+Model YCTIM-1248; No. of Pages 8
ARTICLE IN PRESS
Complementary Therapies in Medicine (2013) xxx, xxx—xxx
Available online at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/ctim
The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial Masoume Rambod a, Nasrin Pourali-Mohammadi b, Nilofar Pasyar c, Forough Rafii d,∗, Farkhondeh Sharif e a
Community Based Psychiatric Care Research Center, Student Research Committee, Medical Surgical Nursing Department, School of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran b School of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran c Medical Surgical Nursing Department, Faculty of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran d Center for Nursing Care Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran e Community Based Psychiatric Care Research Center, Department of Mental Health and Psychiatric Nursing, Faculty Member of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran
KEYWORDS Sleep; Insomnia; Hemodialysis; Relaxation therapy
Summary Objective: This study was performed to evaluate the effectiveness of Benson’s relaxation technique in the quality of sleep of hemodialysis patients. Design: It was a randomized controlled trial with a pre—post-test design. A total of 86 hemodialysis patients referring to hemodialysis units were assigned to either the intervention (receiving Benson’s relaxation technique) or the control group (routine care) through block randomization. Setting: The study was performed in two hemodialysis units affiliated to Shiraz University of Medical Sciences, Shiraz, Iran. Intervention: The patients in the intervention group listened to the audiotape of Benson’s relaxation technique twice a day each time for twenty minutes for eight weeks. Main outcome measures: The global score of Pittsburgh Sleep Quality Index (PSQI) as well as its components was computed in both the intervention and the control group before and at the 8th week of the intervention. Results: The results of ANCOVA indicated significant differences between the two groups regarding the scores of Pittsburgh Sleep Quality Index subscales, such as sleep disturbance, daytime
∗ Corresponding author at: Center for Nursing Care Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid Square, 1419733171, Tehran, Iran. Tel.: +98 21 66933600; fax: +98 21 66941668. E-mail addresses: frafi[email protected], foroughrafi[email protected] (F. Rafii).
0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.08.009
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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M. Rambod et al. dysfunction, the use of sleep medication, and subjective sleep quality and as well as its global scores at the 8th week of the intervention (p < 0.05). Conclusions: This study highlighted the importance of Benson’s relaxation technique in improvement of the sleep quality of the patients on hemodialysis. Thus, educational sessions are recommended to be planned on this cost effective and easy to use relaxation technique in order to improve hemodialysis patients’ sleep quality. Further studies are needed to assess the effectiveness of this technique in other groups of patients. © 2013 Elsevier Ltd. All rights reserved.
Introduction Sleep is a condition in which a process of daily restoration happens.1 Approximately 25—36% of normal adult population suffers from occasional sleep disorders.2 However, the prevalence of these disorders in the patients with uremia on maintenance hemodialysis (HD) ranges from 40 to 85% which is higher than the general population.3,4 It was reported that most of the chronic renal failure cases are poor sleepers.5 The probable reasons for sleep disorders in HD patients include plasma concentrations of toxins (creatinine and urea), anemia, nocturnal hypoxia, and co-morbidities.3 Moreover, anxiety, worry, sadness, and a history of depression are among the major factors significantly associated with sleep disorders in the patients with End Stage Renal Disease (ESRD).6 Poor sleep in HD patients has a negative impact on the physical and mental components of one’s life7 and leads to a decrease in their performance8 as well as cognitive and memory dysfunction.9 Although sleep is very important for the performance of healthy people and ESRD patients on HD, few interventional studies have been done to address the related problems.8 The American Psychological Association (APA) has proposed three psychological treatments for sleep disorders including stimulus control, progressive muscle relaxation, and paradoxical intention.10 Moreover, in the recent years, many people have tried to get rid of their sleep problems using pharmacological agents, complementary/alternative medicine, herbal supplements, and behavioral interventions such as relaxation therapies.11,12 There are different kinds of relaxation technique. One of these techniques which is better tolerated by HD patients is Benson’s relaxation technique (BRT). This technique was identified by Benson (1975) and led to complete relaxation of all the muscles.13 Relaxation techniques are among the cost effective and easy to use methods for treatment of sleep disorders. Relaxation technique as a kind of subjective stress management method14 decreased the anxiety level,15 mood disturbance,16 body discomfort,17 and autonomic nervous system’s activity13 and at least it might affect the quality of sleep. The time needed to fall asleep,18 sleep-onset latency,19 and the frequency of waking up have been reduced by relaxation therapy, as well.18 In a study on the patients with multiple sclerosis, it was shown that muscle relaxation technique improved their sleep quality.20 Furthermore, autogenic relaxation caused the cancer patients to go to sleep faster.21 Other studies revealed that vitality and sleep dimensions of quality of life were also significantly improved at a 6-month follow-up in the relaxation training group compared to the acupuncture
group.22 Yet, one other study showed that acupoints massage improved the ESRD patients’ quality of sleep.8 Most of the studies on the effect of relaxation therapy on sleep disorders have been focused on other relaxation techniques, such as muscle relaxation,20,23 music relaxation,24 and a combination of muscle relaxation with aerobic exercise program.25 In addition, these studies have examined other chronic diseases, such as diabetes26 and multiple sclerosis.20 However, only a limited number of researches have focused on the effect of BRT on a chronic illness such as ESRD. Therefore, this study aims to evaluate the effect of BRT on the quality of sleep of HD patients. We examined the hypothesis: ‘‘after eight weeks of intervention, the quality of sleep of HD patients who have received BRT and routine care will be better than those only receiving routine care’’.
