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PhD candidate, School of Nursing, University of Minnesota, MN, USA and ... Professor, Faculty of Nursing, University of Iceland and Director of Research and ...
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Does the experimental design capture the effects of complementary therapy? A study using reflexology for patients undergoing coronary artery bypass graft surgery Thora Jenny Gunnarsdottir PhD candidate, School of Nursing, University of Minnesota, MN, USA and Assitant Professor, faculty of Nursing, University of Iceland, Reykjavik

Helga Jonsdottir

PhD RN

Professor, Faculty of Nursing, University of Iceland and Director of Research and Development in Nursing Care for the Chronically Ill, National University Hospital, Reykjavik, Iceland

Submitted for publication: 22 March 2005 Accepted for publication: 6 March 2006

Correspondence: Thora Jenny Gunnarsdottir Faculty of Nursing University of Iceland Eirberg Eiriksgata 34 101 Reykjavik Iceland Telephone: þ354 553 0016 Fax: þ354 525 4963 Email: [email protected]

Ó 2007 Blackwell Publishing Ltd doi: 10.1111/j.1365-2702.2006.01634.x

G U N N A R S D O T T I R T J & J O N S D O T T I R H ( 2 0 0 7 ) Journal of Clinical Nursing 16, 777–785 Does the experimental design capture the effects of complementary therapy? A study using reflexology for patients undergoing coronary artery bypass graft surgery Aim. Our purpose was to pilot test whether reflexology may reduce anxiety in patients undergoing Coronary Artery Bypass Graft Surgery in Iceland. Background. Nurses need to study the effects of complementary therapies in general and particularly those that may be beneficial to decrease patients’ anxiety. It has been assumed that reflexology lessens anxiety, but research is needed to substantiate such expectations. Design. A pilot study using randomized design with experimental and control groups. Methods. Nine patients were recruited and randomly assigned into groups with five patients assigned into an experimental group receiving reflexology for 30 minutes and four patients into control group which rested for 30 minutes. Anxiety and physiological variables were measured pre- and post-reflexology sessions once a day over five days. Results. The anxiety scores were lower for patients in the control group on all measures. Systolic blood pressure lowered significantly more in the control group than in the treatment group. No significant changes were observed for other variables. Patients’ comments and responses overwhelmingly suggested increased well-being due to both experimental and control intervention. Conclusion. This study showed little evidence to support reflexology as a mean of reducing anxiety in CABG patients. Several methodological problems were identified that need to be considered further. Relevance to clinical practice. It is suggested that reflexology should be tailored to individual needs and research methods used that allow for capturing its holistic nature. Further scholarly work is warranted to explore several methodological issues in studying complementary therapies in a highly complex treatment situation.

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Key words: anxiety, complementary therapy, coronary artery bypass graft surgery patients, intensive nursing care, quantitative methodology, reflexology

