THE EFFECTS OF ACUPUNCTURE AND AROMATHERAPY
ON THE TREATMENT OF STRESS
______
A Capstone Project
Presented to the
Doctoral Faculty of
Pacific College of Oriental Medicine
______
In Partial Fulfillment
of the Requirements for the Degree of
Doctor of Acupuncture and Oriental Medicine
______
by
East Haradin, L.Ac.
San Diego, 2013 Copyright 2013 All Rights Reserved THE EFFECTS OF ACUPUNCTURE AND AROMATHERAPY
ON THE TREATMENT OF STRESS
______
A Capstone Project
Presented to the
Doctoral Faculty of
Pacific College of Oriental Medicine
______
by
East Haradin, L.Ac.
Approved by:
______Ed Lamadrid, DAOM, L.Ac., LMT, Chair Date
______Kathleen Padecky, Certified Aromatherapist Date
iii ABSTRACT
Objectives: The aim of this study was to determine if aromatherapy combined with acupuncture was more effective than acupuncture alone in reducing stress levels.
Design: Randomized, double-blind, placebo-controlled pilot study.
Participants: Fourteen women with high stress levels were recruited from an in-house residential drug and alcohol rehabilitation center.
Intervention: Participants were randomly assigned to either an aromatherapy group (N = 6) or a placebo group (N = 8). All participants received an acupuncture treatment once a week for 6 consecutive weeks.
Outcome Measures: The Perceived Stress Scale (PSS) and SF12v2 Health
Survey (quality of life measurement) were the instruments used in this study.
Results: The stress levels as measured by the PSS were significantly reduced in both groups (p < 0.05) independently. The aromatherapy group experienced a greater reduction in PSS and a greater increase in SF12v2 Healthy Survey scores compared to the placebo group. A between groups analysis did not result in a significant difference for the PSS scores (p > 0.05). However, a statistical difference was found between groups for SF12v2 scores (p < 0.05).
Conclusions: Between groups analysis did not support the hypothesis that aromatherapy combined with acupuncture reduces stress significantly more than acupuncture alone. However, the aromatherapy group experienced a significantly
iv higher increase in the quality of life scores compared to the placebo group. These results may be due to a small sample size, and more research is warranted.
Keywords: acupuncture, aromatherapy, stress.
v TABLE OF CONTENTS
Chapter I: PROBLEM FORMULATION AND DEFINITION...... 1
Background of the Problem...... 3
Statement of the Problem...... 6
Purpose of the Study...... 7
Research Hypothesis...... 7
Null Hypothesis...... 7
Theoretical Assumptions...... 7
Importance of the Study...... 9
Scope of the Study...... 10
Definition of Terms...... 11
Summary...... 12
Chapter II: LITERATURE REVIEW...... 14
Historical Perspectives...... 14
Theoretical Literature...... 16
Related Research Studies...... 22
Summary of Literature Findings...... 24
Chapter III: RESEARCH METHODS...... 25
Research Approach...... 25
Research Design...... 25
vi Null Hypothesis...... 29
Participant Selection...... 29
Instrumentation...... 31
Data Collection...... 32
Data Analysis...... 32
Methodological Assumptions...... 33
Limitations of Study...... 34
Organization of Remainder of Study...... 34
Chapter IV: RESEARCH FINDINGS...... 35
Description of Participants...... 35
Descriptive Demographics...... 36
Findings Related to the Hypothesis...... 37
Perceived Stress Scale Scores...... 37
SF12v2 Health Survey Scores...... 39
Post-Hoc Tests...... 43
Paired Students t-Test...... 44
Summary...... 45
Chapter V: CONCLUSIONS, DISCUSSION, AND RECOMMENDATIONS...... 47
Research Hypothesis...... 47
Null Hypothesis...... 47
Conclusions...... 48
Discussion...... 48
vii Strengths of the Study...... 50
Limitations of the Study...... 50
Recommendations for Future Research...... 51
Implications for the Profession...... 54
REFERENCES...... 55
APPENDICES
Appendix A: Consent to Participate in Research...... 62
Appendix B: Perceived Stress Scale...... 69
Appendix C: SF12v2 Health Survey...... 71
Appendix D: Participants Wanted Flyer...... 75
Appendix E: Inclusion/Exclusion Criteria Checklist...... 77
Appendix F: ANOVA Tests and Power Analysis for PSS and SF12v2...... 79
viii LIST OF TABLES
Table 1: Research Design Pretest-Posttest Control Design...... 26
Table 2: Demographics Data—Age...... 36
Table 3: Perceived Stress Scale Pretest and Posttest Mean Scores...... 44
Table 4: SF12v2 Health Survey Pretest and Posttest Mean Scores...... 44
Table 5: Paired Student’s t-Test...... 45
ix LIST OF FIGURES
Figure 1: Pretrial PSS scores—Group A (aromatherapy)...... 38
Figure 2: Pretrial PSS scores—Group B (placebo)...... 38
Figure 3: Perceived Stress Scale results—Group A (aromatherapy)...... 39
Figure 4: Perceived Stress Scale results—Group B (placebo)...... 39
Figure 5: Perceived Stress Scale results comparison between Groups A and B...... 40
Figure 6: Pretrial SF12v2 scores Group A (aromatherapy)...... 41
Figure 7: Pretrial SF12v2 scores Group B (placebo)...... 41
Figure 8: SF12v2 health survey results—Group A (aromatherapy)...... 41
Figure 9: SF12v2 health survey results—Group B (placebo)...... 42
Figure 10: SF12v2 health survey pre- and posttrial results comparison...... 43
x Chapter I
PROBLEM FORMULATION AND DEFINITION
Stress1 continues to be a problem in the United States (American Psychological
Association [APA], 2012). In 2011, Americans rated their average stress level as 5.2 on a scale from 1 to 10, where 1 is little or no stress and 10 is a great deal of stress.
Thirty-nine percent said that their stress had increased over the past year, and 22% reported experiencing extreme stress2 (APA, 2012). It was recently determined that
75% to 90% of all doctor visits are for stress-related ailments and complaints (Mental
Health America, 2013; WebMD, 2013). Furthermore, Occupational Safety and Health
Administration (OSHA) declared stress a hazard of the workplace, costing American industry more than $300 billion dollars annually due to absenteeism, turnover, diminished productivity and medical, legal and insurance costs (IMS3 Institute for
Healthcare Informatics, 2012).
Despite these statistics, Americans are not being given adequate support for stress management. In 2012, 53% of Americans surveyed by the APA reported
1Stress is defined as “the non specific result of any demand upon the body, be the effect mental or somatic” (Gates, 2001, p. 390).
2Extreme stress is defined as a scale of an 8, 9, or 10 on a 10-point scale, where 1 is little to no stress and 10 is a great deal of stress (APA, 2013).
3The IMS moniker stands for Intercontinental Medical Statistics, which is the original name for the company.
1 receiving little to no stress management support from their health care providers
(APA, 2013). Lack of support becomes problematic over time as chronic stress has been shown to lead to a number of severe conditions including: anxiety, depression, insomnia, hypertension, stroke, myocardial infarction, diabetes, irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, auto-immune disorders, emphysema, hypertension, and even some cancers (Cohen et al., 2012; Karpen, 1996;
Pert, Dreher & Ruff, 1998; Stahl & Hauger, 1994).
The most common treatment strategy for these conditions listed is the prescribing of pharmaceuticals. This strategy is costly and does not address the root causes of stress. In 2011, Americans spent $263 billion dollars on prescription drugs
(Centers for Medicare & Medicaid Services, 2012). This is a significant increase over the $234.1 billion dollars spent in 2008, which is more than double the amount spent in 1999 (Gu, Dillon, & Burt, 2010). Furthermore, it was found that even patients with insurance spent $49 billion dollars out-of-pocket on prescription drugs in 2010 (IMS,
2012).
Several treatment options are available when considering the treatment of stress. Some of the more common treatments are: Cognitive Behavioral Therapy
(CBT), relaxation techniques, meditation, biofeedback, yoga or other related exercise, massage, acupuncture, aromatherapy, acupressure and/or prescription drugs (Karpen,
1996). Out of these options, the prescription of psychotropic drugs, such as benzodiazepines and/or antidepressants, are most prevalent amongst primary care physicians (van Rijswijk, Borghuis, van de Lisdonk, Zitman, & van Weel, 2007).
These pharmaceuticals have been known to be habit forming, as well as associated
2 with several negative side effects (Lader, Tylee, & Donoghue, 2009; van Rijswijk et al., 2007). Examples of the harmful side effects include:
1. Benzodiazepines (common brand names such as Valium and Xanax) have
been shown to cause dementia as well as impairments in cognition,
memory, coordination, and balance (Anthierens et al., 2010); and
2. Prozac and Zoloft, common brand names falling under the category of
antidepressants, have been shown to come with the following side effects:
nausea, headaches, flu like symptoms, sexual dysfunction, blurred vision,
anxiety/tension, and sweating (Kikuchi, Suzuki, Uchida, Watanabe, &
Kashima, 2011).
Costs associated with the prescription of these drugs are in the billions. For example, in 2010 Americans spent $27 billion dollars on antidepressants and antipsychotics, combined (Smith, 2012).
Given the high cost and potential negative side effects of drugs, options such as acupuncture and aromatherapy may be two of the safest and affordable treatment approaches (Buckle, 1997; Cooke & Ernst, 2000; Leung & Pang, 2011). While several researchers have examined and proven the ability of acupuncture and aromatherapy to reduce stress individually, none have combined the two approaches.
This study explores the efficacy of combining aromatherapy with acupuncture to reduce stress.
Background of the Problem
The APA (2012) offered the following as the most common causes of stress in
America: money, work, the economy, relationships, family responsibilities, family
3 health problems, personal health concerns, job stability, housing costs and personal safety. When experienced at low levels or infrequently, in short bursts, stress is considered somewhat healthy, often acting as a motivating factor (Mayo Clinic, 2013;
McEwen, 2000). Referring to this type of motivating, good stress, Hans Selye (1974) coined the term eustress. The word eustress comes from the prefix eu, which is derived from the Greek word meaning well or good. When eu is placed in front of the word stress, it creates a term referring to good stress (Wikipedia, 2013). When a person is experiencing eustress they feel a positive cognitive response to stress that is healthy and consists of positive feelings (Nelson & Simmons, 2004). However, over time, the hormones and physiology that initially mediate the effects of stress on the body are no longer able to adapt and protect the body, and therefore stress becomes damaging (McEwen, 2000). For example, acute stress enhances immune function while prolonged stress suppresses it (Mayo Clinic, 2013; McEwen, 2000). Acute stress enhances memory of events that are potentially threatening, yet chronic stress causes structural and functional changes within the brain which often lead to depression or Post Traumatic Stress Disorder (PTSD, McEwen, 2000).