Methods Design It was a randomized controlled trial with a pre—post-test design. The study compared two groups of HD patients, the intervention group receiving BRT and routine care and the control group only receiving routine care.
Setting The study was conducted in two HD units affiliated to Shiraz University of Medical Sciences (SUMS) in Shiraz, one of the megacities of Iran, from February 2011 to January 2012.
Participants The study participants included Iranian adult patients on HD. Besides, the target population consisted of HD patients who were listed in the HD units. The inclusion criteria of the study were being 18 years old or above, having been on HD twice a week or more for at least the 3 previous months, being alert and oriented, being literate, and being willing to participate in the study. On the other hand, the exclusion criteria of the study were being diagnosed with unstable hypertension, arrhythmia, cardiac angina, congestive heart failure, acute cerebrovascular accident, and hepatic failure during the study. Presence of physical limitations to learning prior to the training or during the relaxation therapy was among the other exclusion criteria. The patients with emotional turmoil during the previous month were also excluded from the study.
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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Effect of relaxation on sleep
3 Assessed for eligibility, n = 179
Excluded (n =93) ■ Did not have the inclusion criteria (n = 56) ■ Had exclusion criteria (n= 16) ■ Refused (n = 14) ■ lack of interest (n = 7)
Randomized (n = 86)
Allocation Allocated to control (n = 43)
Allocated to experimental (n = 43)
Follow-up ■ Lost to follow-up (n = 0) ■ Discontinue intervention due to kidney transplant(n= 1)
■ Lost to follow-up (n= 0) ■ Discontinue due to kidney transplant (n= 1) ■ Discontinue due to lack of interest (n= 1)
Analysis Analyzed (n= 42) Exclude from the analysis (n = 0)
Figure 1
Analyzed (n= 41) Exclude from the analysis (n = 0)
Flow of participants.
Randomization and sample size A total of eighty six HD patients were recruited into the present study. Simple randomization procedure was performed by a table of random numbers from the list of HD patients. Then, in order to allocate the participants into the study groups, a block randomization procedure with a random sequence of 2 or 4 block sizes was used to provide balance between the groups and prevent selection bias. Therefore, all the patients were randomly allocated into either the intervention (n = 43) or the control group (n = 43) through block randomization. Using a pilot study (n = 10) and based on effect size = 0.73, power of 0.9, and ˛ = 0.05, a 70-subject sample size (35 subjects in each group) was determined for the present study. Considering the probable loss in the sample, the number of subjects in each group was increased to 43. During the study, two patients in the control group were withdrawn because of kidney transplantation and lack of interest to continue their cooperation. One subject in the intervention group was also excluded due to kidney transplantation. Therefore, forty two HD patients in the BRT group participated in the eight week intervention, while 41 subjects in the control group just received the routine care and the study was pursued by 83 patients (Fig. 1).