Introduction Anxiety is a state marked by apprehension, increased motor tension and autonomic arousal (McCartney & Boland 1994). Patients undergoing Coronary Artery Bypass Graft surgery (CABG) experience numerous anxiety-provoking events due to factors such as resuming their lifestyles post-surgery, worrying about pain/discomfort and fearing death from illness or surgery (Carr & Powers 1986,Yarcheski & KnappSpooner 1994). Increased feelings of anxiety and depression have been reported, both pre- and postoperatively (Magni et al. 1987,Duits et al. 1998). Waiting for CABG surgery has been found to be a significant source of anxiety. From the time that surgery is indicated to the actual operation itself, both patients and families experience considerable apprehension (Jo´nsdo´ttir & Baldursdo´ttir 1998, Fitzsimons et al. 2000, Koivula et al. 2001). In Iceland, Jo´nsdo´ttir and Baldursdo´ttir (1998) conducted a descriptive study of patients waiting for CABG surgery and found that 60Æ9% reported an increase in anxiety in the month preceding surgery. Similar findings were reported from Finland, where 42% of CABG patients reported moderate anxiety and 5% reported high anxiety (Koivula et al. 2001). Those at home awaiting CABG experienced medium or high anxiety more frequently (47%) than patients awaiting CABG in a hospital (38%). Likewise, in Northern Ireland, Fitzsimons et al. (2000) showed that anxiety was one of the most predominant feelings expressed by patients awaiting CABG. These patients also reported dissatisfaction that their anxiety was not addressed, which led them to feel anger and frustration. Nurses caring for CABG patients pre- and postoperatively often sense the overwhelming stress and anxiety that many of their patients endure. One particular challenge for nurses is providing their patients with appropriate care immediately after surgery when patients are connected to numerous instruments for assessing and treating their precarious condition (Kreitzer & Jensen 2000). Nurses have begun using complementary therapies (CT) to help patients relieve stress, ease pain and increase their well-being (Snyder & Lindquist 2002). CT refers to those therapies used in addition to conventional therapies and are considered supplementary to mainstream medicine (Snyder & Lindquist 2002). They include, for instance, massage, music, imagery, therapeutic listening and prayer. Cole and Shanley (1998) argue that CTs are within the scope of nursing practice because nursing and CTs uphold the holistic approach. With CTs becoming more 778

common in nurses’ repertoires, improvements in clinical outcomes have been detected (Kreitzer & Jensen 2000,Snyder & Lindquist 2002). Complementary therapies, such as massage, music and relaxation are used within the Landspitali University Hospital in Iceland (Baldursdo´ttir et al. 2002). The purpose of using these therapies is to increase physical and emotional well-being, reduce pain, increase relaxation, increase the quality of sleep and reduce anxiety in patients. However, studies are needed to determine their actual usefulness within these settings. Few studies have been conducted on the effects of complementary therapies for treating anxiety in patients undergoing CABG surgery. The impact of foot massage and guided relaxation on perceived levels of pain, anxiety, tension, calmness, rest, relaxation and physiological variables was tested in 25 CABG patients (Hattan et al. 2002). The interventions were performed once on the second postoperative day. The massage group showed a significant mean improvement of 29Æ78 points in calmness scores. Likewise, the relaxation group exhibited an improvement of 13Æ89 points; however, the control group showed little change in their scores. Significant effects were not found in terms of anxiety or the physiological variables of heart rate, blood pressure and respiration in any of the groups. Aromatherapy foot massage was compared to plain vegetable oil foot massage, verbal communication with no tactile contact and routine care in 100 postcardiac surgery patients randomly assigned to the four groups (Stevensen 1994). The interventions were provided once on the first day after surgery. Significant physiological differences were limited to respiratory rate as an immediate effect of massage but no significant effects on the physiological measurements of heart rate, blood pressure and respiration were found. The aromatherapy group had a marked, but nonsignificant reduction in their levels of anxiety, as measured by a modified Spielberger State and Trait Anxiety Inventory (STAI), compared with the plain vegetable oil group. With such transient results, there is a definite need to test the effects of other CTs on the anxiety and well-being in CABG patients. Reflexology is a complementary therapy that nurses have begun to use within hospital settings to benefit patients (Hodgson 2000,Gambles et al. 2002,Milligan et al. 2002). Reflexology is Eastern in origin (Dougans 1999) and is congruent with the principle of organ representation from Traditional Chinese Medicine (TCM): the whole represents its self in the parts (Kaptchuk 2000). Reflexology is defined as an holistic healing technique that aims to treat the

