1 each). Additionally, participants Our original search retrieved one non-English study reported in in one study received either a venipuncture or IV insertion, and Portuguese, which was translated into English (Santos 1999). Our in another study they received bone marrow aspiration or lumbar updated search retrieved two non-English studies reported in Farsi puncture. Included studies also varied significantly in the age of (Shahabi 2007; Vosoghi 2010), which needed to be reviewed in recruited participants. The majority of studies (n = 22) focused full. We obtained the assistance of a translator recommended by on preschool (two to five years old) or school-aged children only The Cochrane Collaboration who confirmed that one of these (that is, six to 12 years old). Two studies included preschoolers and studies met our inclusion criteria (Vosoghi 2010). He then com- up to age 13 years. Fourteen studies recruited a wide age range of pleted the data extraction form and Risk of bias tool for this study. participants crossing preschool, school age, and adolescence (that In reviewing this study, he also identified an additional study in is, anywhere from two to 19 years old). Only one study focused Farsi which potentially met our inclusion criteria (Alavi 2005). exclusively on adolescents (that is, 13 to 15 years old), which ex- The two studies (Alavi 2005; Shahabi 2007) were excluded be- amined distraction. Interventions involving parent coaching or cause they employed cross-over designs and data were not avail- parent positioning combined with child distraction generally in- able pre-crossover, such that the studies could not be assessed as cluded preschool or school-aged children only, with the exception RCTs. In addition, our updated search identified two studies in of one study which included children and adolescents (that is, 5 German (Hoffman 2011; Kammerbauer 2011) and two in Italian to 18 years old). Otherwise, types of interventions examined were (Bufalini 2009; Lessi 2011), which we had informally reviewed by distributed across the age ranges. All studies included both boys researchers fluent in these languages; however, none of these stud- and girls, with three studies not reporting the sex of participants. ies met our inclusion criteria. One of these studies was excluded Please refer to the ’Characteristics of included studies’ table for ad- because the groups received general anesthesia or conscious seda- ditional detail, including the intervention and control conditions tion (Bufalini 2009) and the other three were excluded because for each of these studies. For consistency, these are described using they were not true RCTs (Hoffman 2011; Kammerbauer 2011; the authors’ wording provided in published reports. Lessi 2011). In total, of the 88 studies identified from these updated searches, 18 studies met our inclusion criteria and provided the data necessary for data pooling. Excluded studies Of the 188 studies identified and reviewed in full in the original review, 51 were excluded because they did not meet all of the inclu- Included studies sion criteria or failed to provide the data necessary for data pool- Overall, this updated review included 21 studies from the original ing. Furthermore, as noted above, eight papers representing seven review (Blount 1992; Cassidy 2002; Cavender 2004; Chen 1999; studies that were included in the original review were excluded Eland 1981; Fanurik 2000; Fowler-Kerry 1987; Gonzalez 1993; from this review update because they did not report adequate ran- Goodenough 1997; Harrison 1991; Katz 1987; Kleiber 2001; domization procedures in the paper or they were unpublished dis-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 11 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. sertation theses (Cohen 1997; Cohen 1999; Cohen 2001; Cohen Weinstein 2003); 2002; French 1994; Krauss 1996; Posner 1998; Zabin 1982). Thus • use of general anesthesia or conscious sedation prior to a total of 58 studies identified in the original review search were needle procedure (n = 2) (Bufalini 2009; Kain 2006); excluded in this update. Of the 88 studies identified and reviewed • failed randomization (n = 2) (Bowen 1999; McCarthy in full for this review update, 70 were excluded because they did 1998); not meet all of the inclusion criteria or did not report data neces- • conference presentation abstract or not a published RCT (n sary for data pooling. Thus a total of 128 studies from the origi- = 3) (Bufalini 2012; Inal 2010; Russell 2012); nal and updated searches were excluded after the full articles were • cross-over design with data not available pre-crossover (n = reviewed. Reasons for exclusion are provided below as well as in 3) (Alavi 2005; El-Sharkawi 2012; Shahabi 2007); the ‘Characteristics of excluded studies’ table. • younger than included age range or infant sample (n = 2) Primary reasons for exclusion fell into the following categories: (Cramer-Berness 2005; Ozdemir 2012); • not a randomized controlled trial, reported assignment not • fewer than five participants per condition (n = 1) (Pederson truly random, quasi-randomized assignment (n = 47) (Alhani 1996); 2010; Ashkenzai 2006; Atkinson 2009; Bagnasco 2012; Boivin • only one group received an adjunct pharmacological 2008; Christiano 1996; Cline 2006; Cohen 1997; Cohen 2001; intervention (n = 1) (Berberich 2009); Cohen 2002; Cohen 2010; Crowley 2011; Davit 2011; • results not presented separately as control versus treatment Dufresne 2010; French 1994; Heckler-Medina 2006; Heden group or secondary analysis and original study included in 2009; Hoffman 2011; Howe 2011; Kammerbauer 2011; Lawes review (n = 1) (McCarthy 2010b); 2008; Lessi 2011; Liossi 2007; MacLaren 2005; MacLaren 2007; • secondary data analysis and original study not included in Manimala 2000; Manne 1990; Manne 1994; McInally 2005; review (n = 1) (Dalhquist 2005). Nilsson 2009; Olsen 1991; Powers 1993; Ramponi 2009; Rogovik 2007; Schechter 2010; Schur 1986; Sikorova 2011; Slifer 2011; Sparks 2001; Stefano 2005; Sury 2010; Thurgate Risk of bias in included studies 2005; Tufekci 2009; Vohra 2011; Wood 2002; Yoo 2011; Zahr All of the 39 studies included in this review were coded using seven 1998); ‘Risk of bias’ categories, which included: 1) random sequence gen- • met inclusion criteria but missing data necessary for eration (selection bias), 2) allocation concealment (selection bias), pooling, such as means, SDs, and cell sizes (n = 23) (Arts 1994; 3) incomplete outcome data addressed (attrition bias), 4) free of Bengston 2002; Carlson 2000; Chen 2000b; Dalhquist 2002; selective reporting, 5) free of other bias, 6) blinding of participants Fassler 1985; Gilbert 1982; Goymour 2000; Inal 2010; Jay and personnel (performance bias), and 7) blinding of outcome as- 1987; Kazak 1996; Kazak 1998; Klingman 1985; Kuttner 1988; sessment (detection bias). Risk of bias results are depicted in Figure Malone 1996; Megel 1998; O’Laughlin 1995; Peretz 1999; Reeb 1 and Figure 2. For random sequence generation, 15 of the studies 1997; Santos 1999; Vernon 1974; Young 1988; Zeltzer 1982); were rated as having a low risk of bias, none were rated as having • older than included age range or adult sample (n = 11) a high risk of bias, and 24 were rated as unclear. For allocation (Agarwal 2008; Anson 2010; Drahota 2008; Jacobson 2006; concealment, two of the studies were rated as having a low risk of Kwekkeboom 2003; Salih 2010; Schneider 2011; Shabanloei bias, seven were rated as having a high risk of bias, and 30 were 2010; Shimizu 2005; Slack 2009; Vika 2009); rated as unclear. For incomplete outcome data addressed, 30 of • no control or comparison group or inappropriate control the studies were rated as having a low risk of bias, three were rated group (n = 8) (Broome 1998; Hawkins 1998; Jay 1995; Kolk as having a high risk of bias, and six were rated as unclear. For free 2000; Slifer 2009; Smith 1989; Smith 1996; Wall 1989); of selective reporting, one of the studies was rated as having a low • surgical procedure (n = 5) (Hatava 2000; Klorman 1980; risk of bias, 16 were rated as having a high risk of bias, and 22 were Lustman 1983; Melamed 1974; Winborn 1989); rated as unclear. For free of other bias, five of the studies were rated • non-published dissertation study (n = 4) (Krauss 1996; as having a low risk of bias, 21 were rated as having a high risk of Myrvik 2009; Posner 1998; Zabin 1982); bias, and 13 were rated as unclear. For blinding of participants and • inappropriate intervention or could not isolate effects of personnel, none of the studies were rated as having a low risk of psychological components from multi-component intervention bias, 37 were rated as having a high risk of bias, and two were rated (n = 3) (Baxter 2011; Jay 1991; Stevenson 2005); as unclear. This result was expected given that it is not typically • inappropriate outcome measures or outcomes not related to feasible to blind participants and personnel when conducting psy- pain or anxiety (n = 3) (Alderfer 2010; Bruck 1995; Jay 1990); chological interventions. However, we decided to code this item as • intervention not primarily psychological (n = 5) we did not want to miss any studies where they may have been able (Anghelescu 2013; Demir 2012; Marec-Berard 2009; Park 2008; to achieve blinding through creative methodology. For example, Wallace 2010); in theory, a study could achieve blinding of participants and per- • no needle procedure (n = 3) (Kettwich 2007; Weber 2010; sonnel if the intervention involved parenting coaching or training

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 12 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. in the use of distraction whereby participants (children receiving ents and children were not made aware that distraction was being the injection) and personnel (nurses administering the injection) used as an intervention, and if the outcomes assessed were only were unaware of the intervention. For blinding of outcome assess- completed by the children and parents, this study would achieve ment, one of the studies was rated as having a low risk of bias, blinding of outcome assessment. Another example could involve a 36 were rated as having a high risk of bias, and two were rated situation in which observer ratings are conducted based on a video as unclear. Again, although it is rare and challenging to achiev- recording of the needle procedure where the observer is blind to ing blinding of outcomes for psychological interventions, it is also the intervention used and the type of intervention received is not possible. For example, if a study assessed an intervention involving discernible from the video. nurse coaching or training in the use of distraction whereby par-

Figure 1. Risk of bias graph: review authors’ judgments about each risk of bias item presented as percentages across all included studies.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 13 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Figure 2. Risk of bias summary: review authors’ judgments about each risk of bias item for each included study.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 14 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. All of the 21 analyses reported below were assessed for heterogeneity. Of these 20 analyses: five had I2 values of 0% suggesting that younger (Cassidy 2002; Gonzalez 1993; Kuttner 1987; Noguchi heterogeneity might not be important; one had an I2 value below 2006; Vosoghi 2010). The variance in age ranges between and 30%, one had an I2 value between 30% and 50%, which may within studies and variability in type of needle procedures limits represent moderate heterogeneity; 11 had I2 values between 50% our ability to make age- or procedure-specific conclusions or rec- and 90% inclusive, which may represent substantial heterogeneity; ommendations. and three had I2 scores above 90%, which indicated considerable Nineteen studies with a total of 1759 participants were entered heterogeneity. into the analysis of the effects of distraction on self-reported pain, resulting in a SMD of -0.61 (95% CI -0.91 to -0.32) and an Effects of interventions I2 of 88%. This effect was significant (Z = 4.08, P < 0.0001) Distraction (Analysis 1.1). Five studies with a total of 447 participants were entered into the analysis of the effects of distraction on observer- reported pain, resulting in a SMD of -0.87 (95% CI -1.75 to As with our original review, the most evidence in terms of number 0.02) and an I2 of 94%. This effect was marginally significant of published RCTs existed for the efficacy of distraction on self- reported pain. In total, there were 19 included studies examin- (Z = 1.92, P = 0.05) (Analysis 1.2). Three studies with a total of ing the effects of distraction, although one of the studies (Bellieni 286 participants were entered into the analysis of the effects of distraction on self-reported distress, resulting in a SMD of -0.66 2006) involved two distraction groups using different strategies. (95% CI -1.37 to 0.06) and an I2 of 87%. This effect was not The distraction techniques in these studies involved: listening to significant (Z = 1.79, P = 0.07) (Analysis 1.3). Two studies with a music (n = 5) (Balan 2009; Caprilli 2007; Kristjansdottir 2010; total of 363 participants were entered into the analysis of the effects Nguyen 2010; Press 2003), watching cartoons (n = 4) (Bellieni 2006; Cassidy 2002; Tak 2006; Wang 2008), playing with a toy of distraction on observer-reported distress, resulting in a SMD of -1.15 (95% CI -2.73 to 0.42) and an I2 of 97%, suggesting there (n = 2) (Vessey 1994; Vosoghi 2010), non-procedural talk (n = 1) is considerable heterogeneity in this analysis. This effect was not (Gonzalez 1993), squeezing a rubber ball (n = 1) (Gupta 2006), significant (Z= 1.44, P = 0.15) (Analysis 1.4). Two studies with a using cards with questions on them (n = 1) (Inal 2012), listening total of 152 participants were entered into the analysis of the effects via earphones to stories being sung or read (n = 1) (Noguchi 2006), of distraction on behavioural measures of pain, resulting in a SMD mother distraction including speaking, caressing, and soothing (n 2 = 1) (Bellieni 2006), or a combination or selection of various dis- of -0.15 (95% CI -0.69 to 0.40) and an I of 62%. This effect was not significant (Z = 0.53, P = 0.59) (Analysis 1.5). Five studies tractors such as toys, books, cartoons, games, or music (n = 4) with a total of 254 participants were entered into the analysisofthe (Fanurik 2000; Jeffs 2007; Kuttner 1987; Sinha 2006). Thus, dis- effects of distraction on behavioural measures of distress, resulting traction interventions varied widely regarding the degree of pas- in a SMD of -0.30 (95% CI -0.76 to 0.16) and an I2 of 63%. sive or active involvement of the child, parental, or health profes- This effect was not significant (Z = 1.28, P = 0.20) (Analysis 1.6). sional involvement, or opportunity for the child to choose a distractor. Of these 19 studies examining distraction, the needle pro- Two studies with a total of 112 participants were entered into the analysis of the effects of distraction on the physiological measure cedures included venipuncture or blood draw only (n = 8) (Balan of heart rate, resulting in a SMD of -0.70 (95% CI -1.08 to - 2009; Bellieni 2006; Caprilli 2007; Inal 2012; Press 2003; Tak 0.32) and an I2 of 0%. This effect was significant (Z = 3.58, P = 2006; Vessey 1994; Wang 2008), immunization or injection (n = 0.0003) (Analysis 1.7). Two studies with a total of 112 participants 4) (Cassidy 2002; Gonzalez 1993; Kristjansdottir 2010; Noguchi were entered into the analysis of the effects of distraction on the 2006), IV insertion (n = 2) (Fanurik 2000; Vosoghi 2010), laceration repair (n = 1) (Sinha 2006), venipuncture via venous cannu- physiological measure of oxygen saturation, resulting in a SMD of 0.60 (95% CI 0.22 to 0.98) and an I2 of 0%. This effect was lation (n = 1) (Gupta 2006), allergy testing involving injection (n significant (Z = 3.10, P = 0.002) (Analysis 1.8). There was only = 1) (Jeffs 2007), bone marrow aspiration (n = 1) (Kuttner 1987), one study that could be analysed for the effects of distraction and lumbar puncture (n = 1) (Nguyen 2010). Although the age on the physiological measures of respiratory rate, systolic blood ranges across the studies were quite broad and varied consider- pressure, and diastolic blood pressure (Nguyen 2010), therefore ably, all of the studies included children 12 years and younger as part of the sample with the exception of one study (Kristjansdottir no additional conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2. 2010), which only examined adolescents aged between 13 and 15 years. Of the remaining 18 studies that included children 12 and under, five of these also included adolescents aged up to 18 years (Caprilli 2007; Fanurik 2000; Jeffs 2007; Press 2003; Sinha Hypnosis 2006) while five studies only included children seven years and

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 15 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. As with our original review, of all of the interventions assessed effects of CBT on self-reported distress, resulting in a SMD of - hypnosis had the largest significant effect sizes across several out- 0.50 (95% CI -1.08 to 0.07) and an I2 of 47%. This effect was not comes. Five studies with a total of 176 participants were entered significant (Z = 1.72, P = 0.08) (Analysis 5.2). Two studies with a into the analysis of the effects of hypnosis on self-reported pain, total of 84 participants were entered into the analysis of the effects resulting in a SMD of -1.40 (95% CI -2.32 to -0.48) and an I2 of of CBT on observer-reported distress, resulting in a SMD of 0.04 85%. This effect was significant (Z = 2.97, P = 0.003) (Analysis (95% CI -0.87 to 0.95) and an I2 of 75%. This effect was not 2.1). Five studies with a total of 176 participants were entered significant (Z = 0.08, P = 0.93) (Analysis 5.3). Lastly, four studies into the analysis of the effects of hypnosis on self-reported distress, with a total of 164 participants were entered into the analysis of resulting in a SMD of -2.53 (95% CI -3.93 to -1.12) and an I2 of the effects of CBT on behavioural measures of distress, resulting 91%. This effect was significant (Z = 3.53, P = 0.0004) (Analysis in a SMD of -0.54 (95% CI -1.16 to 0.09) and an I2 of 71%. This 2.2). Six studies with a total of 193 participants were entered into effect was not significant (Z = 1.69, P = 0.09) (Analysis 5.4). the analysis of the effects of hypnosis on behavioural measures of distress, resulting in a SMD of -1.15 (95% CI -1.76 to -0.53) and an I2 of 71%. This effect was significant (Z = 3.66, P = 0.0003) Parent coaching + child distraction (Analysis 2.3). There was only one study that could be analysed for Three studies with a total of 612 participants were entered into the the effects of hypnosis on either observer-reported distress (Katz analysis of the effects of parent coaching plus child distraction on 1987) or behavioural measures of pain (Huet 2011), therefore no self-reported pain, resulting in a SMD of 0.06 (95% CI -0.19 to additional conclusions could be drawn. Sample size, means, and 0.31) and an I2 of 24%. This effect was not significant (Z = 0.46, P SDs for these outcomes are available in Table 2. = 0.65) (Analysis 6.1). Two studies with a total of 581 participants were entered into the analysis of the effects of parent coaching plus Preparation and information child distraction on observer-reported distress, resulting in a SMD 2 Two studies with a total of 154 participants were entered into the of -0.04 (95% CI -0.21 to 0.12) and an I of 0%. This effect was analysis of the effects of preparation and information on self-re- not significant (Z = 0.52, P = 0.60) (Analysis 6.2). Three studies ported pain, resulting in a SMD of -0.22 (95% CI -1.20 to 0.76) with a total of 635 participants were entered into the analysis of and an I2 of 88%. This effect was not significant (Z = 0.43, P the effects of parent coaching plus child distraction on behavioural = 0.66) (Analysis 3.1). There was only one study that could be measures of distress, resulting in a SMD of -0.36 (95% CI -0.97 to 2 analysed for the effects of preparation and information on ob- 0.25) and an I of 83%. This effect was not significant (Z = 1.16, server-reported pain, observer-reported distress, and the physio- P = 0.25) (Analysis 6.3). There was only one study that could be logical measure of pulse rate (Harrison 1991), as well as only one analysed for the effects of parent coaching plus child distraction study for behavioural measures of distress (Tak 2006). Therefore on either self-reported distress (Windich-Biermeier 2007) or the no additional conclusions could be drawn. Sample size, means, physiological measure of cortisol responsivity (McCarthy 2010), and SDs for these outcomes are available in Table 2. therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2.

Virtual reality Two studies with a total of 50 participants were entered into the Suggestion analysis of the effects of virtual reality on self-reported pain, re- Three studies with a total of 218 participants were entered into the 2 sulting in a SMD of -0.23 (95% CI -0.79 to 0.33) and an I of analysis of the effects of suggestion on self-reported pain, resulting 0%. This effect was not significant (Z = 0.80, P = 0.42) (Analysis in a SMD of -0.13 (95% CI -0.40 to 0.15) and an I2 of 0%. 4.1). This effect was not significant (Z = 0.90, P = 0.37) (Analysis 7.1). There was only one study that could be analysed for the Combined Cognitive Behavioural effects of suggestion on observer-reported pain and self-reported Intervention/Treatment (CBT) distress (Goodenough 1997), as well as only one study for observer- reported distress (Eland 1981); therefore no additional conclusions The interventions in this category of cognitive behavioural in- could be drawn. Sample size, means, and SDns for these outcomes terventions were heterogeneous as they involved different combi- are available in Table 2. nations of cognitive and behavioural components. Three studies with a total of 250 participants were entered into the analysis of the effects of CBT on self-reported pain, resulting in a SMD of - 0.59 (95% CI -1.62 to 0.44) and an I2 of 86%. This effect was not Parent positioning + child distraction significant (Z = 1.12, P =0.26) (Analysis 5.1). Three studies with Only one study provided outcome measures for the effects of a total of 105 participants were entered into the analysis of the parent positioning plus child distraction on pain and distress

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 16 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Cavender 2004), therefore no conclusions could be drawn. Sam- Filmed Modeling ple size, means, and SDs for these outcomes are available in Table The one study assessing filmed modelling that was included in the 2. original review was excluded from this review because of our revised inclusion criteria (that is, non-published dissertation study). Since no studies assessing this intervention category were identi- Memory alteration fied from our updated search strategy, there were no available data to assess the efficacy of this intervention. Only one study provided outcome measures for the effects of memory alteration on pain and distress (Chen 1999), therefore no conclusions could be drawn. Sample size, means, and SDs for these outcomes are available in Table 2. DISCUSSION

Blowing out air Summary of main results The one study analysing this intervention in the original review This review synthesizes the results of 39 RCTs; 21 identified from was excluded from this update because of our revised inclusion the original review (Uman 2006) and an additional 18 identified criteria (that is, the allocation procedure not described as truly ran- from this update. By including only true randomized controlled dom in the study). There was only one additional study analysing trials published in peer-reviewed journals, this review offers a rig- this intervention identified from the updated searches (Gupta orous systematic examination of the efficacy of psychological in- 2006), therefore no conclusions could be drawn. Sample size, terventions for reducing needle-related pain and distress in chil- means, and SDs for these outcomes are available in Table 2. dren and adolescents. Our results show strong evidence supporting the efficacy of distraction and hypnosis. More specifically, trials support the use of distraction for reducing pain, and hypnosis for Distraction + suggestion the reduction of both pain and distress. Despite the availability of two to four RCTs for each type of intervention, no evidence was Only one study provided outcome measures for the effects of dis- available to support the efficacy of preparation and information, traction plus suggestion on pain (Fowler-Kerry 1987), therefore combined CBT, parent coaching plus distraction, suggestion, or no conclusions could be drawn. Sample size, means, and SDs for virtual reality for reducing children’s pain and distress. Our origi- these outcomes are available in Table 2. nal review (Uman 2006) identified sufficient evidence supporting combined CBT; however, due to the more stringent inclusion criteria of this update, three trials examining combined CBT were Nurse coaching + distraction removed (Cohen 1997; Cohen 2002; Posner 1998) and two new The two studies assessing nurse coaching plus distraction that were trials (Bisignano 2006; Wang 2008) were identified in the updated included in the original review were excluded from this review searches. Given this new evidence, the efficacy of combined CBT because of our revised inclusion criteria, explained above (that is, was no longer supported. No conclusions could be made about the allocation procedure was not described as truly random in the the efficacy of memory alteration, parent positioning plus distrac- study). Since no studies assessing this intervention category were tion, blowing out air, or distraction plus suggestion due to the identified from our updated search strategy, there were no available availability of single trials only in those areas. data to assess the efficacy of this intervention. Please refer to the Although this review continues to provide strong evidence for the original review for more information on our previous findings and efficacy of distraction as a whole, significantly variability was noted conclusions prior to conducting this updated review (Uman 2006; in the distraction methods described in the 20 trials reporting Uman 2008). on distraction interventions. We are still lacking clear evidence to identify whether the type of distraction influences its efficacy across child development, and with different needle procedures. Although the type of distraction varies, the majority of the evidence Videotaped modelling + parent coaching for distraction to date is with school-aged children (that is, ages six The one study assessing videotaped modelling plus parent coach- to 12 years), but it is supported by studies including children from ing included in the original review was excluded from this review two to 19 years old. Future studies clarifying these distinctions because of our revised inclusion criteria (that is, non-published are necessary to empirically inform more targeted analyses and dissertation study). Since no studies assessing this intervention cat- treatment recommendations. egory were identified from our updated search strategy, there were Overall, hypnosis had the largest effect sizes for reducing pain and no available data to assess the efficacy of this intervention. distress during needle-related procedures; however, it is important

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 17 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. to note that the majority of these trials have been published by the traction techniques. For example, more recent trials have begun same research group. As such, this raises questions about the gen- distinguishing between ‘active’ distraction, which engages more eralizability and efficacy of this approach when administered by senses and requires more patient engagement (for example, play- different providers in different pediatric settings. Future research ing a video game) versus ’passive’ distraction where the patient should assess the efficacy of hypnosis in different settings, includ- is less actively involved (for example, watching television (TV)). ing multi-site trials with multiple therapists, in order to provide This warrants further investigation as experimental research has additional support for the generalizability of these intervention shown that active or interactive (as compared to passive) virtual- approaches. Furthermore, hypnotisability appears related to the reality based distraction was more efficacious for reducing pain magnitude of treatment benefit (Liossi 2003). Therefore, hypno- in children (Dalhquist 2007). However, a systematic review of sis may not be effective for children who have low hypnotisability. music therapy for painful medical procedures in children found This highlights the important point of needing to not only exam- that passive music therapy was as effective as active music therapy ine intervention efficacy overall but also to consider and evaluate (Klassen 2008). Research is also needed to identify the impact of the match between intervention type and child characteristics. distraction novelty on intervention efficacy as it has been proposed that interventions involving novel materials or activities are more effective at capturing a child’s attention (Sinha 2006; Slifer 2002). Overall completeness and applicability of the Furthermore, the role of child preference or choice in distractors evidence is also of interest given that older and younger children tend to select different distractors when given the choice (Sinha 2006; This review enables identification of current trends in pediatric Windich-Biermeier 2007). A number of included trials involved acute pain research. Since the publication of the original review, parents in the distraction intervention (; Bellieni 2006; Blount we have noted a decrease in use of classic no-treatment control 1992; Cavender 2004; Kleiber 2001; McCarthy 2010) whereas groups, defined as the absence of psychological and pharmacolog- others did not (Gupta 2006; Jeffs 2007; Kristjansdottir 2010; ical pain management, as well as the increased use of topical anes- Noguchi 2006; Tak 2006; Wang 2008). Future research should thetics as part of standard care. This is likely due, in part, to the consider the potential impact of parental involvement on inter- dissemination of advances in pediatric pain management through vention delivery and efficacy, as parental presence alone is known publication and endorsement of clinical practice guidelines and to influence children’s behaviour during painful experiences re- position statements (Taddio 2010). Indeed, withholding topical gardless of parent behaviour (see Vervoort 2008; Vervoort 2011). anesthetics and non-pharmacological intervention in the face of a Thus, although we can conclude overall that distraction is effica- strong evidence base for their effectiveness is widely and accurately cious for reducing needle-related pain, our ability to differentiate justified as unethical (Anderson 2005; World Medical Association which aspects of distraction are most efficacious remains limited. 2008). However, this shift also has practical research implications. Actual engagement of the parent or child, or both, in the distrac- Comparison of interventions with other effective treatments will tion activity should also be routinely monitored in RCTs, as the ef- make it more difficult to detect treatment effects; as such, the field fectiveness of a particular distractor may depend on the level of en- may need to apply new parameters in determining the degree of gagement or dose received. McCarthy and colleagues (McCarthy treatment efficacy (for example, non-inferiority trials). Further- 2010) noted that some parents in their control group engaged more, the use of topical anesthetics needs to be measured and con- naturally in distraction. In order to best identify the impact of trolled for in future trials as their use in standard care may vary, and distraction on needle-related pain and distress, they created three they are not uniformly given to all children (Windich-Biermeier comparison groups based on the actual level of observed parent 2007; Wint 2002), thereby potentially contaminating the group distraction during the intravenous line (IV) insertion, regardless of of additional psychological interventions. While the decreased use experimental group. This secondary analysis provided a more rig- of no-treatment control groups and increased use of topical anes- orous test of the impact that distraction had on child pain. While thetics may reflect a trend towards increased use of evidence-based child engagement and successful use of distraction techniques are strategies, continued suboptimal acute pain assessment and man- critical for making conclusions about efficacy, very few studies agement (Stevens 2012; Taddio 2009) suggests that this knowledge routinely assess and control for this important confounder. is not being widely translated into implementation by providers Importantly, the age range of children included in the trials in this and families. While the results of this review provide information review varied greatly, making it difficult to determine which psy- about research trends, it may not accurately represent what it be- chological interventions are most effective for different age ranges ing implemented in actual clinical practice around the world. or developmental periods. Furthermore, few studies exclusively ex- Although the results of this review are based on 39 trials, the amined interventions in adolescents. Given the rapid developmen- vast majority of studies continue to investigate the efficacy of dis- tal changes that take place from early childhood to late adolescence, traction. Rather than continuing to examine a mix of distractors, it is likely that the efficacy of interventions vary based on devel- we argue that the field would benefit more from studies system- opmental stage and maturity of the individual child. Indeed, self- atically comparing and dismantling the effective aspects of dis-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 18 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. management of needle-related pain and distress using evidence- the quality of evidence is limited by the many studies with high or based psychological interventions may be particularly important unclear risk of bias for their outcomes, the 39 RCTs included in for older children and adolescents when immunizations are often this review can be considered the most rigorous and well-reported given in school settings; reliance on parents decreases throughout studies in the field. An additional 128 studies were excluded due development and the children increasingly rely on cognitive cop- to insufficient rigour or inadequate reporting of findings for meta- ing strategies. For example, children’s inclination towards the use analysis. of particular coping strategies changes across development, with Assessment of risk of bias in trial design and reporting is critical as research indicating that younger children tend to use more be- RCTs with unclear or high risk of bias have been associated with havioural strategies, whereas older children and adolescents use significantly larger treatment effects in RCTs with children and more cognitive strategies (Skinner 2007). Future research should adults (Hartling 2009; Savovic 2012). Addressing incomplete out- assess the relative efficacy of psychological interventions across de- come data was the domain with the greatest proportion of studies velopment in order to inform treatment that matches and bolsters categorized as low risk of bias, although all trials showed the ma- their effectiveness. jority of bias domains as high or unclear risk. In particular, high There was notable variability in the types of needle procedures risk of bias was most commonly found for blinding of participants represented in this review, including those that are expected to and personnel, and blinding of outcome assessment. While there occur multiple times even among healthy children, such as immu- are few studies of psychological interventions where it is possible nizations. However, very few trials assessed the efficacy of psycho- to blind study participants and personnel to the treatment con- logical interventions over time and the maintenance of treatment dition, two of the included studies in this review (Goodenough gains. One notable exception was the work of Liossi and colleagues 1997; McCarthy 2010) successfully blinded the observation cod- (Liossi 2009), who examined children’s use of hypnosis over the ing of outcomes. Thus, while complete blinding of the patient course of three needle-related procedures. In addition to examin- or treatment administrator may not be feasible, we argue that re- ing change over time, the researchers examined pain and distress searchers should use blind outcome coding whenever possible to among children while they received therapist-guided hypnosis at reduce study bias, and that this can sometimes be achieved through an initial procedure and then again while they engaged in self-hyp- careful study design. nosis during two subsequent procedures. This study highlights the Many trials had unclear risk of bias, particularly in the domains importance of examining changes and maintenance of treatment of random sequence generation, allocation concealment, and se- gains within children over time, as well as the generalizability of lective reporting. While this may expose real limitations in study interventions beyond individual providers. design, it may alternatively reflect insufficient reporting of study Lastly, in addition to direct outcomes such as quantifications of methods and procedures in published manuscripts. However, ex- pain and distress, it is also important to consider other relevant aggerated treatment effects have been shown in trials with inad- but indirect evidence. For example, it would be helpful for stud- equate or unclear random sequence generation, allocation con- ies to assess child, caregiver, and health professional preference or cealment, or selective reporting (Chan 2004; Savovic 2012). This beliefs about different intervention techniques, changes over time suggests that researchers should pay careful attention to these do- in the adoption of pain reduction and prevention strategies, data mains in study design and publication. Reporting of adequate se- on needle pain prevention and relief in adult or animal studies, quence generation is the only risk of bias domain with notable and expert opinions. Currently the Canadian Task on Preventa- improvement over the past 30 years of published RCTs in this tive Care classifies the opinions of respected authorities based on area. Researchers should carefully follow the CONSORT guide- clinical experience as level III (lowest rating) in terms of criteria for lines (Moher 2001) when reporting randomized trials to ensure evaluating evidence, while evidence from RCTs is rated as level I that details relevant to randomization, allocation, and blinding are (the highest rating) (Palda 2004). Additional evidence-based clini- adequately addressed. cal practice guidelines for reducing childhood vaccination pain are Over half of the included trials had a high risk of other sources also available and should be considered when conducting future of bias. Potential sources of bias captured in this domain included studies in the area of acute pain (Taddio 2010). concerns regarding the validity or reliability of measurement tools used to assess the outcomes of pain and distress as well as how and when outcomes were assessed (for example, using an unvalidated Quality of the evidence modification of a validated pain assessment tool). Other notable sources of potential bias included potential contamination of the Toour knowledge, this review represents the largest and most up to control or experimental group (for example, venepunctures occur- date review of psychological interventions for needle-related pain ring in a group context and potential for distress contagion), base- and distress in children and adolescents, and includes a total of 39 line differences between groups, and small sample size resulting in RCTs comprising 3394 participants. The evidence supporting the the trial being underpowered to detect group differences. It is per- efficacy of distraction and hypnosis for reducing children’s pain haps surprising that these issues continue to be quite common as and distress is consistent across relevant included trials. Although