The intervention The intervention was started while the HD patients were in separate rooms in their bed in a supine position. The BRT instruction for each patient was performed for 20 min. It required the patients to (1) sit in a comfortable position, (2) close their eyes, (3) relax all their muscles beginning from the soles of the feet, moving forward up, and relax all parts of their body, (4) breath through their nose, pay
attention to the sound of their breathing, and say the word ‘‘one’’ quietly to themselves when the breath was out27,28 ; for example, breath in. . .out, ‘one’; in. . .out, ‘one . . ., and (5) continue for 20 min. The patients were instructed to check the time by opening their eyes. However, using an alarm was prohibited.27
The intervention group Initially, an interventionist who was unaware of the aim of the study and was professional in BRT explained the procedure for each patient. Then, she asked the patients to listen to the audiotape of BRT using earphones and perform it in her presence. Meanwhile, their performance skills were evaluated by the interventionist and the required feedbacks were provided. After the training session, the patients were asked to practice the technique for the next two days. Then, the patients performed the technique again in the presence of the interventionist in order to ensure that they had acquired sufficient skills. The procedure was repeated until the interventionist ensured that the patients had acquired the required skills. Disease status and the characteristics of the sample could also affect the learning process of the relaxation techniques. To prevent this event, a CD on relaxation technique was given to the patients in the intervention group to remember how to do the relaxation techniques at home. They were asked to listen to the CD twice a day for 8 weeks and perform it simultaneously at home. To assess their compliance with BRT, they were asked to fill out a daily self-reporting performance record. The interventionist referred to the HD centers every week for follow up and provided the needed reinforcements regarding the performance of BRT to the subjects. At the same time, their ‘‘performance recording forms’’ were also collected. The mobile phone number of one of the researchers (first author) was given to the
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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M. Rambod et al.
patients and they were asked to contact the researcher if they had any complications or questions during the BRT. To avoid data contamination, the patients in the BRT group were trained in a separate room. Control group The patients in the control group participated in the preand post tests. They just received the routine treatment and care.
Outcome measures The outcome measures in this study included the patients’ scores in the Pittsburgh Sleep Quality Index (PSQI) components as well as its global score.
Measures The PSQI29 is a commonly used self-report questionnaire which measures sleep habits and it takes about 5 min to fill it out. This questionnaire evaluates the participants’ perceived sleep quality and gives information about seven components of sleep, including sleep latency, sleep duration, subjective sleep quality, sleep efficiency, sleep disturbance, daytime dysfunction, and the use of medication for sleep. Its statements are scored from 0 (no difficulty) to 3 (severe difficulty). The total score is calculated by the sum of its seven components and ranges from 0 to 21. A total PSQI score of ≥5 is indicative of poor sleep quality, while good quality of sleep is shown by a total PSQI score of 0.05) (Table 1). The two groups were also similar regarding the length of time on HD (month) (36.53 ± 36.05 vs. 47.67 ± 40.42; t = −1.34, p > 0.05). These results indicated the homogeneity of the subjects in the two study groups.
Blinding Quality of sleep In this study, the HD nurses and physicians remained blind to the outcome measures and allocation of the subjects to the intervention and control groups. Moreover, the
The study results revealed no statistically significant differences between the study groups regarding the global quality
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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Effect of relaxation on sleep Table 1
5
Characteristics of the subjects in the relaxation and control groups.
Characteristic
All subjects
Relaxation group (n = 43)
Control group (n = 43)
t-test P-value
Age (years) Mean (SD)
49.89 (12.47)
49.07 (13.31)
50.72 (11.68)
t = −0.61p = 0.54
The length of time on hemodialysis (months) Mean (SD) 42.10 (38.48) 36.53 (36.05)
47.67 (40.42)
t = −1.34p = 0.18
Gender, n (%) Female Male
33 (38.4) 53 (61.6)
14 (32.6) 29 (67.4)
19 (44.2) 24 (55.8)
2 = 1.22 P = 0.18
Marital status, n (%) Single 8 (9.3) 68 (79.1) Married Widowed 9 (10.5) Divorced 1 (1.2)
4 (9.3) 35 (81.4) 3 (7.0) 1 (2.3)
4 (9.3) 33 (76.7) 6 (14.0) 0 (0.0)
2 = 0.05 P = 0.55
Education, n (%) Elementary Middle school High school College
15 (34.9) 11 (25.6) 7 (16.3) 10 (23.3)
26 (60.5) 7 (16.3) 5 (11.6) 5 (11.6)
2 = 5.84 P = 0.12
41 (47.7) 18 (20.9) 12 (14.0) 15 (17.4)
of sleep or any of the seven subscales of sleep before the intervention (p > 0.05) (Table 2). In the post test, however, the results of ANCOVA demonstrated a significant difference between the intervention and the control group concerning the mean score of the global PSQI (F = 14.85, P < 0.0001) (Table 2). Thus, the results supported the study hypothesis. Moreover, a significant difference was found between the two groups regarding the mean score of sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality subscales of PSQI (P < 0.05). However, no significant difference was observed between the two study groups regarding the mean scores of other subscales, such as sleep latency, sleep duration, and sleep efficiency in the 8th week of the intervention (p > 0.05). In the intervention group, a significant difference was found regarding the mean change of global quality of sleep, sleep latency, sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality before and after the intervention (P < 0.05). However, no differences were observed in the mean change of other subscales of sleep quality, such as sleep duration and sleep efficiency, over the 8 week period (p > 0.05). On the other hand, the control group’s mean change of the global quality of sleep and its subscales did not differ significantly over the 8 week period (p > 0.05) (Table 2). In this study, no one reported any undesirable side effects or unintended harm sign, symptom, or disease related to participation in the study or the relaxation technique.