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individual as an entity, incorporating body, mind and spirit. It is a specific pressure technique that can be applied on the feet or hands based on the premise that reflex areas on the feet and hands correspond with all body parts. Because the feet represent a microcosm of the body, all organs, glands and other body parts are laid out in a similar arrangement on the feet (Dougans 1999). Foot reflexology is an avenue for human touch, which is non-invasive and requires no special equipment. The feet were chosen in this study because they were free of technological instruments and bandages. Reflexology has been shown to be effective in reducing pain and chronic symptoms, but few studies have investigated its effect on anxiety. The effects of reflexology on anxiety and pain in 23 patients with lung and breast cancer were researched by Stephenson et al. (2000). Anxiety and pain were measured before and after 30-minute interventions, showing that patients experienced significant decrease in anxiety. One of three pain measures showed that the patients experienced significant decrease in pain as well. In another reflexology study, Stephenson et al. (2003) found immediate mitigating effects on pain in 36 oncology patients, but lasting effects of reflexology on pain were not supported. Reflexology has also been found to reduce premenstrual syndrome (PMS) and symptoms. Thirty-five women were randomly assigned two groups: 18 received reflexology and 17 received placebo treatment for 30 minutes once a week for eight weeks. Significant reduction in PMS and associated pain was found between the two groups (Oleson & Flocco 1993). The effect of reflexology on migraine headache was examined in an exploratory, prospective study by Launso¨ et al. (1999). A total of 220 patients with migraine headache pain as their most pressing health problem were followed through a course of reflexology treatment for six months and additionally for three months afterwards. Results showed that 19% of the patients had stopped taking headache medication by the final treatment; in addition, no patient had increased his/her medication consumption during the study. At the time of the final treatment, 23% of patients reported being cured of their headache pain and 55% reported that they had experienced substantial symptom relief. Quality of life has been found to be enhanced in cancer patients after reflexology (Hodgson 2000, Gambles et al. 2002, Milligan et al. 2002). Milligan et al. based their findings on the responses to a self-report questionnaire from 20 cancer patients. The patients reported that reflexology reduced pain, improved sleep, enhanced relaxation and reduced stress. Gambles and colleagues further supported this result in their study in which 34 patients commented on reflexology as being emotionally beneficial in reducing

Experimental designs and complementary therapies

anxiety and tension, improving sleep and coping with the side effects of medications. While previous studies on the effects of reflexology suggest its effectiveness in reducing pain and anxiety it is important to note that they have several methodological shortcomings. The most important limitation is that the number of reflexology sessions among these studies varied from once only to once a week for several months. Authors of books on reflexology generally agree that several sessions are needed to make any significant difference (Ingham 1984, Kunz & Kunz 1992, Dougans 1999, Vennells 2001). Furthermore, the method of providing reflexology differs between studies and most of them have small sample sizes. The conceptual framework guiding this study is based on the research of stress and coping (Lazarus & Folkman 1984) and relaxation responses (Benson & Klipper 1976). Patients undergoing CABG surgery often perceive multiple psychological and physiological stressors, with ensuing stress responses. A stress response stimulates the sympathetic nervous system by releasing epinephrine and norepinephrine, resulting in increased heart rate, respiratory rate, arterial blood pressure and state anxiety levels. Reflexology provides tactile stimuli on the reflex arc on the soles of the feet (Mackey 2001). This reflex arc is the smallest portion of the nervous system capable of receiving a stimulus and yielding a response. When the reflex arc becomes stimulated during reflexology the relaxation response is initiated. When relaxation occurs, the stress response is interrupted and sympathetic nervous system activity decreases, resulting in lower heart rate, blood pressure and respiratory rate along with reduced anxiety. Therefore, it was hypothesized that patients receiving reflexology would show decreased anxiety levels, blood pressure, heart rate and respiratory rate compared to patients not receiving reflexology. These CABG patients undergo a complicated surgery process and are treated in the intensive care unit (ICU) with highly complex technical procedures sometimes with minimal direct nurse-patient contact. The development of the hands-on approach to nursing brings many nurses back in touch with their patients receiving highly technological care in the ICUs. As no previous studies were located in this area of reflexology research, it was important to explore any possible methodological problems of conducting a study shortly after surgery.