Additionally, according to the APA (2011), chronic stress is on the rise for many Americans and has reached a critical level. Forty-four percent of American adults report that their stress levels have increased over the past 5 years, and almost a third of children report that they have experienced physical health problems related to stress (APA, 2011). In addition, research on 6,300 individuals found that stress has increased 18% for women and 24% for men from 1983 to 2000 (APA, 2012). Since
4 chronic stress may be one of the primary contributors to the development of diseases, there is a need to reduce and eliminate it before it causes irreparable damage.
The current standard of care relies upon pharmacological treatments to address symptoms associated with chronic stress. Some of the most common prescriptions include sedatives (tranquilizers, hypnotics, and or anxiolytics), antidepressants
(Selective Serotonin Reuptake Inhibitors [SSRIs]) and beta-blockers (Devilbiss,
Jenison, & Berridge, 2012; Stahl & Hauger, 1994). In the Netherlands, it was found that over 50% of all patients treated for a single mood disorder or single anxiety disorder were prescribed one or a combination of these drugs (van Rijswik et al.,
2007).
A major consequence of prescribing drugs to treat stress is that they are often habit forming and have negative side effects (Anthierens et al., 2010). This results in the prescribing of additional drugs to treat the side effects or take people off the habit- forming drugs (Lader et al., 2009). The consequential vicious cycle then becomes one that is increasingly more difficult to break. An example can be made by looking at benzodiazepines, a prescription drug group often prescribed for a General Anxiety
Disorder (GAD), a condition found to be a direct result of chronic stress (Griffith et al., 2008). Benzodiazepines are found to be addictive, have several side effects, and are harmful when taken long term (Lader et al., 2009). One major potential side effect of taking benzodiazepines is dementia. According to de Gage et al. (2012), use of benzodiazepines in older adults increases their chances of falling victim to dementia by 50%. Similarly, SSRIs, another commonly prescribed drug in treating stress-related disorders, come with a set of unpleasant side effects which include headache, nausea,
5 and insomnia (Yim, Ng, Tsang, & Leung, 2009). This leads to the search of alternative options in the treatment of stress. Two such options are acupuncture and aromatherapy.
Acupuncture is a treatment modality that uses the insertion of needles into specific points on the body, which thereby promotes natural healing, harmony within the body, and improves function (Karpen, 1996; Leung & Pang, 2011). This form of treatment is part of Chinese Medicine, dates back thousands of years and has been used for centuries to treat a variety of conditions, including stress (Karpen, 1996).
Aromatherapy, the use of concentrated essential oils extracted from herbs, flowers, and other plant parts to treat various diseases (Cooke & Ernst, 2000), has been used for centuries to treat a wide variety of health conditions, including stress and stress-related issues (Halcon, 2002). Perry and Perry (2006) report that aromatherapy is found to be safe, without having the adverse effects that are common among psychotropic drugs. Furthermore, it was found that aromatherapy is one of the most widely used and requested modality within CAM (Horowitz, 2011; Yim et al., 2009).
This paper will explore whether the combined use of aromatherapy and acupuncture is more effective in the reduction of stress levels than treatments that use acupuncture alone.
Statement of the Problem
Current stress levels are consistently documented at levels much higher than what is considered healthy (APA, 2013). The APA (2013) reported a 35% increase in stress levels compared to the previous year. Some current treatment approaches that include pharmaceuticals have been shown to have harmful consequences. There is an
6 increasing need for patients to become informed about effective treatment options when considering how to reduce, and possibly even eliminate, harmful stress.
Independently, acupuncture and aromatherapy have been effective in treating stress and stress-related diseases (Buckle, 1997; Eshkevari et al., 2012; Horowitz,
2011; Nix, 2012; Perry & Perry, 2006). However, even though these alternative modalities are known by many to treat stress effectively, they are still widely underutilized due to a lack of clinical evidence (Nix, 2012). No research yet exists which examines the effects of combining aromatherapy with acupuncture in the treatment of stress reduction.
Purpose of the Study
The purpose of the study is to compare the efficacy of using aromatherapy and acupuncture together in the treatment of stress reduction versus acupuncture alone.
Research Hypothesis
The hypothesis is: The combined treatment of acupuncture and aromatherapy is more effective than acupuncture only.
Null Hypothesis
The null hypothesis is: There is no significant reduction in stress levels when acupuncture is combined with aromatherapy compared to acupuncture alone.
Theoretical Assumptions
Based on existing clinical evidence, it is assumed that as independent treatments, acupuncture and aromatherapy effectively reduce stress levels (Karpen,
7 1996). Acupuncture, a component of Traditional Chinese Medicine (TCM)4 is a tool used to bring the various parts of the body into harmony with each other (Karpen,
1996). From the viewpoint of TCM, when a person experiences stress, three things occur: Qi5 becomes stagnated, Qi and blood6 become depleted and the spirit7 is disrupted.
In the TCM theoretical paradigm, Qi stagnation is best understood as when the liver, the primary organ system affected by perceived stress, is unable to maintain the smooth and steady function of the whole body (Nix, 2012). The diagnosis of Liver Qi
Stagnation is very common in TCM and has been shown to be a consequence of a stressful life (Mist, Wright, Jones, & Carson, 2011). Symptoms of Liver Qi
Stagnation include: sighing, moodiness, unhappiness, melancholy, irritability, emotional depression, cold limbs from lack of circulation, distension of the hypochondrium and chest, abdominal distension, diarrhea and/or irregular periods
(Maciocia, 1989). Acupuncture can effectively treat the TCM diagnosis of Liver Qi
Stagnation, by coursing8 the Liver and thereby normalizing the free-flow of Qi (Nix,
2012). In terms of Qi and blood exhaustion, also referred to as Qi and blood vacuity
4TCM is considered the most modern and up-to-date version of Chinese Medicine (Nix, 2012).
5Qi is often defined as energy, material force, vital force, or life force (Maciocia, 1989).
6 “Blood” in TCM, is a dense fluid derived from the Qi converted from food by the Spleen. It is a form of Qi as Qi infuses life into blood. “Without Qi, blood would be an inert substance” (Maciocia, 1989, p. 52).
7“Spirit” is a TCM term referring to the spirit of a person’s vitality and the state of mental, emotional, and spiritual being (Maciocia, 1989).
8 For purposes of this study, the term “coursing” means to “get the function of the liver working smoothly” (Nix, 2012, p. 7).
8 or Qi and blood deficiency, acupuncture has also been effective in tonifying, or nourishing the body’s Qi and blood (Deadman, Al-Khafaji, & Baker, 1998; Maciocia,
1989). Finally, acupuncture is an effective treatment used to calm and settle the spirit
(Deadman et al., 1998; Maciocia, 1989).
The final assumption made in this study is that the point protocol utilized will accomplish the goals of: coursing the liver and rectifying the free-flow of Qi, supplementing Qi and blood; and calming the spirit. Liver 3 Tai Chong and Large
Intestine 4 He Gu were selected to address Liver Qi Stagnation. Stomach 36 Zu San Li was chosen to tonify9 Qi and blood. Yin Tang M-HN-3 was added to calm the spirit.
Further discussion of the acupuncture points and their synergistic effects are discussed in Chapter 3.
Importance of the Study
There is great need for evidence-based research to show the potential efficacy of aromatherapy and acupuncture in the treatment of reducing stress levels. Physicians have a desire and need for alternatives to prescription drugs. Forty-four percent of family medical practitioners surveyed reported that they were not in favor of prescribing benzodiazepine, yet they felt there is a lack of clinical evidence to applying nonpharmacologic approaches (Anthierens et al., 2010). Given the potential side effects of prescription drugs, and the high costs associated with them, it becomes increasingly important to demonstrate the efficacy of acupuncture and aromatherapy on lowering stress levels (MacPherson, Hammerschlag, Lewith, & Schnyer, 2008).
9For the purpose of this study, the term “tonify” or “tonifying” is synonymous with supplementing.
9 This study will be the first attempt to compare the effectiveness of lowering stress by combining aromatherapy with acupuncture. To date, research exists that examines the efficacy of acupuncture and aromatherapy independent of one another; however, none that examine the potential effect when both approaches are used together.
Scope of the Study
The study consisted of 14 participants from an in-patient addiction treatment center located in Oceanside, California. The participants were women over the age of
18 who were being treated for drug and alcohol addiction. All participants completed the Participant Consent Form (see Appendix A) and were randomly placed in either
Group A or Group B before the beginning of the 6-week treatment program. In addition, all participants completed the following two questionnaires prior to beginning the trial and after the last treatment of the trial, 6 weeks later: (a) the
Perceived Stress Scale (PSS), and (b) the SF12v2 Health Survey (see Appendices B and C, respectively). These instruments were chosen because they are the most widely used, recognized, and accepted tools for measuring nonspecific perceived stress and quality of life (Cohen, Kamarack, & Mermelstein, 1983; Ware et al., 2010).
The participants received weekly treatments for 6 consecutive weeks. Due to a small number of participants, this study is intended as a preliminary investigation into the efficacy of acupuncture combined with aromatherapy and the reduction of stress.
The resulting findings will provide a basis from which future researchers can build, challenge, and/or validate additional related areas of study.
10 Definition of Terms
For the purposes of this study, a select group of terms is being defined as follows:
Acupuncture: Acupuncture, within the context of TCM, involves the insertion of needles into specific acupuncture points on the body. It is an ancient healing modality that goes back thousands of years and centers on bringing balance within the body (Karpen, 1996; Leung & Pang, 2011).
Aromatherapy: The Institute of Classical Aromatherapy defines aromatherapy as “a natural treatment which uses the concentrated herbal energies in essential oils from plants in association with massage, friction, inhalation, compresses and baths”
(Buckle, 2010, p. 10).