Discussion Due to their impact on mortality and quality of life, sleep disorders are of critical importance in HD patients.34 The purpose of this study was to assess the effect of BRT on the quality of sleep in HD patients. The study results indicated
that BRT improved the quality of sleep and some of its components, such as sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality, in the HD patients. In this study, BRT enhanced the global quality of sleep in the patients on HD. This finding supported the results of a study that indicated the effect of progressive muscle relaxation training on the quality of sleep in the patients with breast cancer undergoing adjuvant chemotherapy. In this study, a significant difference was found between the two groups regarding the mean global PSQI score of the 43rd and the 90th day after the intervention. After the 90th day, the relaxation group indicated good sleep quality, while the control group had poor sleep quality.23 Moreover, it has been shown that progressive muscle relaxation and autogenic training groups influenced the cancer patients’ sleep quality after four weeks.35 It was also revealed that the quality of sleep of the Chinese adults with cardiac disease improved after audio-visual relaxation training.36 Although these studies indicated the effect of relaxation training on the quality of sleep, there are limited published articles on the effect of BRT on the sleep quality of HD patients. The mechanism of effect of relaxation in treatment of insomnia is controversial. Researchers believe that uremic as well as psychological factors, such as fatigue, anxiety, worry, and depression, play a role in the pathogenesis of sleep disorders in the patients with ESRD.37 Relaxation therapy reduces fatigue,23,38,39 anxiety,39,40 depression,27 perceived stress,39,40 and muscle tension40 and may have a positive impact on the quality of sleep in HD patients. Consistent with our study results, researchers have indicated that some relaxation techniques decreased the sleep disturbance,8,32 the use of sleep medication,35,41 and daytime dysfunction23,35 and improved the subjective sleep quality.23,35 Moreover, relaxation technique reduced daytime dysfunction and enhanced daytime energy35 as well as the mind’s capacity to improve physical function and
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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M. Rambod et al. Table 2 Comparison of the Benson’s relaxation technique (G1) and control (G2) groups on global Pittsburgh Sleep Quality Index (PSQI) and their components. Global PSQI
Pre-test Mean (SD)
Post-test Mean (SD)
Mean change
Paired t-test, P-value
G1 G2 Between group analysis; p
9.78 (4.99) 10.97 (5.49) ‡ −1.37; 0.17
7.27 (4.14) 10.84 (5.35) †† 14.85; 0.05
Pre-test Mean (SD)
Post-test Mean (SD)
Mean rank
†
Sleep latency G1 G2 Between group analysis; p
44.88 (66.81) 56.76 (71.79) § 575.000; 0.64
32.00 (31.12) 52.95 (63.13) †† 0.98; 0.32
9.50 7.21
−2.82, 0.005 −0.96, 0.33
Sleep duration G1 G2 Between group analysis; p
5.10 (1.92) 4.94 (1.91) § 876.500; 0.66
5.76 (2.14) 5.05 (1.95) †† 2.13; 0.14
8.10 2.33
−1.89, 0.05 −0.13, 0.89
Sleep sufficiency G1 G2 Between group analysis; p
0.82 (1.23) 1.15 (1.34) § 752.500; 0.19
0.69 (1.1) 1.15 (1.28) †† 1.05; 0.30
6.94 5.75
−0.64, 0.52 −0.60, 0.95
Sleep disturbance G1 G2 Between group analysis; p
8.61 (4.94) 10.28 (6.48) § 792.000; 0.28
5.53 (3.78) 10.58 (6.58) †† 22.22;
ARTICLE IN PRESS
Complementary Therapies in Medicine (2013) xxx, xxx—xxx
Available online at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/ctim
The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial Masoume Rambod a, Nasrin Pourali-Mohammadi b, Nilofar Pasyar c, Forough Rafii d,∗, Farkhondeh Sharif e a
Community Based Psychiatric Care Research Center, Student Research Committee, Medical Surgical Nursing Department, School of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran b School of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran c Medical Surgical Nursing Department, Faculty of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran d Center for Nursing Care Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran e Community Based Psychiatric Care Research Center, Department of Mental Health and Psychiatric Nursing, Faculty Member of Nursing and Midwifery, Shiraz University of Medical Science and Health Services, Shiraz, Iran
KEYWORDS Sleep; Insomnia; Hemodialysis; Relaxation therapy
Summary Objective: This study was performed to evaluate the effectiveness of Benson’s relaxation technique in the quality of sleep of hemodialysis patients. Design: It was a randomized controlled trial with a pre—post-test design. A total of 86 hemodialysis patients referring to hemodialysis units were assigned to either the intervention (receiving Benson’s relaxation technique) or the control group (routine care) through block randomization. Setting: The study was performed in two hemodialysis units affiliated to Shiraz University of Medical Sciences, Shiraz, Iran. Intervention: The patients in the intervention group listened to the audiotape of Benson’s relaxation technique twice a day each time for twenty minutes for eight weeks. Main outcome measures: The global score of Pittsburgh Sleep Quality Index (PSQI) as well as its components was computed in both the intervention and the control group before and at the 8th week of the intervention. Results: The results of ANCOVA indicated significant differences between the two groups regarding the scores of Pittsburgh Sleep Quality Index subscales, such as sleep disturbance, daytime