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 19 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. their potential to lead to inaccurate estimates of treatment effects pain in children and adults (Cepeda 2010; Klassen 2008), psy- has been noted for many years (Moher 1994). chological interventions for chronic or recurrent pain in children and adolescents (Eccleston 2009), and psychological therapies for sickle cell disease and pain (Anie 2012). Potential biases in the review process Strengths of this review include the comprehensive and updated literature searches, the inclusion of non-English publications, and contacting authors when relevant data were missing from pub- AUTHORS’ CONCLUSIONS lished reports. Despite these efforts, 21 studies were excluded solely because they did not provide sufficient data in published reports Implications for practice or via e-mail correspondence to allow for data pooling in the meta- The results of this review suggest that youth, caregivers, and health- analysis. This represents a source of bias as it resulted in a large care practitioners should use distraction techniques or hypnosis number of RCTs that could not be adequately captured in our during needle procedures. Despite the significant variability in dis- review. In order to limit the exclusion of trials, we included RCTs traction interventions (for example, type of distractor, passive or that provided full data for at least one outcome measure. How- active involvement of the child, and parent or nurse involvement), ever, this may pose an additional source of bias given that signif- support is consistent for its efficacy in reducing pain from needle- icant findings are sometimes more fully reported than non-sig- related procedures. The most evidence is available for more com- nificant findings. To minimize this, authors should include sum- mon needle procedures (for example, venepuncture, immuniza- mary statistics (that is, means, SDs, cell sizes) for all assessed out- tion) and with children 12 years and younger, although support comes, regardless of study results. In keeping with other recently also exists for its use with adolescents. Hypnosis can be partic- published Cochrane reviews and updates (for example, Eccleston ularly helpful for more invasive needle procedures (for example, 2012; Williams 2012a), we excluded unpublished dissertation lumbar punctures) and for reducing both pain and distress; how- studies. This may introduce bias by excluding some relevant stud- ever, its application may be limited in practice given the reduced ies and we recommend that dissertation authors submit their re- availability of health professionals trained in hypnosis. In addition search to scientific journals to make their findings more accessible to their efficacy in reducing pain and distress, these psychological and ultimately help translate their research into practice. interventions can also help empower children, adolescents, and Lastly, the timing of assessed pain and distress often varied across their parents in being active agents in their own pain management, studies, sometimes assessed during the needle procedure while in thereby facilitating generalizability across settings and time. other instances assessed at varying times post-procedure. In some cases, the timing of assessed pain and distress was not clearly re- At present there is no evidence for the efficacy of any other psy- ported. This variability in outcome assessments adds potential bias chological intervention, including preparation and information, in comparisons across studies. We recommend the standard as- combined CBT, parent coaching plus distraction, suggestion, or sessment of post-needle pain or distress immediately following the virtual reality, although more trials are needed. No conclusions procedure (that is, as soon as the needle is removed). If studies wish could be made about additional interventions, such as memory to include additional post-needle measures, it would be helpful to alteration, parent positioning plus distraction, blowing out air, or consider establishing a maximum time gap between completion distraction plus suggestion, as only one study examined each of of the needle procedure and measurement of the outcome in order these interventions. Of these interventions, it is likely that those to reduce possible memory-based biases (Noel 2012). including distraction would be most helpful (that is, parent coaching plus distraction, parent positioning plus distraction, and distraction plus suggestion). Agreements and disagreements with other studies or reviews Implications for research To our knowledge, this is the most comprehensive updated review of this topic. However, other systematic reviews in related areas are (1) Types of interventions available, which also support the efficacy of various psychological or non-pharmacological interventions for pediatric pain manage- It is our position that additional RCTs examining the effective- ment. These include, and are not limited to, systematic reviews of ness of distraction to a no-treatment or standard care control have psychological interventions for reducing the pain and distress of limited value. Given the variety of distraction interventions de- childhood immunizations (Chambers 2009), non-pharmacologi- scribed in the included studies, further research on distraction cal interventions for infant procedural pain (Pillai-Riddell 2011a; should compare different types of distractors (for example, active Pillai-Riddell 2011b), music interventions for acute and chronic versus passive) and assess the developmental appropriateness of

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 20 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. interventions, engagement and dose of the intervention, the im- blinding of study outcomes to the extent that is possible (for ex- pact of novelty, or distractor preference and selection. Despite the ample, blind coders coding from videotapes), and ensuring ade- myriad of trials examining distraction, this review also identified quate sample size for sufficient power to detect group differences. a variety of psychological interventions that have been examined These details should be clearly reported in publications, in addi- in only one or two RCTs to date. Several of these suggest promise tion to thorough reporting of all outcomes and reasons for any (for example, preparation and information, blowing out air, dis- withdrawals and dropouts. When selecting outcome measures, re- traction plus suggestion) with significant reductions in pain or searchers should draw from efforts to standardize the use of the distress, or both, in single trials; however, conclusions about their highest quality assessment tools, such as the Initiative on Methods, efficacy cannot be made at this time given the limited evidence Measurement, and Pain Assessment in Clinical Trials (PedIMM- available. PACT) (McGrath 2008).

(2) Consideration of child age and development There is a gap in our understanding of the efficacy of interventions across age ranges. Future trials should investigate potential age and ACKNOWLEDGEMENTS developmental differences, following the standard age ranges provided by the Standards for Research (StaR) in Child Health initia- We wish to thank the many individuals who helped in the prepara- tive (toddlers and preschoolers two to four years, grade-schoolers tion of this updated review as well as the original review. First, we five to 12 years, adolescents 13 to 19 years (Williams 2012b)). would like to thank all members of the Cochrane Pain, Palliative, Furthermore, given the limited evidence specific to adolescents, and Supportive Care (PaPaS) team, particularly Anna Hobson, it is critical for future trials to target that population given that Jessica Thomas, Frances Fairman, Phil Wiffen, Yvonne Roy, Sylvia children’s coping preferences change across development (Skinner Bickley, Jane Hayes, and Chris Eccleston. We would also like to 2007) as does parental involvement, and needle procedures such thank reference librarians Pam Parker, Tim Ruggles, Robin Parker, as immunizations may occur in a variety of settings (for example, and Susan Klawansky for their invaluable assistance. We are also school-based immunization clinics (Kristjansdottir 2010)). grateful to the advice and input of many others including: Kirk Magee, Stephen Morley, G Allen Finley, and Paula Forgeron. We sincerely thank all current and past members of the IWK Centre (3) Consideration of variability in needle procedures for Pediatric Pain Research who helped with this project including Future trials should address our limited understanding regarding Leah Wofsy, Aimee Dort, Kelly Hayton, Crystal Holly, Jessica Fer- the efficacy of interventions for different needle procedures, par- guson, Sarah Peddle, and Darby Eakins. We are especially grateful ticularly those that are more routine (for example, immunization, to Javad Shahidi, Carl von Baeyer, Mirko Manchia, and Narjes venepuncture) versus those that are considered more invasive (for Sadr Momtaz who screened non-English studies for us and, when example, lumbar puncture, bone marrow aspiration), as well as necessary, conducted data extraction and risk of bias coding. single event versus repeated or multiple needle procedures. In addition, it will be important to assess pain and distress scores at dif- We would also like to thank the Dalhousie Cochrane Group and ferent stages of the procedure (for example, pre-procedure, during Pain in Child Health (PICH), a strategic training initiative of the procedure, post-procedure, and at subsequent future procedures) Canadian Institutes of Health Research (CIHR), for their financial to assess longer-term outcomes and to determine whether addi- support. This review update would not have been possible with- tional practice and exposure to psychological interventions lead to out a Category A Grant from the IWK Health Centre awarded more optimal pain management. to LS Uman. Funding was also provided by an IWK Establish- ment Award to CT Chambers. CT Chambers and PJ McGrath are supported by Canada Research Chairs. LS Uman received finan- (4) Improving trial quality and reporting cial support from the Natural Sciences and Engineering Council Although our research suggests that study quality and reporting of Canada (NSERC), the Nova Scotia Health Research Founda- have improved over time (Uman 2010), there remains substantial tion (NSHRF), and the Fonds de Reserche en Sante de Quebec room for improvement as evidenced by the risk of bias scores re- (FRSQ; Quebec Health Research Foundation) while conducting ported in this review. Specifically, researchers should ensure true the original review on which this update is based. Lastly, we wish randomization procedures (for example, computer-generated ran- to thank the many study authors whose studies contributed to this dom numbers) and concealment of random allocation, optimize review, and who responded to our requests for additional data.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 21 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. REFERENCES

References to studies included in this review Gold 2006 {published data only} Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo A. Balan 2009 {published data only} Effectiveness of virtual reality for pediatric pain distraction Balan R, Bavdekar SB, Jadhav S. Can Indian classical during IV placement. Cyberpsychology and Behavior 2006;9 instrumental music reduce pain felt during venepuncture?. (2):207–12. Indian Journal of Pediatrics 2009;76:469–73. Gonzalez 1993 {published data only} Bellieni 2006 {published data only} Gonzalez JC, Routh DK. Effects of maternal distraction Bellieni CV, Cordelli DM, Raffaelli M, Ricci B, Morgese versus reassurance on children’s reactions to injections. G, Buonocore G. Analgesic effect of watching TV during Journal of Pediatric Psychology 1993;18(5):593–604. venipuncture. Archives of Disease in Childhood 2006;91: 1015–7. Goodenough 1997 {published data only} Bisignano 2006 {published data only} Goodenough B, Kampel L, Champion GD, Laubreaux Bisignano A, Bush JP. Distress in pediatric hematology- L, Nicholas MK, Ziegler JB, et al.An investigation of the oncology patients undergoing intravenous procedures: placebo effect and age-related factors in the report of needle Evaluation of a CD-ROM intervention. Children’s Health pain from venipuncture in children. Pain 1997;72:383–91. Care 2006;35(1):61–74. Gupta 2006 {published data only} Blount 1992 {published data only} Gupta D, Agarwal A, Dhiraaj S, Tandon M, Kumar M, Blount RL, Bachanas PJ, Powers SW, Cotter MC, Franklin Singh RS, et al.An evaluation of efﬁcacy of balloon inﬂation A, Chaplin W, et al.Training children to cope and parents on venous cannulation pain in children: A prospective, to coach them during routine immunizations: Effects on randomized, controlled study. Anesthesia and Analgesia child, parent, and staff behaviors. Behavior Therapy 1992; 2006;102:1372–5. 23:689–705. Harrison 1991 {published data only} Caprilli 2007 {published data only} Harrison A. Preparing children for venous blood sampling. Caprilli S, Anastasi F, Grotto RP, Scollo M, Messeri A. Pain 1991;45(3):299–306. Interactive music as a treatment for pain and stress in children during venipuncture: A randomized prospective Huet 2011 {published data only} study. Journal of Developmental and Behavioral Pediatrics Huet A, Lucas-Polomeni MM, Robert JC, Sixou JL. 2007;28:399–403. Hypnosis and dental anesthesia in children: A prospective Cassidy 2002 {published data only} controlled study. International Journal of Clinical and Cassidy K-R, Reid GJ, McGrath PJ, Finley GA, Smith Experimental Hypnosis 2011;59:424–40. DJ, Morley C, et al.Watch needle, watch TV: Audiovisual Inal 2012 {published data only} distraction in preschool immunization. American Academy Inal S, Kelleci M. Distracting children during blood draw: of Pain Medicine 2002;3(2):108–18. Looking through distraction cards is effective in pain relief Cavender 2004 {published data only} of children during blood draw. International Journal of Cavender K, Goff MD, Hollon EC, Guzzetta CE. Parent’s Nursing Practice 2012;18:210–9. positioning and distracting children during venipuncture. Jeffs 2007 {published data only} Journal of Holistic Nursing 2004;22(1):32–56. Jeffs DA. A pilot study of distraction for adolescents during Chen 1999 {published data only} allergy testing. Journal for Specialists in Pediatric Nursing Chen E, Zeltzer LK, Craske MG, Katz ER. Alteration 2007;12(3):170–85. of memory in the reduction of children’s distress during repeated aversive medical procedures. Journal of Consulting Katz 1987 {published data only} and Clinical Psychology 1999;67(4):481–90. Katz ER, Kellerman J, Ellenberg L. Hypnosis in the reduction of acute pain and distress in children with cancer. Eland 1981 {published data only} Journal of Pediatric Psychology 1987;12(3):379–94. Eland JM. Minimizing pain associated with prekindergarten intramuscular injections. Issues in Comprehensive Pediatric Kleiber 2001 {published data only} Nursing 1981;5(5-6):361–72. Kleiber C, Craft-Rosenberg M, Harper DC. Parents as Fanurik 2000 {published data only} distraction coaches during IV insertion: A randomized Fanurik D, Koh JL, Schmitz ML. Distraction techniques study. Journal of Pain and Symptom Management 2001;22 combined with EMLA: Effects of IV insertion pain and (4):851–61. distress in children. Children’s Health Care 2000;29(2): Kristjansdottir 2010 {published data only} 87–101. Kristjansdottir O, Kristjansdottir G. Randomized clinical Fowler-Kerry 1987 {published data only} trial of musical distraction with and without headphones Fowler-Kerry S, Lander JR. Management of injection pain for adolescents’ immunization pain. Scandinavian Journal in children. Pain 1987;30(2):169–75. of Caring Sciences 2011;25:19–26.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 22 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kuttner 1987 {published data only} Tyc 1997 {published data only} Kuttner L. Favorite stories: A hypnotic pain-reduction Tyc VL, Leigh L, Mulhern RK, Kumar Srivastava D, Bruce technique for children in acute pain. American Journal of D. Evaluation of a cognitive-behavioral intervention for Clinical Hypnosis 1988;30(4):289–95. reducing distress in pediatric cancer patients undergoing magnetic resonance imaging procedures. International Liossi 1999 {published data only} Journal of Rehabilitation and Health 1997;3(4):267–79. Liossi C, Hatira P. Clinical hypnosis versus cognitive behavioral training for pain management with pediatric Vessey 1994 {published data only} cancer patients undergoing bone marrow aspirations. The Vessey JA, Carlson KL, McGill J. Use of distraction with International Journal of Clinical and Experimental Hypnosis children during an acute pain experience. Nursing Research 1999;47(2):104–16. 1994;43(6):369–72. Liossi 2003 {published data only} Vosoghi 2010 {published data only} Liossi C, Hatira P. Clinical hypnosis in the alleviation of Vosoghi N, Chehrzad M, Abotalebi G, Atrkar RZ. Effects procedure-related pain in pediatric oncology patients. The of distraction on physiologic Indices and pain intensity in International Journal of Clinical and Experimental Hypnosis children aged 3-6. HAYAT 2010;16(3-4):39–47. 2003;51(1):4–28. Wang 2008 {published data only} Wang ZX, Sun LH, Chen AP. The efficacy of non- Liossi 2006 {published data only} pharmacological methods of pain management in school age Liossi C, White P, Hatira P. Randomized clinical trial of children receiving venepuncture in a paediatric department: local anesthetic versus a combination of local anesthetic with a randomized controlled trial of audiovisual distraction and self-hypnosis in the management of pediatric procedure- routine psychological intervention. Swiss Medical Weekly related pain. Health Psychology 2006;25:307–15. 2008;138(39-40):579–84. Liossi 2009 {published data only} Windich-Biermeier 2007 {published data only} Liossi C, White P, Hatira P. A randomized clinical trial of a Windich-Biermeier A, Sjoberg I, Dale JC, Eshelman D, brief hypnosis intervention to control venepuncture-related Guzzetta CE. Effects of distraction on pain, fear, and distress pain of paediatric cancer patients. Pain 2009;142:255–63. during venous port access and venipuncture in children McCarthy 2010 {published data only} and adolescents with cancer. Journal of Pediatric Oncology McCarthy AM, Hanrahan K, Zimmerman MB, Westhus Nursing 2007;24(1):8–19. N, Allen S. Impact of parent-provided distraction on child Wint 2002 {published data only} responses to an IV insertion. Children’s Health Care 2010; Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects 39:125–41. of distraction using virtual reality glasses during lumbar Nguyen 2010 {published data only} punctures in adolescents with cancer. ONF 2002;29(1): Nguyen TN, Nilsson S, Hellstrom A-L, Bengtson A. Music E8–15. therapy to reduce pain and anxiety in children with cancer References to studies excluded from this review undergoing lumbar puncture: A randomized clinical trial. Journal of Pediatric Oncology Nursing 2010;27(3):146–55. Agarwal 2008 {published data only} Agarwal A, Yadav G, Gupta D, Tandon M, Singh Noguchi 2006 {published data only} PK, Singh U. The role of a flash of light for attenuation Noguchi LK. The effect of music versus nonmusic on of venous cannulation pain: a prospective, randomized, behavioral signs of distress and self-report of pain in placebo-controlled study. Anesthesia and Analgesia 2008; pediatric injection patients. Journal of Music Therapy 2006; 106(3):814–6. 43(1):16–38. Alavi 2005 {published data only} Press 2003 {published data only} Alavi A, Zargham A, Abdyzdan Z, Nmnbati M. The Press J, Gidron Y, Maimon M, Gonen A, Goldman V, comparison of distraction and EMLA cream effects on pain Buskila D. Effects of active distraction on pain of children intensity due to intravenous catheters in 5-12 years old undergoing venipuncture: Who benefits from it?. The Pain thalassemic children. Journal of Shahrekord University of Clinic 2003;15(3):261–9. Medical Sciences 2005;7(3):9–15. Sinha 2006 {published data only} Alderfer 2010 {published data only} Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation Phipps S, Barrera M, Vannatta K, Xiong X, Doyle of nonpharmacologic methods of pain and anxiety JJ, Alderfer MA. Complementary therapies for children management for laceration repair in the pediatric emergency undergoing stem cell transplantation: report of a multisite department. Pediatrics 2006;117:1162–8. trial. Cancer 2010;116(16):3924–33. Tak 2006 {published data only} Alhani 2010 {published data only} Tak JH, van Bon WHJ. Pain- and distress-reducing Alhani F. The effect of programmed distraction on the pain interventions for venepuncture in children. Child: Care, caused by venipuncture among adolescents on hemodialysis. Health, and Development 2006;32(3):257–68. Pain Management Nursing 2010;11(2):85–91.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 23 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Anghelescu 2013 {published data only} Broome 1998 {published data only} Anghelescu DL, Burgoyne LL, Faughnan LG, Hankins Broome ME, Rehwaldt M, Fogg L. Relationships between GM, Smeltzer MP,Pui C. Prospective randomized crossover cognitive behavioral techniques, temperament, observed evaluation of three anthesthetic regimens for painful distress, and pain reports in children and adolescents during procedures in children with cancer. The Journal of Pediatrics lumbar puncture. Journal of Pediatric Nursing 1998;13(1): 2013;162(1):137–41. 48–54. Anson 2010 {published data only} Bruck 1995 {published data only} Anson L, Edmundson E, Teasley S. Implications of Bruck M, Ceci SJ, Francoeur E, Barr R. “I hardly cried when evidence-based venipuncture practice in a pediatric health I got my shot!” Inﬂuencing children’s reports about a visit care magnet facility. Journal of Continuing Education in to their pediatrician. Child Development 1995;66:193–208. Nursing 2010;41(4):179–85. Bufalini 2009 {published data only} Arts 1994 {published data only} Bufalini A. Role of interactive music in oncological pediatric Arts SE, Abu-Saad HH, Champion GD, Crawford patients undergoing painful procedures [Ruolo della musica MR, Fisher RJ, Juniper KH, et al.Age-related response interattiva nel paziente pediatrico oncologico sottoposto to lidocaine-prilocaine (EMLA) emulsion and effect of a procedure dolorose]. Minerva Pediatrica 2009;61(4): music distraction on the pain of intravenous cannulation. 379–90. Pediatrics 1994;93:797–801. Bufalini 2012 {unpublished data only} Ashkenzai 2006 {published data only} Bufalini A. The effect of live music on oncological paediatric Ashkenazi M, Blumer S, Eli I. Effectiveness of various patients during painful procedures. European Journal of modes of computerized delivery of local anesthesia in Integrative Medicine 2012. primary maxillary molars. Pediatric Dentistry 2006;28(1): Carlson 2000 {published data only} 29–39. Carlson KL, Broome M, Vessey JA. Using distraction to Atkinson 2009 {published data only} reduce reported pain, fear, behavioral distress in children Atkinson P, Chesters A, Heinz P. Pain management and and adolescents: A multisite study. Journal of the Society of sedation for children in the emergency department. BMJ Pediatric Nurses 2000;5:75–85. 2009;339:b4234. Chen 2000b {published data only} Bagnasco 2012 {published data only} Chen E, Craske MG, Katz ER, Schwartz E, Zeltzer LK. Bagnasco A, Pezzi E, Rosa F, Fornoni L, Sasso L. Distraction Pain-sensitive temperament: Does it predict procedural techniques in children during venipuncture: an Italian distress and response to psychological treatment among experience. Journal of Preventive Medicine and Hygiene children with cancer?. Journal of Pediatric Psychology 2000; 2012;53:44–8. 25(4):269–78. Baxter 2011 {published data only} Christiano 1996 {unpublished data only} Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Christiano BA. Children’s coping and distress during Baeyer CL. An integration of vibration and cold relieves invasive dental procedures: The effects of matching coping venipuncture pain in a pediatric emergency department. interventions to coping styles. Doctoral Dissertation. Case Pediatric Emergency Care 2011;27(12):1151–6. Western Reserve University, 1996. Bengston 2002 {unpublished data only} Bengston BS, Jacobson RM, Friedrich WM, Vierkant RA, Cline 2006 {published data only} Poland GA. Teaching self-hypnosis to alleviate vaccination- Cline RJ, Harper FW, Penner LA, Peterson AM, Taub related distress in children: A randomized, single-blinded JW, Albrecht TL. Parent communication and child pain controlled trial. In preparation. and distress during painful pediatric cancer treatments. Social Science & Medicine 2006;63(4):883–98. Berberich 2009 {published data only} Berberich FR, Landman Z. Reducing immunization Cohen 1997 {published data only} discomfort in 4- to 6-year-old children: A randomized Cohen LL, Blount RL, Panopoulos G. Nurse coaching clinical trial. Pediatrics 2009;124:e203–9. and cartoon distraction: An effective and practical intervention to reduce child, parent, and nurse distress Boivin 2008 {published data only} during immunizations. Journal of Pediatric Psychology 1997; Boivin JM, Poupon-Lemarquis L, Iraqi W, Fay R, 22(3):355–70. Schmitt C, Rossignol P. A multifactorial strategy of pain management is associated with less pain in scheduled Cohen 1999 {published data only} vaccination of children. A study realized by family Cohen LL, Blount RL, Jansevics Cohen R, Schaen practitioners in 239 children aged 4-12 years old. Family ER, Zaff JF. Comparative study of distraction versus Practice 2008;25(6):423–9. topical anesthesia for pediatric pain management during Bowen 1999 {published data only} immunizations. Health Psychology 1999;18(6):591–8. Bowen AM, Dammeyer MM. Reducing children’s Cohen 2001 {published data only} immunization distress in a primary care setting. Journal of Cohen LL, Blount RL, Jansevics Cohen R, Ball CM, Pediatric Nursing 1999;14:296–303. McClellan CB, Bernard RS. Children’s expectations and