Essential Oils: These oils are obtained from concentrated steam distillates from aromatic plants, as well as the expression from the peels of some citrus fruits (Buckle,
1997; Perry & Perry, 2006). The process in which essential oils are extracted is as follows: Plant material is placed in a still and steam is passed through it. The steam, mixed with volatile oils, is then passed through a condenser which cools it. After cooling, the oils which are nonsoluble in water, float to the top and are tapped off.
The resulting fluid comprises essential oils. To provide an idea of the quantities of plant material necessary to make essential oils, 200 kg of Lavandula augustifolia flowers will produce 1 kg of essential oil, while between 2 and 5 metric tons of rose petals will be needed to produce the same quantity (Buckle, 1997).
11 Limbic System: From the Latin word “limbus” which means border, the limbic system10 refers to structures on the inner border of the cerebrum and floor of the diencephalon (Tortora & Grabowski, 1993). Sometimes called the “emotional” brain, the limbic system has primary functions in memory associations with pain, pleasure, anger, rage, fear, sorrow, docility, and affection. For example, inhalation of a scent from a food that once made an individual ill will travel through the olfactory pathways and limbic system, and cause feelings of nausea (Tortora & Grabowski, 1993).
Olfactory System: For purposes of this study, olfactory system will refer to the physiology within the body that is responsible for olfaction, otherwise known as the sense of smell. Specifically, the olfactory system is made up of: olfactory receptor cells, olfactory bulb, and olfactory tract (Tortora & Grabowski, 1993).
Stress: For purposes of this study, stress is being defined as “The non-specific response of the body to any demand for change” (Selye, 1956, p. 54). Stated another way, stress is “a constraining force or influence: as a physical, chemical, or emotional factor that causes bodily or mental tension and may be a factor in disease causation”
(Merriam Webster, 2013b, para. 1[c]).
Summary
The goal of this project is to assess the use of aromatherapy and acupuncture in the reduction of stress. It is hoped that by presenting clinical evidence of the efficacy of aromatherapy combined with acupuncture that more TCM practitioners will
10 The components of the limbic system include: the limbic lobe, dentate gyrus, amygdala, septal nuclei, mammillary bodies of the hypothalmus, anterior thalamic nucleus, olfactory bulbs, and bundles of interconnected myelinated axons (Tortora & Grabowski, 1993).
12 incorporate aromatherapy into their treatments and thereby increase the possibility of treatment efficacy.
13 Chapter II
LITERATURE REVIEW
The purpose of this pilot study is to determine if acupuncture combined with aromatherapy is more effective in reducing stress levels than acupuncture treatment only. Fourteen women, randomly placed into two groups, participated in a 6-week clinical trial, wherein everyone received a weekly acupuncture treatment. One group received aromatherapy, and one group received a placebo of spring water.
This chapter will present historical and theoretical perspectives on stress, acupuncture, and aromatherapy. Following that discussion will be a review of important and related research studies.
Historical Perspectives
Hans Selye found that regardless of the cause of stress, be it physical, mental/emotional or chemical in nature, real or imagined, the same physiological and behavioral reactions occur. The reactions referred to here include negative autonomic, endocrine, and behavioral responses (Selye, 1956). While performing experiments,
Selye (1956) discovered that injecting rats with stress hormones resulted in enlarged adrenal glands, shrunken lymphatic glands and bleeding gastro-intestinal ulcers. He surmised that the more stress a person experienced, the more likely it was the he or she would become ill (Buckle, 1997).
14 Acupuncture, an ancient form of Asian medical treatment going back as far as the Stone Age or farther, is considered an effective method to prevent illness, maintain health, and has been used to treat a myriad of stress-related physical and mental conditions (Liangyue et al., 1987). The practice of acupuncture has been used for centuries to minimize the negative effects that stress has on the body (Lucas, 2011).
More recently, extensive studies have been conducted in an effort to explain the underlying mechanisms of the efficacy of acupuncture (Cabioglu & Cetin, 2008). In their systematic review, Cabioglu and Cetin (2008) presented several studies providing evidence that acupuncture is effective in treating a myriad of conditions including dysmenorrheal, osteoarthritis, fibromyositis, trigeminal neuralgia, anxiety, depression and weight loss.
Originally “aromatherapie,” aromatherapy is known to have come from the
French chemist Rene-Maurice Gattefosse in the late 1920s, who began exploring the use of essential oils for medicinal purposes after his hand was badly burned in a laboratory experiment. He soaked his injury in pure lavender oil and soon noticed rapid, almost miraculous healing and pain relief (Buckle, 1997, p. 37). For thousands of years, aromatherapy has been used as a healing modality in many cultures, such as:
Iraq, France, Mesopotamia, Egypt, China, India, Tibet, Greece, Persia, Arabia, and
Europe. It has been said that Hippocrates maintained that aromatic baths and massages promoted good health (Robins, 1999).
Contemporary aromatherapy proposes that various natural plant-based aromas possess therapeutic properties that have the ability to have a positive influence on mood, behavior, and health (Herz, 2009). Being highly regarded for its healing ability,
15 French medical students are required to study aromatherapy, and it is prescribed by licensed physicians (Lavabre, 1990). Aromatherapy is delivered either through inhalation, or transdermally through massage or skin application (Holmes, 1995). For the purposes of this trial, participants will receive aromatherapy via inhalation.
Theoretical Literature
There is a good deal of research that supports the possible relationship between stress and causes of death (Cohen et al., 2012; Lucas, 2011). The Center for Disease
Control (CDC) reported that the five leading causes of death in the United States are:
(a) heart disease; (b) cancer; (c) stroke; (d) respiratory disease; and (e) “accidents,” further defined as unintentional injuries (Murphy, Xu, & Kochanek, 2012). Three examples are as follows:
1. Chronic stress in adults causes the release of norepinephrine, epinephrine,
cortisol, aldosterone, growth hormone, additional stress hormones and
thyroxin, which has been found to cause heart disease (Robert-McComb,
Tacon, Randolph, & Caldera, 2004).
2. Delvilbiss et al. (2012) found that stress was a major contributing factor in
over half of all work place accidents; and (3) Cohen et al. (2012) examined
the effects of chronic stress on inflammation and glucocorticoid receptor
resistance. In particular, they found that stress disrupts the Hypothalamic-
Pituitary-Adrenocortical (HPA) axis response. Put another way, this
disruption negatively affects the body’s ability to regulate inflammation and
results in an exaggerated release of inflammatory cytokines within the nose
which almost always leads to upper respiratory disease (Cohen et al., 2012).
16 From a TCM point of view, the negative effects of stress are associated with the following patterns: (a) Liver Qi Stagnation; (b) Qi and/or blood deficiency; and/or
(c) Restless Spirit (Deadman et al., 1998; Maciocia, 1989). In the case of Liver Qi
Stagnation, escalated and harmful levels of stress impair the Liver’s ability to perform its function of promoting the free flow of Qi in the body. Therefore, Qi stagnates and does not reach the organ systems and various parts of the body. Symptoms of Liver Qi
Stagnation mirror those associated with stress from a Western medical point of view and include: depression, sighing, poor appetite, irritability, anger, fatigue,
Premenstrual Syndrome (PMS), muscle tension, chest pain, and headache (APA, 2013;
Liangyue et al., 1987).
The 39th chapter of Basic Questions11 says: “Overstrain or stress consume the vital energy of the body” (Liangyue, et al., 1987, p. 249). Qi and blood are the substances that comprise the vital energy of the body which is the nourishment necessary for the organ systems of the body to properly perform their functions
(Liangyue et al., 1987). For example, when the Liver organ is not properly nourished with Qi and blood, it cannot perform its function of circulating Qi to the other organ systems and the body as a whole. Without an adequate supply of Qi and blood, the ability of the other organ systems to perform their respective functions is inhibited, thereby leading to disease patterns within the body (Liangyue et al., 1987). Stress shares many of the same signs and symptoms of Qi and blood deficiency. For example, stress, as well as Qi and blood deficiency, commonly present as fatigue,
11The Basic Questions, also known as the Suwen, is an ancient Chinese medical text considered to be the fundamental doctrinal source for Chinese Medicine.
17 irritability, depression, sudden weight loss, and/or headache (APA, 2013; Maciocia,
1989).
In addition to stagnating Liver Qi and depleting Qi and blood, stress can affect a person’s spirit. When stress levels reach a point that begins to deplete a person’s general state of vitality, a person’s spirit can be unsettled, which is not considered a healthy state. The “Simple Questions,” as cited by Maciocia (1989), says: “If there is spirit the person thrives, if there is no spirit the person dies” (p. 144). Symptoms of disrupted spirit are similar to symptoms associated with stress: insomnia, unhealthy complexion, depression, anger, lack of energy, an unclear mind, and/or difficulty breathing (APA, 2012; Maciocia, 1989). Therefore, in the treatment of stress it is important to move Liver Qi, tonify and nourish the substances of Qi and blood, and settle/calm the spirit.
In 2003, the World Health Organization stated that acupuncture is an effective therapy in treating stress among 50 other diseases (Eshkevari et al., 2012). With the emergence of more clinical evidence, acupuncture is now being an accepted treatment option (Leung & Pang, 2011). In fact, recent studies have shown that acupuncture is now the best-known and frequently used technique in alternative medicine (Leung &
Pang, 2011).
Specific acupuncture points have empirical12 evidence in their effectiveness of moving, or “coursing” the Liver Qi, tonifying Qi and blood, and calming the spirit
12 For purposes of this study, empirical is defined as: “originating in or based on observation or experience” (Merriam-Webster, 2013a, para. 1).
18 (Deadman et al., 1998). While there are several acupuncture points that fall within these categories, a select group was selected for this study.
The first four of the seven points used in this study are collectively referred to as “The Four Gates” and consist of bilateral needle insertion of Liver 3 Tai Chong and
LI 4 He Gu. The Four Gates are commonly used to treat stress resulting from Qi and emotions being stuck in the body (Howard, 2010).
Stomach 36 Zu San Li, a common TCM acupuncture point, has been used to treat stress among a variety of health conditions (Eshkevari et al., 2012). According to one of the classic texts of TCM, Stomach 36 Zu San Li will produce the following actions when stimulated: tonify Qi, nourish blood, and calm the spirit (Deng et al.,
1997). Deadman et al. (1998) claims it is the single most important point in generating Qi and blood. Furthermore, experiments performed on participants during acute stress showed that stimulation of Stomach 36 Zu San Li blocked chronic stimulation of the hypothalamic-pituitary-adrenal axis, thereby reducing the negative physiological effects of the acute stress (Eshkevari et al., 2012).