∗ Corresponding author at: Center for Nursing Care Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid Square, 1419733171, Tehran, Iran. Tel.: +98 21 66933600; fax: +98 21 66941668. E-mail addresses: frafi[email protected], foroughrafi[email protected] (F. Rafii).
0965-2299/$ — see front matter © 2013 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ctim.2013.08.009
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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M. Rambod et al. dysfunction, the use of sleep medication, and subjective sleep quality and as well as its global scores at the 8th week of the intervention (p < 0.05). Conclusions: This study highlighted the importance of Benson’s relaxation technique in improvement of the sleep quality of the patients on hemodialysis. Thus, educational sessions are recommended to be planned on this cost effective and easy to use relaxation technique in order to improve hemodialysis patients’ sleep quality. Further studies are needed to assess the effectiveness of this technique in other groups of patients. © 2013 Elsevier Ltd. All rights reserved.
Introduction Sleep is a condition in which a process of daily restoration happens.1 Approximately 25—36% of normal adult population suffers from occasional sleep disorders.2 However, the prevalence of these disorders in the patients with uremia on maintenance hemodialysis (HD) ranges from 40 to 85% which is higher than the general population.3,4 It was reported that most of the chronic renal failure cases are poor sleepers.5 The probable reasons for sleep disorders in HD patients include plasma concentrations of toxins (creatinine and urea), anemia, nocturnal hypoxia, and co-morbidities.3 Moreover, anxiety, worry, sadness, and a history of depression are among the major factors significantly associated with sleep disorders in the patients with End Stage Renal Disease (ESRD).6 Poor sleep in HD patients has a negative impact on the physical and mental components of one’s life7 and leads to a decrease in their performance8 as well as cognitive and memory dysfunction.9 Although sleep is very important for the performance of healthy people and ESRD patients on HD, few interventional studies have been done to address the related problems.8 The American Psychological Association (APA) has proposed three psychological treatments for sleep disorders including stimulus control, progressive muscle relaxation, and paradoxical intention.10 Moreover, in the recent years, many people have tried to get rid of their sleep problems using pharmacological agents, complementary/alternative medicine, herbal supplements, and behavioral interventions such as relaxation therapies.11,12 There are different kinds of relaxation technique. One of these techniques which is better tolerated by HD patients is Benson’s relaxation technique (BRT). This technique was identified by Benson (1975) and led to complete relaxation of all the muscles.13 Relaxation techniques are among the cost effective and easy to use methods for treatment of sleep disorders. Relaxation technique as a kind of subjective stress management method14 decreased the anxiety level,15 mood disturbance,16 body discomfort,17 and autonomic nervous system’s activity13 and at least it might affect the quality of sleep. The time needed to fall asleep,18 sleep-onset latency,19 and the frequency of waking up have been reduced by relaxation therapy, as well.18 In a study on the patients with multiple sclerosis, it was shown that muscle relaxation technique improved their sleep quality.20 Furthermore, autogenic relaxation caused the cancer patients to go to sleep faster.21 Other studies revealed that vitality and sleep dimensions of quality of life were also significantly improved at a 6-month follow-up in the relaxation training group compared to the acupuncture
group.22 Yet, one other study showed that acupoints massage improved the ESRD patients’ quality of sleep.8 Most of the studies on the effect of relaxation therapy on sleep disorders have been focused on other relaxation techniques, such as muscle relaxation,20,23 music relaxation,24 and a combination of muscle relaxation with aerobic exercise program.25 In addition, these studies have examined other chronic diseases, such as diabetes26 and multiple sclerosis.20 However, only a limited number of researches have focused on the effect of BRT on a chronic illness such as ESRD. Therefore, this study aims to evaluate the effect of BRT on the quality of sleep of HD patients. We examined the hypothesis: ‘‘after eight weeks of intervention, the quality of sleep of HD patients who have received BRT and routine care will be better than those only receiving routine care’’.