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 24 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. memories of acute distress: Short- and long-term efﬁcacy El-Sharkawi 2012 {published data only} of pain management interventions. Journal of Pediatric El-Sharkawi HFA, El-Housseiny AA, Aly AM. Effectivness Psychology 2001;26(6):367–74. of new distraction technique on pain associated with injection of local anesthesia for children. Pediatric Dentistry Cohen 2002 {published data only} 2012;34(2):142–5. Cohen LL, Bernard RS, Greco LA, McClellan CB. A child- focused intervention for coping with procedural pain: Are Fassler 1985 {published data only} parent and nurse coaches necessary?. Journal of Pediatric Fassler D. The fear of needles in children. The American Psychology 2002;27(8):749–57. Journal of Orthopsychiatry 1985;55(3):371–7. Cohen 2010 {published data only} French 1994 {published data only} Cohen L. A multifaceted distraction intervention may French GM, Painter EC, Coury DL. Blowing away reduce pain and discomfort in children 4-6 years of age shot pain: A technique for pain management during receiving immunisation. Evidence Based Nursing 2010;13: immunization. Pediatrics 1994;93(3):384–8. 15–6. Gilbert 1982 {published data only} Cramer-Berness 2005 {published data only} Gilbert BO, Bennett Johnson S, Spillar R, McCallum Cramer-Berness LJ, Friedman AG. Behavioral Interventions M, Silverstein JH, Rosenbloom A. The effect of a peer- for Infant Immunizations. Children’s Health Care 2005;34 modelling ﬁlm on children learning to self-inject insulin. (2):95–111. Behavior Therapy 1982;13:186–93. Crowley 2011 {published data only} Goymour 2000 {published data only} Crowley MA, Storer A, Heaton K, Naccarato MK, Goymour K, Stephenson C, Goodenough B, Boulton Proehl JA, Moretz JD, Li S. Emergency nursing resource: C. Evaluating the role of play therapy in the pediatric needle-related procedural pain in pediatric patients in the emergency department. AENJ 2000;3(2):10–2. emergency department. Journal of Emergency Nursing 2011; Hatava 2000 {published data only} 37(3):246–51. Hatava P, Olsson GL, Lagerkranser M. Preoperative Dalhquist 2002 {published data only} psychological preparation for children undergoing ENT Dahlquist LM, Pendley JS, Landthrip DS, Jones CL, operations: a comparison of two methods. Paediatric Steuber CP. Distraction intervention for preschoolers Anaesthesia 2000;10:477–86. undergoing intramuscular injections and subcutaneous port Hawkins 1998 {published data only} access. Health Psychology 2002;21(1):94–9. Hawkins PJ. Hypnosis in the alleviation of procedure Dalhquist 2005 {published data only} related pain and distress in paediatric oncology patients. Dahlquist LM, Shroff Pendley J. When distraction fails: Contemporary Hypnosis 1998;15(4):199–207. Parental anxiety and children’s responses to distraction Heckler-Medina 2006 {published data only} during cancer procedures. Journal of Pediatric Psychology Heckler-Medina GA. The importance of child life and pain 2005;30(7):623–8. management during vascular access procedures in pediatrics. Davit 2011 {published data only} Journal of the Association for Vascular Access 2006;11(3): Davit CJ, Hundley RJ, Bacic JD, Hanson EM. A pilot 144–51. study to improve venipuncture compliance in children and Heden 2009 {published data only} adolescents with autism spectrum disorders. Journal of Hedén L, von Essen L, Ljungman G. Randomized Developmental and Behavioral Pediatrics 2011;32(7):521–5. interventions for needle procedures in children with cancer. Demir 2012 {published data only} European Journal of Cancer Care 2009;18(4):358–63. Demir G, Cukurova Z, Eren G, Tekdos Y, Hergunsel Hoffman 2011 {published data only} O. The effect of “Multiphase Sedation” in the course of Hoffmann F, Deanovic D. Prehospital pain management in computed tomography and magnetic resonance imaging on children and adolescents [Präklinische Schmerztherapie bei children, parents and anesthesiologists. Revista Brasileira de Kindern und Jugendlichen]. Notfall and Rettungsmedizin Anestesiologia 2012;62(4):511–9. 2011;14(7):549–53. Drahota 2008 {published data only} Howe 2011 {published data only} Drahota A, Galloway E, Stores R, Ward D, Severs M, Howe CJ, Ratcliffe SJ, Tuttle A, Dougherty S, Lipman Dean T. Audiovisual distraction as an adjunct to pain and TH. Needle anxiety in children with type 1 diabetes and anxiety relief during minor surgery. Foot (Edinburgh) 2008; their mothers. MCN. The American Journal of Maternal 18(4):211–9. Child Nursing 2011;36(1):25–31. Dufresne 2010 {published data only} Inal 2010 {published data only} Dufresne A, Dugas MA, Samson Y, Barré P, Turcot L, Inal S, Kelleci M. External thermomechanical stimulation Marc I. Do children undergoing cancer procedures under and distraction are effective on pain relief of children pharmacological sedation still report pain and anxiety? A during blood draw. 14th International Nursing Research preliminary study. Pain Medicine 2010;11(2):215–23. Conference, Burgos 2010.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 25 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Jacobson 2006 {published data only} Klingman 1985 {published data only} Jacobson AF. Cognitive-behavioral interventions for IV Klingman A. Mass inoculation in a community: the effect insertion pain. AORN J 2006;84(6):1031–48. of primary prevention of stress reactions. American Journal of Community Psychology 1985;13(3):323–32. Jay 1987 {published data only} Jay SM, Elliott CH, Katz E, Siegel SE. Cognitive-behavioral Klorman 1980 {published data only} and pharmacologic interventions for children’s distress Klorman F, Hilpert PL, Michael R, LaGana C, Sveen OB. during painful medical procedures. Journal of Consulting Effects of coping and mastery modelling on experienced and and Clinical Psychology 1987;55(6):860–5. inexperienced pedodontic patients’ disruptiveness. Behavior Therapy 1980;11:156–68. Jay 1990 {published data only} Kolk 2000 {published data only} Jay SM, Elliott CH. A stress inoculation program for parents Kolk AM, van Hoof R, Fiedeldij Dop MJC. Preparing whose children are undergoing painful medical procedures. children for venepuncture. The effect of an integrated Journal of Consulting and Clinical Psychology 1990;58(6): intervention on distress before and during venipuncture. 799–804. Child: Care, Health and Development 2000;26(3):251–60. Jay 1991 {published data only} Krauss 1996 {unpublished data only} Jay SM, Elliott CH, Woody PD. An investigation of Krauss WJ. Videotape modelling and parent participation: cognitive-behavior therapy combined with oral Valium for Effects on reducing distress behavior in children undergoing children undergoing painful medical procedures. Health immunization procedures. Doctoral Dissertation, Psychology 1991;10(5):317–22. California School of Professional Psychology 1996. Jay 1995 {published data only} Kuttner 1988 {published data only} Jay S, Elliott CH, Fitzgibbons I, Woody P, Siegel S. A Kuttner L, Bowman M, Teasdale M. Psychological comparative study of cognitive behavior therapy versus treatment of distress, pain, and anxiety for young children general anesthesia for painful medical procedures in with cancer. Developmental and Behavioral Pediatrics 1988; children. Pain 1995;62:3–9. 9(6):374–81. Kain 2006 {published data only} Kwekkeboom 2003 {unpublished data only} Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg Kwekkeboom KL. Music versus distraction for procedural ME, Wang SM, MacLaren JE, Blount RL. Family-centered pain and anxiety in patients with cancer. ONF 2003;30(3): preparation for surgery improves perioperative outcomes 433–40. in children: a randomized controlled trial. Anesthesiology Lawes 2008 {published data only} 2007;106(1):65–74. Lawes C, Sawyer L, Amos S, Kandiah M, Pearce L, Symons J. Impact of an education programme for staff Kammerbauer 2011 {published data only} working with children undergoing painful procedures. Kammerbauer N, Becke K. Acute pain management in Paediatric Nursing 2008;20(2):33–7. pediatric and geriatric medicine - pain measurement: What pain scale in which patients? [Akutschmerztherapie Lessi 2011 {published data only} in Pädiatrie und Geriatrie – Akutschmerztherapie Lessi E, Biasutto M, Ferrazzo M. The pain from im Kindesalter]. Anästhesiologie, Intensivmedizin, venipuncture in children: The beneﬁt of visual distraction Notfallmedizin, Schmerztherapie - AINS 2011;46:344–53. [Il dolore da venipuntura nel bambino: Il beneﬁcio della distrazione con audiovisivi]. Gli Infermieri dei Bambini Kazak 1996 {published data only} GISIP 2011;3(2):43–8. Kazak AE, Penati B, Boyer BA, Himelstein B, Brophy Liossi 2007 {published data only} P, Waibel MK, et al.A randomized controlled perspective Liossi C, White P, Franck L, Hatira P. Parental pain outcome study of a psychological and pharmacological expectancy as a mediator between child expected and intervention protocol for procedural distress in pediatric experienced procedure-related pain intensity during painful leukemia. Journal of Pediatric Psychology 1996;21(5): medical procedures. The Clinical Journal of Pain 2007;23 615–31. (5):392–9. Kazak 1998 {published data only} Lustman 1983 {published data only} Kazak AE, Penati B, Brophy P,Himelstein B. Pharmacologic Lustman NM. The effectiveness of two different and psychologic interventions for procedural pain. Pediatrics components of stress inoculation, preparatory information 1998;102(1):59–66. and the teaching of coping devices aimed at mothers whose Kettwich 2007 {published data only} children are undergoing minor surgery. Yale University Kettwich SC, Sibbitt Jr WL, Brandt JR, Johnson (Doctoral Dissertation) 1983. CR, Wong CS, Bankhurst AD. Needle phobia and MacLaren 2005 {published data only} stress-reducing medical devices in pediatric and adult MacLaren JE, Cohen LL. A comparison of distraction chemotherapy patients. Journal of Pediatric Oncology strategies for venipuncture distress in children. Journal of Nursing 2007;24(1):20–8. Pediatric Psychology 2005;30(5):387–96.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 26 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. MacLaren 2007 {published data only} Myrvik 2009 {unpublished data only} MacLaren JE, Cohen LL. Interventions for paediatric Myrvik MP. A behavioral intervention targeting a procedure-related pain in primary care. Paediatrics & Child reduction in child distress during a routine immunization. Health 2007;12(2):111-6. Dissertation, University of North Dakota 2008.

Malone 1996 {published data only} Nilsson 2009 {published data only} Malone AB. The effects of live music on the distress Nilsson S, Finnström B, Kokinsky E, Enskär K. The use of pediatric patients receiving intravenous starts, of Virtual Reality for needle-related procedural pain and venipunctures, injections, and heel sticks. Journal of Music distress in children and adolescents in a paediatric oncology Therapy 1996;33(1):19–33. unit. European Journal of Oncology Nursing 2009;13(2): 102–9. Manimala 2000 {published data only} O’Laughlin 1995 {published data only} Manimala R, Blount RL, Cohen LL. The effects of parental O’Laughlin E, Ridley-Johnson. Maternal presence during reassurance versus distraction on child distress and coping children’s routine immunizations: The effect of mother as during immunizations. Child Health Care 2000;29:161–77. observer in reducing child distress. Children’s Health Care 1995;24(3):175–91. Manne 1990 {published data only} Olsen 1991 {published data only} Manne SL, Redd WH, Jacobsen PB, Gorfinkle K, Schorr O. Olsen BR. Brief interventions for routine use with children Behavioral intervention to reduce child and parent distress in a phlebotomy laboratory. West Virginia University during venipuncture. Journal of Consulting and Clinical (Doctoral Dissertation) 1991. Psychology 1990;58(5):565–72. Ozdemir 2012 {published data only} Manne 1994 {published data only} Ozdemir FK, Tufekci FG. The effect of using musical Manne SL, Bakerman R, Jacobsen PB, Gorfinkle K, Redd mobiles on reducing pain in infants during vaccination. WH. An analysis of a behavioral intervention for children Journal of Research in Medical Sciences 2012;17(7):662–7. undergoing venipuncture. Health Psychology 1994;13(6): Park 2008 {published data only} 556–66. Park SH, Bang SM, Nam E, Cho EK, Shin DB, Marec-Berard 2009 {published data only} Lee JH, Ahn JY. A randomized double-blind placebo- Marec-Bérard P, Bissery A, Kebaïli K, Schell M, Aubert F, controlled study of low-dose intravenous Lorazepam to Gaillard S, et al.A positioning pillow to improve lumbar reduce procedural pain during bone marrow aspiration and puncture success rate in paediatric haematology-oncology biopsy. Pain Medicine 2008;9(2):249–52. patients: a randomized controlled trial. BMC Cancer 2009; Pederson 1996 {published data only} 21: doi:10.1186/1471–2407-9-21. Pederson C. Promoting parental use of nonpharmacologic techniques with children during lumbar punctures. Journal McCarthy 1998 {published data only} of Pediatric Oncology Nursing 1996;13(1):21–30. McCarthy AM, Cool VA, Hanrahan K. Cognitive behavioral interventions for children during painful Peretz 1999 {published data only} procedures: Research challenges and program development. Peretz B, Gluck GM. Assessing an active distracting Journal of Pediatric Nursing 1998;13(1):55–63. technique for local anesthetic injection in pediatric dental patients: repeated deep breathing and blowing out air. The McCarthy 2010b {published data only} Journal of Clinical Pediatric Dentistry 1999;24(1):5–8. McCarthy AM, Kleiber C, Hanrahan K, Zimmerman Posner 1998 {unpublished data only} MB, Westhus N, Allen S. Factors explaining children’s Posner K. A pharmacobehavioral intervention to reduce responses to intravenous needle insertions. Nursing Research child cancer distress. Ferkauf Graduate School of 2010;59(6):407–16. Psychology, Doctoral Dissertation. Yeshiva University, McInally 2005 {published data only} 1998. McInally W. Whose line is it anyway? Management of Powers 1993 {published data only} central venous catheters in children. Paediatric Nursing Powers SW, Blount RL, Bachanas PJ, Cotter MW, Swan 2005;17(5):14–8. SC. Helping preschool leukemia patients and their parents cope during injections. Journal of Pediatric Psychology 1993; Megel 1998 {published data only} 18(6):681–95. Megel ME, Houser CW, Gleaves LS. Children’s responses Ramponi 2009 {published data only} to immunizations: Lullabies as a distraction. Issues in Ramponi D. Reducing pain in pediatric procedures in the Comprehensive Pediatric Nursing 1998;21:129–45. emergency department. Journal of Emergency Nursing 2009; Melamed 1974 {published data only} 35(4):379–82. Melamed BG, Hawes RR, Heiby E, Glick J. Use of filmed Reeb 1997 {published data only} modelling to reduce uncooperative behavior of children Reeb RN, Busch JP.Preprocedural psychological preparation during dental treatment. Journal of Dental Research 1974; in pediatric oncology: A process-oriented intervention 54(4):797–801. study. Children’s Health Care 1997;25:265–79.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 27 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Rogovik 2007 {published data only} Slack 2009 {published data only} Rogovik AL, Goldman RD. Hypnosis for treatment of pain Slack D, Nelson L, Patterson D, Burns S, Hakimi in children. Canadian Family Physician 2007;53(5):823-5. K, Robinson L. The feasibility of hypnotic analgesia in ameliorating pain and anxiety among adults undergoing Russell 2012 {unpublished data only} needle electromyography. American Journal of Physical Russell K, Nicholson R, Legge L, Leauanae E, Olsen A, Medicine & Rehabilitation 2009;88(1):21–9. Marsh S, Naidu R. Reducing the pain of Bicillin injections in the rheumatic fever population of CMDHB. Conference Slifer 2009 {published data only} presentation 2012. Slifer KJ, Demore M, Vona-Messersmith N, Pulbrook- Vetter V, Beck M, Dalhquist L, et al. Comparison of two Salih 2010 {published data only} brief parent-training interventions for child distress during Salih N, Bäumler PI, Simang M, Irnich D. Deqi sensations parent-administered needle procedures. Child Health Care without cutaneous sensory input: results of an RCT. BMC 2009;38(1):23–48. Complementary and Alternative Medicine 2010;10:81. Slifer 2011 {published data only} Santos 1999 {published data only} Slifer KJ, Hankinson JC, Zettler MA, Frutchey RA, Santos LMCN, Borba RIH, Sabates AL. The importance of Hendricks MC, Ward CM, Reesman J. Distraction, the preschool in the preparation for intramuscular injection exposure therapy, counterconditioning, and topical using the play [La importancia del preparo de ninos en edad anesthetic for acute pain management during needle sticks prescolar para la injeccion intramuscular con el uso del in children with intellectual and developmental disabilities. juguete]. Acta Paulista de Enfermagem 2000;13(2):52–8. Clinical Pediatrics 2011;50(8):688–97. Schechter 2010 {published data only} Smith 1989 {published data only} Schechter NL, Bernstein BA, Zempsky WT, Bright NS, Smith KE, Ackerson JD, Blotcky AD. Reducing distress Willard AK. Educational outreach to reduce immunization during invasive medical procedures: Relating behavioral pain in ofﬁce settings. Pediatrics 2010;126(6):1514–21. interventions to preferred coping style in pediatric cancer patients. Journal of Pediatric Psychology 1989;14(3):405–19. Schneider 2011 {published data only} Smith 1996 {published data only} Schneider SM, Kisby CK, Flint EP. Effect of virtual reality Smith JT, Barabasz A, Barabasz M. Comparison of hypnosis on time perception in patients receiving chemotherapy. and distraction in severely ill children undergoing painful Support Care in Cancer 2011;19(4):555–64. medical procedures. Journal of Counseling Psychology 1996; Schur 1986 {unpublished data only} 43(2):187–95. Schur JM. Alleviating behavioral distress with music or Sparks 2001 {published data only} lamaze pant-blow breathing in children undergoing bone Sparks L. Taking the “ouch” out of injections for children: marrow aspirations and lumbar punctures. The University Using distraction to decrease pain. The American Journal of of Texas Health Science Center at Dallas (Doctoral Maternal/Child Nursing 2001;26(2):72–8. Dissertation) 1986. Stefano 2005 {unpublished data only} Shabanloei 2010 {published data only} Stefano C, Giancarlo I, Corrado V. The experience of Shabanloei R, Golchin M, Esfahani A, Dolatkhah R, control related to the procedure of non-pharmacologic Rasoulian M. Effects of music therapy on pain and anxiety pain management in paediatric oncology and heamatology. in patients undergoing bone marrow biopsy and aspiration. Poster abstract - no source identiﬁed. 2005. AORN J 2010;91(6):746–51. Stevenson 2005 {published data only} Shahabi 2007 {published data only} Stevenson MD, Bivins CM, O’Brien K, Gonzalez del Rey Shahabi M, Kalani-Tehrani D, Eghbal M, Alavi-Majd H, JA. Child life intervention during angiocatheter insertion in Abed Saidi J. Comparing the effects of EMLA ointment the pediatric emergency department. Pediatric Emergency with a diversionary activity (music) on vein puncture pain Care 2005;21(11):712–8. at school-age children. Journal of Nursing and Midwifery Sury 2010 {published data only} 2007;17:56. Sury M, Bullock I, Rabar S, DeMott K. Sedation for Shimizu 2005 {published data only} diagnostic and therapeutic procedures in children and Shimizu T, Inomata S, Kihara S, Toyooka H, Brimacombe young people: summary of NICE guidance. BMJ 2010; JR. Rapid injection reduces pain on injection with propofol. 341:c6819. European Journal of Anaesthesiology 2005;22(5):394–6. Thurgate 2005 {published data only} Thurgate C, Heppell S. Needle phobia--changing Sikorova 2011 {published data only} venepuncture practice in ambulatory care. Paediatric Sikorova L, Hrazdilova P. The effect of psychological Nursing 2005;17(9):15–8. intervention on perceived pain in children undergoing venipuncture. BioBiomedical papers of the Medical Faculty of Tufekci 2009 {published data only} the University Palacky, Olomouc, Czechoslovakia 2011;155 Tüfekci FG, Celebio lu A, Küçüko lu S. Turkish children (2):149–54. loved distraction: using kaleidoscope to reduce perceived

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 28 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. pain during venipuncture. Journal of Clinical Nursing 2009; Zahr 1998 {published data only} 18(15):2180–6. Zahr KL. Therapeutic play for hospitalized preschoolers in Vernon 1974 {published data only} Lebanon. Pediatric Nursing 1998;24(5):449–54. Vernon DTA. Modeling and birth order in responses to Zeltzer 1982 {published data only} painful stimuli. Journal of Personality and Social Psychology Zeltzer L, LeBaron S. Hypnosis and nonhypnotic techniques 1974;29(6):794–9. for reduction of pain and anxiety during painful procedures Vika 2009 {published data only} in children and adolescents with cancer. Pediatrics 1982; Vika M, Skaret E, Raadal M, Ost LG, Kvale G. One- 101(6):1032–5. vs. five-session treatment of intra-oral injection phobia: a Additional references randomized clinical study. European Journal of Oral Sciences 2009;117(3):279–85. AAFP 2004 American Academy of Family Physicians. www.aafp.org. Vohra 2011 {published data only} Accessed 2 January, 2004. Vohra S, Nilsson S. Does music therapy reduce pain and anxiety in children with cancer undergoing lumbar AAP 2004 puncture?. Focus on Alternative and Complementary American Academy of Pediatrics. www.aap.org Accessed 2 Therapies 2011;16(1):66–7. January, 2004. Wall 1989 {published data only} ACIP 2004 Wall VJ, Womack W. Hypnotic versus active cognitive Advisory Committee on Immunization Practices. strategies for alleviation of procedural distress in pediatric www.csc.gov/nip/acip Accessed 2 January, 2004. oncology patients. American Journal of Clinical Hypnosis Alvarez 1997 1989;31(3):181–91. Alvarez CB, Marcos AF. Psychological treatment of evoked Wallace 2010 {published data only} pain and anxiety by invasive medical procedures in Wallace DP, Allen KD, Lacroix AE, Pitner SL. The “cough paediatric oncology. Psychology in Spain 1997;1(1):17–36. trick:” a brief strategy to manage pediatric pain from Anderson 2005 immunization injections. Pediatrics 2010;125(2):e367–73. Anderson B, Cranswick N. The placebo (I shall please) - is it so pleasing in children?. Pediatric Anesthesia 2005;15: Weber 2010 {published data only} 809–13. Weber FS. The influence of playful activities on children’s anxiety during the preoperative period at the outpatient Anie 2012 surgical center. Jornal de Pediatria 2010;86(3):209–14. Anie K, Green J. Psychological therapies for sickle cell disease and pain. Cochrane Database Of Systematic Weinstein 2003 {published data only} Reviews 2012;Art. No.: CD001916(2):DOI: 10.1002/ Weinstein P, Raadal M, Naidu S, Yoshida T, Kvale G, 14651858.CD001916.pub2. Milgrom P. A videotaped intervention to enhance child Barlow 1999 control and reduce anxiety of the pain of dental injections. Barlow DH, Durand VM. Abnormal Psychology: An European Journal of Paediatric Dentistry 2003;4:181–5. Integrative Approach. California: Brooks/Cole Publishing Winborn 1989 {published data only} Company, 1999. Winborn MD. Associative and dissociative preparatory Beyer 1992 strategies for children undergoing dental treatment. Beyer JE, Denyes MJ, Villarruel AM. The creation, Memphis State University (Doctoral Dissertation). validation, and continuing development of the Oucher: a Wood 2002 {published data only} measure of pain intensity in children. Journal of Pediatric Wood C. Introducing a protocol for procedural pain. Nursing 1992;7:335–46. Paediatric Nursing 2002;14(8):30–3. Blount 1989 Yoo 2011 {published data only} Blount RL, Corbin SM, Sturges JW, Wolfe VV, Prater JM, Yoo H, Kim S, Hur HK, Kim HS. The effects of an James LD. The relationship between adults’ behavior and animation distraction intervention on pain response of child coping and distress during BMA/LP procedures: A preschool children during venipuncture. Applied Nursing sequential analysis. Behavior Therapy 1989;20:585–601. Research 2011;24(2):94–100. Blount 1990 Young 1988 {published data only} Blount RL, Sturges JW, Powers SW. Analysis of child and Young MR, Fu VR. Influence of play and temperament adult behavioral variations by phase of medical procedure. on the young child’s response to pain. CHC 1988;16(3): Behavior Therapy 1990;21:33–48. 209–15. Blount 1997 Zabin 1982 {unpublished data only} Blount RL, Cohen LL, Frank NC, Bachanas PJ. The Child- Zabin MA. The modification of children’s behavior during Adult medical procedure interaction scale-revised: an blood work procedures. Doctoral Dissertation, West assessment of validity. Journal of Pediatric Psychology 1997; Virginia University 1982. 22:73–88.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 29 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Blount 2001 Cummings 1996 Blount RL, Bunke VL, Cohen LL, Forbes CJ. The Child- Cummings EA, Reid GJ, Finley A, McGrath PJ, Ritchie JA. Adult Medical Procedure Integration Scale-Short Form Prevalence and source of pain in pediatric inpatients. Pain (CAMPIS-SF): Validation of a rating scale for children’s 1996;68:25–31. and adults’ behaviors during painful medical procedures. Dalhquist 2007 Journal of Pain and Symptom Management 2001;22:591–9. Dalhquist LM, McKenna KD, Jones KK, Dilinger L, Weiss Blount 2003 KE, Ackerman CS. Active and passive distraction using a Blount RL, Piira T, Cohen LL. Management of pediatric head-mounted display helmet: effects on cold pressor pain pain and distress due to medical procedures. In: MC in children. Health Psychology 2007;26(6):794–801. Roberts editor(s). Handbook of Pediatric Psychology. Third Devine 2004 Edition. New York: The Guilford Press, 2003. Devine K, Benoit M, Simons LE, Cheng PS, Seri LG, Broome 1989 Blount RL. Psychological interventions for acute pediatric Broome ME, Lillis PP.A descriptive analysis of the pediatric pain. [The Suffering Child] www.thesufferingchild.net 19 pain management research. Applied Nursing Research 1989; June 2004;6:1–22. 2(2):74–81. Eccleston 2009 Broome 1990 Eccleston C, Palermo T,Williams A, Lewandowski A, Morley Broome ME, Bates TA, Lillis PP, McGahee TW. Children’s S. Psychological therapies for the management of chronic medical fears, coping behaviors, and pain perceptions and recurrent pain in children and adolescents. Cochrane during a lumbar puncture. ONF 1990;17(3):361–7. Database Of Systematic Reviews 2009;Art. No.: CD003968 Cepeda 2010 (2):DOI: 10.1002/14651858.CD003968.pub2.. Cepeda M, Tzortzopoulou A, Thackrey M, Hudcova Eccleston 2012 J, Arora Gandhi P, Schumann R. Adjusting the pH of Eccleston C, Palermo TM, Fisher E, Law E. Psychological lidocaine for reducing pain on injection. Cochrane Database interventions for parents of children and adolescents with Of Systematic Reviews 2010;Art. No.:CD006581(12):DOI: chronic illness. Cochrane Database of Systematic Reviews 10.1002/14651858.CD006581.pub2. 2012;Issue 8:Art. No.: CD009660. DOI: 10.1002/ Chambers 1998 14651858.CD009660.pub2. Chambers CT, Craig KD. An intrusive impact of anchors in Hartling 2009 children’s faces pain scales. Pain 1998;78:27–37. Hartling L, Ospina M, Liang Y, Dryden DM, Hooton N, Chambers 2009 Seida JK, et al.Risk of bias versus quality assessment of Chambers C, Taddio A, Uman L, McMurtry C. randomized controlled trials: Cross sectional study. BMJ Psychological interventions for reducing pain and distress 2009;339:b4012–7. during routine childhood immunizations: a systematic Hicks 2001 review. Clinical Therapeutics 2009;31:S77–103. Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Champion 1998 Goodenough B. The Faces Pain Scale-Revised: toward a Champion GD, Goodenough B, von Baeyer CL, Thomas common metric in pediatric pain measurement. Pain 2001; W. Measurement of pain by self-report. Measurement of Pain 93:173–83. in Infants and Children. Seattle: IASP Press, 1998:123–60. Higgins 2011 Chan 2004 Higgins JPT, Green S (editors). Cochrane Handbook Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, for Systematic Reviews of Interventions Version 5.1.0 Altman DG. Empirical evidence for selective reporting of [updated March 2011]. The Cochrane Collaboration. outcomes in randomized trials: Comparison of protocols to Version 5.0.2 [updated September 2009]. Vol. Available published articles. JAMA 2004;291:2457–65. from www.cochrane-handbook.org, Copenhagen: The Cochrane Collaboration, 2011. Chen 2000a Chen E, Joseph MH, Zeltzer LK. Acute pain in children: IASP 2004 Behavioral and cognitive interventions in the treatment of IASP Task Force on Taxonomy. Classiﬁcation of Chronic pain in children. Pediatric Clinics of North America 2000;47 Pain. Second Edition. Seattle: IASP Press, 2004. (3):1–13. Jadad 1996 Christophersen 2001 Jadad A, Moore RA, Carroll D, Jenkinson C, Reynolds Christophersen ER, Mortweet SL. Assessment and DJ, Gavaghan DJ, et al.Assessing the quality of reports of management of pain. Treatments that work with children: randomized clinical trials: Is blinding necessary?. Controlled Empirically supported strategies for managing childhood Clinical Trials 1996;17:1–12. problems. Washington: American Psychological Association, Jay 1983 2001. Jay SM, Ozoling M, Elliott C, Caldwell S. Assessment CPS 2004 of children’s distress during painful medical procedures. Canadian Paediatric Society. www.cps.ca 2004. Journal of Health Psychology 1983;2:133–47.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 30 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kazak 2001 MedLine 2004 Kazak AE, Kunin-Batson A. Psychological and integrative MedlinePlus Medical Encyclopedia. www.nlm.nih.gov/ interventions in pediatric procedure pain. In: GA Finley, PJ medlineplus/mplusdictionary.html Accessed 4 February, McGrath editor(s). Acute and Procedure Pain in Infants and 2004. Children. Seattle: IASP Press, 2001:77–100. Merkel 1997 Keefe 1992 Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The Keefe FJ, Dunsmore J, Burnett R. Behavioral and cognitive- FLACC: A behavioral scale for scoring postoperative pain in behavioral approaches to chronic pain: Recent advances young children. Pediatric Nursing 1997;23(3):293–7. and future directions. Special issue: Behavioral medicine: Moher 1994 An update for the 1990s. Journal of Consulting and Clinical Moher D, Dulberg CS, Wells GA. Statistical power, sample Psychology 1992;60(4):528–36. size, and their reporting in randomized controlled trials. Klassen 2008 JAMA 1994;272:122–4. Klassen J, Liang Y, Tjosvold L, Klassen T, Hartling L. Moher 2001 Music for pain and anxiety in children undergoing medical Moher D, Schulz KF, Altman D for the CONSORT Group. procedures: A systematic review of randomized controlled The CONSORT statement: Revised recommendations trials. Acute Pain 2008;10(2):106. for improving the quality of reports of parallel-group Kleiber 1999 randomized trials. JAMA 2001;285:1987–91. Kleiber C, Harper DC. Effects of distraction on children’s Noel 2012 pain and distress during medical procedures: A meta- Noel M, Chambers CT, Petter M, McGrath PJ, Klein analysis. Nursing Research 1999;48(1):44–9. RM, Stewart SH. “Pain is not over when the needle ends”: Loebach 1979 A review and preliminary model of acute pain memory Loebach S. The use of color to facilitate communication of development in childhood. Pain Management 2012;2(5): pain in children. Thesis, University of Washington 1979. 487–97. OLMD 2004 Luebbert 2001 On-Line Medical Dictionary. www.cancerweb.ncl.ac.uk/ Luebbert K, Dahme B, Hasenbring M. The effectiveness of omd Accessed 4 February, 2004. relaxation training in reducing treatment-related symptoms and improving emotional adjustment in acute non-surgical Palda 2004 cancer treatment: A meta-analytic review. Psycho-Oncology Palda VA, Guise JM, Wathen CN, and Canadian Task 2001;10:490–502. Force on Preventive Health Care. Interventions to promote breast-feeding: applying the evidence in clinical practice. McGrath 1985 Canadian Medical Association Journal 2004;170:976–8. McGrath PJ, Johnson G, Goodman JT, et al.CHEOPS: a behavioral scale for rating postoperative pain in children. Pillai-Riddell 2011a In: HL Fields, R Dubner, F Cervero editor(s). Advances in Pillai Riddell R, Racine N, Turcotte K, Uman LS, Horton Pain Research and Therapy. Proceedings of the Fourth World R, Din Osmun L, et al.Nonpharmacological management Congress on Pain. Vol. 9, New York: Raven Press, 1985: of procedural pain in infants and young children: An 395–402. abridged Cochrane review. Pain Research and Management McGrath 1998 2011;16(5):321–30. McGrath PJ. Behavioral measures of pain. Measurement of Pillai-Riddell 2011b Pain in Infants and Children. Seattle: IASP Press, 1998: Pillai Riddell R, Racine N, Turcotte K, Uman LS, Horton R, 83–102. Gerwitz-Stern A, et al.Non-pharmacological management McGrath 2008 of infant and young child procedural pain. Cochrane McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown Database Of Systematic Reviews 2011;Art. No.: CD006275 MT, Davidson K, et al.Core outcome domains and measures (10):DOI: 10.1002/14651858.CD006275.pub2. for pediatric acute and chronic/recurrent pain clinical trials: Powers 1999 PedIMMPACT recommendations. Journal of Pain 9;9: Powers SW. Empirically supported treatments in pediatric 771–83. psychology: Procedure-related pain. Journal of Pediatric McMurtry 2006 Psychology 1999;24(2):131–45. McMurtry CM, McGrath PJ, Chambers CT. Reassurance Puntillo 2004 can hurt: Parental behavior and painful medical procedures Puntillo KA, Morris AB, Thompson CL, Stanik-Hutt J, (Commentary). The Journal of Pediatrics 2006;148:560–1. White, CA, Wild, LR. Pain behaviors observed during six McMurtry 2010 common procedures: Results from Thunder Project II. McMurtry CM, Chambers CT, McGrath PJ, Asp E. When Critical Care Medicine 2004;32(2):421–7. “Don’t Worry” communicates fear: Children’s perceptions RevMan 2011 of parental reassurance and distraction during a painful The Nordic Cochrane Centre. Review Manager (RevMan). medical procedure. Pain 2010;150:52–8. 5.1. Copenhagen: The Nordic Cochrane Centre, 2011.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 31 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Saile 1988 Uman 2006 Saile H, Burgmeier R, Schmidt LR. A meta-analysis of Uman LS, Chambers CT, McGrath PJ, Kisely S. studies on psychological preparation of children facing Psychological interventions for needle-related procedural medical procedures. Psychology and Health 1988;2:107–32. pain and distress in children and adolescents (Review). The Savovic 2012 Cochrane Database of Systematic Reviews 2006;Art. No.: Savovic J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal CD005179(4):DOI:10.1002/14651858.CD005179.pub2. J, et al.Inﬂuence of reported study design characteristics on Uman 2008 intervention effect estimates from randomized, controlled Uman LS, Chambers CT, McGrath PJ, Kisely S. A trials. Annals of Internal Medicine 2012;157:429–38. systematic review of randomized controlled trials examining Shroeder 1979 psychological interventions for needle-related procedural Shroeder P. Use of Eland’s color method in pain assessment pain and distress in children and adolescents: An abbreviated of burned children. Unpublished research conducted at Cochrane Review. Journal of Pediatric Psychology 2008;33: Shriner’s Burn Hospital, Ohio 1979. 842–54. Skinner 2007 Uman 2010 Skinner EA, Zimmer-Gembeck MJ. The development of Uman LS, Chambers CT, McGrath PJ, Kisely S, Matthews coping. Annual Review of Psychology 2007;58:119–44. D, Hayton K. Assessing the quality of randomized Slifer 2002 controlled trials examining psychological interventions for Slifer K, Tucker C, Dahlquist L. Helping children and pediatric procedural pain: Recommendations for quality caregivers cope with repeated invasive procedures: How are improvement. Journal of Pediatric Psychology 2010;35: we doing?. Journal Of Clinical Psychology In Medical Settings 693–703. 2002;9(2):131–52. Vervoort 2008 Stevens 2011 Vervoort T, Goubert L, Eccleston C, Verhoeven K, De Stevens B, Abbott L, Yamada J, Harrison D, Stinson J, Clercq A, Crombez G, et al.The effects of parental presence Finley A, et al.Epidemiology and management of painful upon the facial expression of pain: The moderating role of procedures in children in Canadian hospitals. Canadian child pain catastrophizing. Pain 2008;138(2):277–85. Medical Association Journal 2011;183(7):E403–10. Vervoort 2011 Stevens 2012 Vervoort T, Caes L, Trost Z, Sullivan M, Vangronsveld Stevens BJ, Harrison D, Rashotte J, Yamada J, Abbott K, Goubert L. Social modulation of facial pain display LK, Coburn G, et al.Pain assessment and intensity in in high-catastrophizing children: An observational study hospitalized children in Canada. Journal of Pain 2012;13 in schoolchildren and their parents. Pain 2011;152(7): (9):857–65. 1591–9. Stinson 2006 Stinson JN, Kavanagh R, Yamada J, Gill N, Stevens von Baeyer 2007 B. Systematic review of the psychometric properties, von Baeyer CL, Spagrud LJ. Systematic review of interpretability and feasibility of self-report pain intensity observational (behavioural) measures of pain for children measures for use in clinical trials in children and adolescents. and adolescents aged 3 to 18 years. Pain 2007;127:140–50. Pain 2006;125:143–57. von Baeyer 2009 Sweet 1998 von Baeyer CL, Forsyth SJ, Stanford EA, Watson M, Sweet SD, McGrath PJ. Physiological measures of pain. In: Chambers CT. Response biases in preschool children’s GA Finley, PJ McGrath editor(s). Measurement of Pain in ratings of pain in hypothetical situations. European Journal Infants and Children. Seattle: IASP Press, 1998:59–81. of Pain 2009;13:209–13.