Finally, the last of the acupuncture points selected for this study, Yin Tang
M-HN-3, calms the spirit and is a powerful and effective point in the treatment of insomnia, anxiety, and agitation (Deadman et al., 1998).
There is a wealth of literature that explores the potential of aromatherapy as a healthy modality. Over the past 20 years, there has been an emergence of clinical trials and research into the effects of aromatherapy. A systematic review of literature on aromatherapy performed in 2000, resulted in finding 12 randomized control trials. Six of the trials were found to have no independent replication, and 6 of the 12 trials
19 related to the relaxing effects of massage (Cooke & Ernst, 2000). A more recent systematic review of aromatherapy literature was performed resulting in 18 studies, providing clinical evidence that aromatherapy can significantly affect mood, cognition, physiology, and behavior (Herz, 2009). Additional evidence of the efficacy of aromatherapy to reduce stress came from a study performed in Korea wherein 36 female high school students were randomly assigned to either receive aroma treatment or placebo to reduce stress. Stress levels were significantly lower when the students received the aromatherapy (via inhalation) compared to when they received placebo
(Seo, 2009). While aromatherapy was found to be beneficial, all authors concluded that more research was needed (Cooke & Ernst, 2000; Kiecolt-Glaser et al., 2008).
The specific essential oils used to create the aromatherapy in this study include: ylang-ylang, rose, grapefruit, and lavender. These oils were selected based on clinical evidence of efficacy in treating stress, examples of which follow.
For years, ylang-ylang has been widely regarded as possessing sedative properties (Moss, Hewitt, Moss, & Wesnes, 2008; Tisserand, 1993). Ylang-ylang was the key essential oil found to significantly increase calmness in a study testing the effects of peppermint and ylang-ylang on cognitive performance and mood (Moss et al., 2008). Hongratanaworakit and Buchbauer (2004) found that ylang-ylang aromatherapy significantly reduced blood pressure and heart rate. This is a significant finding, since hypertension and high heart rate have been linked to the development of heart disease (Robert-McComb et al., 2004). Finally, a group of researchers combined ylang-ylang with lavender essential oils to create a blend aimed at reducing stress.
After inhalation of the blend once daily for 4 weeks, participants in this study
20 experienced a reduction in subjective stress, serum cortisol levels, and blood pressure.
Thus, it was concluded that the combination of ylang-ylang with lavender is an effective treatment for stress (Hwang, 2006).
In a study performed on 40 healthy volunteers, inhalation of rose essential oil
(Rosa damascene) caused significant decreases of breathing rate, blood oxygen saturation, and systolic blood pressure. The findings from this research provided evidence that rose oil is effective in reducing stress and depression in humans
(Hongratanaworakit, 2009).
Grapefruit essential oil (Citrus paradis) was added to the blend to address depression that is often associated with Liver Qi Stagnation and stress (Mist et al.,
2011). A group of Japanese researchers found that citrus essential oils, such as grapefruit, restored stress-induced immunosuppression and induced calm behavior.
Furthermore, they discovered that the application of these oils to depressive patients made it possible to markedly reduce the doses of antidepressants needed (Komori,
Fujwara, Tanida, & Nomura, 1995).
Finally, the effects of lavender have been studied extensively. Buckle (1993) used the essential oils from two different species of lavender in a randomized, double-blind trial and found that the effects of two different species of lavenders were significantly different. Specifically, it was found that Lavandula burnati was almost twice as effective as Lavandula angustafolia in reducing the emotional and behavioral stress levels. This disproved the hypothesis that aromatherapy is effective purely because of touch, massage, or placebo and proved the efficacy of lavender (Buckle,
1993). In addition, Horowitz (2011) highlighted the positive effects of lavender in her
21 systematic review of current aromatherapy research. Presented in her research was a study of the effects of lavender on cortisol and chromogranin A (stress markers) on 30 healthy adults. A statistically significant difference was found between the lavender group compared to the control group (Horowitz, 2011).
Research into aromatherapy from a TCM point of view revealed that each of the essential oils employed for this study address the three patterns resulting from stress. For example, lavender, grapefruit, and rose move Liver Qi stagnation and course the Liver (Willmont, 2005; Yuen, 2002), Rose and ylang-ylang tonify Qi and blood (Holmes, 2001), and lavender, rose, and ylang-ylang calm the spirit (Holmes,
2001; Willmont, 2005; Yuen, 2002).
Related Research Studies
An online search of many sites13 did not produce publications that focused on the combination of acupuncture and aromatherapy to treat stress. However, the search did unearth three studies involving the use of aromatherapy with acupressure.14 Shin and Lee (2007) performed a pilot study on the treatment of hemiplegic shoulder pain and motor power in stroke patients using aromatherapy and acupressure. They concluded that when aromatherapy was combined with acupressure more positive effects resulted versus acupressure alone. At the same time, they suggested that more research is needed. Yip and Tse (2004) found that acupressure with lavender
13 Sites searched include: PubMed, MEDLINE, Liebertonline, Acupuncture Today, AMED, EMBASE, and EBSCO.
14For purposes of this study, acupressure shall be defined as the application of physical pressure by fingers, elbows, or other devises on specific acupuncture points on the body (Jarmey & Tindall, 1991).
22 aromatherapy was significantly more effective than care that did not include these modalities. A few years later, Yip and Tse (2006) concluded that acupressure combined with lavender essential oil was more effective in reducing nonspecific neck pain more than acupressure treatment.
Yim et al. (2009) conducted a meta analysis of studies published from 2000 to
2008 that reported on the efficacy of using aromatherapy to treat depression. They concluded that the use of essential oils is significantly more effective in treating depressive disorder than the use of a placebo.
In terms of research on individual essential oils, an increasing number of studies have been conducted to assess lavender’s effect on the autonomic nervous system (Duan et al., 2007; Horowitz, 2011). Findings demonstrated that the use of lavender fragrance depresses sympathetic activity while augmenting parasympathetic activity in normal adults, thereby promoting relaxation and being beneficial in treating patients with various types of autonomic dysfunctions. Since the autonomic nervous system supports so many of the body’s involuntary actions and organ systems, it seems safe to suggest that lavender can treat a large number of conditions, with stress, undoubtedly, being one of them (Duan et al., 2007; Horowitz, 2011).
Summary of Literature Findings
The historical and theoretical research literature presents a great deal of evidence to support the assumptions that acupuncture and aromatherapy are effective in treating stress independent of each other. However, while the studies on the independent treatments of acupuncture and aromatherapy have preliminarily shown to
23 reduce stress levels, no research, to date, has considered the combined use and potential effects of these modalities. Only three studies were found to be remotely similar, wherein the researchers combined aromatherapy with acupressure in the treatment of pain (Shin & Lee, 2007; Yip & Tse, 2004, 2006). This project examined the treatment efficacy of combining aromatherapy with acupuncture in the reduction of stress.
24 Chapter III
RESEARCH METHODS
This study examined the efficacy of combining aromatherapy with acupuncture in the treatment of stress. Specifically, the purpose of the study was to determine whether acupuncture combined with aromatherapy reduces stress more than acupuncture treatment alone. Participating in the study were 14 women recruited from an addiction recovery center, a population with inherently high stress levels.
Participants received a 30-minute acupuncture treatment once a week for a period of
6 weeks. One group received aromatherapy while the other group received a placebo of spring water.
This chapter presents the research methods utilized to determine the effectiveness of using aromatherapy with acupuncture to reduce stress. The guidelines and parameters of the clinical study are discussed. In addition, a detailed explanation of the acupuncture point protocol and essential oils is included.
Research Approach
This study is a randomized, double-blind, placebo-controlled pilot study.
Research Design
This study used two blinded groups in a randomized controlled group pretest-posttest design (Table 1). While both groups received the same acupuncture
25 treatment, Group A received aromatherapy and Group B, serving as the control group, received a placebo.
Table 1
Research Design Pretest-Posttest Control Design
Group Pretest Posttest Group A Acupuncture and Group A Pre Group A Post Aromatherapy Group B Acupuncture and Group B Pre Group B Post Placebo
The duration of the study was 6 weeks and examined the efficacy of adding aromatherapy to acupuncture to reduce perceived stress levels and improve quality of life.
Two assistants participated in this study—“Assistant-1” and “Assistant-2.”
Both have an educational and experiential background in acupuncture and TCM with
Assistant-1 being a licensed acupuncturist and Assistant-2 a graduate of the Masters of
Traditional Oriental Medicine program, awaiting state licensure. Assistant-1 provided prescreening at the beginning of the trial, collected pretrial surveys, delivered the aromatherapy to the participants during their weekly treatment, and collected posttrial surveys. Assistant-2 prepared the bottles of aromatherapy and placebo prior to the commencement of the study and secured15 the trial documentation (surveys) and data.
The two aromatherapy bottles were prepared by placing a sticker with “A” on one
15Surveys containing participant data were held by Assistant-2 in a locked filing cabinet until the trial was completed to prevent bias.
26 bottle and “B” on the other. Assistant-2 was the only one with knowledge of which bottled contained the aromatherapy versus which one contained a spring water placebo. The “A” bottle contained aromatherapy in spring water and the “B” bottle contained spring water only.
A key problem with human olfactory research is the creation of a placebo. In terms of prior research, few studies are blind (single or double) and many assess only a single odor without control conditions (Kiecolt-Glaser et al., 2008). For the purposes of this study, inhalation was chosen for the method of aromatherapy administration based on prior studies, and the use of a placebo was elected to prevent bias by not giving one group aromatherapy treatment (Moss et al., 2008; Takeda et al., 2008).
Randomization of the participants was accomplished by placing 30 slips of paper within sealed security envelopes.16 Fifteen of the 30 envelopes contained slips of paper with “Group A” on them and 15 envelopes contained slips of paper with
“Group B.” All 40 envelopes were placed in a box, and participants selected an envelope at random.
All participants received the same weekly acupuncture treatment from the
Primary Investigator (PI)/acupuncturist.17 Serin brand, single use, 34 gauge, 1.5 inch needles were inserted at each of the specific acupuncture points to a depth of approximately 1/4 to 1/2 of an inch and turned slightly clockwise once.