Methods Design It was a randomized controlled trial with a pre—post-test design. The study compared two groups of HD patients, the intervention group receiving BRT and routine care and the control group only receiving routine care.
Setting The study was conducted in two HD units affiliated to Shiraz University of Medical Sciences (SUMS) in Shiraz, one of the megacities of Iran, from February 2011 to January 2012.
Participants The study participants included Iranian adult patients on HD. Besides, the target population consisted of HD patients who were listed in the HD units. The inclusion criteria of the study were being 18 years old or above, having been on HD twice a week or more for at least the 3 previous months, being alert and oriented, being literate, and being willing to participate in the study. On the other hand, the exclusion criteria of the study were being diagnosed with unstable hypertension, arrhythmia, cardiac angina, congestive heart failure, acute cerebrovascular accident, and hepatic failure during the study. Presence of physical limitations to learning prior to the training or during the relaxation therapy was among the other exclusion criteria. The patients with emotional turmoil during the previous month were also excluded from the study.
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
+Model
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Effect of relaxation on sleep
3 Assessed for eligibility, n = 179
Excluded (n =93) ■ Did not have the inclusion criteria (n = 56) ■ Had exclusion criteria (n= 16) ■ Refused (n = 14) ■ lack of interest (n = 7)
Randomized (n = 86)
Allocation Allocated to control (n = 43)
Allocated to experimental (n = 43)
Follow-up ■ Lost to follow-up (n = 0) ■ Discontinue intervention due to kidney transplant(n= 1)
■ Lost to follow-up (n= 0) ■ Discontinue due to kidney transplant (n= 1) ■ Discontinue due to lack of interest (n= 1)
Analysis Analyzed (n= 42) Exclude from the analysis (n = 0)
Figure 1
Analyzed (n= 41) Exclude from the analysis (n = 0)
Flow of participants.
Randomization and sample size A total of eighty six HD patients were recruited into the present study. Simple randomization procedure was performed by a table of random numbers from the list of HD patients. Then, in order to allocate the participants into the study groups, a block randomization procedure with a random sequence of 2 or 4 block sizes was used to provide balance between the groups and prevent selection bias. Therefore, all the patients were randomly allocated into either the intervention (n = 43) or the control group (n = 43) through block randomization. Using a pilot study (n = 10) and based on effect size = 0.73, power of 0.9, and ˛ = 0.05, a 70-subject sample size (35 subjects in each group) was determined for the present study. Considering the probable loss in the sample, the number of subjects in each group was increased to 43. During the study, two patients in the control group were withdrawn because of kidney transplantation and lack of interest to continue their cooperation. One subject in the intervention group was also excluded due to kidney transplantation. Therefore, forty two HD patients in the BRT group participated in the eight week intervention, while 41 subjects in the control group just received the routine care and the study was pursued by 83 patients (Fig. 1).