Methods Study design The purpose of this study was to pilot test the effects of foot reflexology intervention given to patients undergoing CABG

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surgery for five consecutive days on the variables of anxiety and physiological variables. The effects of reflexology were compared to cream application and rest. The study employed a two-group pretest-posttest between participants design. Participants were randomly assigned to either a treatment or control group. Measurements on physiological variables of blood pressure, heart rate and respiratory rate and anxiety were conducted before and after interventions in each group once a day over a five-day period. The research question was as follows: Do patients undergoing CABG surgery report significantly less anxiety as measured by the State Anxiety Inventory, decreased blood pressure, heart rate and respiratory rate after reflexology, compared with patients receiving cream applications and rest?

Participants Approval from: (a) the Institutional Review Board of the University of Minnesota, USA (i.e. the Human Subjects Committee), (b) the Data Protection Authority in Iceland (Perso´nuvernd), (c) the National Bioethics Committee (Vı´sindasidanefnd) and (d) Landspitali University Hospital in Reykjavik, Iceland, was provided for the study. A nonprobability convenience sample of patients awaiting elective CABG surgery at one university hospital was used, since it is the only hospital in Iceland that performs CABG surgery. Patients were recruited after being informed and signing informed consent. Strict inclusion and exclusion criteria were established to minimize sample variability. The patients had to be 18 years or older, on a waiting list for CABG surgery and able to make their own daily care decisions. The patients were excluded if they were having acute or repeated CABG surgery or undergoing both CABG and valve replacement. Patients needed to be assessed again after surgery for further inclusion criteria, since surgery might have altered their eligibility to remain in the study. Six hours after extubation from a ventilator, the nurse in charge within the ICU setting evaluated whether the patient was alert and mentally coherent and if drainage into chest tubes was less than 50 ml/hour. If the patient would not be able to continue to take part in the study, data collection was to be ceased and the patient would drop out of the study. Eleven patients were recruited in this study: nine men and two women. It was expected that well over 20 patients would be undergoing CABG surgery during the study period. However, fluctuations in the availability of patients due to their illness severity affected the sample size. Men and women were recruited in numbers respective of how they were called in for surgery. A flip of the coin was used to divide the sample 780

into the specific groups to make sure that each subject had an equal known probability of being assigned to one of the two groups. Of the final sample, five patients were recruited into the treatment group and four in the control group. Two of the patients dropped out of the study; the first one dropped out due to postoperative bleeding, which caused the patient to undergo repeat surgery, while the second had to drop out because of complications during surgery.

Procedures Four types of data were collected. Information on baseline demographic data was obtained upon study entry from the patients including their medical records on age, gender, primary medical diagnosis and current medications. Anxiety was measured using the State Anxiety Inventory scale (SAI) of the State-Trait Anxiety Inventory (STAI) (Spielberger 1983), which consists of 20 items and is designed to measure respondents’ anxiety at any given moment in time or state anxiety. The Trait Inventory was not used in this study. Each SAI item is given a weighted score from 1 to 4. The scores can therefore vary from a minimum of 20 (low anxiety) to a maximum of 80 (high anxiety). Construct validity for the STAI has been tested with 855 students (Spielberger 1983). Test-retest reliability correlations reported for the S-Anxiety form range from 0Æ16 to 0Æ62 (Spielberger 1983). Alpha reliability coefficient values obtained to measure internal consistency range from 0Æ91 to 0Æ93 for the S-Anxiety form (Spielberger 1983). The Inventory has been translated into Icelandic but the reliability coefficients have not yet been reported for that population. Physiological variables, blood pressure and heart rate were measured at the thoracic ward with a Hewlett Packard mobile monitor. In the ICU the bedside patient monitor (Hewlett Packard) displayed both blood pressure and heart rate. Respiration rate was counted. The nurse in charge of the patient obtained all measurements within 1–2 minutes before and after the treatments. The final data collection method was the researcher’s journal where the first author noted her observations of the patients while interacting with them, particularly comments they made related to receiving the interventions.