16Thick paper stock was used to ensure that contents inside the envelope could not be seen from the outside.
17The PI/acupuncturist is a licensed acupuncturist and has been practicing TCM and acupuncture for over 13 years.
27 The seven acupuncture points included in the acupuncture point protocol used in each weekly treatment included: Liver 3 Tai Chong (bilateral), Large Intestine 4 He
Gu (bilateral), Stomach 36 Zu San Li (bilateral) and Yin Tang M-HN-3. The protocol was designed to course Liver Qi, tonify Qi and blood, as well as calm the spirit.
The PI/acupuncturist vacated the room after insertion of all the needles.
Assistant-1 then came into the room and provided the aromatherapy by placing three sprays from either Bottle A or Bottle B onto a cotton ball and placed that same cotton ball onto the participant’s chest, within 12 inches from the participant’s nose. Bottle A contained aromatherapy, and Bottle B contained the placebo of spring water. This method of placebo control group was elected due to its ease of administration and effective use in prior studies (Kiecolt-Glaser et al., 2008).
The aromatherapy employed for this study was a blend of natural and organic essential oils. Natural and organic oils are considered superior over, and more effective than, synthetic oils (Holmes, 1995). In addition, a blend versus single essential oil approach was chosen to avoid negative associations with a single essential oil, which may then alter the results of the study (Holmes, 2009). The essential oils used to create the blend were specifically selected because they are widely purported relaxant odors, with stress relief repeatedly ascribed to them (Buckle, 1997; Worwood,
1991).
The following Snow Lotus18 essential oils were added to one of the 2-ounce glass spray bottles containing spring water to make up the aromatherapy: ylang-ylang
18Snow Lotus, Inc., a company providing organic and natural essential oils, is located in Santa Rosa, CA.
28 (2 drops), rose (2 drops), grapefruit (4 drops), and lavender (2 drops). Clinical evidence on the effectiveness of some of these oils blended together, as well as specific individual efficacy, is presented in Chapter 2.
After 25 minutes, Assistant-1 returned to the room and removed the cotton ball from the participant’s chest, as well as from the room. The PI/acupuncturist then returned to the room and removed the needles. Having Assistant-1 deliver and remove the aromatherapy was an attempt to keep the PI/acupuncture blind and thereby unbiased. In addition, the room was aired for a minimum of 5 minutes in preparation for the next participant and to ensure no aromas lingered after the treatment was completed.
Null Hypothesis
The null hypothesis tested was: There is no significant (p > .05) reduction in stress levels due to acupuncture combined with aromatherapy compared to acupuncture alone.
Participant Selection
The study was a two group, double-blinded, controlled pilot. Initially, 32 participants were included in an effort to obtain an adequate number of participants to show significance (n = 30), while maintaining manageability and accounting for anticipated attrition (MacPherson et al., 2008). A flyer was posted on a community bulletin board 3 weeks prior to the study commencement (see Appendix D). A random assignment method was used whereby participants who passed the initial inclusion/exclusion criteria (see Appendix E) selected an envelope from a box. There were 30 security sealed envelopes within the box. Fifteen envelopes had “Group A”
29 on a slip of paper inside the envelope; 15 had “Group B.” Group A received the aromatherapy, while Group B received a placebo of spring water.
Participants were recruited from a San Diego County in-house residential drug and alcohol rehabilitation center that caters to women over the age of 18 that have children, or who are pregnant. All women receive standardized care that includes counseling, lifestyle training, and, when necessary, prescribed medications. Typical treatment and residency ranges from 8 to 18 months. While the center houses women over the age of 18, the ages of participants selected for the study fell within the range of 22 to 49 and included individuals from all racial and ethnic groups.
This particular population was chosen for its inherently high levels of stress.
It has been found that due to concurrent legal, familial, and financial problems, recovering addicts entering recovery programs have substantially higher stress levels compared to those of healthy19 adults (Hyman et al., 2009).
An initial inclusion/exclusion criteria checklist consisting of six questions was performed on all prospective participants (see Appendix E). Examples of the questions include: “Are you currently pregnant or have you delivered a child in the past 6 weeks?”; “Can you lie down on your back for 30 minutes?”; “To your knowledge do you have allergies or adverse reactions to essential oils or aromatherapy”; and “Can you read English?”
19For purposes of this study, “healthy” will be defined as having PSS and SF12v2 scores within normal ranges as defined by the creators of each measurement instrument.
30 Using a random assignment method, participants were placed into one of two groups—Group A or Group B. Group A received the aromatherapy; Group B received a placebo.
Participants received weekly treatments for 6 consecutive weeks. Each treatment lasted 30 minutes and consisted of acupuncture and aromatherapy. The
Primary Investigator/acupuncturist, with over 13 years of experience, performed all of the needle insertions, manipulations, and removals. Assistant-1 delivered all the aromatherapy, while the PI/acupuncturist was out of the room.
Instrumentation
The Perceived Stress Scale (PSS) and the SF12v2 Health Survey were used to assess stress level and perceived quality of life (Appendices B and C, respectively).
The two instruments used to measure stress levels in this study required different means in order to obtain scores from the individual questionnaires. The PSS is a
10-question survey with the following scoring possibilities for each question:
(0) Never, (1) Almost Never, (2) Sometimes, (3) Fairly Often, (4) Very Often. For questions numbered 1, 2, 3, 6, 9, and 10, the answers circled on the survey are calculated on the 0 to 4 scale shown above. For questions numbered 4, 5, 7, and 8, the answers circled on the survey are inverted whereby 2s become 3s and 3s become 2s.
After conversion of questions 4, 5, 7, and 8, all scores are added together to result in a final PSS score. This conversion was done for all the participants’ responses to the
PSS survey.
Use of the SF12v2 Health Survey is granted only by permission. Permission to use the SF12v2 Health Survey, as well as the statistical software that analyzes the
31 results, was granted. The specific statistical software program used to calculate the
SF12v2 Health Survey scores was the Quality Metric Health OutcomesTM Scoring
Software version 4.5.
A mixed 2 x 2 ANOVA test and power analysis was performed on data using a professional edition of SPSS, version 20. The data analysis was conducted upon completion of the study and the mixed 2 x 2 ANOVA tests and power analysis were performed by an independent statistician, in order to eliminate bias on the part of the
PI/acupuncturist.
Data Collection
Participants filled out the two surveys prior to receiving the first treatment and after receiving the final treatment 6 weeks later. Assistant-2 reviewed each survey to make sure it was complete, then secured said surveys until completion of the trial.
Index cards, created for each participant, contained the participant’s name, group association (A or B), and treatment dates. The index cards were held and managed by
Assistant-1, who also provided the aromatherapy for each treatment. This information was kept from the PI/acupuncturist to prevent bias.
Data Analysis
The pretest, baseline data collected were the participants’ initial responses to two surveys: The Perceived Stress Scale (PSS) and the SF12v2 Health Survey.
Posttest data included participants’ responses to the same surveys after 6 weeks of treatment. Confirmation that the data were normally distributed was achieved by performing an Anderson-Darling test on all results. Therefore, parametric tests were employed to reveal treatment efficacy. Pre-post test PSS and SF12v2 were initially
32 analyzed using a paired Student’s t-Test. Thereafter, between groups analysis was performed using a 2 (group) x 2 (time) analysis of variance (ANOVA), with repeated measures for both the PSS and SF12v2 Health Survey scores.
Methodological Assumptions
For the purposes of this study, several assumptions were made. First, it was assumed that all participants have functioning olfactory systems. A properly working olfactory system will transmit the aroma to the brain for processing. More specifically, upon inhalation, the scent from the aromatherapy would travel into the nose and be received by millions of hair-like receptors, which are connected to the olfactory bulb. From the olfactory bulb, the smell travels through the olfactory tract to the olfactory center of the brain where it connects to the limbic system. From here a chain reaction occurs, which affects other parts of the body (Buckle, 1997).
Study participants were required to attend all six treatments, consecutively.
They were dropped from the study if they missed one treatment. They were instructed to report pregnancy or adverse reactions20 to Assistant-1. Either of these conditions would also result in their removal from the study.
Since this was a double-blinded study, Assistant-2 delivered the aromatherapy only after the PI/acupuncturist left the room. The same assistant removed the aromatherapy before the PI/acupuncturist returned to remove the needles. The cotton ball containing aromatherapy or placebo was removed from the treatment room after
20 Adverse reactions included: allergic reaction, headaches, or any intolerable discomfort from the acupuncture or aromatherapy.
33 each treatment. In addition, the room was aired for 5 minutes between treatments to dissipate lingering of aromas.
Limitations of Study
A discussion of limitations merits consideration in this study. First, the final number of participants was small. While recruitment was easy, retention was challenging. For example, three participants became pregnant during the course of the study, six became ill and were quarantined, three were required to appear in court, and four could not find child care. Therefore, the final number of 14 participants resulted due to attrition.
Lastly, when testing odor, or in this case aromatherapy, it is difficult to have a control group or placebo. Spring water was used as the placebo for this study, as it was found to be an effective control method in prior research (Goel, Hyungsoo, & Lao,
2005; Kiecolt-Glaser et al., 2008).
Organization of Remainder of Study
In the chapters to follow, an analysis of collected data for all participants will be presented. The final chapter will contain conclusions and recommendations for further study.
34 Chapter IV
RESEARCH FINDINGS
The purpose of this study was to determine if combining aromatherapy with acupuncture as a method of treatment was more effective in reducing stress levels compared to acupuncture, alone. Specifically, the research hypothesis was: The combined treatment of acupuncture and aromatherapy is more effective than acupuncture alone. This chapter describes the findings of this study, along with an analysis of trends and patterns.
This chapter is organized into four subsections: Description of Participants,
Descriptive Demographics, Findings Related to the Hypothesis, and Summary. The
ANOVA tests and power analysis are listed in Appendix F.
Fourteen women participated in the study. All participants received a weekly treatment consisting of the same acupuncture treatment and aromatherapy that was either true aromatherapy or a placebo of spring water.
Description of Participants
Participants in this study were females between the ages of 22-49. Thirty-two were initially recruited. However, two did not pass the initial inclusion/exclusion criteria due to pregnancy. Thus, 30 participants passed the initial inclusion/exclusion criteria and began the 6-week program. Each of the 30 participants was randomly placed into either Group A or Group B. In the course of the trial, 16 participants
35 dropped out of the trial, leaving 14 study participants or N = 14. Six were in Group A
(received the aromatherapy intervention) and eight were in Group B (received the placebo of spring water).