The intervention The intervention was started while the HD patients were in separate rooms in their bed in a supine position. The BRT instruction for each patient was performed for 20 min. It required the patients to (1) sit in a comfortable position, (2) close their eyes, (3) relax all their muscles beginning from the soles of the feet, moving forward up, and relax all parts of their body, (4) breath through their nose, pay
attention to the sound of their breathing, and say the word ‘‘one’’ quietly to themselves when the breath was out27,28 ; for example, breath in. . .out, ‘one’; in. . .out, ‘one . . ., and (5) continue for 20 min. The patients were instructed to check the time by opening their eyes. However, using an alarm was prohibited.27
The intervention group Initially, an interventionist who was unaware of the aim of the study and was professional in BRT explained the procedure for each patient. Then, she asked the patients to listen to the audiotape of BRT using earphones and perform it in her presence. Meanwhile, their performance skills were evaluated by the interventionist and the required feedbacks were provided. After the training session, the patients were asked to practice the technique for the next two days. Then, the patients performed the technique again in the presence of the interventionist in order to ensure that they had acquired sufficient skills. The procedure was repeated until the interventionist ensured that the patients had acquired the required skills. Disease status and the characteristics of the sample could also affect the learning process of the relaxation techniques. To prevent this event, a CD on relaxation technique was given to the patients in the intervention group to remember how to do the relaxation techniques at home. They were asked to listen to the CD twice a day for 8 weeks and perform it simultaneously at home. To assess their compliance with BRT, they were asked to fill out a daily self-reporting performance record. The interventionist referred to the HD centers every week for follow up and provided the needed reinforcements regarding the performance of BRT to the subjects. At the same time, their ‘‘performance recording forms’’ were also collected. The mobile phone number of one of the researchers (first author) was given to the
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M. Rambod et al.
patients and they were asked to contact the researcher if they had any complications or questions during the BRT. To avoid data contamination, the patients in the BRT group were trained in a separate room. Control group The patients in the control group participated in the preand post tests. They just received the routine treatment and care.
Outcome measures The outcome measures in this study included the patients’ scores in the Pittsburgh Sleep Quality Index (PSQI) components as well as its global score.
Measures The PSQI29 is a commonly used self-report questionnaire which measures sleep habits and it takes about 5 min to fill it out. This questionnaire evaluates the participants’ perceived sleep quality and gives information about seven components of sleep, including sleep latency, sleep duration, subjective sleep quality, sleep efficiency, sleep disturbance, daytime dysfunction, and the use of medication for sleep. Its statements are scored from 0 (no difficulty) to 3 (severe difficulty). The total score is calculated by the sum of its seven components and ranges from 0 to 21. A total PSQI score of ≥5 is indicative of poor sleep quality, while good quality of sleep is shown by a total PSQI score of 0.05) (Table 1). The two groups were also similar regarding the length of time on HD (month) (36.53 ± 36.05 vs. 47.67 ± 40.42; t = −1.34, p > 0.05). These results indicated the homogeneity of the subjects in the two study groups.
Blinding Quality of sleep In this study, the HD nurses and physicians remained blind to the outcome measures and allocation of the subjects to the intervention and control groups. Moreover, the
The study results revealed no statistically significant differences between the study groups regarding the global quality
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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Effect of relaxation on sleep Table 1
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Characteristics of the subjects in the relaxation and control groups.
Characteristic
All subjects
Relaxation group (n = 43)
Control group (n = 43)
t-test P-value
Age (years) Mean (SD)
49.89 (12.47)
49.07 (13.31)
50.72 (11.68)
t = −0.61p = 0.54
The length of time on hemodialysis (months) Mean (SD) 42.10 (38.48) 36.53 (36.05)
47.67 (40.42)
t = −1.34p = 0.18
Gender, n (%) Female Male
33 (38.4) 53 (61.6)
14 (32.6) 29 (67.4)
19 (44.2) 24 (55.8)
2 = 1.22 P = 0.18
Marital status, n (%) Single 8 (9.3) 68 (79.1) Married Widowed 9 (10.5) Divorced 1 (1.2)
4 (9.3) 35 (81.4) 3 (7.0) 1 (2.3)
4 (9.3) 33 (76.7) 6 (14.0) 0 (0.0)
2 = 0.05 P = 0.55
Education, n (%) Elementary Middle school High school College
15 (34.9) 11 (25.6) 7 (16.3) 10 (23.3)
26 (60.5) 7 (16.3) 5 (11.6) 5 (11.6)
2 = 5.84 P = 0.12
41 (47.7) 18 (20.9) 12 (14.0) 15 (17.4)
of sleep or any of the seven subscales of sleep before the intervention (p > 0.05) (Table 2). In the post test, however, the results of ANCOVA demonstrated a significant difference between the intervention and the control group concerning the mean score of the global PSQI (F = 14.85, P < 0.0001) (Table 2). Thus, the results supported the study hypothesis. Moreover, a significant difference was found between the two groups regarding the mean score of sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality subscales of PSQI (P < 0.05). However, no significant difference was observed between the two study groups regarding the mean scores of other subscales, such as sleep latency, sleep duration, and sleep efficiency in the 8th week of the intervention (p > 0.05). In the intervention group, a significant difference was found regarding the mean change of global quality of sleep, sleep latency, sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality before and after the intervention (P < 0.05). However, no differences were observed in the mean change of other subscales of sleep quality, such as sleep duration and sleep efficiency, over the 8 week period (p > 0.05). On the other hand, the control group’s mean change of the global quality of sleep and its subscales did not differ significantly over the 8 week period (p > 0.05) (Table 2). In this study, no one reported any undesirable side effects or unintended harm sign, symptom, or disease related to participation in the study or the relaxation technique.