Intervention Patients in both groups were placed in a comfortable position supine in bed while data on anxiety and physiological measurements were collected. After applying the feet with a neutral lubricant cream for one minute, patients in the experimental group received reflexology for 30 minutes on

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Experimental designs and complementary therapies

both feet while laying supine in bed. The Ingham method of reflexology (Ingham 1984) was used on the entire soles of the feet with the purpose of stimulating the whole body, increase the blood flow, eliminate waste materials and increase relaxation. The first three minutes were used to warm up each foot, rotating the toes and ankles. Reflexology was then used on the whole feet with special attention on all glands and the solar plexus. The control intervention consisted of applying neutral cream on the feet for one minute gently without massage strokes or pressure on any part of the foot. Then the patients were asked to rest for 30 minutes. By applying the lubricant the researcher wanted to have the patient believe that they were receiving some kind of intervention. The same procedure was used for the experimental and control groups in terms of the frequency and circumstances of the sessions. The sessions were carried out five times all by the first author; the first session took place in the evening before surgery after the patient had showered. The second one was carried out in the ICU at least six hours after extubation, between 10 and 12 p.m. The third, fourth and fifth sessions all took place at the thoracic unit during a resting period, between 1 and 3 p.m. Careful considerations and precautions were taken not to disturb any other therapy or usual procedures that the patient was receiving. A good working relationship was established between the investigator and the nurses in the thoracic ward and the ICU; the timing of the sessions was decided with their cooperation.

Data analysis To assess the effectiveness of the intervention in terms of the five variables measured (systolic and diastolic blood

pressure, heart rate, respiratory rate and SAI), five new variables were computed. The scores after each of the five interventions (post) were subtracted from those obtained before each intervention (pre), creating a new variable identifying changes in the status of the five variables of interest. Since the intervention was administered five times to each patient, five change scores on each of the five variables were obtained. The treatment and control groups were compared by conducting Mann–Whitney U-tests on the change scores.

Results Characteristics of the sample The two groups were similar on all demographic data. Age ranged from 49 to72 years. The treatment group consisted of four males and one female, with a mean age of 65Æ2 years, all diagnosed with three clogged arteries. The control group consisted of four males, with a mean age of 65Æ6 years. One had two arterial occlusions, while each of the remaining had three arterial occlusions. All of the patients had been waiting for the surgery for more than three weeks, but less than six months.

Anxiety The SAI scores at the onset and on all subsequent measures were lower for patients in the control group than the experimental group on all measures. Scores for the experimental group ranged from 22 to 56 (SD ¼ 8Æ56) and for the control group 20–43 (SD ¼ 5Æ54). The mean SAI scores pre

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Treatment

30 Control

Control

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Mean SAI1PRE

Mean SAI2PRE

Mean SAI3PRE

Mean SAI4PRE

Mean SAI5PRE

Mean SAI1POST Mean SAI2POST Mean SAI3POST Mean SAI4POST Mean SAI5POST

State anxiety score before each treatment

State anxiety score after each treatment

Figure 1 Mean state anxiety scores before and after each treatment for both treatment group (broken line) and control group (unbroken line). Ó 2007 Blackwell Publishing Ltd, Journal of Clinical Nursing, 16, 777–785

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Treatment group Control group Total

Anxiety (STAI) (SD)

Systolic pressure (SD)

Diastolic pressure (SD)

Heart rate (SD)

Respiratory rate (SD)

1Æ36 (5Æ8) 0Æ85 (4Æ8) 1Æ1 (5Æ3)

0Æ3 (10Æ3) 4Æ6 (7Æ2)* 1Æ9 (9Æ3)

1Æ6 (5Æ1) 0Æ9 (5Æ2) 1Æ3 (5Æ1)

1Æ3 (5Æ6) 0Æ7 (4Æ7) 0Æ4 (5Æ3)

1Æ2 (2Æ4) 0Æ1 (2Æ6) 0Æ7 (2Æ5)

Table 1 Mean pre/postdifference scores and standard deviations (SD) for both groups on anxiety and physiological variables

*Mann–Whitney U-tests significant at P < 0Æ05.

and post, for the five days of intervention, for both groups are presented in Fig. 1.

researcher. One said: ‘Did you see how good my responses were?’