Descriptive Demographics
The participants in this study were women from diverse racial and ethnic backgrounds. Each had delivered at least one child. Age was the only demographic data collected from the study participants.
The mean ages of both groups were similar, with Group A = 34 and Group B =
33. Details of the age ranges are shown in Table 2.
Table 2
Demographics Data—Age
Group A Group B N = 6, Age range 26-49 N = 8, Age range 22-41 Mean age 34, SDa = 9.9 Mean age 33, SD = 5.7 ID Age ID Age 1234 42 1245 32 1235 49 1237 39 1236 27 1238 40 1241 32 1239 22 1244 26 1240 31 1247 25 1242 30 1243 36 1246 32 aSD = Standard deviation.
36 Findings Related to the Hypothesis
Scores from each of the instruments used to measure stress are presented below.
The first discussion will present results of the Perceived Stress Scale (PSS) scores for both groups. The score considered healthy for women is 13.7, with higher scores reflecting higher levels of stress (Cohen et al., 1983). A discussion of study findings from the SF12v2 Health Survey Scores for both groups is also included. In this case, a score of 50 is considered healthy, with lower scores reflecting poorer quality of life and higher stress levels. In general, then, a decrease in score for the PSS and an increase in score for the SF12v2 Health Survey is preferred and reflects a decrease in stress levels and improved quality of life.
Perceived Stress Scale Scores
The Perceived Stress Scale (PSS) is a 10-question survey that measures the perception of stress. Each question ranges from 0 to 4 in value. Upon completion of the survey, all items are summed resulting in an overall PSS score. A lower score is interpreted as a reflection of lower stress levels. The normal value for females with no regard to ethnicity or age is 13.7, with a standard deviation of 6.6 (Cohen et al., 1983).
In pre-trial scoring, both groups scored higher than the norm for females, with
Group A having a mean pretrial PSS score of 29.2 and Group B having a mean pretrial
PSS score of 26. Individual PSS scores for each participant within Group A and
Group B are shown in Figures 1 and 2.
After 6 weeks of weekly treatments, participants were asked to respond again to the PSS and SF12v2 Health Survey. In all but two instances, posttrial scores revealed a reduction in stress levels for both groups with Group A (Aromatherapy) having a
37 mean posttrial PSS score of 18.7 and Group B (Placebo) having a mean posttrial PSS score of 19.6. The two instances of posttrial scores remaining the same or increasing came from Group B (Placebo). All participants in the aromatherapy group experienced reduction in stress levels as measured by the PSS.
Figure 1. Pretrial PSS scores—Group A (aromatherapy), n = 6, mean = 29.2.
Figure 2. Pretrial PSS scores—Group B (placebo), n = 8, mean = 26.
Study findings further reveal that Group A (aromatherapy) experienced a greater decrease in PSS scores compared to Group B (placebo). Group A
(aromatherapy) went from a mean score of 29.2 to 18.7 (a 36% reduction or decrease of 10.5 points) versus Group B (placebo) went from a mean of 26 to 19.6 (a 25%
38 reduction or decrease of 6.4 points). Figures 3 and 4 present a comparison of the pretest and posttest PSS scores for each participant in each group.
Figure 3. Perceived Stress Scale results—Group A (aromatherapy), n = 6.
Figure 4. Perceived Stress Scale results—Group B (placebo), n = 8.
Figure 5 shows the comparative reduction in mean stress levels for each group as measured by the Perceived Stress Scale.
SF12v2 Health Survey Scores
The SF12v2 Health Survey is a shorter form of the SF36v2 Health Survey that uses 12 (versus 36) questions to measure functional health and wellbeing. The
SF12v2 Health Survey covers the same eight domains as the SF36v2 Health Survey:
(a) Physical functioning; (b) Role-Physical; (c) Bodily pain; (d) General health;
39 Figure 5. Perceived Stress Scale results comparison between Groups A and B.
(e) Vitality; (f) Social functioning; (g) Role-emotional; and (h) Mental health. The eight domains are organized into two main categories: Physical Health and Mental
Health. The SF12v2 Health Survey scoring system assigns a score for each category ranging from 1 to 50, with scores equal to or greater than 45 considered normal, or healthy (Ware et al., 2010). For purposes of this study, the SF12v2 Health Survey scores for each participant were calculated by averaging the scores from the Physical
Health and Mental Health categories. For example, if a respondent scored 31 points on the Physical Health category questions and 40 points on the Mental Health category questions, the overall SF12v2 Health Survey score for that participant would be 35.5.
In both groups, mean baseline SF12v2 Health Survey scores (Group A = 39.1 and Group B = 41.5) were considered worse than those for the general population
(score of 45 - 50) and were similar to the norms for individuals diagnosed with depressive disorder (Ware, 2010). The mean pretrial SF12v2 scores for participants in
Group A (aromatherapy) and Group B (placebo) are presented in Figures 6 and 7, respectively.
40 Figure 6. Pretrial SF12v2 scores Group A (aromatherapy).
Figure 7. Pretrial SF12v2 scores Group B (placebo).
Figures 8 and 9 present the pretest and posttest SF12v2 Health Survey results for each participant in Group A (Figure 8) and Group B (Figure 9).
Figure 8. SF12v2 health survey results—Group A (aromatherapy).
41 Figure 9. SF12v2 health survey results—Group B (placebo).
The SF12v2 Health Survey scores increased for all participants in Group A
(aromatherapy), and for all but one participant for Group B (placebo). This participant experienced a decrease in her SF12v2 Health Survey score (ID-1246). Upon looking at the trial data for participant ID-1246, it was found that the Physical Health subcomponent of her SF12v2 Health Survey score had dropped, thereby dropping her overall SF12v2 Health Survey score. Specifically, the Physical Health portion of her pretest score was 61 versus 41 in her posttest score. Her Mental Health subcomponent score increased, however, from a Mental Health pretest score of 50 versus posttest score of 60. This might suggest that her mental health quality of life improved during treatment, while she experienced a decline in physical health. No other participants experienced a decrease in SF12v2 Health Survey scores.
Figure 10 shows the comparative increase in mean SF12v2 Health Survey scores for both groups.
42 Figure 10. SF12v2 health survey pre- and posttrial results comparison.
As can be seen by the data, both groups presented with increased scores on the SF12v2 Health Survey after the 6-week treatment intervention. Group A
(aromatherapy) experienced a greater increase in SF12v2 Health Survey scores compared to Group B (placebo), with Group A increasing from mean scores of 39.5 to
50.9 (22% and 11.4 point increase) and Group B increasing from 45.5 to 49.9 (10% and 4.4 point increase).
Post-Hoc Tests
Tables 3 and 4 present the results of the post-hoc tests, comparing the results between both groups for both measurement instruments. A normal, low stress score for the PSS is 13.7, and for the SF12v2 a score of 45 or higher is considered low stress and normal quality of life.
43 Table 3
Perceived Stress Scale Pretest and Posttest Mean Scores
Group PSS pretest PSS posttest Group A 29.2 18.7 Aromatherapy Group B 26.0 19.6 Placebo
Note. Reduction is preferred.
Table 4
SF12v2 Health Survey Pretest and Posttest Mean Scores
Group SF12v2 pretest SF12v2 posttest Group A 39.5 50.9 Aromatherapy Group B 45.5 49.9 Placebo
Note. Increase is preferred.
Paired Student’s t-Test
A Paired Student’s t-Test was performed to determine if the intervention significantly reduced stress and/or increased quality of life (p < 0.05). The p-values and standard deviations are presented in Table 5. The p-values for both groups fell below 0.05, thereby showing statistical significance for acupuncture with aromatherapy, as well as acupuncture with placebo. Since both groups received acupuncture, it can be concluded that treatments combining aromatherapy with acupuncture, as well as acupuncture alone, significantly reduce stress. While the aromatherapy group experienced greater reduction in PSS scores and a larger increase
44 in SF12v2 scores, between group statistical significance was only found in the SF12v2
Health Survey which measures quality of life. A significant difference was not found between groups for the PSS measurement instrument (p > 0.05). Since the PSS was the primary instrument in measuring stress rejection, the hypothesis was thereby rejected.
Table 5
Paired Student’s t-Test
Group A Group B Aromatherapy (n = 6) Placebo (n = 8)
Pretest Posttest Pretest Posttest
Test Mean ± SDa p-value Mean ± SD p-value
PSS 29.2 + 4.54 18.7 + 6.65 0.013 26.0 + 4.21 19.6 + 5.68 0.025
SF12v2 39.5 + 7.12 50.9 + 4.91 0.012 45.5 + 6.75 49.9 + 6.20 0.022 aSD = standard deviation.
Summary
This study found evidence that acupuncture can be effective in reducing stress levels. Specifically, the point protocol used in this study significantly reduced stress levels. Furthermore, when aromatherapy is provided in conjunction with acupuncture, a greater reduction in stress levels has been found compared to using acupuncture treatment alone.
According to the PSS Survey results, the aromatherapy group had a greater reduction in stress levels compared to the placebo group with Group A (aromatherapy) experiencing a 36% reduction and Group B (placebo) a 25% reduction. Results from
45 the SF12v2 Health Survey revealed that Group A had a larger increase compared to
Group B, with Group A experiencing a 29% increase and Group B a 10%.
While the aromatherapy group experienced a greater reduction in stress levels as measured by the PSS, a between group significant difference was not achieved.
However, a statistical significance was found between groups in analyzing the quality of life measurement SF12v2 Health Survey. The limited sample size (N = 14) may have contributed to the PSS scores not showing significance, and further investigation is warranted.
46 Chapter V
CONCLUSIONS, DISCUSSION, AND RECOMMENDATIONS
The purpose of this study was to determine if using a treatment approach that combined aromatherapy and acupuncture was more effective in reducing stress than acupuncture, alone. Specifically, this randomized, double-blind, placebo controlled pilot study focused on the treatment experiences of 14 female participants during a
6-week duration, of which nearly half received a combined acupuncture and aromatherapy approach and the other half received acupuncture, alone.
This chapter analyzes the resultant data, offers findings and conclusions, and provides a discussion of the implications for action and recommendations for further research.