Discussion Due to their impact on mortality and quality of life, sleep disorders are of critical importance in HD patients.34 The purpose of this study was to assess the effect of BRT on the quality of sleep in HD patients. The study results indicated
that BRT improved the quality of sleep and some of its components, such as sleep disturbance, daytime dysfunction, the use of sleep medication, and subjective sleep quality, in the HD patients. In this study, BRT enhanced the global quality of sleep in the patients on HD. This finding supported the results of a study that indicated the effect of progressive muscle relaxation training on the quality of sleep in the patients with breast cancer undergoing adjuvant chemotherapy. In this study, a significant difference was found between the two groups regarding the mean global PSQI score of the 43rd and the 90th day after the intervention. After the 90th day, the relaxation group indicated good sleep quality, while the control group had poor sleep quality.23 Moreover, it has been shown that progressive muscle relaxation and autogenic training groups influenced the cancer patients’ sleep quality after four weeks.35 It was also revealed that the quality of sleep of the Chinese adults with cardiac disease improved after audio-visual relaxation training.36 Although these studies indicated the effect of relaxation training on the quality of sleep, there are limited published articles on the effect of BRT on the sleep quality of HD patients. The mechanism of effect of relaxation in treatment of insomnia is controversial. Researchers believe that uremic as well as psychological factors, such as fatigue, anxiety, worry, and depression, play a role in the pathogenesis of sleep disorders in the patients with ESRD.37 Relaxation therapy reduces fatigue,23,38,39 anxiety,39,40 depression,27 perceived stress,39,40 and muscle tension40 and may have a positive impact on the quality of sleep in HD patients. Consistent with our study results, researchers have indicated that some relaxation techniques decreased the sleep disturbance,8,32 the use of sleep medication,35,41 and daytime dysfunction23,35 and improved the subjective sleep quality.23,35 Moreover, relaxation technique reduced daytime dysfunction and enhanced daytime energy35 as well as the mind’s capacity to improve physical function and
Please cite this article in press as: Rambod M, et al. The effect of Benson’s relaxation technique on the quality of sleep of Iranian hemodialysis patients: A randomized trial. Complement Ther Med (2013), http://dx.doi.org/10.1016/j.ctim.2013.08.009
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M. Rambod et al. Table 2 Comparison of the Benson’s relaxation technique (G1) and control (G2) groups on global Pittsburgh Sleep Quality Index (PSQI) and their components. Global PSQI
Pre-test Mean (SD)
Post-test Mean (SD)
Mean change
Paired t-test, P-value
G1 G2 Between group analysis; p
9.78 (4.99) 10.97 (5.49) ‡ −1.37; 0.17
7.27 (4.14) 10.84 (5.35) †† 14.85; 0.05
Pre-test Mean (SD)
Post-test Mean (SD)
Mean rank
†
Sleep latency G1 G2 Between group analysis; p
44.88 (66.81) 56.76 (71.79) § 575.000; 0.64
32.00 (31.12) 52.95 (63.13) †† 0.98; 0.32
9.50 7.21
−2.82, 0.005 −0.96, 0.33
Sleep duration G1 G2 Between group analysis; p
5.10 (1.92) 4.94 (1.91) § 876.500; 0.66
5.76 (2.14) 5.05 (1.95) †† 2.13; 0.14
8.10 2.33
−1.89, 0.05 −0.13, 0.89
Sleep sufficiency G1 G2 Between group analysis; p
0.82 (1.23) 1.15 (1.34) § 752.500; 0.19
0.69 (1.1) 1.15 (1.28) †† 1.05; 0.30
6.94 5.75
−0.64, 0.52 −0.60, 0.95
Sleep disturbance G1 G2 Between group analysis; p
8.61 (4.94) 10.28 (6.48) § 792.000; 0.28
5.53 (3.78) 10.58 (6.58) †† 22.22;