Taddio 2009 Williams 2012a Taddio A, Chambers CT, Halperin SA, Ipp M, Lockett Williams ACDC, Eccleston C, Morley S. Psychological D, Rieder, MJ, et al.Inadequate pain management during therapies for the management of chronic pain (excluding routine childhood immunizations: The nerve of it. Clinical headache) in adults. Cochrane Database of Systematic Reviews Therapeutics 2009;31 Suppl 2:S152–67. 2012;Issue 11:Art. No.: CD007407. DOI: 10.1002/ Taddio 2010 14651858.CD007407.pub3. Taddio A, Appleton M, Bortolussi R, Chambers CT, Dubey V, Halperin, S, et al.Reducing the pain of childhood Williams 2012b vaccination: An evidence-based clinical practice guideline. Williams K, Thomson D, Seto I, Contopoulos-Ioannidis Canadian Medical Association Journal 2010;182:E843–55. DG, Ioannidis JP, Curtis S, et al.Standard 6: Age groups for pediatric trials. Pediatrics 2012;129:S153–60. Tomlinson 2010 Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A Wong 1988 systematic review of faces scales for the self-report of pain Wong DL, Baker CM. Pain in children: comparison of intensity in children. Pediatrics 2010;126:e1168–98. assessment scales. Pediatric Nursing 1988;14:9–17.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 32 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. World Medical Association 2008 World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/ 10policies/b3/ 2008. Young 2005 Young KD. Pediatric procedural pain. Annals of Emergency Medicine 2005;45(2):160–71. ∗ Indicates the major publication for the study

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 33 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. CHARACTERISTICSOFSTUDIES

Characteristics of included studies [ordered by study ID]

Balan 2009

Methods Allocation: randomized using a random number table

Participants Needle Procedure: venepuncture for blood collection Inclusion: -children aged 5-12 years requiring venepuncture for blood collection (Note: children over 7 enrolled only if provided assent) Exclusion: -children with a history of hypersensitivity to local anesthetics of the amide type (lidocaine, prilocaine, mepivicaine, bupivicaine, etidocaine) or to one or more constituents of EMLA -history of congenital or idiopathic methaemoglobinaemia, glucose-6-phosphatase deﬁ- ciency or severe hepatic disease -children with altered sensorium and this found to have hearing impairment on clinical examination -children whose clinical condition warranted urgent administration of drugs N: 100 Age: 5-12 years Gender: F=45, M=55 Diagnosis: heterogeneous. See exclusion criteria Setting: Inpatient department at hospital, Mumbai

Interventions 1. Music Therapy (n = 50): Indian instrumental classical music (Type of music: Hin- dustani classical music - instrumental - raaga) ‘Todi’ was played with the walkman for children belonging to the music group 2. Local Anaesthesia (LA) (n = 50): Similar procedure as the placebo group; however EMLA cream (lidocaine 2.5% and prilocaine 2.5%) and not a placebo cream was used for local application 3. No Intervention (Placebo) (n = 50): The placebo group was included in the study, as ‘not using anything’ (equivalent to placebo). Placebo cream (2.5g) consisting of 100% petroleum jelly was applied to the local body part with an occlusive dressing for 45 min. Earphones attached to a ‘Walkman’ were applied to the child’s ears for 15 min before the procedure, through the procedure and for 5 minutes thereafter; however, no music was played

Outcomes Pain (all ratings at minute 0): Self-report: VAS (0-10) Caregiver/Parent: VAS Nurse/Health Professionals: VAS (by investigator), VAS (by independent observer)

Notes We used a total N of 100 for this study (instead of 150) because we only assessed 2/3 conditions (music therapy versus placebo group)

Risk of bias

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 34 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Balan 2009 (Continued)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomized…using random number ta- bias) ble” p.470 Par 1

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g. random number table)

Incomplete outcome data (attrition bias) Unclear risk “Whenever possible this child was also told All outcomes to indicate his or her score on the VAS.” p. 470 Par 2

Selective reporting (reporting bias) High risk One or more outcomes reported incompletely for inclusion in meta-analysis

Other bias Low risk Appears to be free of other bias that would affect outcomes

Blinding of participants and personnel High risk Participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment and researcher provided intervention All outcomes and outcome assessment

Bellieni 2006

Methods Allocation: “using random numbers from a computer generated sequence”

Participants Needle Procedure: venepuncture Inclusion: -7-12 years old -last meal at least 3 h before venepuncture Exclusion: -no neurodevelopmental delay -no frequent venepunctures (more than 1/year) N: 69 Age: 7-12 years old Gender: F=36, M=33 Diagnosis: “outpatients” Setting: no detail provided, Italy

Interventions 1. Cartoon TV Distraction (n = 23): For the TV group, the children were set in front of a TV screen, at a distance of approximately 2.5 m; movies started at least 120 s before venepuncture. The children were invited to watch the cartoon when it started and no other distraction. Mothers were present in the blood sampling room, but were requested to not do anything to distract the children during venepuncture

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 35 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Bellieni 2006 (Continued)

2. Mother-Directed Distraction (n = 23): Mothers were asked to actively distract their children during the venepuncture by speaking, caressing, and soothing them 3. No Distraction Control (n = 23): Mothers were present in the blood sampling room, but were requested to not do anything to distract the children during venepuncture

Outcomes 1. OUCHER - child self-report 2. OUCHER - parent-report

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “using a random numbers from a computer bias) generated sequence” p.1015 Par 2

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists (e.g. parenting pain rating…“ignoring the score given by the child” p.1015)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Bisignano 2006

Methods Allocation: stratiﬁed randomization process was used, randomized according to gender’s TAQ scores (high, medium, low) - TAQ-threat appraisals

Participants Needle Procedure: IV Procedures Inclusion: -English-speaking 7-18 year olds scheduled for IV procedures at the paediatric haematology/oncology clinic at a large urban medical centre

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 36 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Bisignano 2006 (Continued)

-histories included at least two previous IVs Exclusion: -none given N: 30 Age: 6-18 years (Mean = 11.4) Gender: F=15, M=15 Diagnosis: cancer inpatients and outpatients at a paediatric haematology/oncology clinic. Also, sickle cell anaemia, lymphoma, leukaemia, osteosarcoma, etc Setting: Haematology/Oncology clinic at large urban medical centre

Interventions 1. CD-ROM Intervention (n=14): CD Rom available free of charge from Starlight Star- bright to children, families, and health professionals as part of the STARBRIGHT Ex- plorerSeries (http://www.starlight.org). The CD-ROM was designed to help children learn about the medical procedure. Children in the intervention condition had approximately 20 min to interact with the CD-ROM. Spotlight on IVs is an interactive CD- ROM that consists of four components: education/information, pre-procedural preparation (video modelling), breathing exercises, and distracting imagery. In the education/ information section, the CD-ROM allows children to ask questions such as “What is an IV?” and “How does an IV work?” using an animated nurse character named Ima Helpa. In addition, children are educated on IV procedural terms. During pre-procedural preparation, children are given a choice of viewing two videos on IV procedure. The first demonstrates a young girl being given an IV by a nurse, and the second uses a young boy to demonstrate how to get around with an IV attachment. In the breathing exercises section, the children are taught simple breathing exercises by Ima Helpa. Children are instructed to take a deep breath and to let it out slowly. For imagery, children are taught a simple imagery technique focusing on a calming location. This may serve two purposes, distraction and relaxation. In addition to Spotlight on IVs, a second CD-ROM, Spotlight on IV Catheters, developed by the first author, was utilized. This CD-ROM focused on the particular IV procedures used with some of the children (i.e., Broviac, Port-a- cath), because Spotlight on IVs does not provide images of these procedures. Haema- tology-oncology paediatric patients encounter various types of IVs, including Hickman, Broviac, Port-a-cath, and PICC. Spotlight on IV Catheters contains information and images specific to all three kinds of IVs, whereas Spotlight on IVs only demonstrates PICCs. Like Spotlight on IVs, Spotlight on IV Catheters is colourful and appropriate for children ages 7 to 18. Children in the treatment group viewed both CD-ROMs. 2. Standard Medical Care Condition (n=16): Children received the routine hospital preparation for the IV procedure. This preparation included an explanation of the IV procedure and explanation of the topical anesthetic cream (EMLA) approximately 1 hr prior to the IV procedure

Outcomes 1. Children’s Pain Self-Report (Pain-SR) - aka a “pain thermometer”, ranging from 0- 100 - immediately after IV 2. Children’s Fear Self-Report (Fear-SR) - single item faces scale. Administered 1) after intervention and before IV and 2) after IV (only interested in after IV) 3. VAS (administered by trained RA) - measuring overall anxiety during IV, range 1-5 4. Procedural Behavioral Rating Scale (PBRS) - 3 phases, 1) before 2) during pre-numb swab/anaesthetic 3) during procedure until needle is out (only interested in phase 3)

Notes None

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 37 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Bisignano 2006 (Continued)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) High risk No reason provided for missing data and All outcomes imbalance in missing data across groups

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems

Blinding of participants and personnel High risk Participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Blount 1992

Methods Allocation: Randomized - no further details

Participants Needle Procedure: Routine immunization Inclusion: -children attending a local county health department Exclusion: - none given N: 60 Age: 3-7 years (M = 5 years, SD = 10 months) Gender: M = 32, F= 28 Diagnosis: none Setting: Local county health department

Interventions 1. Distraction + Coping Skills Training + use of a party blower as an age appropriate version of deep breathing (n = 30): Activities the children would engage in prior to the procedures included coloring, playing with toys/puzzles, or interactive reading of a book. Coping skills training involved providing parents with a rationale for the training and instructing them to coach their child to blow a party blower immediately prior to and during the injections. The use of these components was modelled for the parents and

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 38 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Blount 1992 (Continued)

children by assistants assuming the roles of nurse, child, and parent. The parent then practised the coaching in a role-play with the assistant using a pretend needle, and was given feedback and praise. Children were allowed to play with the toys and blowers, and were encouraged to watch the training. One role-play was attempted with the child. The total training session took 10-12 minutes 2. No-Treatment Control (n = 30): Control condition parents were asked to provide demographic information and rate their child’s fear and how much they expected to be able to help their child during the medical procedures. Children were asked to provide ratings of their fear using a faces scale. The control subjects waited until called for their immunization, while the treatment subjects completed the demographic questionnaire and underwent the coping skills training prior to completing the other pre-injection inventories

Outcomes 1. Child-Adult Medical Procedure Interaction Scale (CAMPIS) 2. Observational Scale of Behavioral Distress (OSBD) 3. Behavioral Approach-Avoidance and Distress Scale (BAADS) 4. Parent ratings of child fear, pain, and distress using a 10 cm VAS 5. Child self-reports of fear and pain using a 5-faces scale 6. Nurse ratings of child distress

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Potential source of bias related to validity of measurement tool with participant young age

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 39 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Caprilli 2007

Methods Allocation: “children were randomly assigned to one of two groups”

Participants Needle Procedure: venepuncture Inclusion: -only native-born, Italian speaking children Exclusion: -signiﬁcant hearing or visual impairments -cognitive disorders -previous experience of hospitalization N: 108 Age: 4-13 Gender= F=56, M=52 Diagnosis: unclear Setting: Anna Meyer Pediatric Hospital, Florence, Italy

Interventions 1. Music Distraction (n = 54): Children received live music intervention before, during, and after blood sampling. The same two musicians participated in the entire study. One of the two musicians met the child and the parent in the waiting room. He started playing, singing, and proposing sonorous objects to the child and the parents and invited everybody to join the performance: the musician’s aim was to create a relationship with the child and the parents. The musician then asked whether the child would be happy to have him in the procedure room, and if the child agreed, he went in and continued playing and singing while the procedure was going on. After the procedure was ﬁnished, he went back to the waiting room together with the child and the parent, always interacting and playing music with them. The musician stayed with the child approximately 20 minutes 2. Control (n = 54): Children in this group received standard medical care. The doctor and nurse who performed the procedure were the same for the control and the music groups, and they were instructed to maintain their normal modes of consolation and/or distraction

Outcomes Pain: Self-Report: Wong Baker Faces Scale (higher = more pain) Distress: Behavioral report: Amended form of Observation Scale of Behavioral Distress (OBSD- A) Phase 2=during needle, Phase 3=after needle

Notes Only used outcomes for phase 2 in analyses.

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 40 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Caprilli 2007 (Continued)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Had a potential source of bias related to the speciﬁc study design (e.g. timing of parent ratings)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Cassidy 2002

Methods Allocation: Randomized using a standard randomization table for each cluster of 10 subjects

Participants Needle Procedure: DPTP immunization Inclusion: - 5 years old - due to receive standard DPTP preschool immunization - in good health - developmentally normal (i.e. the absence of developmental delays, in the expert opinion of the attending paediatrician) - subject’s parent/guardian agreement to participate after initial recruitment contact Exclusion: - previously immunized with the preschool DPTP vaccine - previously hospitalized - the presence of any acute or chronic medical condition N: 62 Age: all 5 years old Gender: M = 28, F = 34 Diagnosis: none Setting: two urban paediatric practices in Halifax, Nova Scotia, Canada

Interventions 1. Audio-Visual (AV) Distraction Using an Age-Appropriate TV Musical Cartoon (n = 29): For both the distraction and control group, once in the examining room, the child sat on the examining table and faced a 30 x 36 cm TV screen at eye level approximately 2 m away from the examining table. A video recorder was placed above the television, and the research stood behind the AV equipment to operate the video camera. The research greeted the child and asked him/her to watch the TV screen. The parent was asked to stand to the child’s right side, hold his/her right hand, and not to talk during

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 41 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cassidy 2002 (Continued)

the intervention. For the distraction group, the cartoon was turned on by the researcher after the clinician approached the child from the left side and immediately before the immunization. The section of cartoon chosen was started at a point in a musical number to be optimally engaging 2. Blank TV Screen Control (n = 33): Same initial procedure as treatment group; however, in this in this group, the TV was not turned on

Outcomes 1. Parent ratings of child anxiety before procedure on 10 cm VAS (1 = no anxiety, 10 = worst anxiety imaginable) 2. Child self-report of pain immediately after procedure using the Faces Pain Scale (FPS) 3. Blinded experimenter ratings of pain from videotaped procedures using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) 4. Blinded experimenter ratings of pain from videotaped procedures using the Child Facial Coding System (CFCS) 5. Two objective distraction scores for “watch TV” (i.e. time spent watching TV screen) and “watch needle” (i.e. time spent watching needle) coded from videotaped procedures by experimenters

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “subjects were randomly assigned…using a bias) standard randomization table” p.110 Par 2

Allocation concealment (selection bias) Low risk Use of an open random allocation schedule (e.g., random number table)

Incomplete outcome data (attrition bias) Unclear risk No reasons for missing data provided and All outcomes unclear of potential impact on outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g., non-neutral control stimulus)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 42 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cavender 2004

Methods Allocation: Randomized - using a table of random numbers

Participants Needle Procedure: venepuncture or IV insertion Inclusion: - English-speaking between 4 and 11 years old - had medical order written for venepuncture or IV insertion Exclusion: - children with chronic illness - children presenting with possible child abuse N: 43 Age: 4-11 years old (M = 7.88 years, SD = 1.74 years) Gender: M = 19, F = 24 Diagnosis: 11 = Surgical, 7 = Trauma, 9 = Vomiting, 4 = Other Setting: Emergency department of a private, 322 - bed, paediatric medical centre in the Southwestern United States

Interventions 1. Parental Positioning + Distraction (n = 20): In addition to receiving standard care, the parents in this group were taught by a child life specialist, using a standard script, how to position and distract their child during venepuncture. The two types of positioning included side-sitting (parent sat in chair next to exam table and child sat sideways on his/her lap) or chest-to-chest sitting (parent sat in chair next to exam table and child sat on his/her lap chest-to-chest). The parent and patient decided which of the two types of positioning to use based on age and size of the patient and parent. In addition, all patients in the experimental group chose from one of three distraction items to use during the procedure. These included the Illusion Kaleidoscope (glitter suspended in a fluid-filled tube passes before the lens when held to the eye and requires no manipulation to change images), I Spy: Super Challenger book (child asked to find items hidden on the page among multiple graphic designs) or Thomas the Tank Engine’s Big Lift-and- Look Book (child encouraged to open flaps to find hidden items). Following parental positioning, parents were instructed to engage their child with the distraction by asking the child repeated questions about the activity and reminding them to concentrate on what they were saying and what they were asking the child (e.g., “Look at the colors in the Kaleidoscope. Tell me what you see”) 2. Standard Care Comparison/Control (n = 23): Children received the institution’s standard care for venepuncture, including a full explanation of the procedure and parental presence for support

Outcomes 1. Child self-reported pain during procedure using the FACES scale 2. Child self-reported fear during the procedure using the Glasses Fear Scale 3. Parent and Child Life Specialist ratings of child fear during the preprocedural and post-procedural time periods using the Glasses Fear Scale 4. Child Life Specialist ratings of child distress using the Procedural Behavior Checklist (PBCL)

Notes ’Positioning’ (e.g., positioning the parent and/or child in such a way as to increase proximity and comfort during the procedure) was not included as one of the interventions explicitly assessed in this review because it was conceptualized as more of a physical intervention than a psychological one. However, we still included this study in this review under a separate intervention category called ’Parent Positioning + Child Distraction’, because the positioning was incorporated into the distraction and the distraction was a

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 43 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Cavender 2004 (Continued)

fundamental component of the intervention

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly assigned…by a table of random bias) numbers” p.36 Par 2

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g. random number table)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists (e.g. reliability of fear scale)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Chen 1999

Methods Allocation: Randomized - no further details

Participants Needle Procedure: three consecutive lumbar punctures (LPs; baseline, post-intervention, and follow-up) Inclusion: - diagnosis of Acute Lymphoblastic Leukemia (ALL) - 3-18 years old - English or Spanish speaking Exclusion - none given N: 50 Age: 3-18 years (M = 7.3 years, SD = 3.7 years) Gender: M = 67%, F = 33% Diagnosis: Acute Lymphoblastic Leukaemia (ALL) Setting: outpatient Children’s Center for Cancer and Blood Diseases at the Children’s Hospital Los Angeles

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 44 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Chen 1999 (Continued)

Interventions 1. Brief Alteration of Memory Intervention (n = 25): Treatment was conducted at two time points: immediately following the first LP and before the second LP. Parents were allowed to be present but did not actively participate. Children’s memories of the most recent LP were elicited through a memory interview that tested for biases in recall of threatening details, anxiety, and pain. In conducting the intervention, the therapist encouraged children to (a) reevaluate their reactions to the last LP through enhancing their beliefs about the efficacy of their own coping strategies (e.g., reminding them how asking the physician assistant questions helped them), (b) realistically appraise their responses to the LP (e.g., assessing the extent to which they cried, screamed, or protested), and (c) increase the accuracy of their subjective memory. The therapist and child discussed specific differences between the child’s memories and observed behaviours or the child’s previous self-report. Children were not taught coping skills but were encouraged to remember successful coping attempts that they naturally had made. To remind them about the intervention techniques during subsequent procedures, children were offered a fluorescent card that contained a cartoon drawing of a child thinking about his or her LP experience. Children wrote down memories discussed during the intervention on the card and then took the card into the procedure room. This card was intended to trigger thinking about the intervention in the absence of the therapist (during future LPs) 2. Attentional Control (n = 25): Children spent the same amount of time with the therapist as did the treatment group, both after the first and second LP,but were engaged in non-procedure related activities (e.g., drawing). Children in both groups were offered support and encouragement by the nurse and physician assistant during LPs and received preparation from the child life staff, including information and demonstration with dolls. However, children in the attention control group did not have a card to take with them during the LPs

Outcomes 1. Child self-reports of anxiety and pain on 10 cm vertical VAS 2. Parent ratings of child anxiety and pain using 10cm vertical VAS 3. Physician assistant performing the LP ratings of child’s procedural distress on the same VAS (physical assistants not blind to treatment condition) 4. Pain and anxiety questions administered to all children; however, they were not analysed if the child was too young to understand 5. 35-item Memory interview 6. Procedure Behavior Check List (PBCL) coded by trained unblinded observers 7. Child systolic and diastolic blood pressure ratings 8. Child heart rate 9. Child salivary cortisol

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 45 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Chen 1999 (Continued)

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk Reasons for missing data unlikely to be re- All outcomes lated to true outcome

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely (i.e. number of participants per group)

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g. potential impact of group setting)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Eland 1981

Methods Allocation: Randomized - no further details

Participants Needle Procedure: intramuscular injection Inclusion: - children scheduled for pre-kindergarten physical examinations Exclusion: - none given N: 20 Age: 4.9-5.9 years Gender: M = 20, F = 20 Diagnosis: none Setting: private paediatrician’s ofﬁce in a Midwestern city with a population of 60,000

Interventions 1. Frigiderm Coolant with Cognitive Information (n = 10) 2. Frigiderm Coolant with No Cognitive Information (n = 10) 3. Control Aerosol Spray with Cognitive Information (n = 10) 4. Control Aerosol Spray with No Cognitive Information (n = 10) Frigiderm Coolant (treatment condition): Altered the transmission of pain messages from the skin surface by spraying a skin coolant on the injection site immediately prior to the injection Cognitive Information (treatment condition): Attempted to alter the processing and interpretation of the pain stimulus by the use of positive suggestion. These children were told by the nurse immediately prior to the administration of the injection, “I’m going to spray something on your leg before your shot that will not hurt, will make your leg

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 46 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Eland 1981 (Continued)

feel cool, and the spray will make this shot hurt less than other shots you’ve had” Aerosol Spray (control condition): Aerosol air was sprayed on the child’s leg immediately prior to the injection No Cognitive Information (control condition): These children were told by the nurse immediately prior to the administration of the injection, “I’m going to spray something on your leg before the shot”

Outcomes 1. Child self-reports of pain using an adaptation of the tool used by Loebach 1979 and Shroeder 1979 comprised of eight 1 1/2 inch color squares placed across the bottom of a white felt board representing different events related to varying levels of pain. To compare the evaluation of pain according to the two levels of each treatment, intervals on the colour scale were assigned numerical ratings. The most painful hurt was rated as a “3”, moderate pain was weighted a “2”, mild pain a “1”, and no pain a “0” 2. Parent and nurse ratings of child anxiety. Parents and nurses were asked to rate the child’s anxiety about injections in one of three arbitrary categories: not anxious (scored as a “1”), somewhat anxious (scored as a “2”), or very anxious (scored as a “3”)

Notes We used a total N of 20 for this study (instead of 40) because we only assessed 2/4 conditions (Control Aerosol Spray with Cognitive Information versus Control Aerosol Spray with No Cognitive Information). Also, in this study the description of “Cognitive Information” was more in line with the deﬁnition of “Suggestion” as an intervention technique, so it was classiﬁed as “Suggestion” rather than “Preparation/Information” in the Results and Analyses

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Potential source of bias related to outcome measurement (e.g. modiﬁed measure with “limited reliability” p.370 Par 4)

Blinding of participants and personnel High risk Personnel were not blinded (performance bias) All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 47 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Eland 1981 (Continued)

Blinding of outcome assessment (detection Low risk Unclear if participant blinding, but judged bias) not likely to inﬂuence outcome measure- All outcomes ment

Fanurik 2000

Methods Allocation: Randomized - children were assigned to one of four stratiﬁed age groups (2- 4 years, 5-8 years, 9-12 years, 13-16 years) and then randomized to the treatment or control group - no further details

Participants Needle Procedure: IV insertion Inclusion: - 2-16 years - generally healthy - would have EMLA applied for at least 60 min prior to their IV insertion Exclusion: - children with chart-documented, parent-reported, or suspected developmental delay or cognitive impairment N: 160 Age: 2-16 years Gender: not reported Diagnosis: none (but undergoing elective outpatient gastrointestinal endoscopy) Setting: paediatric outpatients in the Gastroenterology Division of the Arkansas Chil- dren’s Hospital

Interventions 1. Age-Appropriate Distraction (n = 80): Bubbles and musical sound story books were used with the two youngest age groups (2-4, 5-8 years). Sound story books and headsets with a choice of a selection of music were used for children in the 9-12-year old group, depending on their preferences as well as staff assessment of attention span and maturity. Children 13 years and older listened to their choice of selection of music through headsets. Distraction materials were provided to the children while they were waiting to be called to the endoscopy suite, and when they arrived in the suite, nurses immediately engaged them with the distraction materials. Parents were informed that although the nurses would be distracting their children, they could stand close and touch their children. Nurses had been instructed in the use of distraction techniques by a paediatric psychologist 2. Typical Intervention Control (n = 80): Healthcare personnel interacted in their usual manner with the children but did not attempt to distract them from the procedure. Parents and children were asked to use whatever coping strategies whey would typically employ in this situation. An age-appropriate book was placed on the stretcher in clear view of the parents and children before the family entered the treatment room (although no speciﬁc instructions were given about using the book)

Outcomes 1. Child self-reports of pain and anxiety using 100 mm VASs obtained for children 5 years of older after IV was taped in place and prior to administration of medication for sedation 2. Three ratings of behavioral distress (pre-procedure, procedure, post-procedure) were recorded on a 6-point numerical scale (0 = not at all distressed, 5 = extremely distressed) by one of the GI specialty nurses (not involved in the medical procedure or intervention)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 48 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Fanurik 2000 (Continued)

, or a research assistant (nurses and research assistants were not blind to experimental group) 3. Parental predictions of child anxiety during IV insertions using 100 mm VAS 4. Behaviours of the children and parents in the comparison group were recorded by observers in a brief narrative form (coded as ’distraction’ or ’non-distraction’ strategies)

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) High risk Imbalance in numbers for missing data All outcomes across intervention groups

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Fowler-Kerry 1987

Methods Allocation: Randomized - randomly assigned with the restriction that there be equal numbers of boys and girls in each group- no further details

Participants Needle Procedure: immunization Inclusion: - healthy children 4.5-7 years old Exclusion: - none given N: 160 Age: 4.6-6.2 years (M = 5.5 years) Gender: M = 100, F = 100

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 49 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Fowler-Kerry 1987 (Continued)

Diagnosis: none Setting: patients attending one of three community health clinics located near a large metropolitan area

Interventions 1. Distraction (n = 40): Subjects had headphones placed over their ears and a piece of music suitable for children was played immediately prior to and during the injection 2. Suggestion (n = 40): Subjects were told that the experimenter was going to help them when they had their injection. The headphones were placed over their ears but no music was played 3. Distraction + Suggestion (n = 40): Subjects received both the music and the suggestion of assistance with pain relief 4. Control condition with headphones (n = 40): Subjects did not receive distraction or suggestions, but did wear headphones 5. Control condition without headphones (n = 40): Subjects did not receive distraction or suggestions, and did not wear headphones *Note: The study results combined the two control conditions into one overall control group of 80 participants

Outcomes Child self-report of pain using four-point VAS (0 = no pain, 3 = most pain possible) where subjects were shown a card with four equal sized blocks representing the range of pain of the scale and asked to point to the block which represented their pain

Notes We used a total N of 160 for this study (instead of 200) because we only assessed 4/5 conditions (Distraction versus Combined 2 Control Conditions and Suggestion versus Combined 2 Control Conditions)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists (e.g., “failure of suggestion may be attributed to an ineffective suggestion statement” p.174 Par 2)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 50 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Fowler-Kerry 1987 (Continued)

Blinding of participants and personnel High risk Although authors report blinding of par- (performance bias) ticipants and personnel, the nature of psy- All outcomes chological intervention precludes this

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment (see previous comment) All outcomes

Gold 2006

Methods Allocation: stratiﬁed according to age (7-9, 10-12), then randomized to condition

Participants Needle Procedure: paediatric IV placement Inclusion: -awaiting outpatient MRI or CT scans required IV placement Exclusion: -children with known or reported cognitive disabilities -taking pain medication -children who did not pass the cognitive and physical screening N: 20 Age: 8-12 years Gender: F=8, M=12 Diagnosis: heterogeneous, 12/20 had “medical conditions” Setting: Children’s hospital, Department of Radiology

Interventions 1. Virtual Reality (VR) Distraction (n= 10): This intervention involved a VR distraction presented via a head-mounted display. The virtual environment (VE), Street Luge, by Fifth Dimension Technologies (5DT), featured a fast-moving reality-based world in which the player races downhill lying on top of a big skateboard. The VE was presented via the 5DT HMD 800, a high-performance professional HMD that provides active matrix LCDs with full SVGA (800 600 3 [rgb]) pixel resolution. An InterSense Inertia Cube2 with a 3-degrees-of-freedom (DOF) tracker was attached. The player navigated through the VE with a Logitech rumble pad that provided tactile feedback and music via headphones, thus supplying a multi-sensory immersive experience. The HMD was connected to a Dell laptop (), Inspiron 8500 with 2.6-GHz processing speed and 1 GB of RAM, operating on Microsoft Windows XP and a NVIDIA GeForce4 4200 Go video card. Children in this treatment group received the VR intervention plus standard care. They began interacting with the VE 5 minutes prior to the IV placement, continued play throughout, and interacted with the VR for 5 subsequent minutes 2. Standard Care (n= 10): Topical anesthesia spray prior to IV placement, with no distraction. Children in this control group received only standard care and no VR. They were given an opportunity to play with the VR for 3 min following the completion of their IV placement.