Research Hypothesis
The hypothesis is: The combined treatment of acupuncture and aromatherapy is more effective in treating stress levels than acupuncture alone. The hypothesis was rejected with statistical significance not being achieved (p > 0.05) in a between group analysis (2 x 2 mixed ANOVA) of the PSS scores.
Null Hypothesis
The null hypothesis is: There is no significant reduction in stress levels when acupuncture is combined with aromatherapy compared to acupuncture alone. The null
47 hypothesis was supported by comparing the results of both groups over time
(2 x 2 mixed ANOVA) as measured by the PSS.
Conclusions
The main aim of this study was to determine if combining aromatherapy with acupuncture reduces stress more than acupuncture treatment alone. While the results from this study suggest that aromatherapy combined with acupuncture reduces stress levels more than acupuncture alone, statistical significance was not achieved for the
Perceived Stress Scale scores. However, a significant difference was found between groups in the SF12v2 Health Survey, providing evidence that aromatherapy combined with acupuncture increases perceived quality of life significantly more than acupuncture alone. Furthermore, results from this study confirmed that acupuncture is one possible treatment to effectively reduce stress.
Discussion
The hypothesis of this study proposed that combining aromatherapy with acupuncture is more effective that treatments using acupuncture alone in the treatment of stress. While the aromatherapy group experienced greater reduction in stress levels, statistical significance was not achieved for the primary stress measurement instrument, the PSS, therefore rejecting the hypothesis. However, a significant difference between groups was found in the quality of life measurement instrument,
SF12v2 Health Survey. Therefore, results from this study suggest that aromatherapy combined with acupuncture is significantly more effective than acupuncture alone in improving perceived quality of life. A larger sample size may have demonstrated statistical significance and more compelling results. Unfortunately, attrition rates for
48 participants resulted in a drop from an original group of 30 individuals to a final group of 14 individuals with only 6 receiving the intervention of aromatherapy and the other
8 receiving acupuncture only. In addition, results may have shown greater significance if there had been a larger and more equal distribution of participants in each group (for example 50 in Group A and 50 in Group B versus 6 in Group A and 8 in Group B).
Several of the studies examined in the pursuit of this project concluded that more research is needed in the areas that consider the treatments of acupuncture and/or aromatherapy (Herz, 2009; Leung & Pang, 2011; Shin & Lee, 2007). At the same time, research on this topic revealed that while medical physicians want to offer their patients more options beyond prescribing pharmaceuticals when treating stress and stress-related diseases, they are reticent to do so without sufficient evidence
(Anthierens et al., 2010). Therefore, further research is warranted.
As more research and clinical evidence demonstrate the efficacy of using acupuncture combined with aromatherapy approach, three results are possible:
(a) more people will consider aromatherapy and/or acupuncture for the treatment of stress; (b) more health care providers will suggest this combined approach when reviewing treatment options with their patients; and (c) more acupuncturists will combine aromatherapy with acupuncture and thereby increase the efficacy of their treatments.
The most significant impact of this research is providing patients with the knowledge that aromatherapy and acupuncture, when used together, may effectively reduce stress levels. Some possible benefits of the proposed approach in this study
49 are a reduction of symptoms and a possible reduced need for pharmaceuticals, less exposure to side effects, and a reduction in health care costs.
Strengths of the Study
The results of this study suggest a few strengths worth considering. Because the study participants represent a highly stressed population, with baseline stress levels measuring out of the range considered normal, this study offers one powerful way to reduce stress in their lives. A second strength is that the acupuncture point protocol used in this study was confirmed to reduce stress levels. This second point is important because it validates findings from previous studies (Eshkevari et al., 2012;
Howard, 2010; Leung & Pang, 2011; Lucas, 2011) when demonstrating the ability to reduce, significantly, stress levels by way of nonpharmaceutical treatments. The final strength of the study is the instrumentation used to measure stress. Both the PSS and
SF12v2 Health Survey are widely used assessment tools used to measure stress levels and quality of life scores. Employing previously tested and validated tools in the assessment of stress reduction is important, because stress is a difficult concept to define, study, and measure (Cohen et al., 1983; Karpen, 1996).
Limitations of the Study
One major limitation of the study was its small sample size. Patient attrition limited the amount of data. The study’s 6-week duration also proved to be a limitation. Perhaps a shorter timeframe of 4 weeks rather 6 six weeks may have decreased the number of participants being dropped from the study. Lastly, the trial design of requiring participants to attend all six of the weekly treatments may have
50 also been a limitation. Allowing participants to skip one treatment may have further reduced overall attrition.
Recommendations for Future Research
Results from this pilot study offer nine recommendations for future research:
1. Study Design—Sample Size. The first recommendation would be to start
with a larger sample size. It is believed that a larger sample size with
n > 30 would present stronger results.
2. Study Design—Trial Length. Due to convenience, prior research, and
clinical experience, this study was designed to last 6 weeks. A shorter trial
duration of 4 weeks is recommended and may address participant attrition.
An alternative possibility to reducing trial length is allowing participants to
miss one treatment in the 6-week trial. However, a more flexible policy for
participation may introduce another confounding variable.
3. Study Design—Male Participants. This study only recruited women from
an addiction recovery center. No men participated in this study. Adding
men to the group of participants would be an even more powerful way to
determine treatment efficacy between genders. Studies focusing on stress
reduction have included male and female participants (Luine, Beck,
Bowman, Frankfurt, & Maclusky, 2007). Of particular merit are the
differentiated garnered responses. For example, Luine et al. (2007) found
that chronic stress reduces anxiety in male rats and increased stress in
female rats.
51 4. Study Design—Participant Selection. Many other populations experience
high stress levels. For example, students may be a group worth studying
because of their context-specific stress levels and large population count
(Herz, 2009; Seo, 2009). Healthcare practitioners and care providers are
another highly stressed population (APA, 2013; Griffith et al., 2008;
Kemper et al., 2011). In both of these examples, it would be useful to know
if combining aromatherapy with acupuncture is an effective, low-cost,
noninvasive way to reduce stress levels.
5. Study Design—Aromatherapy Delivery. The inhalation method of
aromatherapy was used in this trial. Specifically, a blend of aromatherapy
suspended in spring water was sprayed onto a cotton ball and placed below
participants’ noses while receiving acupuncture treatments lying in the
supine position. Other studies used different methods when delivering
aromatherapy as part of a treatment. For example, Moss et al. (2008) placed
participants in a 2.4m long x 1.8m wide x 2.4m high testing cubicle and
secured an aromatherapy diffuser under the participant’s seat. This may be
an approach worth considering because the primary investigator and
research assistants would not see the aromatherapy delivery device. Use of
personal inhalers containing aromatherapy may be another effective
delivery system because it would ensure blinding of the primary investigator
and research assistants, as well as offer more exposure to the aromatherapy
(Varney & Buckle, 2013).
52 6. Study Design—Blinding Method. Kiecolt-Glaser et al. (2008) required the
primary investigator and research assistants to wear surgical masks to
prevent potential exposure to aromatherapy and further ensured blinding in
their study.
7. Study Design—Incentives. Offering enticing incentives may increase
participant inclusion and decrease fall out. Ideas include a monetary
reward, a massage package, and/or free or reduced price acupuncture
sessions for participants that complete the entire study.
8. Potential Research—Drug Reduction. It would be interesting to study the
effects of acupuncture combined with aromatherapy versus acupuncture
alone in the potential reduction of medications. For example, it would be
interesting to see if the group receiving acupuncture with aromatherapy is
more successful in reducing the need for pain medications than a group that
received only acupuncture treatments.
9. Potential Research—Other Conditions. While stress reduction was the
specific condition studied in this trial, acupuncture and aromatherapy have
been used independently to treat other conditions such as: high blood
pressure, pain, insomnia, PTSD, dementia, depression, anxiety, and/or
weight loss. Research into the combined use of these modalities may reveal
an even more powerful and consistent treatment outcome versus treatments
using acupuncture alone.
10. Potential Research—Natural versus Synthetic. In pursuing this project,
research from Holmes (1995) suggests that synthetic oils do not possess the
53 same healing properties as natural oils. For example, certain essential oils
have been proven to effectively treat infection; however, the synthetic
version could not provide the same effects (Holmes, 1995). While an
in-depth exploration of this topic is out of the scope for this project, it
appears to be an opportunity and recommendation for future research.
Implications for the Profession
The results of this study have positive implications for the fields of TCM,
Western medicine, and aromatherapy. Acupuncturists may find that including aromatherapy with acupuncture increases the efficacy of their treatments. Further research on the efficacy of combining aromatherapy and acupuncture when treating other conditions may also provide other health practitioners with additional treatment strategies. For example, Western medical practitioners may feel more confident suggesting acupuncture and/or aromatherapy as one of the viable options worth considering when treating stress.
In this age of choice, and increased self-involvement with health care decisions, patients are looking for more options to address their acute and chronic conditions.
Providing them with knowledge about the potential benefits of a combined approach utilizing acupuncture and aromatherapy may well be the noninvasive, cost-effective treatment option they are seeking in an ever emerging sea of health modalities.
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61 APPENDIX A
CONSENT TO PARTICIPATE IN RESEARCH
62 CONSENT TO PARTICIPATE IN RESEARCH
Acupuncture Combined With Aromatherapy in the Treatment of Stress
Principal Investigator/Acupuncturist: East L. Haradin, L.Ac.
Sub-Investigators/Assistants: (Assistant 1) Lisa Cavalier; and (Assistant 2) xxxxxxxx.
Study Coordinator (or Contact Person): East L. Haradin, L.Ac.
Research Site(s): Family Recovery Center, Oceanside, California
Before you start reading about this research, please read the California Experimental Subjects' Bill of Rights, which is page 5 of this form.
This is a clinical trial (a type of research study or medical experiment). Clinical trials include only persons who choose to take part. Please take your time to make your decision. Discuss it with your friends and family. Be sure to ask questions about anything you do not understand.
Why is this research being done?
This research is being done to find out if acupuncture combined with aromatherapy is significantly more effective in reducing stress levels that acupuncture alone.
The researchers are asking you to participate because clients within a recovery treatment center typically have high levels of stress.
Up to 30 people will be in this study, all of which will come from Family Recovery Center, Oceanside, California.
What makes this different from usual treatment? and What is experimental about this research?