Physiological measures

Discussion

Only one of the five outcome measurements showed statistical significance between the treatment and control groups. Systolic blood pressure lowered significantly more in the control group than in the treatment group (P < 0Æ05). No significant changes were observed for anxiety, heart rate, diastolic blood pressure and respiratory rate, see Table 1.

The results from this study demonstrate no significant differences between reflexology and the control intervention on anxiety, as measured by State Anxiety Inventory or the physiological variables of diastolic blood pressure, heart rate and respiratory rate in patients undergoing CABG surgery. The systolic blood pressure however lowered significantly more in the control group than in the treatment group. The maximum SAI score in this study was 56 out of 80 possible and the lowest score were 20 out of 20 possible. The SAI scores found in this study are lower than in previous studies. A likely reason for relatively low SAI scores is that patients may have already experienced some relief of anxiety because the waiting period for the surgery was over when the intervention started. Other explanations need to be considered, such as questions about the validity of the SAI in the Icelandic culture, particularly as it has not been used previously for Icelandic patients undergoing CABG surgery. The SAI is composed of statements where patients are requested to express to what extent they feel calm, secure, tense, frightened, worried, etc. The validity of inquiring into the phenomena of anxiety in this way may be questioned as Icelandic people may be reluctant to express themselves in this way, particularly compared to North American people for whom the SAI instrument was constructed. Patients’ eagerness to convince the researcher that they were low on the anxiety scores is noteworthy; how to interpret that is not apparent. Regardless of these results, the literature shows that patients undergoing CABG surgery do experience considerable anxiety. This being said, it is necessary to acknowledge the dearth of studies comparing anxiety scores before and after CABG surgery. The control group had lower anxiety on both the pre- and post-measures, compared to the experimental group. No clear explanation was found for this result other than the

Other findings Patients in both groups spontaneously gave comments on the experience of receiving the interventions. In the experimental group one said: ‘I have been waiting for your massage all day.’ Another one said: ‘I love it when you rub my feet.’ At the end of the study, one patient said: ‘Did you notice I had no anxiety?’ All patients appeared relaxed during the reflexology sessions. Snoring sounds or deep breathing was noticed in almost all sessions and four of the patients commented on how relaxed they felt during their reflexology. Three patients in the control group had some remarks on the cream that was applied on their feet. One commented that he really liked having the cream rubbed on the feet and indicated that this intervention must have some healing effects. Some of these patients anticipated the researcher’s visit and looked forward to having the cream applied on their feet. ‘Oh, you are finally here,’ one responded while some took the opportunity to talk about their surgery experiences as the researcher was applying the cream. As she stayed for one minute only to perform this procedure the patients asked her to come back for a visit, which she did after the study period was over. Two of the patients in the control group maintained that they experienced no anxiety and said to the nurse when filling out the SAI scale: ‘I have no anxiety.’ Later they were eager to report their anxiety scores to the 782