Outcomes Pain and Distress measures: 1. Faces Pain Scale-Revised (FPS-R) to assess affective pain (worry about both related to pain 2. Wong Baker FACES Pain Rating scale to assess affective pain (worry about both related

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 51 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Gold 2006 (Continued)

to pain 3. Visual Analog Scales (VASs) to assess pre-existing pain, IV pain intensity, past IV pain intensity, and anticipatory anxiety about the current procedure

Notes Other outcome measures not speciﬁcally related to procedural pain and distress were also used (e.g., measures for anxiety sensitivity, sickness, engagement, etc) but are not reported here because they were not relevant to this review. Similarly, VAS anticipatory anxiety was also assessed but was not included in our analyses because we focused on anxiety during the procedure

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely (i.e. nurse and parent report)

Other bias High risk Small sample size potential source of bias affecting outcomes

Blinding of participants and personnel High risk Participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Gonzalez 1993

Methods Allocation: Randomized - using a block randomization procedure that took age into account - no further details

Participants Needle Procedure: routine injections Inclusion: - none given Exclusion: - none given

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 52 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Gonzalez 1993 (Continued)

N: 28 Age: 3-7 years Gender: M = 21, F = 21 Diagnosis: none Setting: recruited from the general pediatric primary care clinic at a large, urban public hospital

Interventions 1. Maternal Reassurance (n = 14): Mothers received: (a) oral instructions on how to reassure their child verbally during the medical procedure, (b) listened to an audio cassette of a parent demonstrating the type of verbal reassurances that should be used, and (c) practised their reassuring verbal strategies with the help of an assistant. Mothers were also instructed to engage in reassurance throughout the recording period 2. Distraction (n = 14). Mothers received: (a) oral instructions on how to distract their child verbally during the medical procedure, (b) listened to an audio cassette of a parent demonstrating the type of distractions that should be used, and (c) practiced their distracting verbal strategies with the help of an assistant. Mothers were also instructed to engage in distraction throughout the recording period For both the Maternal Reassurance and Distraction groups, a large sign with examples of appropriate vocalizations was posted approximately 2 metres from the parents to help cue them during the medical procedure. Throughout the procedure a research assistant pointed to the sign each time the mother stopped engaging in the appropriate vocalization for more than 10 seconds. The two research assistants who were present throughout the procedure did not interact with the mother or child in any other manner 3. Control (n = 14): Mothers received a short lecture on transportation to the hospital, listened to an audio cassette that provided additional information about transportation, and discussed transportation issues with a research assistant

Outcomes 1. Research assistant ratings of child distress using the Modiﬁed Frankl Behavior Rating Scale 2. Child self-report of pain during the procedure using the Oucher Pain Rating Scale 3. Observers blind to group assignment ratings of child distress during the procedure, using the Observational Scale of Behavioral Distress-Revised (OSBD-R) coded from videotapes of the injection for the injection and post-injection time periods 4. Observers blind to group assignment ratings of parental adherence to the experimental manipulation using the ’nonprocedure-related talk’ and ’reassuring comment’ codes of the Child-Adult Medical Procedure Interaction Scale (CAMPIS)

Notes We used a total N of 28 for this study (instead of 42) because we only assessed 2/3 conditions (Distraction versus Control). This is because there is already considerable existing research to suggest that reassurance is a distress-promoting strategy, and was therefore not included as one of the interventions assessed in this review

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 53 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Gonzalez 1993 (Continued)

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel Unclear risk Insufﬁcient information to permit judg- (performance bias) ment of ’low’ or ’high’ risk All outcomes

Blinding of outcome assessment (detection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk (e.g. research All outcomes assistant ratings)

Goodenough 1997

Methods Allocation: Randomized - stratiﬁed by age - no further details

Participants Needle Procedure: venepuncture Inclusion: - children aged 3-17 years consecutively scheduled to undergo venepuncture Exclusion: - children with a major mental handicap N: 78 Age: 3.5-17.7 years Gender: M = 73, F = 44 Diagnosis: none (although 36 children were undergoing venipuncture as part of ongoing investigation for chronic illness) Setting: Sydney Children’s Hospital

Interventions 1. Placebo Cream + Suggestion (n = 39): The placebo cream involved a disinfectant handwash which was odourless thick white foam with no anesthetic properties. The suggestion involved having the nurse say to the child “We are trying out a new special cream. I am going to put some cream on your arm that might make it (the needle) hurt less”. In this condition, the cream was dispensed from a brightly wrapped container as a means of visually reinforcing the child’s expectancy that the cream might help 2. Placebo Cream Alone (n = 39): Only application of the placebo cream described above with no suggestion. In this condition, the nurse said to the child “I am going to put some cream on your arm” and the cream was dispensed from a plain while wrapped container For both of the above conditions using the placebo cream, the cream was applied to the arm with cotton wool, rubbed into the skin, and the excess was removed using cotton wool

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 54 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Goodenough 1997 (Continued)

3. No Cream Control (n = 39): No cream was applied and the nurse did not say anything beyond standard procedural instruction

Outcomes 1. Child self-report of pain using the Faces Pain Scale (FPS) 2. Child self-report of anxiety using the Children’s Anxiety and Pain Scale (CAPS) 3. Child self-report of whether the cream had helped to reduce the needle-pain 4. Observer ratings of child behavioral reaction to pain during the needle

Notes We used a total N of 78 for this study (instead of 117) because we only assessed 2/3 conditions (Placebo Cream + Suggestion versus Placebo Cream Alone)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk Reasons for missing data unlikely to be re- All outcomes lated to true outcome

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Low risk Appears to be free of other bias that would affect outcomes

Blinding of participants and personnel Unclear risk Insufﬁcient information to permit judg- (performance bias) ment of ’low’ or ’high’ risk All outcomes

Blinding of outcome assessment (detection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk All outcomes

Gupta 2006

Methods Allocation: prospective randomized study, randomized with a computer-generated table of random numbers

Participants Needle Procedure: venepuncture “venous cannulation” Inclusion: -children aged 6-12 years, ASA physical status I-II, undergoing venous routine surgical procedures Exclusion:

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 55 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Gupta 2006 (Continued)

-children with delayed milestones, cardiac or neurobiological impairment, or failure to cannulate on ﬁrst attempt N: 75 Age: 6-12 years Gender: F=31, M=44 Diagnosis: paediatric patients, ASA physical status I-II, undergoing elective surgery Setting: not speciﬁed (just states that procedure was done in “preoperative area”)

Interventions 1. Distraction group (n=25): Patients were given a rubber ball (which produces a squeaky sound on being compressed) in the palm of their hand which was not to be cannulated. The patients were asked to alternately compress and release the ball 2. Balloon group (n=25): Patients were asked to inflate a balloon at least for 20 seconds before initiation of the venipuncture. The cannula insertion was performed during the act of forceful expiration. A small plastic hollow pipe was attached to the end of the balloon from where it is inflated and fixed to make the assembly easier to hold with one hand, thus making the act of inflation easier. According to study authors, balloon inflation may have a combined effect of distraction and increasing intrathoracic pressure making the veins more prominent and easier to cannulate 3. Control group (n=25): Patients did not press a rubber ball nor were they asked to inflate a balloon

Outcomes Pain: Self-report: VAS (10cm). On back of Pain Face Scale. Children placed sliding marker between extreme anchors/faces. Administered during venepuncture

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “consecutive pediatric patients were ran- bias) domized with a computer generated table of random numbers” p.1372 Par 3

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes reported incompletely for inclusion in meta-analysis

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 56 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Gupta 2006 (Continued)

Blinding of participants and personnel High risk Participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Harrison 1991

Methods Allocation: Randomized - no further details

Participants Needle Procedure: venous blood sampling Inclusion: - 6-12 year olds reporting to four hospital laboratories in Kuwait Exclusion: - none given N: 100 Age: 6-12 years Gender: M = 51, F = 49 Diagnosis: none Setting: four hospital laboratories in Kuwait

Interventions 1. Preparation (n = 50): Children in this group were read a preparation story accompanied by pictures, and were encouraged to ask questions. The story offered a simple description of the venous blood sampling procedure, why it is carried out, and what happens to the blood after it has been collected. It emphasized that the procedure creates a brief period of pain, and that the pain is noticeable but not unbearable. The story also stressed that venepuncture is less painful if a child relaxes his arm and cooperates with the technician. In order to increase the likelihood of children modeling the behaviour of the child featured in the story, sex- and age-appropriate models of average appearance were used, and local children, parents, and hospital settings were photographed 2. No Preparation control (n = 50): No speciﬁc description of this group was mentioned in the study. However, it was noted that initial observations revealed that laboratory technicians generally made no attempt to prepare children for venepuncture or to talk them through the procedure. If children protested and struggled, their strategy was to physically restrain the child and complete the procedure. Often, parents were recruited to help

Outcomes 1. Child self-report of pain using 6-point histogram VAS 2. Parent observer-report of pain and fear using 0-5 scale 2. Radial pulse rates of children before and after the procedure 3. Parent responses to questions related to the procedure

Notes None

Risk of bias

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 57 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Harrison 1991 (Continued)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Unclear risk Insufﬁcient reporting of exclusions to per- All outcomes mit judgment of “low” or “high” risk (e.g. some parent-report missing)

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Had a potential source of bias related to the speciﬁc study design (e.g. potential impact of group setting)

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Huet 2011

Methods Allocation: Randomized - randomly assigned by lottery

Participants Needle Procedure: local dental anaesthetic using “standard metal syringe without electronic assistance after applying a topical anesthetic for 1 min to the area where local anesthetic would be injected” Inclusion: Exclusion: N: 29 Age: 5-12 years old (Median = 9 for control group and 8 for intervention group) Gender: M = 16, F = 13 Diagnosis: none Setting: Department of Pediatric Dentistry at Rennes University Hospital

Interventions 1. Hypnosis Intervention (n = 14, + 1 excluded from analyses): Hypnosis was performed following the usual three-step Ericksonian procedure. Hypnotic induction began once the subject was seated in the dentist’s chair. Speaking slowly in a monotone voice, the hypnotherapist made the child focus on her (hypnotherapist) voice and on images to establish a “hypnotic relation”, ﬁrst taking into account items in the room and then using suggestions and stories. The suggestions or stories used during the induction were

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 58 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Huet 2011 (Continued)

linked with things the child was interested in and were chosen according to the initial interview. The child could express any discomfort using a predeﬁned code. All external interventions (e.g., examination with the mirror, placement of towels, injection) were carried out with agreement of the hypnotherapist, who incorporated these interventions in her explanations to the child. A hypnotic trance was considered to have been achieved when the hypnotherapist noted muscular relaxation, regular breathing, and immobility (cataleptic state). The dental anesthesia and treatments were then performed. The hypnotherapist continued speaking to the child to maintain the state of trance. At the end of the treatment session, the hypnotherapist gradually “awoke” the child by speaking a little bit louder and using the items in the room to help the child come back to the initial conscious state. The hypnosis was performed by a single trained operator 2. No-Hypnosis Control (n = 15): The same general procedure as described above was also used for all the children in this group, except for the hypnosis

Outcomes 1. Child self-report of pain: Visual Analogue Scale (0-10) 2. Modiﬁed Objective Pain Score (MOPS) (0-10 score) 3. Modiﬁed Yale preoperative anxiety scale (mYPAS)

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly assigned by lottery” (p.426) bias)

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk Missing data minimal and unlikely to be All outcomes related to true outcome

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Multiple potential sources of bias related to study design and other problems

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 59 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Inal 2012

Methods Allocation: computer-generated table of random numbers into 2 approx equal groups

Participants Needle Procedure: blood draw (venepuncture) x1 Inclusion: - 6-12 year old patients who required blood tests Exclusion: -neurodevelopmentally delayed -verbal difﬁculties -hearing or visual impairments -have taken an analgesic within the last 6hrs -had a history of syncope due to blood draws N: 123 Age: 6-12 years Gender: F=61, M=62 Diagnosis: unclear; “non-chronic” illness status (n=49 control; n=53 experimental) , “chronic” illness (n=13 control, n=8 experimental) e.g., diabetes, CF, thalassaemia, coeliac Setting: paediatric clinic, Istanbul, Turkey

Interventions 1. Distraction group (n = 61): Children looked through 5 x 8 cm “Flippits (R)” distraction cards which consisted of various pictures and shapes. The same nurse asked the child questions about the cards during the blood draw procedure that child only answer if he/ she examined the cards carefully. The blood-drawing procedure started when the child began looking at the distraction cards carefully. Questions were asked about the cards until the end of the procedure (e.g., “how many spots do the ladybugs have in total?”) 2. Control group (n = 62): Children received no intervention

Outcomes Pain: Child self-report: FPS-R Caregiver/Parent-Report: FPS-R Nurse report: FPS-R Anxiety: Caregiver/Parent Report: Anxiety set of children’s Anxiety and Pain Scales (CAPS) - higher is more anxiety Nurse Report: Anxiety set of Children’s Anxiety and Pain Scales (CAPS)

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomized with a computer-generated bias) table of random numbers” p.212 Par 6

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g., random number table)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 60 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Inal 2012 (Continued)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Jeffs 2007

Methods Allocation: ’randomly assigned to groups’ ’using computer generated random numbers table’

Participants Needle Procedure: Phase II of allergy testing involving injection Inclusion: early and middle phase adolescents aged 11-17 years -environmental or food allergen testing -parental presence -ability to read and write English Exclusion: -bee venom allergy testing -cognitive and developmental disability (determined by presence of individual educational plan or accommodation that parents identiﬁed as related to cognitive delay) N: 27 Age: 11-17 Gender: F=15, M=17 Diagnosis: not speciﬁed explicitly but practice was for allergy, asthma, and immunology patients Setting: outpatient allergy, asthma, and immunology medical practice within large medical centre

Interventions 1. Self Selected Distraction (n = 9): This group made one selection from an investigator- developed collection of music CDs, including alternative, hip-hop, pop, pop country, and rock music. Popular teen books on cassette and videotapes, including movies, music videos, sports programs, and cartoons, were also available. Several adolescents who were not study participants assisted in the selection of the media 2. Investigator Selected Distraction (n = 10): This group watched a nursing recruitment videotape targeting an adolescent audience that showed interviews with nurses, identiﬁed various nursing roles, and explained the work performed by nurses Both distraction groups listened to the media through headphones. All media and equip-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 61 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Jeffs 2007 (Continued)

ment were new and provided by the researcher. Distraction was implemented in the intervention groups just prior to and continuously during the actual allergy testing procedure. The physicians’ office nurses, who conducted the allergy testing, were directed to avoid interrupting the distraction 3. Usual Care Control (n= 8): The UC group received the typical care provided by the physicians’ office nurses who performed the allergy skin testing without any scripting or prompting. Usual care consisted of the typical communication between the office nurse and adolescent about non-allergy testing topics, such as favourite school subjects and sports, as well as allergy testing information. The UC group received no experimental intervention. Allergy testing materials were kept within view of the adolescent; no attempt was made to conceal testing materials

Outcomes Self-Report Pain: Adolescent Pediatric Pain Tool (used pain rating for data extraction) Wong Baker FACES Scale (0-10)

Notes Phase I allergy testing was used to determine the presence of non-reactive allergens. Distraction was resumed during Phase 2 testing, therefore only Phase II testing was used in the analyses for this review. Phase 1 involved an N of 32 while Phase 2 involved and N of 27; therefore, the total N reported for this study is 27. Also, the two distraction conditions were pooled together to create one overall distraction condition

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk p.175 Par #2 participants randomly as- bias) signed “using a computer-generated random numbers table”

Allocation concealment (selection bias) Unclear risk Unclear if all appropriate safeguards taken with assignment envelopes (i.e., sequen- tially numbered or opaque)

Incomplete outcome data (attrition bias) Low risk No missing data for phase included in cur- All outcomes rent review

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g., low statistical power)

Blinding of participants and personnel High risk p.172 Par #7 “unblinded experimental de- (performance bias) sign” All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 62 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Jeffs 2007 (Continued)

Blinding of outcome assessment (detection High risk p.172 Par #7 “unblinded experimental de- bias) sign” and no blinding of self-report of out- All outcomes come assessment

Katz 1987

Methods Allocation: Randomized - stratiﬁed by sex - no further details

Participants Needle Procedure: bone marrow aspiration (BMA) (approximately 50% of the children also underwent a lumbar puncture immediately following their BMA) Inclusion: - baseline self-reported pain score > 50 (possible range: zero to 100) - baseline self-reported fear score > 4 (possible range: 1 to 7) - Procedural Behavior Rating Scale-revised score > 4 (possible range: zero to 33) - nurse rating of child anxiety > 3 (possible range: one to ﬁve) Exclusion: - none given N: 36 Age: 6-11 years old (M = 8.3 years, SD = 1.68 years) Gender: M = 24, F = 12 Diagnosis: Acute lymphoblastic leukaemia (ALL) Setting: Hematology-Oncology clinic at the Children’s Hospital of Los Angeles

Interventions 1. Hypnosis (n = 18): Comprised training in hypnosis and self-hypnosis by one of two psychologists experienced in psychological aspects of oncology and hypnosis. Major components of this intervention included the development of rapport, direct discussions about the child’s medical history and treatment needs, a hypnotic induction utilizing eye ﬁxation with or without eye closure, active imagery tailored to the interests of each individual child, deep muscle relaxation, and suggestions. The speciﬁc suggestions incorporated were as follows: imagery to reduce or reframe sensory/pain experiences; distraction and relaxation; pairing positive affect with medical procedures; developing a sense of mastery and control over sensory and affective experience; and post-hypnotic suggestions for practicing and re-entering hypnosis with a cue from their therapist during actual procedures 2. Play control condition (n = 18): This condition was comprised of non-directed play sessions designed to control for the amount of time and attention the child received from a sympathetic hospital professional (i.e., the psychologists performing the interventions) . Subjects in this condition were seen prior to BMAs for the same amount of time as those in the hypnosis condition and by the same psychologists. Elements of the non- directed play condition included development of rapport, non-medical play, and no- medical verbal interactions. No discussions about the child’s illness or treatment were initiated. If the child initiated such conversations, the therapists subtly changed the subject

Outcomes 1. Observer ratings of child distress during three temporal phases using the Procedural Behavior Rating Scale- Revised (PBRS-R) 2. Nurse ratings of child anxiety during the procedure using one to ﬁve Likert scale 3. Child self-report of fear during the procedure using the Fear Self-Report measure

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 63 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Katz 1987 (Continued)

4. Child self-report of pain during the procedure using the Pain Self-Report (comprised of a graphic rating scale patterned after a thermometer where 0 = no hurt at all, and 100 = the most hurt possible) 5. Therapist ratings of rapport with patient and child’s response to hypnosis on one to ﬁve scale (1 = excellent, 5 = poor)

Notes Outcomes were assessed at baseline and intervention with repeated measures on the intervention condition as there were 3 BMAs (i.e., Baseline, Post-Treatment 1, Post- Treatment 2, and Post-Treatment 3). Each subject was seen for two intervention sessions prior to their next BMA and sessions were 30 minutes long. For the purpose of this review, we only used data from the ﬁrst BMA procedure (i.e., Post-Treatment 1)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Potential source of bias related to timing of outcome measurement (e.g., sometimes after multiple procedures)

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 64 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kleiber 2001

Methods Allocation: Randomized - permutated block randomization used to assure that a balanced number of children with histories of high distress were randomized to the control and experimental groups; randomization conducted according to the procedures outlined by Friedman et al, 1996. Randomization achieved using a table of random numbers (see note)

Participants Needle Procedure: IV Insertion Inclusion: - no neurological or sensory impairment at the IV site - child able to distinguish between biggest and smallest in order to Oucher pain scale - parent with legal custody agreed to be with the child during the procedure - parent able to speak and read English Exclusion: - none given N: 44 Age: 4-7 years Gender: M = 11, F = 33 Diagnosis: children being treated or evaluated for non-life threatening conditions such as chronic urinary tract infections, urinary incontinence, chronic constipation, growth failure, and reactive airway disease Setting: large Midwestern tertiary care hospital that serves as the primary specialty referral site for a population of approximately three million people. It is located in a state in which the population is predominantly Caucasian, with other races accounting for 5% of the population

Interventions 1. Parent Coaching + Distraction (n = 22): Parents viewed a 7-minute educational video on distraction that was developed for this study (available from authors upon request) . The children remained with their parents during the video, and were encouraged to watch it. The narration tells the viewer why and how distraction should be used with children. The viewer is given suggestions on how to choose the most effective distraction strategy. Three parents model distraction with their preschool aged children and explain why they found distraction to be helpful. Finally, parents are told to involve the child in choosing the distraction and to praise the child at the end of the procedure. The video ends with a written summary of the following key points: (a) Focus your child’s attention away from the medical procedure, (b) use activities that keep your child’s attention (interactive books, blowing bubbles, surprise or novel toys, favourite stories), (c) if you lose your child’s attention, keep trying to get it back, (d) using distraction takes some effort, but it can help you child feel more comfortable, and (e) praise your child at the e4nd of the procedure. After viewing the video, the parents and children were shown a basket of distraction items and were encouraged to pick something to use during the IV insertion 2. Standard Care Control (n = 22): Standard practice in this setting was for individual practitioners to decide whether or not to apply a topic anesthetic cream (EMLA) at the IV site. Parents were invited to accompany their child to the procedure room and stay during the IV insertion. They received no instruction on what to do during the insertion

Outcomes 1. Parent ratings of child’s previous distress during medical procedures using a seven- point scale 2. Child self-report of pain during the IV insertion using the Oucher Scale 3. Parent ratings of child distress using the Perception of Procedures Questionnaire-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 65 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kleiber 2001 (Continued)

Revised (PPQ-R) 4. Observer ratings of child distress using the Observer Scale of Behavioral Distress- Revised (OSBD-R) 5. Observer ratings of parent distraction behavior coded from videotapes (each 10-second interval of the procedure coded for the presence/absence of parental distraction)

Notes Although it was not stated in the paper, personal communication with the author con- ﬁrmed that randomization was achieved via a random table of numbers

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk Reasons for missing data unlikely to be re- All outcomes lated to true outcome and balanced across intervention groups

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g., low reliability of parent outcome measure)

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report and parent-re- bias) port of outcome assessment All outcomes

Kristjansdottir 2010

Methods Allocation: table of random numbers

Participants Needle Procedure: Polio Immunization Inclusion: -Icelandic-speaking adolescents scheduled for a ninth grade immunization Exclusion: none listed N: 118

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 66 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kristjansdottir 2010 (Continued)

Age: 13-15 Gender: F=55, M=63 Diagnosis: healthy (community sample attending school) Setting: school, Iceland

Interventions 1. Music Distraction with Headphones (n = 38): Participants were asked to wear headphones to listen to music 2. Music Distraction without Headphones (n = 41): Participants were not asked to wear headphones to listen to music. Instead, they were asked to listen to music from loudspeakers In designing the intervention, therapeutic nursing intervention guidelines on distraction to relieve pain and music therapy were used. In addition, a music therapist was consulted. The intervention protocol was the same for both intervention groups and included the following: (a) explaining the purpose of the music to the adolescents (i.e., to distract and to help them cope during/after the immunization), (b) asking them to concentrate on and ‘disappear into’ the music, and continue to do so for a few minutes (2-3 minutes) before and after the immunization, and (c) creating a sense of control in the adolescents by giving them choice (i.e., selecting a CD and controlling the volume setting). The music for the study was selected based upon results from a pilot study. Using a hypothetical immunization, 6 teens (13-15 years old) were interviewed showing they preferred top ten chart music to relaxing music during the immunization. Acknowledging this, the music used in the study was largely chosen from top 10 charts of the day, with the exception of one relaxing classical CD. In selecting the top ten chart music for the study, advice from a music marketing manager who knew adolescent music preferences, was sought 3. Standard Care Control (n = 39): The school nurses were encouraged to maintain their normal modes of caring, which was to comfort and guide the adolescents verbally. If the adolescents had any questions or concerns prior to the immunization, or discomfort after the immunization, the school nurses responded to these with care

Outcomes Pain: Self-report: VAS (0-10)

Notes The data from the two distraction conditions were pooled together to create one overall distraction condition

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “table of random numbers was used to random- bias) ize into groups” (p.20 Par 11)

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e. g., random number table)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 67 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kristjansdottir 2010 (Continued)

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Kuttner 1987

Methods Allocation: Randomized - no further details

Participants Needle Procedure: bone marrow aspiration (BMA) Inclusion - leukaemia patients who had expressed difﬁculty in coping with the recurrent BMAs and Lumbar Punctures (LPs) that constituted an essential part of their treatment for cancer - children 6 years old and younger Exclusion - none given N: 25 Age: 3-6.11 years (larger study compared 3-6 year olds with 7-10 year olds but this paper reports results of younger group only) Gender: not reported Diagnosis: Leukaemia Setting: treatment/surgery room - no further details

Interventions 1. Hypnosis (n = 9): This group received the hypnotic techniques in which the child’s favourite story became the hypnotic vehicle to create a pleasant imaginative involvement that would lead to a different interpretation of the noxious experience. The favourite stories included hypnotic suggestions and reframing. Prior to the medical procedure, the researcher asked the child to tell his/her favourite story, noted the child’s choice of words and emphasis, and then suggested the following plan of action: ‘When we go into the treatment room, how would it be if I tell the story of (insert child’s story title) while the BMA gets done? I wouldn’t be surprised if the procedure didn’t go much quicker, and by the time the story ends the band-aid will be on and everything will be ﬁnished!’ After a 10-20 minute induction and practice session, the researcher accompanied the child and parent into the surgery room where, as soon as the child was lying on the table, a trance was induced and maintained through the procedure. The hypnotic process incorporated active involvement with the child, ﬂexibility, informality, and narrowed/increase absorption of attention. Procedural and sensory information was interwoven into the story-line (e.g., indirect/direct suggestions for comfort, diminishing

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 68 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kuttner 1987 (Continued)

pain awareness, and increased coping within the story-line). The central characters and heroes/heroines were used as metaphors of courage and feelings of accomplishment. Parents were encouraged to be present and touch or hold the child’s hand; however, the therapist was generally the only adult to talk with the child during the procedure 2. Distraction (n = 8): Physical objects such as pop-up books, bubbles, and squeezy toys were used during the BMA to shift the child’s attention away from the painful procedure and onto these physical objects which contained elements of surprise, play, and opportunities for the child to demonstrate some accomplishment, instead of feeling helpless. For example, the child was encouraged to count interesting objects in the pop- up book, or to blow bubbles, or was challenged to correctly name physical objects 3. Standard Medical Care Control (n = 8): This group received the standard medical practice, which included providing some information, reassurance, and support