Since August of 2008, the Pacific College of Oriental Medicine has offered acupuncture services to the clients of the Family Recover Center. The difference with this study is that participants will receive aromatherapy in conjunction with acupuncture during a 30 minute treatment sessions.
63 How long will I be in the study?
If the study suits you and you agree to join, you will be in it for a total of seven (7) weeks. For six weeks you will receive a treatment each week and on the seventh week you will be asked to respond to a health survey and additional questions.
What will happen to me during the study?
You will first come to the primary researcher (East L. Haradin, L.Ac.) for a screening visit which will last approximately 25 minutes. During this visit you will be asked questions about your health and given a simple smelling test to make sure your sense of smell is working. You will be asked to smell two substances and identify them to the primary researcher. In addition, you will be asked some questions to see if you qualify for participation.
If you are accepted into the study and still wish to participate, you will be assigned, by chance (like flipping a coin), to either the aromatherapy with acupuncture group or the acupuncture with a placebo group. You will have a 50/50 chance of being placed into either group. A “placebo” will appear to be aromatherapy but contains no essential oils. You won’t know which group you are in and neither will the investigator/ acupuncturist. The investigator could find out in an emergency.
Once the study starts you will receive an acupuncture treatment once a week for six weeks in a row. Each treatment will last a total of thirty minutes and include acupuncture and aromatherapy (or a placebo aromatherapy). You will lie face up on a massage table in a treatment room with the primary researcher/acupuncturist and two assistants. The acupuncture you will receive will include seven needles with the following general placement: 2 on your feet, 2 on your hands, 2 near your knees and one between your eye brows. The needles are sterile, disposable, very thin and will be inserted approximately ¼ to ½ of an inch into your skin. The aromatherapy will be sprayed onto a cotton ball which will then be placed onto your chest as you lay face up for your treatment. After 25 minutes the needles will be removed. At any time you can request to have the needles removed or stop treatment.
After receiving six treatments, you will be asked to come back one week after the sixth treatment to answer some health questions. This visit will last approximately 30 minutes and will not include a treatment.
Could I experience any side effects or discomforts?
Aromatherapy is considered non-toxic and has shown to be safe and effective for most everyone. Should you feel uncomfortable in any way (i.e. headache, nausea or dizziness) simply inform the study team and you may discontinue participation in the trial.
64 These side effects are rare, extremely mild and usually go away within 20 minutes of exposure to aromatherapy:
C Headache C Nausea C Dizziness
Acupuncture is done by insertion of needles through the skin at certain point on or near the surface of the body to attempt to treat bodily pain or disease, to change or stop pain awareness, and to normalize the body’s functions. There are rare occasions where people have experienced certain unpleasant side effects. The risks of acupuncture treatment include, but are not limited to:
C Local bruising C Minor bleeding C Fainting C Pain or discomfort C Infection C Possible irritation of symptoms that were there before acupuncture treatment.
In these cases the side effects were uncommon and temporary. At any time, any participant is free to stop acupuncture treatment.
Other medications
It is permissible to be taking other medications while participating in this survey.
Will I benefit from participating?
You may feel better after receiving aromatherapy and/or acupuncture, but we cannot promise that you will.
Will I be paid?
No, you will not be paid to be in the study. However upon completion of the study you will receive a gift with a $15 value.
Will it cost anything to be in the study?
No, there is no cost to participate.
What if I end the study early?
At any time you may withdrawal from the study.
65 What treatments could I take instead of joining this study?
You can continue with any traditional treatments you may be receiving or even continue coming to the weekly scheduled acupuncture sessions offered by the Pacific College of Oriental Medicine. In addition, you can try things like exercise, meditation, hypnosis, yoga or see a psychologist that specializes in stress to treat your stress levels.
What are my rights?
C You can call the staff to ask any questions about this study. The telephone number to call is xxx-xxx-xxxx. C You can decide not to be in this study or you can quit after starting. Whatever you do, your care at the Family Recovery Center will not be affected. C If you have any questions about your rights, call the PCOM Office for the Protection of Research Subjects at xxx-xxx-xxxx. You should also read the Experimental Subject's Bill of Rights, which is toward the end of this form. C You do not have to be in this study. You still have all your legal rights whether you join the study or not. C You have the right to be told about any new information that might make you change your mind about staying in the study.
What are my responsibilities if I join?
If you are in this study, you are expected to: C Follow the instructions of the research staff C Report any serious or unusual side effects to the investigator C Keep your study appointments
What about confidentiality?
The investigator will keep your personal information confidential whenever they can. We can’t promise that no one will see it.
For more information, see the Authorization to use your Private Health Information at the end of this consent form.
What if I get hurt while in the study?
You can call East L. Haradin, L.Ac. at xxx-xxx-xxxx if you get sick or injured while in this study.
If you need medical or urgent care during the study, it will be provided. You or your medical insurance will be billed for any treatment given.
66 Will the investigator benefit from this study?
There are no financial disclosures to report.
I agree to participate.
I have read and understood the explanation of the study. The study has also been explained to me by East Haradin. I have had a chance to ask questions and have them answered to my satisfaction. I agree to take part in this study. I have not been forced or made to feel obligated to take part.
I have read the attached Experimental Subject's Bill of Rights and the Authorization to use my Private Health Information that contain some important information about research studies. I must sign this consent form, the Experimental Subject's Bill of Rights and the Authorization to use my Private Health Information. I will be given a signed copy of each to keep.
______Printed Name of Subject
______Signature of Subject Date
______Signature of person conducting the informed Date consent discussion
______Role of person named above in the research project
67 EXPERIMENTAL SUBJECT'S BILL OF RIGHTS*
If I am asked to consent to be a subject in a research study involving a medical experiment, or if I am asked to consent for someone else, I have the right to:
Learn the nature and purpose of the experiment (also called “study” or “clinical trial”).
Receive an explanation of the procedures to be followed in the study, and any drug or device to be used.
Receive a description of any discomforts and risks that I could experience from the study.
Receive an explanation of any benefits I might expect from the study.
Learn about the risks and benefits of any other available procedures, drugs or devices that might be helpful to me.
Learn what medical treatment will be made available to me if I should be injured because of the study.
Ask any questions about the study or the procedures involved.
Quit the study at any time, and my decision will not be used as an excuse to withhold necessary medical treatment.
Receive a copy of the signed and dated consent form.
Decide to consent or not to consent to a study without feeling forced or obligated.
If I have questions about a research study, I can call the contact person listed on the consent form. If I have concerns about the research staff, or need more information about my rights as a subject, I can contact the Pacific College of Oriental Medicine IRB, which protects volunteers in research studies. I may telephone the Office at 619-574-6909, 9:00 a.m. to 5:00 p.m. weekdays, or I may write to the PCOM IRB, 7445 Mission Valley Road, Suite 109, San Diego CA, 92108-4407.
By signing this document, I agree that I have read and received a copy of this Bill of Rights.
______Signature of Subject or Legal Representative Date
*California Health & Safety Code, Section 24172
68 APPENDIX B
PERCEIVED STRESS SCALE
69 PERCEIVED STRESS SCALE
The questions in this scale ask you about your feelings and thoughts during the last month. In each case, you will be asked to indicate by circling how often you felt or thought a certain way.
Name ______Date ______
Age ______Gender (Circle): M F Other ______
0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often
1. In the last month, how often have you been upset because of something that happened unexpectedly?...... 0 1 2 3 4
2. In the last month, how often have you felt that you were unable to control the important things in your life?...... 0 1 2 3 4
3. In the last month, how often have you felt nervous and "stressed"? .... 0 1 2 3 4
4. In the last month, how often have you felt confident about your ability to handle your personal problems?...... 0 1 2 3 4
5. In the last month, how often have you felt that things were going your way?...... 0 1 2 3 4
6. In the last month, how often have you found that you could not cope with all the things that you had to do? ...... 0 1 2 3 4
7. In the last month, how often have you been able to control irritations in your life?...... 0 1 2 3 4
8. In the last month, how often have you felt that you were on top of things?...... 0 1 2 3 4
9. In the last month, how often have you been angered because of things that were outside of your control? ...... 0 1 2 3 4
10. In the last month, how often have you felt difficulties were piling up so high that you could not overcome the...... 0 1 2 3 4
70 APPENDIX C
SF12v2 HEALTH SURVEY
71 SF12v2 HEALTH SURVEY
72 73 74 APPENDIX D
PARTICIPANTS WANTED FLYER
75 PARTICIPANTS WANTED FLYER
Wanted: Clinical Trial Participants
For research on the affects of aromatherapy combined with acupuncture in treating stress.
Incentive: Free Aromatherapy product worth $15.
Who: All women currently in residential or day-treatment at FRC.
What: Six 30-minute acupuncture with aromatherapy treatments given once a week for 6 consecutive weeks and a follow-up session 1 week after the sixth treatment. (7 weeks total and participants must attend all 7 weeks.)
Please sign up with East Haradin on Thursday in the acupuncture rom or call: xxx-xxx-xxxx to sign up.
THANK YOU!!!
76 APPENDIX E
INCLUSION/EXCLUSION CRITERIA CHECKLIST
77 INCLUSION/EXCLUSION CRITERIA CHECKLIST
1. Are you currently pregnant or have you delivered a child in the past six weeks?
If “No”: Continue.
If “Yes”: Disqualified.
2. Can you come six weeks consecutively, not missing one treatment?
If “Yes”: Continue.
If “No”: Disqualified.
3. Can you lie down on your back for thirty minutes?
If “Yes”: Continue.
If “No”: Disqualified.
4. To your knowledge, are you allergic to any essential oils?
If “No”: Continue.
If “Yes”: Disqualified.
5. Can you read English?
If “Yes”: Continue.
If “No”: Disqualified.
6. Are you over 18 years of age?
If “Yes”: Continue.
If “No”: Disqualified.
78 APPENDIX F
ANOVA TESTS AND POWER ANALYSIS FOR PSS AND SF12v2
79 ANOVA TESTS AND POWER ANALYSIS FOR
PERCEIVED STRESS SCALE (SSS)
Full Sample
80 81 By group
82 2 x 2 mixed ANOVA for PSS
83 84 85 ANOVA AND POWER ANALYSIS FOR
SF12v2 HEALTH SURVEY
Full sample
86 87 By group
88 2 x 2 mixed ANOVA for SF12v2 Health Survey
89 Small partial ç2 = .01, medium = .059, and large = .138
90 Simple effects
91 92