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small sample size, as the two groups were comparable with respect to demographic variables and the length waiting time before surgery. The sample size was smaller than planned for which is disappointing. Several patients were excluded from participating because they had to undergo more complicated surgery and several patients underwent percutanious transluminal coronary angioplastic (PTCA) which reduced the sample size. A predetermined anxiety score could have been used as inclusion criteria into the study to better test whether or not reflexology is appropriate for anxious patients. The ways in which patients expressed themselves in relation to anxiety call for further consideration. This study, therefore, suggests that more research is needed on anxiety in particular and on developing outcome measures that captures better the effects of reflexology in general. In this study reflexology does not alter physiological variables. In addition to small sample size, the effects of medication most likely explain these results, as patients in the study were on medication to keep their blood pressure, pulse and heart rate within specific limits. Another explanation might be that patients were interrupted abruptly during their relaxation as a nurse went into their rooms to measure physiological variables 1–2 minutes after each reflexology section ended. This may have disturbed the real effects of the reflexology and is of serious concern. Nurses in critical care have reported that treating anxiety is important, but that commonly used strategies involving mainly pharmacological interventions are too limited (Frazier et al. 2003). In this study, the experimental and control interventions were provided to the patients on the operation day, six hours after being removed from the ventilator. This procedure was successful and neither the patients nor the nurses expressed or retrospectively observed, any negative side effects due to reflexology. The feet are, in most cases, the only area of the body that is free from leads and intravenous lines and can be used by nurses to reduce anxiety and to increase comfort in this stressful situation. Reflexology should therefore be explored further as it may have much to offer these patients. The research design of this study needs further consideration with respect to its limitations. The literature on reflexology is only beginning to emerge and many questions regarding the proper design, control and intervention protocols need further considerations. A debate exists in the literature as to what the proper design should be when complementary and alternative therapies are being studied (Richardson 2000,Verhoef et al. 2002,Miller et al. 2004). The use of randomized controlled trials (RCT) is the golden standard and that design has an important place in

Experimental designs and complementary therapies

assessing the efficacy of complementary therapies (Miller et al. 2004). The following challenges of randomized controlled trials (RCT) have been described by Verhoef et al. (2002) when researching complementary therapies, all of which were apparent in this study: RCT may be complex in nature; standardizing treatment does not allow for flexibility for each individual; definitions of clinical problems concerning the subject are often difficult, as the focus of complementary therapy is often more on restoring balance than on treating symptoms; recruitment and randomization can be problematic due to individual beliefs and practices; appropriate placebo treatment may not be possible to find; and finally, the impact of the patientprovider relationships are generally minimized. It is implied that RCTs only address the effects of the intervention but the reason why it works (i.e. how patients experience the intervention and how they give meaning to these experiences) is lacking. Adding qualitative research methods would greatly enhance the understanding of complementary therapies (Verhoef et al. 2002) as the use of research specific standardized treatment protocols may not capture the holistic nature of reflexology. Individually tailored interventions have been shown to be important as one size does not fit all (Milligan et al. 2002) and should be given further attention. The appropriateness of measuring anxiety in this population has already been addressed. Research involving the impact of the reflexologist incorporated into the treatment protocol is not found in the existing literature, but responses from the patients indicate that therapists make them feel comfortable, relaxed and calm (Milligan et al. 2002). Furthermore, these patients feel that therapists are important in terms of having someone with whom to share their concerns and to receive information and advice (Gambles et al. 2002). The responses from the patients in this study indicate that they were pleased with and enjoyed the intervention and the researchers’ observations suggest that they felt relaxed. New approaches are thus needed in order to gain a better understanding of what exactly takes place during reflexology sessions. Patients undergoing CABG surgery were chosen as the population in this study because they present a large number of relatively homogenous patients who have been shown to experience anxiety and pain while undergoing surgery. The study arose from an attempt to identify a safe, feasible and effective therapeutic intervention to enhance their well-being at this sensitive point in their recovery. The outcomes of the study did only partly support these efforts. It is concluded that further research is needed where a research methodology that better harmonizes with the

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holistic notion of the person is applied. Such methodology needs to allow for tailoring treatments to individual needs, it needs to capture the nature of the intervention process and finally it needs to be sensitive to the real outcomes of reflexology. To conclude, further studies in this area are needed. The explication of anxiety in this group of patients and the instruments that are used to capture it need further exploration. As the use of reflexology to mediate anxiety and other emotional disturbances is in its infancy much further studies need to be undertaken.

Contributions Study design: TJG, HJ; data collection and analysis: TJG, HJ; manuscript preparation: TJG, HJ.

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