Outcomes 1. Observer ratings of child distress using the Procedure Behavior Rating Scale- Revised (PBRS-R) 2. Observer, physician, nurse, and parents ratings of child’s pain and anxiety on ﬁve- point rating scales 3. Child self-report of pain and anxiety using an interval picture ﬁve-point scale

Notes Data necessary for the meta-analysis data pooling (i.e., means and SDs) was reported for the PBRS-R only. Also, because there were two treatment sessions, data was reported for three time points (i.e., baseline, 1st intervention, 2nd intervention). For the analyses in this review, we used data for the 1st intervention only

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Unclear risk Insufﬁcient reporting of exclusions to per- All outcomes mit judgment of “low” or “high” risk. One or more outcomes of interest are reported incompletely

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Multiple potential sources of bias related to study design (e.g., small sample size)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 69 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Kuttner 1987 (Continued)

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Liossi 1999

Methods Allocation: Randomized - table of random numbers (see note)

Participants Needle Procedure: bone marrow aspirations (BMAs; baseline and intervention) Inclusion: - Leukaemia patients between 5 and 15 years old whose medical protocol required at least two BMAs within 2.5 months Exclusion: - previous therapy with hypnosis and/or cognitive behavioral (CB) coping - concurrent treatment during the project with analgesic or psychotropic medication - a major affective disorder or other psychiatric diagnosis N: 30 Age: 5-15 years (mean = 8 years, SD = 2.5 years Gender: M = 17, F = 13 Diagnosis: Leukaemia Setting: treatment room of clinic - no further details

Interventions 1. Cognitive Behavioural (CB) Intervention (n = 10): This condition involved: (a) relaxation training (two relaxation techniques were taught in the sessions: progressive muscle relations, and an abbreviated form of autogenic relaxation; imagery was not included), (b) breathing exercises (each child was instructed to take a deep breath and to let it out slowly while making a hissing sound), and (c) cognitive restructuring (included training in attention redirection and restructuring self-defeating cognitions; patients were taught to identify helpless or self-defeating thoughts and to interrupt and change these using prepared substitute positive coping thoughts such as “I know I can do it”, or afﬁrma- tions by focusing attention on neutral or pleasant events /objects or by occupying their attention through mental repetition of afﬁrmations, songs, or prayers) 2. Hypnosis (n = 10): Hypnosis was induced by visual imagery (favorite place, activity, or television program). Two relaxation techniques were taught in sessions: progressive muscle relations and an abbreviated form of autogenic relaxation. Reference to patient well-being, strengths, competence, and comfort were included in the image. Following several minutes of hypnotic involvement, the patient was given analgesic suggestions. Hypnotic suggestions included the following: request for numbness (to make lower back go to sleep for a few minutes), topical anaesthesia (imaging painting numbing medicine on our back), local anaesthesia (imaging injecting and anesthetic into the back), and glove anaesthesia (let hand go numb and let the numb feeling transfer from the hand to back) 3. Standard Treatment Control (n = 10). All patients in this control condition as well as patients in the above two treatment conditions received a standard lidocaine injection

Outcomes 1. Child self-report of pain and pain-related anxiety during one BMA at baseline (time 1) using a six-point faces rating scale (0 = no pain/anxiety, 5 = as much pain/anxiety child can imagine)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 70 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 1999 (Continued)

2. Nurse ratings of child distress using the Procedure Behavior Checklist (PBCL) 3. Child’s hypnotic ability assessed using a Greek translation of the Stanford Hypnotic Clinical Scale for Children (SHCS-Children)

Notes Although it was not stated in the paper, personal communication with author confirmed that randomization was achieved via a random table of numbers. Also, the authors note that verbal communication from therapist to child during the procedure comprised brief encouragements (e.g., “You’re doing fine”, “It’s almost over”) and were the same for patients in all the groups. While the authors conceptualized these statements as ‘encouragement’, other research literature would categorize these statements as ‘reassurance’ which has been shown to be a distress-promoting strategy. However, although this could potentially reduce the efficacy of the interventions, since all three conditions received these statements, this would not present as a confound and comparisons between groups are still feasible. Lastly, outcomes were assessed at baseline and post-treatment. For this review, only post-treatment scores were used

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk “the small number of subjects in this study seriously compromise power and may yield spuriously high correlations” p.112 Par 3

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 71 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2003

Methods Allocation: Randomized - no further details

Participants Needle Procedure: series of lumbar punctures (LPs) (baselines and using intervention) Inclusion: - children with leukaemia or non-Hodgkin’s lymphoma - 6-16 years old - undergoing regular lumbar punctures over a 4-year period Exclusion: -previous hypnosis treatment -concurrent treatment during the project with analgesic or psychotropic medication -a major affective disorder or other psychiatric diagnosis N: 60 Age: 6-16 years (mean = 8.63 years, SD = 2.86 years) Gender: not reported Diagnosis: Leukaemia or Non-Hodgkin’s Lymphoma Setting: Hematology/Oncology Department of the Children’s Hospital Aglaia Kyriakou, Athens, Greece

Interventions 1. Direct Hypnosis with Standard Medical Treatment (n = 20): Hypnotic suggestions included: request for numbness (to make lower back go to sleep for a few minutes), topical anaesthesia (imaging painting numbing medicine on our back), local anaesthesia (imaging injecting and anaesthetic into the back), glove anaesthesia (let hand go numb and let the numb feeling transfer from the hand to back), and switchbox (imagining using a switch to turn off or modulate incoming pain message nerve signals going from the body to the brain). 2. Indirect Hypnosis with Standard Medical Treatment (n = 20): Using metaphors of a setting sun and Mexican food to imagine details scenes using various senses (e.g., sight, smell, taste), develop cues to experience immediate relaxation, and pictures ways to adapt to discomfort Both the direct and indirect hypnosis groups ended with a post-hypnotic suggestion that the hypnotic experience would be repeated during the actual medical procedure with the help of the therapist, and that this would provide comfort during the LP 3. Attentional Control with Standard Medical Treatment (n = 20): Included elements such as development of rapport, non-medical play, and no-medical verbal interactions (e.g., discussing school, activities, sports, etc). New coping skills were not introduced 4. Standard Medical Treatment (n = 20): Patients in this group received no therapist contact or treatment intervention, but, like all patients, received standard interventions provided by the hospital staff for pain control during LPs (i.e., medical and nursing staff offered information, support, and reassurance)

Outcomes 1. Child self-report of pain and anxiety during three consecutive LPs at baseline and for two consecutive LPs with the intervention, using the six-point Wong and Baker faces rating scale 2. Nurse ratings of child pain during three consecutive LPs at baseline and during two consecutive LPs with the intervention, using the Procedure Behavior Checklist (PBCL) 3. Child self-reports of pain and anxiety during the ﬁrst, third, and sixth LPs in which self-hypnosis was used 4. Hypnotic ability assessed within two weeks after the last LP using a Greek-translation of the Stanford Hypnotic Scale for Children (SHCS-Children)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 72 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2003 (Continued)

Notes The data from the two hypnosis conditions were pooled together to create one overall hypnosis treatment condition. We used a total N of 60 for this study (instead of 80) because we only assessed 3/4 conditions (Direct + Indirect Hypnosis versus Attentional Control with Standard Medical Treatment). Outcomes were assessed at various time points; however, for this review we only used the ’intervention’ time point

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Low risk Appears to be free of other bias that would affect outcomes

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Liossi 2006

Methods Allocation: Randomized - table of random numbers

Participants Needle Procedure: series of lumbar punctures (LPs) (baselines and using intervention) Inclusion: Greek-speaking patients with leukaemia or non-Hodgkin’s lymphoma - between 6 and 16 years - undergoing regular LPs Exclusion: - previous hypnosis treatment - concurrent treatment during the project with analgesia or psychotropic medication - major affective disorder or other psychiatric diagnosis N: 30 Age: 6-16 years Gender: M = 23, F = 22

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 73 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2006 (Continued)

Diagnosis: leukaemia or non-Hodgkin’s lymphoma Setting: Hematology/Oncology Department of the Children’s Hospital Aglaia Kyriakou, Athens, Greece

Interventions 1. EMLA + Hypnosis (n = 15): The hypnotic induction procedure was adapted according to the child’s age, interests, and cognitive and social development. References to patient well-being, strengths, competence, and comfort were also included in the inductions. Following several minutes of hypnotic involvement, the patient was given “analgesic suggestions” including request for numbness, topical anaesthesia, local anaesthesia, glove anaesthesia, and switchbox - Please see above descriptions for other studies by same authors (e.g., Liossi 2003) for more information about these components. The session ended with a post-hypnotic suggestion that the hypnotic experience would be repeated and would provide comfort during the actual medical procedure, when the therapist would stroke the child’s cheek. It was also mentioned that the application of EMLA 60 min before the LP would be an additional cue for the child to start relaxing and start feeling calm and ready for the procedure to follow 2. EMLA + Attention (n = 15): Elements of the intervention included development of rapport, non-medical play, and non-medical verbal interactions. New coping skills were not introduced. During sessions, child and therapist were usually discussing school and extracurricular activities as well as playing board games or assembling model airplanes or building brick walls, depending on the child’s age and interests. Overall, the therapist was supportive and warm, encouraged the child to express freely his or her interests, and formed a close relationship with the child 3. EMLA only (n = 15): All patients received standard interventions provided by the hospital staff for pain control during LPs (i.e., medical and nursing staff offered information, support, and reassurance, and EMLA cream was applied approximately 60 min before the procedure)

Outcomes 1. Child self-reported pain using the Wong-Baker FACES Pain Rating Scale 2. Observer ratings of child distress and discomfort using the Procedure Behavior Check- list (PBCL) 3. Hypnotic ability assessed using a Greek translation of the Stanford Hypnotic Scale for Children (SHCS-Children)

Notes We used a total N of 30 for this study (instead of 45) because we only assessed 2/3 conditions (EMLA + Hypnosis versus EMLA + Attention). Outcomes were assessed at various time points; however, for this review we only used the outcomes assessed closest to the procedure (i.e., during the procedure or after the procedure if a during procedure outcome was not available)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly allocated…with the use of a ta- bias) ble of random numbers” p.308 Par 9

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g., random number table)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 74 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2006 (Continued)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Low risk Appears to be free of other bias that would affect outcomes

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Liossi 2009

Methods Allocation: randomly allocated using a computer-generated random positive integers, “computer generated randomization sequence”

Participants Needle: venepuncture for blood sampling Inclusion: -Greek-speaking patients with cancer -between 7-16 years who were off active treatment and undergoing regular venepuncture as part of disease status monitoring -had one parent in attendance Exclusion: -major affective psychiatric disorders within last 5 years -concurrent treatment during project with analgesic or psychotropic meds -no clearly visible veins as judged by nursing performing procedure -excluded parents if had diagnosis of anxiety or mood disorder or other psychiatric diagnosis in past 5 years N: 30 Age: 6-14 Gender: M=14, f=16 Diagnosis: Paediatric outpatients Setting: haematology/oncology clinic of hospital

Interventions 1. EMLA + Hypnosis (n = 15): The hypnosis session included an induction which was adapted according to the child’s age, interests and cognitive and social development. References to patient well-being, strengths, competence, and comfort were also included in the inductions. Following several minutes of hypnotic involvement, the patient was given “analgesic” suggestions, including request for numbness, topical anaesthesia, local anaesthesia, glove anaesthesia, and switchbox - Please see above descriptions for other studies by same authors (e.g., Liossi 2003., Liossi 2006) for more information about these components. The session ended with a post-hypnotic suggestion that the hypnotic

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 75 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2009 (Continued)

experience would be repeated and provide comfort during the actual medical procedure when the parent would stroke the child’s hand not receiving the venepuncture. It was also mentioned that in the future, the application of EMLA 60 min before the LP would be an additional cue for the child to start relaxing and feeling calm and ready for the procedure to follow. Following that, children in the EMLA + Hypnosis group were taught self-hypnosis following an abbreviated version of Gardner’s model 2. EMLA + Attention (n = 15): The attention control procedure was similarly based on manuals developed in our previous studies. Patients in the attention control group spent identical amount of time with the therapist as did patients in the hypnosis group, to control for professional attention. However, the therapist did not lead the attention control patients in imagery, relaxation, or other coping skills. Rather, the therapist developed rapport with the patient and engaged in nonmedical verbal interactions about topics such as extracurricular activities, school, and sports Both the hypnosis and attention control sessions were delivered to patients individually by the same therapist according to the study protocol manual and were standardized to last 15 min 3. EMLA only (n = 15): Treated only with EMLA cream applied to the intact skin for approximately 60 minutes before the procedure. The other two groups also received the same EMLA application

Outcomes 1. Self-Report 100mm VAS pain (range 0-10) 2. Self-Report 100mm VAS of needle-related anxiety 3. Behavioural Measure of Distress: Procedure Behavior Checklist (PBCL) 4. Parent Self-Reported Anxiety using 100mm VAS (i.e., parents rated their own anxiety)

Notes The study involved 3 time points (Time 1, Time 2, and Time 3) but we only included Time 1 which occurred during the venepuncture and closest to the intervention. Times 2 and 3 were 3 and 6 months after the initial session and did not involve therapist-led intervention; therefore, they were not included in this review. Also, we used a total N of 30 for this study (instead of 45) because we only assessed 2/3 conditions (EMLA + Hypnosis versus EMLA + Attention)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk p.256 Par 4 randomly allocated using com- bias) puter-generated random positive integers

Allocation concealment (selection bias) High risk Used an open random allocation schedule p.256 par 11

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 76 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Liossi 2009 (Continued)

Other bias Low risk Appears to be free of other bias that would affect outcomes

Blinding of participants and personnel High risk Participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

McCarthy 2010

Methods Allocation: “randomly assigned”

Participants Needle Procedure: IV needle insertion Inclusion: -4-10 years of age undergoing a scheduled IV needle insertion for a diagnostic medical procedure Exclusion: -developmental disabilities -limited English language skills to answer study questions -children with cancer N: 542 Age: 4-10 Gender: F=262, M=280 Diagnosis: gastro clinic (45%), nephrology (17%), endocrinology (12%), pulmonary (8%), cardiology (3%), 12% from other clinics (primarily radiology) Setting: 3 Midwestern children’s hospitals

Interventions 1. Parent Distraction Coaching Training (n = 293): In this condition, one parent was asked to volunteer to be the child’s main support person (coach) in the treatment room during the IV procedure. The designated parent received the multifaceted 15-min intervention on how to provide distraction coaching, which included educational materials, a video, and discussion with a research assistant. The parent and child then selected distracters such as books, toys, and video games. Questions were answered, and practice with the distracters was encouraged 2. Routine Care Control (n = 249): Families randomized to the control group received routine care in the clinic, and the parent was encouraged to do whatever he or she normally did to help the child during a medical procedure. Distraction items were clearly visible in the treatment room and available to the parent, but there was no direction to use them

Outcomes Pain: Self-report: Oucher Anxiety/Stress: Caregiver/parent: Parent report of child distress using 1-item from the perception of procedures questionnaire (“how stressed was your child today during the IV procedure?

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 77 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. McCarthy 2010 (Continued)

”) Observational: OSBD-R -higher score = more distress, videotaped and coded later Physiology: salivary cortisol, “measured by % change in cortisol levels between the matched clinic and baseline cortisol levels”

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judgment of ’low’ bias) or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) High risk Considerable variation in numbers of missing data All outcomes across outcomes; reasons not provided

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Had a potential source of bias likely to inﬂuence outcome (e.g., “control group contamination” p.137)

Blinding of participants and personnel High risk Although authors report blinding of personnel, par- (performance bias) ents aware of group assignment All outcomes

Blinding of outcome assessment (detection High risk No blinding of parent-reported outcome assessment bias) All outcomes

Nguyen 2010

Methods Allocation: randomization was carried out using opaque envelope, half of which contained a paper that said “music” and half that said “no music”

Participants Needle procedure: lumbar puncture Inclusion: -children with leukaemia -aged 7-12 years -were due to undergo LP at oncology ward at NHP, Hanoi Exclusion: -signiﬁcant hearing or visual impairments -cognitive disorder N: 40

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 78 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Nguyen 2010 (Continued)

Age: 7 to12 Gender: F=15, M=25 Diagnosis: children with leukaemia Setting: Hospital/oncology ward. NHP, Hanoi, Vietnam

Interventions 1. Music (n = 20): Music via earphones. Children chose songs they liked (traditional Vietnamese songs and children’s songs) played into earphones from an iPod ® (portable music player with earphones) 2. Control (n = 20): Earphones without music were used. All the children were given identical pre-procedural information about the procedures and the study. The children were instructed on how to use the iPod® before entering the procedure. In the investigation room, the child put on the earphones and did or did not listen to music, according to his/her group, 10 minutes before the LP procedure started. At the same time, the physician and nurses washed their hands and prepared the chemotherapy. Apart from the child, the parent, physician, and nurse were present in the room during the procedure

Outcomes Pain: Self-Report Numerical Rating Scale (NRS; range 0-10) administered before, during and after LP Anxiety: Short form of the Spielberger State-Trait Anxiety Inventory (STAI; range 6-24) assessed before and after LP Physiological measures of anxiety: Heart Rate, Blood Pressure (Systolic and Diastolic), Oxygen Saturation, and Respiratory Rate

Notes Outcomes were assessed at various time points (e.g., before, during, and after procedure) . For this review, we used ’during’ outcomes when available, and when not available, we used ’after’ outcomes

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Low risk Unclear if all appropriate safeguards taken with assignment envelopes (i.e. sequen- tially numbered or sealed)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 79 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Nguyen 2010 (Continued)

Other bias Unclear risk Potential source of bias related to measurement of outcomes

Blinding of participants and personnel High risk Participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Noguchi 2006

Methods Allocation: Based on a randomly-generated sequence of numbers

Participants Needle Procedure: “at least one of the following injections..” (i.e., immunization(s)) Inclusion: -between 4-6.5 years old -would be receiving one or more injections -were able to comprehend English well enough to understand and complete the focus of attention task Exclusion: -none given N: 62 (ﬁnal analysis) Age: 4-6 years old Gender: F=26, M=38 (not clear if 2 excluded participants were boys or girls) Diagnosis: Pediatric patients but presumed healthy Setting: 3 medical clinics, United States

Interventions 1. Musical Story Distraction (n = 21): A focus of attention task was designed around a musical recording for children entitled ‘Little Squirrel’, which contained lyrics that told a story about a little squirrel and the things he did one day. The song was performed by a male vocalist and included an instrumental accompaniment 2. Non-Music/Spoken Story Distraction (n = 21): The non-music/spoken version of the same story was recited at the same tempo by a male volunteer Both stories (music and spoken) were recorded onto a CD-R. These selections, each 1 minute and 56 seconds in duration, were presented to the participants via a portable CD player and headphones. For the purpose of infection control, the headphones were wrapped with fresh pieces of plastic wrap each time they were used by a participant. Visual aids depicting events and characters in the story were created using clip art. There were ﬁve event visuals: squirrel shaking tail, squirrel wiggling nose, squirrel digging a hole, squirrel cracking a nut, and squirrel taking a nap. There were also ﬁve animal character visuals: mouse, owl, rabbit, bee, and dog. Velcro backings were placed on the ten laminated visuals, and were presented to the participants on a Velcro board. The child was told by the examiner that he/she would be listening to a “story about a little squirrel who did many things and saw many animals while he was running around”. The experimenter then labeled the squirrel action visuals one at a time, stating what action was taking place (e.g., ‘he shook his tail’) and pointing at the corresponding picture on

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 80 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Noguchi 2006 (Continued)

the Velcro board. The experimenter asked the child to state what was happening in each picture. In situations when the child did not state the action, the experimenter asked a yes/no question (e.g., ‘Is he wiggling his nose in this picture?’) and restated what action was taking place. The animal visuals were presented in a similar manner. Children were told to listen carefully to the story because they would need to point to the various pictures to answer questions about the story. If the child became distracted from the task by the injection process, the experimenter attempted to redirect the child to the activity by using phrases such as “keep pointing” and “look at the pictures”. In instances when the injection procedure lasted longer than the CD recording, the recording was replayed. The child was reinforced by the examiner throughout the procedure for pointing behaviours (e.g., “Good pointing”) and provided with reassurance (e.g., “It’s almost done. You’re doing a good job”) as warranted 3. Standard Care Control (n = 20): When the nurse left the room to prepare the syringe (s), the experimenter and observer positioned themselves in the doorway of the exam room, in an attempt to keep their interactions with the parent/guardian and child to a minimum

Outcomes Pain: Self-Report: Faces Pain Scale (FPS) Nurse/health Professional: FPS (as rated by the experimenter and trained observer) Anxiety/Distress: Behavioral: Observational Scale of Behavioral Distress (OSBD)

Notes The data for the music and non-music story distraction conditions were pooled together to create one overall distraction treatment condition. Outcomes were assessed at 3 time points or phases (pre-injection, injection, and post-injection). For this review, we used data from the injection phase. Also, the distraction conditions included reassurance which has been shown in other studies to be distress promoting

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly assigned…based on a ran- bias) domly-generated sequence of numbers” p. 19 Par 1

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 81 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Noguchi 2006 (Continued)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Press 2003

Methods Allocation: Randomized - no further details

Participants Needle Procedure: venepuncture Inclusion: -ages 6-16 years undergoing venepuncture -conscious -Hebrew-speaking -no hearing problems Exclusion: -none given N: 94 Age: 6-16 years Gender: M = 57, F = 37 Diagnosis: none Setting: Pediatric Emergency Department of the Saroka University Medical Center, Israel

Interventions 1. Uncertainty Reduction + Active Distraction (n = 48): Uncertainty reduction: one of the two attending nurses told the patient: “Today you and I will do everything to make you feel good during the test. I’ll show you how you can help yourself feel good”. Active distraction: the child was shown a pair of headphones, was asked what they were, was offered to touch them, and instructed the put them on his/her ears. The child was told “I’ll put a song on for you, listen to is until the end, and wait for a question about it”. This was intended to produce active listening and more cognitive demands during the distraction. After hearing the song (and completing the venepuncture) the nurse asked the child a question about the song’s content (the same question for all children in the experimental condition) 2. Usual Care control (n = 46): For both the experimental and control groups, nurses provided usual care for reducing the child’s pain and distress (calming words, soothing encouraging parental help, etc)

Outcomes 1. Child self-report of pain during venipuncture using a 10 cm VAS combined with a faces pain scale 2. Parent and nurse ratings of child pain using the same 10 cm VAS and faces pain scale 3. Physician measured pressure/pain threshold of children using a dolorimeter positioned on 13 points throughout the body

Notes Parent and nurse VAS ratings were pooled together to create one overall ’observer-reported pain’ score. Also, for this review, we classiﬁed the treatment condition (Uncer-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 82 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Press 2003 (Continued)

tainty Reduction + Distraction) as ’Distraction’ because based on the deﬁnition described in the study, it did not appear to represent an additional intervention technique, and was not overly different from statements made to participants in other distraction-based studies

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Had a potential source of bias related to the speciﬁc study design (e.g., modiﬁed pain measure)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Sinha 2006

Methods Allocation: randomly assigned by a patient allocation scheme implementing a stratiﬁed block design to ensure equal gender

Participants Participants: Needle Procedure: laceration repair Inclusion: -children between 6-18 years of age visiting the ED for laceration repair between 12noon and midnight -had sustained an uncomplicated laceration involving only the skin and subcutaneous tissue, <5cm in length which could be repaired using basic suture repair techniques Exclusion: -children presenting with multiple lacerations, greater than or equal to 1 complex laceration, or a laceration associated with other injuries

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 83 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Sinha 2006 (Continued)

-patients who were unable to understand or fully participate in the informed consent process or study protocol, for whatever reason N: 240 Age: 6-18 years Gender: F=120, M=120 Diagnosis: included only children who sustained an uncomplicated laceration involving only the skin and subcutaneous tissue, <5cm in length, only single laceration included Setting: Hospital (emergency department)

Interventions 1. Distraction (n = 120): Children were given a choice of age-appropriate distractors including music, video games, or cartoon video. For children who did not show interest in any of these distractors, a certiﬁed child life worker offered to read a book or help blow bubbles during the procedure. A CD player with headphones was provided for those selecting music distraction, and subjects were given a choice of music. Children in this group received distraction plus the standard care received in the control group 2. Standard Care Control (n = 120): To minimize compensatory rivalry and resentful demoralization in the control group, time allocated to patients was identical regardless of study group assignment. The experienced ED child life staff explained to children in both groups what he or she might experience during the procedure by using developmentally appropriate words and in a non-threatening manner

Outcomes Pain: Self-report: 7pt Facial Pain Scale Anxiety/Distress: Self-Report: State Trait Anxiety Inventory for Children (STAIC) was only administered to children over the age of 10 years. It distinguishes between transitory anxiety (state anxiety) and general anxiety proneness (trait anxiety). In this study, the state anxiety scale was used to measure situational anxiety in children before and after laceration repair Caregiver/Parent report:100-mmVAS to measure pain distress (range: no distress-most distress). Before and after laceration repair

Notes SDs were not reported in the paper. However, we were able to calculate SDs from the data available, and these SDs were used in the data analyses. Although the STAIC outcome was only used with children 10 years and older rather than the full sample, we still included this data in our analyses

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Unclear if all appropriate safeguards taken with assignment envelopes (i.e., opaque)

Incomplete outcome data (attrition bias) Low risk Reported missing data did not impact out- All outcomes comes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 84 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Sinha 2006 (Continued)

Selective reporting (reporting bias) Low risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g., “heightened awareness of distraction techniques amongst ED personnel” p. 1167)

Blinding of participants and personnel High risk Participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report and parent-re- bias) port outcome assessment All outcomes

Tak 2006

Methods Allocation: Randomized - no further details

Participants Needle Procedure: venepuncture Inclusion: -Dutch patients receiving a venepuncture Exclusion: -children of non-Dutch parentage N: 94 Age: 3-12 years (mean = 6.4, SD = 2.5) Gender: M = 73, F = 63 Diagnosis: none Setting: outpatient centre of the St Antonius Ziekenhuis in Nieuwegein (the Netherlands)

Interventions Deﬁnitions for the following condition components are provided below 1. Placebo, Distraction, Information (n = 20) 2. EMLA, Distraction, Information (n = 21) 3. Placebo, Information (n = 20) 4. EMLA, Information (n = 21) 5. Information (n = 26) 6. Non-Treatment Control (n = 28) Distraction: During the venepuncture, a funny 6-minute fragment of a video cartoon (Walk Disney’s ’The Beauty and the Beast’) was shown. Sound could be heard through a headphone Procedural Information: All children except those in the control groups received information on the venepuncture by means of a photo book. The supervising research assistant asked the child to read the book with his/her parent(s) while in the waiting room. The 24 photos, each accompanied by a short and simple text, showed step by step what was to come from entrance to departure from the hospital. A boy 8 years old acted as the model EMLA: Eutectic mixture of local anaesthetics (EMLA) cream was applied by the labo-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 85 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Tak 2006 (Continued)

ratory personnel on duty who did not know whether the cream was EMLA or a placebo type of cream. These were not necessarily the same persons as those who did the pricking Placebo: A placebo cream was applied by the laboratory personnel on duty who did not know whether the cream was EMLA or a placebo type of cream. These were not necessarily the same persons as those who did the pricking *Because EMLA requires 1 hour to produce its effect, the children in the four ‘cream conditions’ passed that time in the waiting room in the presence of their parent(s) Non-Treatment Control: No treatment provided.

Outcomes 1. Child self-reported pain using the Oucher scale for children younger than 6 years, and the VAS which children of 6 and over - a research assistant administered these scales immediately after the venepuncture 2. Research assistant ratings of child distress using the Groningen Distress Scale (GDS) , a 5-point categorical behavioral observation scale of distress based on three categories: breathing, crying, and muscle tone - scored at three time points (when child entered room, just before venepuncture, and during venepuncture)

Notes We used a total N of 94 for this study (instead of 136) because we only assessed 4/ 6 conditions (i.e., Placebo, Distraction, Information versus Placebo, Information and Information versus Non-Treatment Control). Although GDS ratings were calculated at three time points in this study (child entering the room, just before venepuncture, and during venepuncture), we only used the ’during venepuncture’ scores in the analyses for this review

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Unclear risk No reasons for missing data provided All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Participants and personnel were not (performance bias) blinded All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 86 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Tak 2006 (Continued)

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Tyc 1997

Methods Allocation: Randomized - no further details

Participants Needle Procedure: IV insertion prior to MRI Inclusion: - ages 6-18 years old and English-speaking - scheduled to receive a magnetic resonance imaging (MRI) procedure of the brain or spine - had received at least one prior MRI procedure at St Jude’s Children’s Hospital within the last 12 months -in remission or had stable disease, or both Exclusion: - patients who had relapsed or had evidence of progressive disease or had severe cognitive deﬁcits, or both (IQ < 70) based on medical chart review, psychosocial histories, or available psychological assessment data N: 55 Age: 6.3-18.6 years (mean = 12.5 years) Gender: M = 50.9%, F = 49.1% Diagnosis: Approximately 27% = medulloblastoma, 24% = CNS glioma, and 49% = variety of malignant CNS neoplasms Setting: St Jude’s Children’s Hospital, Tennessee

Interventions 1. Cognitive-Behavioural Treatment (CBT) (n = 28): The CBT intervention consisted of a package of five components including: (a) filmed modelling (two age appropriate versions of a 15-minute film that depicted the steps involved in preparation of the MRI procedure), (b) breathing exercises (patients learned both passive and active breathing exercises as modeled in the film such as instructions to breathe at a slower than normal rate while focusing on rhythmic breathing), (c) emotive imagery/distraction (focus on emotive images including heroes like “Superman” or pleasant mental images like beaches that were incompatible with distress), (d) behavioral rehearsal (involved two tasks including practice for starting and IV and an MRI simulation task that provided the opportunity to lie still inside the MRI), and (e) positive incentive (showing the child a small trophy and saying he/she could win the trophy by “doing the best they could do”) 2. Standard Care Control (SCC) (n = 27): Prior to their procedures, patients in this group had the opportunity to discuss details about the MRI procedure with the MRI technologist and also view the magnet. This is the standard preparation for the MRI exam at this institution. Patients did not, however, receive additional intervention from the Psychology staff

Outcomes 1. Child self-report of anxiety using the State-Trait Anxiety Inventory for Children (STAI-C) 2. Child, parent, and staff ratings of child IV distress 3. Chid, parent, and staff ratings of child MRI distress

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 87 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Tyc 1997 (Continued)

4. Staff MRI Distress Ratings 5. MRI Behavior Checklist

Notes Parent and staff IV distress ratings were pooled together to create one overall ’observer- reported distress’ outcome. Only outcomes related to the IV (not the MRI) were used in the analyses for this review. The STAI-C scores were used in this study to assess background variables, therefore they were not included in the analyses for this review

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Multiple potential sources of bias related to study design and other problems

Blinding of participants and personnel High risk Study participants were not blinded (performance bias) All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Vessey 1994

Methods Allocation: Randomized - using table of random numbers

Participants Needle Procedure: routine blood draws Inclusion: - must have had two or fewer blood draws in the six months preceding the procedure - free of chronic conditions - ﬂuent in English Exclusion: - none given N: 100 Age: 3.6-12.11 years (mean = 7.4 years, SD = 3.3 months)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 88 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Vessey 1994 (Continued)

Gender: M = 62%, F = 38% Diagnosis: none Setting: Ambulatory Care Clinics of a children’s hospital in the south central United States

Interventions 1. Distraction (n = 50). Subjects were given the Illusion Kaleidoscope to look through during the blood draw. This toy was selected since it requires no manipulation to change images; rather, glitter suspended in a ﬂuid-ﬁlled tube (space tube) passes before the lens when held to the eye. The subjects were encouraged to concentrate on what they were seeing by phrases such as, ”Do you see the different designs?” 2. Standard Care Control (n = 50): Subjects received standard preparation that consisted of being comforted by physical touch and soft voices

Outcomes 1. Child self-report of pain using the Wong-Baker FACES Pain Rating Scale (FACES) 2. Investigator ratings of child pain using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS)

Notes The authors found that age was a signiﬁcant covariate, whereby younger children reported perceiving greater intensities of pain and demonstrated more active observable behavioural distress to the venepuncture that the older children. They provided adjusted means (but not adjusted SDs). Since the adjusted means were only slightly different from the original means, we used the original means and SDs for the analyses in this review

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “subjects were randomly assigned…using a bias) random number table” p.370 Par 10

Allocation concealment (selection bias) High risk Use of an open random allocation schedule (e.g., random number table)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 89 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Vosoghi 2010

Methods Allocation: RCT - convenience sample

Participants Needle Procedure: IV Insertion Inclusion: -3-6 years of age -orientation to time, place and people -ability to make verbal communication Exclusion: -pain, seizure, or any life-threatening condition -administration of pain killers -insertion of more than one catheter -time of attempting to insert the catheter more than 60 seconds N: 72 Age: 3-6 years old Gender: F=35, M=37 Diagnosis: 57 patients with a diagnosis of infectious diseases and 15 with a diagnosis of internal medicine diseases. No healthy children Setting: Emergency department of a children’s hospital

Interventions 1. Distraction (n = 36): Two minutes before the IV insertion, distraction was done using a bubble maker (i.e., a train that whistles and makes bubbles while moving) and was continued until the end of the procedure 2. Control (n = 36): Same overall study procedure for all participants (e.g., heart rate and oxygen saturation were assessed 3 minutes after the catheter was ﬁxed, pain assessment was completed 10 minutes after catheterization), but in this control group, no distraction was administered

Outcomes Pain: Self-Reported: OUCHER - was done 20 min after the procedure Physiological measures: Heart rate (pre/post-intervention), Oxygen Saturation (pre/post-intervention)

Notes This was an article in Farsi and we had a translator help us with data extraction. For study exclusion criteria, the authors did not explain what they meant by ’pain’ but presumably this was pain not explicitly due to the needle procedure. In addition, although means and SDs for the OUCHER were not reported in the paper, these were obtained via contact with the study authors

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judgment bias) of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 90 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Vosoghi 2010 (Continued)

Incomplete outcome data (attrition bias) Unclear risk Insufﬁcient reporting of exclusions to permit All outcomes judgment of ’low’ or ’high’ risk

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely to include in meta-analyses

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk No mention of blinding but nature of psycho- (performance bias) logical intervention precludes this All outcomes

Blinding of outcome assessment (detection High risk No blinding of outcome assessment bias) All outcomes

Wang 2008

Methods Allocation: according to random numbers from 1-300 by research randomizer

Participants Needle Procedure: venepuncture Inclusion: -8-9 years old requiring initial venepuncture for a period of intravenous treatment in the paediatric department Exclusion: -history of puncture during the past 3 months -treatment with anxiolytic or narcotic analgesics medication 72h prior to the venepuncture -presence of insufﬁcient mental development, alteration of mental status and cognitive impairment -visual and auditory deﬁcits N: 300 Age: 8-9 years old Gender: F=154, M=146 Diagnosis: pneumonia, asthma, encephalitis, allergic purpura Setting: “pediatric department” in hospital, China

Interventions 1. Audiovisual Distraction (n = 100): Patients were given a choice of 10 appropriate cartoon videos. A TV set coupled with a DVD player was provided for patients to play their favourite animated cartoons. During the showing of the cartoon films (about three minutes after the film began), venepuncture was performed by a registered nurse 2. Psychological Interventions (n = 100): Patients received conventional psychological interventions in a fixed scheme delivered by a research nurse (e.g., comfort provided, procedure explained, therapeutic touch, guided imagery, and encouragement) with no audiovisual distraction. The intervention methods, including explaining before venepuncture, therapeutic touch, encouragement and guided imagery during the procedure, were actu- alized by utilizing developmentally appropriate words and in a non-threatening manner

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 91 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Wang 2008 (Continued)

3. Control Condition (n = 100): Patients underwent venepuncture without any special intervention (i.e., no audiovisual distraction or psychological interventions)

Outcomes 1. Self Report Pain: 10 cm Visual Analogue Scale (VAS) 2. Cooperative Behaviour Scale of Children in Venepuncture (CBSCV): Scale created by authors and used by research nurses to evaluate the cooperation of children in the three groups

Notes None

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly assigned…according to random bias) numbers…generated for Research Ran- domizer” p. 580 Par 6

Allocation concealment (selection bias) Unclear risk Unclear if all appropriate safeguards taken with assignment envelopes (i.e., opaque)

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Other bias High risk Had a potential source of bias related to sig- niﬁcantly different to length of procedure time (p.581)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Windich-Biermeier 2007

Methods Allocation: “randomly assigned using an SPSS pseudo-random number generator”

Participants Needle Procedure: venous port access or venepuncture Inclusion: -5-18 years old -able to understand and speak English -able to hear and see

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 92 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Windich-Biermeier 2007 (Continued)

-had a diagnosis of leukaemia, lymphoma, a solid tumor, or histiocytosis -were receiving chemotherapy -had a physician’s order for a port access/venepuncture -had at least one previous access/venepuncture Exclusion: -youth with cancer excluded if they were septic, dehydrated, vomiting, sedated, medically unstable, diagnosed with mental illness, or scheduled for another procedure following the port access/venepuncture N: 50 Age: 5-18 years old Gender: F=23, M=27 Diagnosis: cancer Setting: Hospital - University afﬁliated regional, paediatric medical centre

Interventions 1. Parent Coaching + Child Distraction (n = 22): In addition to standard care, the intervention group also used a self-selected distracter. Participants chose one from a pool of ﬁve distracters including: (a) the I Spy Super Challenger book where parents asked their child to look for hidden pictures or items on the page among various graphic designs, (b) bubbles (parents below bubbles using a magic wand, (c) music table (vibroacoustic music felt through speakers built into the mattress of the procedure table; sound is heard via speakers and also channeled through headphones; children selected a 45-minute music CD of music from Radio Disney-Kid Jams and other children’s classics), (d) Virtual Reality glasses (similar to oversized sunglasses with attached earphones, showing a 3D video with stereo-sound music), and (e) Nintendo Gameboy (handles gaming device with colour screen displaying fast-moving action packed games with sound effects). After the participant selected a distracter, the parent was instructed by one of the co-investigators using a standardized script, to actively coach the child to use the distraction item. During the procedure, the participants were repeatedly encouraged by their parents to focus all of their attention on the distracter instead of the procedure. Just prior to beginning the procedure and during the procedure, the parent provided constant and repeated verbal distraction cues to the patient (e.g., “Help me ﬁnd the rabbits on this page”, “Can you count the number of bubbles in the air?”, etc) 2. Standard Care (n = 28): The comparison group received standard care including: (a) a full explanation of the procedure given to the participant and parent, (b) parental presence at the participant’s side during the procedure for support, and (c) use of a topical anesthetic over the needle puncture site (either EMLA or Fluori-Methane, depending on participant/parent preference), which is the standard practice for all non-emergent needle stick procedures)

Outcomes Self Report: Pain: Color Analogue Scale (bottom narrow/no pink color -> no pain/hurt/top wide, very red -> worst pain/hurt) Anxiety/Distress: Self Report: Glasses Fear Scale (a type of VAS to asses fear) - empty cylinder = no fear, ﬁlled cylinder = worst fear Caregiver/Parent report: assessed child’s fear pre and post-procedure Nurse/Health professional report: assessed child’s fear pre and post-procedure Behavioural Measure of Distress: Observation Scale of Behavioral Distress (OSBD) assessed by nurse pre and post-proce-

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 93 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Windich-Biermeier 2007 (Continued)

dure Other Outcome(s): Investigator-developed IV Poke Questionnaire (IPQ) used by nurse to interview participants (IPQ-Subject) and their parents (IPQ-Parent) about their experiences during the port access/venepuncture

Notes Data for parent-reported fear, nurse-reported fear, and OBSD broken down by group (intervention versus control) were not reported, and therefore could not be included in the analyses for this review. Also, although the authors label the intervention as “distraction”, they describe it as involving distraction with parent coaching. Therefore, we classiﬁed it in the ’Parent Coaching + Child Distraction’ intervention category for this review. Lastly, the intervention and control groups differed in terms of various variables (e.g., type of topical analgesic used, parental presence, number of cannulation attempts) ; however, there were no statistically signiﬁcant differences between the groups on any of these variables

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Low risk “randomly assigned using an SPSS pseudo- bias) random number generator” (p.9)

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias Unclear risk Insufﬁcient information to assess whether an important risk of bias exists

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 94 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Wint 2002

Methods Allocation: Randomized - no further details

Participants Needle Procedure: lumbar puncture (LP) Inclusion: - between the ages of 10-19 years being treated for cancer - receiving LPs as part of therapy and undergoing at least a second LP - all ethnicities, and able to understand and communicate in English - able to hear and see Exclusion: - none given N: 30 Age: 10-19 years Gender: M = 16, F = 14 Diagnosis: Acute Lymphoblastic Leukaemia = 20, B-cell Lymphoma = 1, Lymphoma = 1, T-cell = 2, T-cell ALL = 4, T-cell Lymphoma = 2 Setting: private, in-hospital clinic treatment room within a 322-bed paediatric teaching hospital in the southwest United States

Interventions 1. Virtual Reality (VR) Distraction (n = 17): Adolescents in this wore VR glasses during their LPs, in addition to receiving standard nursing care. The glasses were similar to oversized sunglasses with earphones attacked. Subjects were placed in the standard side lying position for their LPs with a videocassette recorder/television placed at eye level. They all watched the same video through the glasses, which provided 3D viewing, and listened to music in stereo sound. The VR video entitled ‘Escape’ included 64 minutes of footage and contained experiences of skiing down the Swiss Alps, explosive drag racing, a stroll down Paris sidewalks, and visions of quiet mountain streams. Prior to conscious sedations, nurses used a standardized script to explain the purpose of the VR glasses to subjects and the need to focus their attention on what they were hearing and seeing instead of on the discomfort of the procedure. The subjects started watching the video when placed on the procedure table at the beginning of the LP and ﬁnished when the sedation recovery criteria were met 2. Standard Care Comparison (n = 13): Adolescents in this group received standard nursing care for an LP including: (a) weight-based conscious sedations using Fentanyl and Midazolam, (b) 2.5 grams of EMLA cream applied at the spinal injection site, (c) a full explanation of the LP given to them and their parent, and (d) parental presence at their patient’s side for support. Although subjects received sedation, they were cognitively aware of the environment and able to respond, move, and verbalize discomfort and anxiety during the LP

Outcomes 1. Child/Adolescent self-report of pain using 100 mm vertical VAS 2. Nurse ratings of child’s sedation level following the LP using the Sedation Assessment Scale 3. Investigator developed ten-item questionnaire completed by the children/adolescents to determine their experiences during the LP in both groups, and the subjective experience of the VR glasses by those in the experimental group

Notes None

Risk of bias

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 95 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Wint 2002 (Continued)

Bias Authors’ judgement Support for judgement

Random sequence generation (selection Unclear risk Insufﬁcient information to permit judg- bias) ment of ’low’ or ’high’ risk

Allocation concealment (selection bias) Unclear risk Insufﬁcient information to permit judgment of ’low’ or ’high’ risk

Incomplete outcome data (attrition bias) Low risk No missing data All outcomes

Selective reporting (reporting bias) High risk One or more outcomes of interest are reported incompletely

Other bias High risk Multiple potential sources of bias related to study design and other problems (e.g., small and unequal sample size)

Blinding of participants and personnel High risk Study participants and personnel were not (performance bias) blinded All outcomes

Blinding of outcome assessment (detection High risk No blinding of self-report outcome assess- bias) ment All outcomes

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Agarwal 2008 Older than included age range/adult sample

Alavi 2005 Cross-over design with data not available pre-crossover

Alderfer 2010 Inappropriate outcome measures/outcomes not related to pain or anxiety

Alhani 2010 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Anghelescu 2013 Intervention not primarily psychological

Anson 2010 Older than included age range/adult sample

Arts 1994 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 96 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Ashkenzai 2006 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Atkinson 2009 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Bagnasco 2012 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Baxter 2011 Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention

Bengston 2002 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Berberich 2009 Only one group received an adjunct pharmacological intervention

Boivin 2008 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Bowen 1999 Failed randomization

Broome 1998 No control/comparison group or inappropriate control group

Bruck 1995 Inappropriate outcome measures/outcomes not related to pain or anxiety

Bufalini 2009 Use of general anaesthesia/conscious sedation prior to needle procedure

Bufalini 2012 Conference presentation abstract/not a published RCT

Carlson 2000 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Chen 2000b Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Christiano 1996 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cline 2006 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cohen 1997 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cohen 1999 ?

Cohen 2001 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cohen 2002 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cohen 2010 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Cramer-Berness 2005 Younger than included age range/infant sample

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 97 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Crowley 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Dalhquist 2002 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Dalhquist 2005 Secondary data analysis/original study not included in review

Davit 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Demir 2012 Intervention not primarily psychological

Drahota 2008 Older than included age range/adult sample

Dufresne 2010 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

El-Sharkawi 2012 Cross-over design with data not available pre-crossover

Fassler 1985 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

French 1994 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Gilbert 1982 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Goymour 2000 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Hatava 2000 Surgical procedure

Hawkins 1998 No control/comparison group or inappropriate control group

Heckler-Medina 2006 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Heden 2009 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Hoffman 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Howe 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Inal 2010 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Jacobson 2006 Older than included age range/adult sample

Jay 1987 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 98 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Jay 1990 Inappropriate outcome measures/outcomes not related to pain or anxiety

Jay 1991 Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention

Jay 1995 No control/comparison group or inappropriate control group

Kain 2006 Use of general anaesthesia/conscious sedation prior to needle procedure

Kammerbauer 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Kazak 1996 Means or standard deviations, or both, not available

Kazak 1998 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Kettwich 2007 No needle procedure

Klingman 1985 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Klorman 1980 Surgical procedure

Kolk 2000 No control/comparison group or inappropriate control group

Krauss 1996 Non-published dissertation study

Kuttner 1988 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Kwekkeboom 2003 Older than included age range/adult sample

Lawes 2008 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Lessi 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Liossi 2007 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Lustman 1983 Surgical procedure

MacLaren 2005 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

MacLaren 2007 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Malone 1996 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Manimala 2000 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 99 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Manne 1990 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Manne 1994 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Marec-Berard 2009 Intervention not primarily psychological

McCarthy 1998 Failed randomization

McCarthy 2010b Results not presented separately as control versus treatment group/secondary analysis and original study included in review

McInally 2005 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Megel 1998 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Melamed 1974 Surgical procedure

Myrvik 2009 Non-published dissertation study

Nilsson 2009 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

O’Laughlin 1995 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Olsen 1991 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Ozdemir 2012 Younger than included age range/infant sample

Park 2008 Intervention not primarily psychological

Pederson 1996 Fewer than ﬁve participants per condition

Peretz 1999 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Posner 1998 Non-published dissertation study

Powers 1993 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Ramponi 2009 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Reeb 1997 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Rogovik 2007 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Russell 2012 Failed randomization

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 100 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Salih 2010 Older than included age range/adult sample

Santos 1999 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Schechter 2010 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Schneider 2011 Older than included age range/adult sample

Schur 1986 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Shabanloei 2010 Older than included age range/adult sample

Shahabi 2007 Cross-over design with data not available pre-crossover

Shimizu 2005 Older than included age range/adult sample

Sikorova 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Slack 2009 Older than included age range/adult sample

Slifer 2009 No control/comparison group or inappropriate control group

Slifer 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Smith 1989 No control/comparison group or inappropriate control group

Smith 1996 No control/comparison group or inappropriate control group

Sparks 2001 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Stefano 2005 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Stevenson 2005 Inappropriate intervention/cannot isolate effects of psychological components from multi-component intervention

Sury 2010 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Thurgate 2005 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Tufekci 2009 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Vernon 1974 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Vika 2009 Older than included age range/adult sample

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 101 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

Vohra 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Wall 1989 No control/comparison group or inappropriate control group

Wallace 2010 Intervention not primarily psychological

Weber 2010 No needle procedure

Weinstein 2003 No needle procedure

Winborn 1989 Surgical procedure

Wood 2002 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Yoo 2011 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Young 1988 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Zabin 1982 Non-published dissertation study

Zahr 1998 Not a randomized controlled trial/reported assignment not truly random/quasi-randomized assignment

Zeltzer 1982 Met inclusion criteria but missing data necessary for pooling such as means, standard deviations, and/or cell sizes

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 102 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DATA AND ANALYSES

Comparison 1. Distraction

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 19 1759 Std. Mean Difference (IV, Random, 95% CI) -0.61 [-0.91, -0.32] 2 Observer-reported pain 5 447 Std. Mean Difference (IV, Random, 95% CI) -0.87 [-1.75, 0.02] 3 Self-reported distress 3 286 Std. Mean Difference (IV, Random, 95% CI) -0.66 [-1.37, 0.06] 4 Observer-reported distress 2 363 Std. Mean Difference (IV, Random, 95% CI) -1.15 [-2.73, 0.42] 5 Behavioral measures- Pain 2 152 Std. Mean Difference (IV, Random, 95% CI) -0.15 [-0.69, 0.40] 6 Behavioral measures- Distress 5 254 Std. Mean Difference (IV, Random, 95% CI) -0.30 [-0.76, 0.16] 7 Physiological measure - Heart 2 112 Std. Mean Difference (IV, Random, 95% CI) -0.70 [-1.08, -0.32] Rate 8 Physiological measure - Oxygen 2 112 Std. Mean Difference (IV, Random, 95% CI) 0.60 [0.22, 0.98] Saturation

Comparison 2. Hypnosis

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 5 176 Std. Mean Difference (IV, Random, 95% CI) -1.40 [-2.32, -0.48] 2 Self-reported distress 5 176 Std. Mean Difference (IV, Random, 95% CI) -2.53 [-3.93, -1.12] 3 Behavioral measures- Distress 6 193 Std. Mean Difference (IV, Random, 95% CI) -1.15 [-1.76, -0.53]

Comparison 3. Preparation and information

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 2 154 Std. Mean Difference (IV, Random, 95% CI) -0.22 [-1.20, 0.76]

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 103 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Comparison 4. Virtual reality

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 2 50 Std. Mean Difference (IV, Random, 95% CI) -0.23 [-0.79, 0.33]

Comparison 5. CBT-combined

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 3 250 Std. Mean Difference (IV, Random, 95% CI) -0.59 [-1.62, 0.44] 2 Self-reported distress 3 105 Std. Mean Difference (IV, Random, 95% CI) -0.50 [-1.08, 0.07] 3 Observer-reported distress 2 84 Std. Mean Difference (IV, Random, 95% CI) 0.04 [-0.87, 0.95] 4 Behavioral measures- Distress 4 164 Std. Mean Difference (IV, Random, 95% CI) -0.54 [-1.16, 0.09]

Comparison 6. Parent coaching + child distraction

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 3 612 Std. Mean Difference (IV, Random, 95% CI) 0.06 [-0.19, 0.31] 2 Observer-reported distress 2 581 Std. Mean Difference (IV, Random, 95% CI) -0.04 [-0.21, 0.12] 3 Behavioral measures- Distress 3 635 Std. Mean Difference (IV, Random, 95% CI) -0.36 [-0.97, 0.25]

Comparison 7. Suggestion

No. of No. of Outcome or subgroup title studies participants Statistical method Effect size

1 Self-reported pain 3 218 Std. Mean Difference (IV, Random, 95% CI) -0.13 [-0.40, 0.15]

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 104 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.1. Comparison 1 Distraction, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Balan 2009 50 2.88 (2.26) 50 7.94 (1.68) 5.2 % -2.52 [ -3.05, -1.99 ]

Bellieni 2006 46 13.15 (16.3) 23 23.04 (24.57) 5.3 % -0.50 [ -1.01, 0.00 ]

Caprilli 2007 54 1.81 (0.89) 54 2.33 (1.19) 5.6 % -0.49 [ -0.87, -0.11 ]

Cassidy 2002 31 1.36 (1.39) 28 2.03 (1.9) 5.2 % -0.40 [ -0.92, 0.12 ]

Fanurik 2000 53 22.6 (24.03) 56 27.29 (29.27) 5.7 % -0.17 [ -0.55, 0.20 ]

Fowler-Kerry 1987 40 1.34 (1.14) 80 1.78 (1.14) 5.6 % -0.38 [ -0.77, 0.00 ]

Gonzalez 1993 14 2.86 (1.61) 14 3.29 (1.44) 4.5 % -0.27 [ -1.02, 0.47 ]

Gupta 2006 25 2.36 (1.15) 25 4 (1.32) 4.9 % -1.30 [ -1.92, -0.69 ]

Inal 2012 61 3.9 (1.94) 62 6.51 (1.65) 5.6 % -1.44 [ -1.84, -1.04 ]

Jeffs 2007 19 4.12 (2.01) 8 3.49 (2.05) 4.2 % 0.30 [ -0.53, 1.13 ]

Kristjansdottir 2010 79 0.94 (1.58) 39 1 (0.95) 5.6 % -0.04 [ -0.43, 0.34 ]

Nguyen 2010 20 2.35 (1.9) 20 5.65 (2.5) 4.6 % -1.46 [ -2.16, -0.75 ]

Noguchi 2006 42 3.34 (2.67) 20 3.53 (2.76) 5.2 % -0.07 [ -0.60, 0.46 ]

Press 2003 48 2.8 (2) 46 3.8 (2.9) 5.6 % -0.40 [ -0.81, 0.01 ]

Sinha 2006 120 0.27 (0.74) 120 0.39 (0.74) 6.0 % -0.16 [ -0.42, 0.09 ]

Tak 2006 20 2.58 (1.89) 20 1.85 (1.18) 4.9 % 0.45 [ -0.17, 1.08 ]

Vessey 1994 50 2.18 (1.61) 50 3.23 (1.78) 5.6 % -0.61 [ -1.02, -0.21 ]

Vosoghi 2010 36 2.11 (0.97) 36 4.55 (1.42) 5.1 % -1.99 [ -2.55, -1.42 ]

Wang 2008 100 4.55 (2.26) 100 5.22 (2.53) 5.9 % -0.28 [ -0.56, 0.00 ] Total (95% CI) 908 851 100.0 % -0.61 [ -0.91, -0.32 ] Heterogeneity: Tau2 = 0.36; Chi2 = 151.01, df = 18 (P<0.00001); I2 =88% Test for overall effect: Z = 4.08 (P = 0.000045) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 105 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.2. Comparison 1 Distraction, Outcome 2 Observer-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 2 Observer-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Balan 2009 50 3.09 (1.96) 50 7.75 (1.75) 19.7 % -2.49 [ -3.02, -1.96 ]

Bellieni 2006 46 17.61 (15.58) 23 21.3 (19.9) 19.9 % -0.21 [ -0.71, 0.29 ]

Inal 2012 61 3.83 (2.19) 61 6.43 (1.61) 20.4 % -1.34 [ -1.74, -0.95 ]

Noguchi 2006 42 3.74 (2.02) 20 4.53 (2.09) 19.7 % -0.38 [ -0.92, 0.16 ]

Press 2003 48 3.25 (2) 46 3.1 (2.08) 20.3 % 0.07 [ -0.33, 0.48 ] Total (95% CI) 247 200 100.0 % -0.87 [ -1.75, 0.02 ] Heterogeneity: Tau2 = 0.96; Chi2 = 72.24, df = 4 (P<0.00001); I2 =94% Test for overall effect: Z = 1.92 (P = 0.054) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 106 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.3. Comparison 1 Distraction, Outcome 3 Self-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 3 Self-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Fanurik 2000 56 35.5 (30.1) 59 35 (29.8) 35.6 % 0.02 [ -0.35, 0.38 ]

Nguyen 2010 20 8.1 (2.22) 20 13 (4.17) 28.5 % -1.44 [ -2.14, -0.73 ]

Sinha 2006 68 26.72 (5.44) 63 30.41 (4.99) 35.8 % -0.70 [ -1.06, -0.35 ] Total (95% CI) 144 142 100.0 % -0.66 [ -1.37, 0.06 ] Heterogeneity: Tau2 = 0.34; Chi2 = 15.72, df = 2 (P = 0.00039); I2 =87% Test for overall effect: Z = 1.79 (P = 0.074) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Analysis 1.4. Comparison 1 Distraction, Outcome 4 Observer-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 4 Observer-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Inal 2012 61 1.38 (0.89) 62 3.33 (1.07) 49.4 % -1.97 [ -2.40, -1.53 ]

Sinha 2006 120 0.57 (0.98) 120 1.02 (1.46) 50.6 % -0.36 [ -0.62, -0.11 ] Total (95% CI) 181 182 100.0 % -1.15 [ -2.73, 0.42 ] Heterogeneity: Tau2 = 1.26; Chi2 = 39.29, df = 1 (P<0.00001); I2 =97% Test for overall effect: Z = 1.44 (P = 0.15) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 107 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.5. Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 5 Behavioral measures- Pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Cassidy 2002 27 5.16 (2.67) 25 4.69 (2.96) 44.2 % 0.16 [ -0.38, 0.71 ]

Vessey 1994 50 7.76 (2.5) 50 8.73 (2.38) 55.8 % -0.39 [ -0.79, 0.00 ] Total (95% CI) 77 75 100.0 % -0.15 [ -0.69, 0.40 ] Heterogeneity: Tau2 = 0.10; Chi2 = 2.64, df = 1 (P = 0.10); I2 =62% Test for overall effect: Z = 0.53 (P = 0.59) Test for subgroup differences: Not applicable

-1 -0.5 0 0.5 1 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 108 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.6. Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 6 Behavioral measures- Distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Caprilli 2007 54 6.8 (7.5) 54 13.5 (9.7) 26.8 % -0.77 [ -1.16, -0.38 ]

Gonzalez 1993 14 4.84 (1.46) 14 5.81 (1.2) 17.2 % -0.70 [ -1.47, 0.06 ]

Kuttner 1987 8 13.8 (4.4) 8 9.1 (5.5) 12.2 % 0.89 [ -0.15, 1.93 ]

Noguchi 2006 42 3.32 (2.86) 20 3.98 (3.51) 23.0 % -0.21 [ -0.75, 0.32 ]

Tak 2006 20 2.67 (0.94) 20 2.83 (1.02) 20.7 % -0.16 [ -0.78, 0.46 ] Total (95% CI) 138 116 100.0 % -0.30 [ -0.76, 0.16 ] Heterogeneity: Tau2 = 0.16; Chi2 = 10.89, df = 4 (P = 0.03); I2 =63% Test for overall effect: Z = 1.28 (P = 0.20) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 109 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 1.7. Comparison 1 Distraction, Outcome 7 Physiological measure - Heart Rate.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 7 Physiological measure - Heart Rate

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Nguyen 2010 20 102.7 (9.24) 20 117.7 (19.49) 33.9 % -0.96 [ -1.62, -0.31 ]

Vosoghi 2010 36 124.87 (20.1) 36 137.2 (22.98) 66.1 % -0.57 [ -1.04, -0.09 ] Total (95% CI) 56 56 100.0 % -0.70 [ -1.08, -0.32 ] Heterogeneity: Tau2 = 0.0; Chi2 = 0.93, df = 1 (P = 0.33); I2 =0.0% Test for overall effect: Z = 3.58 (P = 0.00034) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Analysis 1.8. Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen Saturation.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 1 Distraction

Outcome: 8 Physiological measure - Oxygen Saturation

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Nguyen 2010 20 99.2 (1.14) 20 98 (2.77) 35.9 % 0.56 [ -0.08, 1.19 ]

Vosoghi 2010 36 97.22 (1.65) 36 95.59 (3.25) 64.1 % 0.63 [ 0.15, 1.10 ] Total (95% CI) 56 56 100.0 % 0.60 [ 0.22, 0.98 ] Heterogeneity: Tau2 = 0.0; Chi2 = 0.03, df = 1 (P = 0.86); I2 =0.0% Test for overall effect: Z = 3.10 (P = 0.0019) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 110 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.1. Comparison 2 Hypnosis, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 2 Hypnosis

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Katz 1987 17 55 (36.9) 19 51.81 (33.8) 21.4 % 0.09 [ -0.57, 0.74 ]

Liossi 1999 10 1.9 (0.99) 10 4.2 (0.63) 16.5 % -2.65 [ -3.92, -1.39 ]

Liossi 2003 40 1.95 (1.3) 20 4.3 (0.6) 21.4 % -2.07 [ -2.73, -1.41 ]

Liossi 2006 15 1.27 (0.8) 15 2.67 (1.05) 20.2 % -1.46 [ -2.28, -0.64 ]

Liossi 2009 15 2.74 (0.83) 15 4.17 (1.44) 20.5 % -1.18 [ -1.97, -0.40 ] Total (95% CI) 97 79 100.0 % -1.40 [ -2.32, -0.48 ] Heterogeneity: Tau2 = 0.93; Chi2 = 26.98, df = 4 (P = 0.00002); I2 =85% Test for overall effect: Z = 2.97 (P = 0.0030) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 111 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.2. Comparison 2 Hypnosis, Outcome 2 Self-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 2 Hypnosis

Outcome: 2 Self-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Katz 1987 17 4.8 (1.9) 19 5.2 (1.4) 21.7 % -0.24 [ -0.89, 0.42 ]

Liossi 1999 10 0.9 (1.1) 10 4.6 (0.52) 17.2 % -4.12 [ -5.79, -2.45 ]

Liossi 2003 40 1.45 (1.4) 20 4.4 (0.6) 21.5 % -2.43 [ -3.13, -1.73 ]

Liossi 2006 15 0.4 (0.63) 15 2.13 (0.74) 20.5 % -2.45 [ -3.43, -1.47 ]

Liossi 2009 15 2.35 (0.52) 15 4.17 (0.38) 19.1 % -3.89 [ -5.16, -2.61 ] Total (95% CI) 97 79 100.0 % -2.53 [ -3.93, -1.12 ] Heterogeneity: Tau2 = 2.26; Chi2 = 44.13, df = 4 (P<0.00001); I2 =91% Test for overall effect: Z = 3.53 (P = 0.00042) Test for subgroup differences: Not applicable

-10 -5 0 5 10 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 112 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 2.3. Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 2 Hypnosis

Outcome: 3 Behavioral measures- Distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Katz 1987 17 6.6 (3.3) 19 7.3 (3.4) 18.8 % -0.20 [ -0.86, 0.45 ]

Kuttner 1987 9 8.2 (3.7) 8 9.1 (5.5) 15.2 % -0.18 [ -1.14, 0.77 ]

Liossi 1999 10 5.1 (4.41) 10 12.6 (3.83) 13.9 % -1.74 [ -2.80, -0.68 ]

Liossi 2003 40 8.3 (5.7) 20 16 (4.8) 19.5 % -1.40 [ -2.00, -0.81 ]

Liossi 2006 15 7.4 (3.22) 15 13.33 (2.79) 16.0 % -1.92 [ -2.80, -1.03 ]

Liossi 2009 15 5.07 (0.59) 15 6.3 (0.91) 16.6 % -1.56 [ -2.39, -0.73 ] Total (95% CI) 106 87 100.0 % -1.15 [ -1.76, -0.53 ] Heterogeneity: Tau2 = 0.41; Chi2 = 17.50, df = 5 (P = 0.004); I2 =71% Test for overall effect: Z = 3.66 (P = 0.00025) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 113 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 3.1. Comparison 3 Preparation and information, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 3 Preparation and information

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Harrison 1991 50 2 (1.73) 50 3.06 (1.22) 51.6 % -0.70 [ -1.11, -0.30 ]

Tak 2006 26 2.82 (1.76) 28 2.3 (1.66) 48.4 % 0.30 [ -0.24, 0.84 ] Total (95% CI) 76 78 100.0 % -0.22 [ -1.20, 0.76 ] Heterogeneity: Tau2 = 0.44; Chi2 = 8.54, df = 1 (P = 0.003); I2 =88% Test for overall effect: Z = 0.43 (P = 0.66) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Analysis 4.1. Comparison 4 Virtual reality, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 4 Virtual reality

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Gold 2006 10 1.9 (2.36) 10 2.2 (1.98) 40.7 % -0.13 [ -1.01, 0.75 ]

Wint 2002 17 12.41 (13.57) 13 17.23 (18.67) 59.3 % -0.29 [ -1.02, 0.43 ] Total (95% CI) 27 23 100.0 % -0.23 [ -0.79, 0.33 ] Heterogeneity: Tau2 = 0.0; Chi2 = 0.08, df = 1 (P = 0.78); I2 =0.0% Test for overall effect: Z = 0.80 (P = 0.42) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 114 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 5.1. Comparison 5 CBT-combined, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 5 CBT-combined

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Bisignano 2006 14 20.93 (33.08) 16 10.44 (15.94) 33.8 % 0.40 [ -0.32, 1.13 ]

Liossi 1999 10 2.7 (0.67) 10 4.2 (0.63) 26.8 % -2.21 [ -3.37, -1.05 ]

Wang 2008 100 4.38 (2.32) 100 5.22 (2.53) 39.4 % -0.34 [ -0.62, -0.07 ] Total (95% CI) 124 126 100.0 % -0.59 [ -1.62, 0.44 ] Heterogeneity: Tau2 = 0.68; Chi2 = 13.95, df = 2 (P = 0.00094); I2 =86% Test for overall effect: Z = 1.12 (P = 0.26) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 115 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 5.2. Comparison 5 CBT-combined, Outcome 2 Self-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 5 CBT-combined

Outcome: 2 Self-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Bisignano 2006 14 1.64 (0.842) 16 2.25 (1.57) 32.9 % -0.46 [ -1.19, 0.27 ]

Liossi 1999 10 3.5 (1.08) 10 4.6 (0.52) 23.1 % -1.24 [ -2.22, -0.27 ]

Tyc 1997 28 2.7 (2.4) 27 3.1 (3) 44.0 % -0.15 [ -0.67, 0.38 ] Total (95% CI) 52 53 100.0 % -0.50 [ -1.08, 0.07 ] Heterogeneity: Tau2 = 0.12; Chi2 = 3.78, df = 2 (P = 0.15); I2 =47% Test for overall effect: Z = 1.72 (P = 0.085) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Analysis 5.3. Comparison 5 CBT-combined, Outcome 3 Observer-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 5 CBT-combined

Outcome: 3 Observer-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Bisignano 2006 13 2.21 (1.12) 16 1.69 (0.75) 45.9 % 0.54 [ -0.21, 1.29 ]

Tyc 1997 28 2.15 (2.06) 27 3.1 (2.72) 54.1 % -0.39 [ -0.92, 0.14 ] Total (95% CI) 41 43 100.0 % 0.04 [ -0.87, 0.95 ] Heterogeneity: Tau2 = 0.32; Chi2 = 3.95, df = 1 (P = 0.05); I2 =75% Test for overall effect: Z = 0.08 (P = 0.93) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 116 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 5.4. Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 5 CBT-combined

Outcome: 4 Behavioral measures- Distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Bisignano 2006 13 0.54 (0.877) 16 0.25 (0.577) 23.8 % 0.39 [ -0.35, 1.13 ]

Blount 1992 30 16.2 (16.1) 30 38.95 (26.37) 28.3 % -1.03 [ -1.57, -0.49 ]

Liossi 1999 10 8.9 (2.64) 10 12.6 (3.83) 19.5 % -1.08 [ -2.03, -0.12 ]

Tyc 1997 28 1 (1.1) 27 1.9 (2.6) 28.4 % -0.45 [ -0.98, 0.09 ] Total (95% CI) 81 83 100.0 % -0.54 [ -1.16, 0.09 ] Heterogeneity: Tau2 = 0.28; Chi2 = 10.49, df = 3 (P = 0.01); I2 =71% Test for overall effect: Z = 1.69 (P = 0.092) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 117 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 6.1. Comparison 6 Parent coaching + child distraction, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 6 Parent coaching + child distraction

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Kleiber 2001 22 3.24 (1.95) 22 2.7 (1.4) 14.9 % 0.31 [ -0.28, 0.91 ]

McCarthy 2010 240 3.39 (3.54) 278 3.07 (3.21) 68.7 % 0.09 [ -0.08, 0.27 ]

Windich-Biermeier 2007 22 0.28 (0.41) 28 0.84 (2.21) 16.4 % -0.33 [ -0.89, 0.23 ] Total (95% CI) 284 328 100.0 % 0.06 [ -0.19, 0.31 ] Heterogeneity: Tau2 = 0.02; Chi2 = 2.64, df = 2 (P = 0.27); I2 =24% Test for overall effect: Z = 0.46 (P = 0.65) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Analysis 6.2. Comparison 6 Parent coaching + child distraction, Outcome 2 Observer-reported distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 6 Parent coaching + child distraction

Outcome: 2 Observer-reported distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Kleiber 2001 22 10.8 (4.2) 22 9.9 (4) 7.6 % 0.22 [ -0.38, 0.81 ]

McCarthy 2010 247 3.64 (2.15) 290 3.78 (2.16) 92.4 % -0.06 [ -0.23, 0.10 ] Total (95% CI) 269 312 100.0 % -0.04 [ -0.21, 0.12 ] Heterogeneity: Tau2 = 0.0; Chi2 = 0.79, df = 1 (P = 0.37); I2 =0.0% Test for overall effect: Z = 0.52 (P = 0.60) Test for subgroup differences: Not applicable

-100 -50 0 50 100 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 118 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 6.3. Comparison 6 Parent coaching + child distraction, Outcome 3 Behavioral measures- Distress.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 6 Parent coaching + child distraction

Outcome: 3 Behavioral measures- Distress

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Blount 1992 30 16.2 (16.1) 30 38.95 (26.37) 30.9 % -1.03 [ -1.57, -0.49 ]

Kleiber 2001 22 1.89 (1.22) 22 2.13 (2.77) 29.5 % -0.11 [ -0.70, 0.48 ]

McCarthy 2010 244 3.18 (3.91) 287 3.27 (3.98) 39.6 % -0.02 [ -0.19, 0.15 ] Total (95% CI) 296 339 100.0 % -0.36 [ -0.97, 0.25 ] Heterogeneity: Tau2 = 0.24; Chi2 = 12.07, df = 2 (P = 0.002); I2 =83% Test for overall effect: Z = 1.16 (P = 0.25) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 119 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 7.1. Comparison 7 Suggestion, Outcome 1 Self-reported pain.

Review: Psychological interventions for needle-related procedural pain and distress in children and adolescents

Comparison: 7 Suggestion

Outcome: 1 Self-reported pain

Std. Std. Mean Mean Studyorsubgroup Treatment Control Difference Weight Difference N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI

Eland 1981 10 2.3 (0.82) 10 2.8 (0.63) 9.2 % -0.65 [ -1.56, 0.25 ]

Fowler-Kerry 1987 40 1.59 (1.13) 80 1.78 (1.14) 52.4 % -0.17 [ -0.55, 0.21 ]

Goodenough 1997 39 1.2 (2) 39 1.1 (1.6) 38.4 % 0.05 [ -0.39, 0.50 ] Total (95% CI) 89 129 100.0 % -0.13 [ -0.40, 0.15 ] Heterogeneity: Tau2 = 0.0; Chi2 = 1.99, df = 2 (P = 0.37); I2 =0.0% Test for overall effect: Z = 0.90 (P = 0.37) Test for subgroup differences: Not applicable

-4 -2 0 2 4 Favours treatment Favours control

ADDITIONAL TABLES

Table 1. Deﬁnitions of medical procedures

Procedure Deﬁnition

Immunization (also known as immunisation) Protection against a particular disease or treatment of an organism by protect- ing against certain pathogen attacks; the introduction of microorganisms that have previously been treated to make them harmless

Venepuncture (also known as venipuncture) The surgical puncture of a vein typically for withdrawing blood or administering intravenous medication

Finger prick/pin Obtaining blood by puncturing the tip of the ﬁnger.

Injection The act of forcing a liquid into tissue, the vascular tree, or an organ

Subcutaneous injection Injection administered under the skin.

Intramuscular injection Injection administered by entering a muscle.

Lumbar punctures (LP) (also known as spinal tap) The withdrawal of cerebrospinal ﬂuid or the injection of anesthesia by puncturing the subarachnoid space located in the lumbar region of the spinal cord

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 120 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 1. Deﬁnitions of medical procedures (Continued)

Bone marrow aspiration (BMA) The bone marrow is the tissue that manufactures the blood cells and is in the hollow part of most bones. This test is done by suctioning some of the bone marrow for examination

Bone marrow biopsy (BMB) The removal and examination of tissue, cells, or ﬂuids from the bone marrow of a living body; usually performed at the same time as a BMA

IV/catheter insertion A narrow short, ﬂexible, synthetic (usually plastic) tube known as a catheter, that is inserted approximately one inch into a vein to provide temporary intravenous access for the administration of ﬂuid, medication, or nutrients

Central line (also known as central venous catheter) Insertion of a catheter into the large vein above the heart, usually the subclavian vein, through which access to the blood stream can be made. This allows drugs and blood products to be given and blood samples withdrawn

Suture (also known as laceration repair) A stitch made with a strand or ﬁber used to sew parts of the living body

Accessing a portacath (also known as a port) Insertion of a needle into an implanted access device (portacath) which fa- cilitates the drawing of blood and intravenous (or intra-arterial) injections by not having to locate and insert a cannula into a new vessel. Some ports are connected for intrathecal, intraperitoneal or intracavitary injections

Arterial puncture A hole, wound, or perforation of an artery made by puncturing

Arterial blood gas (ABG) A test which analyses arterial blood for oxygen, carbon dioxide and bicarbonate content in addition to blood pH. Used to test the effectiveness of respiration

Arterial line (also known as intra-arterial catheter) Insertion of a catheter into an artery.

Thoracocentesis (also called thoracentesis) Aspiration of ﬂuid from the chest.

Paracentesis A surgical puncture of a bodily cavity (e.g. abdomen) with a trocar, aspirator, or other instrument usually to draw off an abnormal effusion for diagnostic or therapeutic purposes

Table 2. Means and standard deviations for outcomes from single trials

Intervention Outcome Study Treatment Control

N Mean (SD) N Mean (SD

Distraction Physio- Nguyen 2010 20 25.1 (3.6) 20 28.5 (3.86) logical measure - Respiratory rate

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 121 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 2. Means and standard deviations for outcomes from single trials (Continued)

Physio- Nguyen 2010 20 97.1 (8.57) 20 105.6 (15.97) logical measure - Systolic BP

Physio- Nguyen 2010 20 65.2 (6.83) 20 69.8 (11.67) logical measure - Diastolic BP

Hypnosis Observer- Katz 1987 17 3 (0.9) 19 3.3 (0.6) reported distress

Behavioural Huet 2011 14 1.07 (1.05) 15 2.86 (2.16) measure - Pain

Preparation/ Observer- Harrison 1991 50 1.89 (1.27) 50 2.81 (1.11) Information reported pain

Observer- Harrison 1991 50 2.43 (1.62) 50 3.17 (1.3) reported distress

Behavioural Tak 2006 26 2.64 (1.1) 28 2.37 (1.12) measure - Dis- tress

Physio- Harrison 1991 50 84.6 (8.6) 50 88.6 (8.3) logical measure - Pulse rate

Memory Alter- Self-reported Chen 1999 15 -0.06 (3.9) 9 -0.02 (3.2) ation pain (during procedure change score)

Observer- Chen 1999 20 04. (3.1) 22 -0.1 (1.8) reported pain (during procedure change score)

Observer- Chen 1999 25 -0.2 (2.6) 25 -0.5 (1.9) reported distress (during procedure change score)

Behavioural Chen 1999 25 -0.62 (3.7) 25 -0.48 (2.0) measure - Dis- tress

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 122 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 2. Means and standard deviations for outcomes from single trials (Continued)

(during procedure change score)

Physio- Chen 1999 24 0.1 (26.9) 20 -4.9 (21.8) logical measure - Heart rate (during procedure change score)

Physio- Chen 1999 22 0.01 (0.18) 22 0.01 (0.2) logical measure - Cortisol (during procedure change score)

Physio- Chen 1999 23 -0.5 (11.8) 19 -5.4 (7.9) logical measure - Systolic BP (during procedure change score)

Physio- Chen 1999 23 -4.1 (10.9) 19 2.9 (10.2) logical measure - Diastolic BP (during procedure change score)

Parent Coach- Self-reported Windich- 22 0.36 (0.9) 28 0.54 (1.04) ing plus Child distress Biermeier 2007 Distraction

Physiological McCarthy 2010 115 23.4 (7.9) 123 50.8 (9.4) measure - Corti- sol responsivity

Parent Position Self-reported Cavender 2004 20 2.3 (1.87) 23 2.74 (1.63) plus Child Dis- pain traction

Self-reported Cavender 2004 20 2.15 (1.81) 23 2.74 (1.86) distress

Observer- Cavender 2004 20 1.24 (1.3) 23 2.34 (1.72) reported distress

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 123 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Table 2. Means and standard deviations for outcomes from single trials (Continued)

Behavioural Cavender 2004 20 13.7 (7.83) 23 16.39 (8.81) measure - Dis- tress

Suggestion Self-reported Goodenough 39 0.7 (1.1) 39 1.1 (1.3) distress 1997

Observer- Goodenough 39 0.9 (1.6) 39 1.7 (2.3) reported pain 1997

Observer- Eland 1981 10 1.8 (0.71) 10 1.8 (0.79) reported distress

Blowing Out Self-reported Gupta 2006 25 1.24 (1.3) 25 4 (1.32) Air pain

Distraction Self-reported Fowler-Kerry 40 1.07 (1.02) 80 1.78 (1.14) plus Suggestion pain 1987

APPENDICES

Appendix 1. MEDLINE search strategy 1 Needles/ 2 (needle* or inject*).mp. 3 (immuni* or vaccin* or ﬁnger prick* or heel prick*).mp. 4 (lumbar puncture* or spinal tap*).mp. 5 (bone marrow adj (aspiration or biops*)).mp. 6 (intravenous or intra-venous or venepuncture* or venous cannulation*).mp. 7 (catheter adj5 insert*).mp. 8 (central line adj5 insert*).mp. 9 (local adj (analges* or anaesthe* or anesthe*)).mp. 10 (arterial adj (puncture or line*)).mp. 11 (artery adj5 puncture).mp. 12 (thoracocentesis or paracentesis).mp. 13 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 14 Pain/ 15 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp. 16 14 or 15 17 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk or selftalk* or stop signal* or structured attention).mp. 18 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp. 19 (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile* stimulat*).mp.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 124 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 20 ((multisensory or multi-sensory) adj stimulation).mp. 21 Therapeutic Touch/ 22 Relaxation/ 23 Breathing Exercises/ 24 Laughter Therapy/ 25 exp Psychotherapy/ 26 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp. 27 (autogenic training or auto suggestion*).mp. 28 ((colour* or color* or music* or play) and (therap* or distract*)).mp. 29 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 30 exp Child/ 31 exp Infant/ 32 exp Adolescent/ 33 (child* or infant* or adolescent* or adolescence).mp. 34 30 or 31 or 32 or 33 35 13 and 16 and 29 and 34 key: mp=title, original title, abstract, name of substance word, subject heading word, unique identiﬁer

Appendix 2. PsycINFO search strategy 1 (needle* or inject*).mp. 2 (immuni* or vaccin* or ﬁnger prick* or heel prick*).mp. 3 (lumbar puncture* or spinal tap*).mp. 4 (bone marrow adj (aspiration or biops*)).mp. 5 (intravenous or intra-venous or venepuncture* or venous cannulation*).mp. 6 (catheter adj5 insert*).mp. 7 (central line adj5 insert*).mp. 8 (local adj (analges* or anaesthe* or anesthe*)).mp. 9 (arterial adj (puncture or line*)).mp. 10 (artery adj5 puncture).mp. 11 (thoracocentesis or paracentesis).mp. 12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 13 Pain/ 14 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp. 15 13 or 14 16 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk* or selftalk* or stop signal* or structured attention).mp. 17 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp. 18 (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile stimulat*).mp. 19 ((multisensory or multi-sensory) adj stimulation).mp. 20 exp relaxation therapy/ 21 Relaxation/ 22 exp psychotherapy/ 23 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp. 24 (autogenic training or auto suggestion*).mp. 25 ((colour* or color* or music* or play) and (therap* or distract*)).mp.

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 125 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 26 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 27 (child* or infant* or adolescent* or adolescence).mp. 28 12 and 15 and 26 and 27 key: [mp=title, abstract, heading word, table of contents, key concepts]

Appendix 3. CENTRAL search strategy #1 MeSH descriptor Needles, this term only #2 needle* or inject* #3 immuni* or vaccin* or (ﬁnger next prick*) or (heel next prick*) #4 (lumbar next puncture*) or (spinal next tap*) #5 bone next marrow next (aspiration or biops*) #6 intravenous or intra-venous or venepuncture* or (venous next cannulation*) #7 catheter near insert* #8 (central next line) near insert* #9 local next (analges* or anaesthe* or anesthe*) #10 arterial next (puncture or line*) #11 artery near puncture #12 thoracocentesis or paracentesis #13 (#1OR#2OR#3OR#4OR#5OR#6OR#7OR#8OR#9OR#10 OR#11 OR#12) #14 MeSH descriptor Pain, this term only #15 (needle* or immuni* or vaccin* or inject* or procedure* or intervention*) near (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*) #16 (#14 OR #15) #17 rehears* or coping or (verbal* next encourage*) or (positiv* next reinforce*) or reward* or token* or (self next talk*) or selftalk* or (stop next signal*) or (structured next attention) #18 (cognitive* or behaviour* or behavior*) near (intervention* or therap* or distract*) #19 (((audiovisual or (audio next visual) or visual*) and distract*) or movie* or television* or tv or game* or toy* or (virtual next reality) or (tactile next stimulat*)) #20 (multisensory or multi-sensory) next stimulation #21 MeSH descriptor Therapeutic Touch, this term only #22 MeSH descriptor Relaxation, this term only #23 MeSH descriptor Breathing Exercises, this term only #24 MeSH descriptor Laughter Therapy, this term only #25 MeSH descriptor Psychotherapy explode all trees #26 desensiti* or relax* or (therapeutic next touch*) or (breathing next exercise*) or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap* #27 (autogenic next training) or (auto next suggestion*) #28 (colour* or color* or music* or play) and (therap* or distract*) #29 (#17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28) #30 MeSH descriptor Child explode all trees #31 MeSH descriptor Infant explode all trees #32 MeSH descriptor Adolescent explode all trees #33 child* or infant* or adolescent* or adolescence #34 (#30 OR #31 OR #32 OR #33) #35 (#13 AND #16 AND #29 AND #34)

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 126 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Appendix 4. EMBASE search strategy 1 exp needle/ 2 (needle* or inject*).mp. 3 (immuni* or vaccin* or ﬁnger prick* or heel prick*).mp. 4 (lumbar puncture* or spinal tap*).mp. 5 (bone adj (aspiration or biops*)).mp. 6 (intravenous or intra-venous or venepuncture* or venous cannulation*).mp. 7 (catheter adj5 insert*).mp. 8 (central line adj5 insert*).mp. 9 (local adj (analges* or anaesthe* or anesthe*)).mp. 10 (arterial adj (puncture or line*)).mp. 11 (artery adj5 puncture).mp. 12 (thoracocentesis or paracentesis).mp. 13 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 14 pain/ 15 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) adj5 (pain* or distress* or discomfort or fear* or fright* or anxious or anxiet*)).mp. 16 14 or 15 17 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* or token* or self talk* or selftalk* or stop signal* or structured attention).mp. 18 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or distract*)).mp. 19 (((audiovisual or audio visual or visual*) and distract*) or movie* or television* or tv or game* or toy* or virtual reality or tactile stimulat*).mp. 20 ((multisensory or multi-sensory) adj stimulation).mp. 21 breathing exercise/ 22 HYPNOSIS/ 23 exp psychotherapy/ 24 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosis or hypnoti* or hypnotherapy or image* or psychotherap*).mp. 25 (autogenic training or auto suggestion*).mp. 26 ((colour* or color* or music* or play) and (therap* or distract*)).mp. 27 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 28 child/ 29 infant/ 30 adolescent/ 31 (child* or infant* or adolescent* or adolescence).mp. 32 28 or 29 or 30 or 31 33 13 and 16 and 27 and 32 key: mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer

Appendix 5. IBI Web of Knowledge search strategy

# 6 396 #5 AND #4 AND #3 AND #2 Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 127 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

# 5 >100,000 Topic=(audio visual* OR audiovisual* OR touch* OR humor OR humour OR laugh* OR psychotherapy OR desensit*) OR Topic=(hypnotherap* OR coach* OR inform* OR thought-stop* OR thought stop* OR thought*) OR Topic= (coping* OR cope OR memor* OR train*) Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

# 4 >100,000 Topic=(intervention* OR cognitive* OR cbt OR behavio* OR distract* OR music*) OR Topic=(virtual reality OR rehears* OR coping* OR reinforce* OR hypnosis OR hypnot*) OR Topic=(reward* OR selftalk OR self talk OR relax* OR breath* OR suggest* OR image*) Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

# 3 >100,000 Topic=(intervention* OR cognitive* OR cbt OR behavio* OR distract* OR music*) OR Topic=(virtual reality OR rehears* OR coping* OR reinforce* OR hypnosis OR hypnot*) Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

# 2 4,391 Topic=(child* OR youth* OR teen* OR adolescen* OR infant*) AND Topic=(pain* OR hurt* OR anxiety OR anxious OR distress OR discomfort* OR fear*) AND Topic= (needle* OR inject* OR procedure* OR vaccin* OR lumbar puncture* OR bone marrow OR spinal tap OR intravenous OR venepuncture*

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 128 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. (Continued)

OR venipuncture* OR catheter* OR puncture* OR thoracentes* OR paracentes* OR central line*) Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

# 1 >100,000 Topic=(child* OR youth* OR teen* OR adolescen* OR infant*) Databases=SCI-EX- PANDED, SSCI, A&HCI, CPCI-S, CPCI-SSH Timespan=2005-2011

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 129 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Appendix 6. CINAHL search strategy

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 130 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Query Limiters/Expanders Last Run Via Results Action S9 (AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 and S4 and S5 and S6) Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text 272 Edit S9 S8 (AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 and S4 and S5 and S6) Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S8 S7 AB intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S7 S6 AB intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR TV* OR DVD* OR virtual reality OR rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual OR audio visual OR movie* OR therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR desensit* OR hypnosis OR hypnoti*

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 131 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought-stop* OR though stop* OR coping OR cope OR memor* OR train* or muscle* OR model* or rehears* Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S6 S5 AB pain* OR hurt* OR anxiety OR anxious OR distress* OR discomfort* OR fear* Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S5 S4 AB child* OR youth* or teen* or adolescen* OR infant* Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S4 S3 AB needle* OR inject* OR vaccin* OR lumbar puncture* OR bone marrow OR spinal tap OR intravenous OR venepuncture* OR venipuncture* OR catheter* OR puncture* OR thoracentes* OR paracentes* OR central line* Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S3 S2 AB needle and AB pain and AB children Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 132 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Display Edit S2 S1 needle and pain and children Limiters - Published Date from: 20050101- Expanders - Apply related words Search modes - Boolean/Phrase Interface - EBSCOhost Search Screen - Advanced Search Database - CINAHL with Full Text Display Edit S1

WHAT’S NEW Last assessed as up-to-date: 2 September 2013.

Date Event Description

2 September 2013 New citation required and conclusions have changed Since the last version of this review (published in 2006) , new relevant studies have provided additional information to change the conclusions

20 March 2013 New search has been performed Review updated. This update differed from the original review by limiting the included studies to true RCTs published in academic journals (i.e. excluded quasi-randomized trials and dissertation studies). As such we excluded seven studies from the 28 included in the original review and added an additional 18 studies from this review update, for a total of 39 RCTs included in the update

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 133 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. HISTORY Protocol ﬁrst published: Issue 1, 2005 Review ﬁrst published: Issue 4, 2006

Date Event Description

24 September 2010 Amended Contact details updated.

13 May 2009 Amended Contact details updated.

2 July 2008 Amended Converted to new review format.

CONTRIBUTIONSOFAUTHORS Lindsay Uman was the lead review author and was involved with review development, study searching, study retrieval, abstract and study review, study selection, data extraction, data entry, statistical analyses, and report writing. Kathryn Birnie was involved in conducting literature searches, abstract and study review, data extraction, risk of bias coding, report writing, and report editing. Melanie Noel was involved in conducting literature searches, abstract and study review, data extraction, risk of bias coding, report writing, and report editing. Jennifer Parker was involved in conducting literature searches, reporting writing, and report editing. Christine Chambers provided pediatric and pain management expertise, assisted with protocol development, study selection, interpretation of results, and report editing. Patrick McGrath provided pediatric and pain management expertise, assisted with protocol development, study selection, and report editing. Stephen Kisely provided expertise in conducting systematic reviews, statistical analyses, protocol development, reporting results, and report editing.

DECLARATIONSOFINTEREST None to declare

SOURCES OF SUPPORT

Psychological interventions for needle-related procedural pain and distress in children and adolescents (Review) 134 Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Internal sources • No sources of support supplied

External sources • CGS-M Award from the National Science and Engineering Research Council (NSERC) awarded to LS Uman (2004 to 2005), Canada. • Graduate Award from the Nova Scotia Health Research Foundation (NSHRF) awarded to LS Uman (2005 to 2006), Canada. • Pain in Child Health (PICH) top-up funding awarded to LS Uman (2004 to 2006), Canada. • Dalhousie Cochrane Group funding awarded to LS Uman, Canada. • Canada Research Chairs (CRCs) awarded to C Chambers and P McGrath, Canada.

DIFFERENCESBETWEENPROTOCOLANDREVIEW Expanded age range from three to 18 to two to 18 years from the protocol to the original review. This updated review differed from the original review by excluding non-randomized trials and excluding non-published trials (for example, dissertations).

NOTES Not applicable.

INDEX TERMS

Medical Subject Headings (MeSH) ∗Needles; Anxiety [∗prevention & control; psychology]; Central Venous Catheters [adverse effects]; Cognitive Therapy [∗methods]; Hypnosis; Immunization; Pain [∗prevention & control; psychology]; Phlebotomy [psychology]; Punctures [∗psychology]; Randomized Controlled Trials as Topic

MeSH check words Adolescent; Adult; Child; Child, Preschool; Humans