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Received: 2024/06/10 | Accepted: 2024/08/9 | Published: 2024/08/20
Received: 2024/06/10 | Accepted: 2024/08/9 | Published: 2024/08/20
How to cite this article
Mirbagher Ajorpaz N, Mohammadi M, Sadat Z, Rahemi Z, Mousavi S. The Effect of Thai Massage Therapy on the Quality of Sleep in Patients with Hemodialysis; A Randomized Controlled Trial. J Clinic Care Skill 2024; 5 (3) :117-123
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1- Autoimmune Diseases Research Center, Kashan University of Medical Sciences, Kashan, Iran
2- Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran
3- School of Nursing, Clemson University, Clemson, US
4- Department of Physical Education and Sport Science, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran
2- Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran
3- School of Nursing, Clemson University, Clemson, US
4- Department of Physical Education and Sport Science, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran
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Introduction
End-stage renal disease (ESRD) is one of the top leading causes of death in the world. This disease is defined as the irreversible destruction of kidneys. In this stage of renal disease, the patient needs to undergo hemodialysis (HD) [1]. In the United States, there are about 675,000 ESRD patients, from which more than 400,000 patients are under HD treatment [2]. In Iran, the number of patients undergoing HD is increasing; the number of ESRD patients in 2014 was 24,000 and is projected to be 90,000 in 2022 [3].
Long-term treatments using HD can lead to a set of medical conditions known as uremic syndrome. One of the frequent problems associated with this syndrome in HD patients is sleep disorders [3, 4]. Additionally, bone pain, itching, anxiety, immobility, and napping during HD can lead to nighttime sleep disturbances [2]. Sleep disorder is a significant complication associated with HD and is diagnosed through disturbed and interrupted sleep patterns [3]. More than 80% of patients with chronic renal failure reported complaints related to sleep [4]. Most common sleep complaints in these patients are related to initiating and maintaining sleep, leading to sleep inadequacy, increased fall risk, concentration difficulty, and memory problems [3, 4]. However, despite the importance and rates of sleep disorders in patients, healthcare professionals frequently overlook sleep disorders [2].
Evidence indicates that sleep disorders are disturbances related to the disruption of sleep patterns or the quality and quantity of sleep that can negatively affect a person’s daily functions [3, 4]. Pharmacological treatments are the most common interventions in the management of sleep disorders. However, pharmacological treatments can cause multiple side effects, including changes in sleep patterns, tolerance and resistance to drugs, withdrawal syndrome, daily sleepiness, falls, and deterioration of medical conditions. Despite these side effects, sedatives and hypnotic medications are frequently used to manage sleep disorders [5].
Due to the side effects of pharmacological treatments, complementary medicine methods are currently recommended as a more efficient method in managing sleep disorders. Complementary medicine interventions by nurses that are shown to improve the quality of sleep include acupressure, acupuncture, aromatherapy, massage therapy, reflexology, and therapeutic touch [6, 7]. Massage may help improve sleep in two primary ways. The first is by alleviating stress. Stress is known to affect sleep. Massage reduces stress by decreasing cortisol (a stress hormone) and increasing serotonin and dopamine (neurotransmitters that help stabilize mood). Using massage to decrease stress and to promote relaxation may help sleep better [6]. There are about 80 different types of massage in practice, such as Swedish massage, exercise massage, traditional Thai massage (TTM), reflexology, Yumeiho massage, Japanese massage, and Chinese massage [8]. A Thai massage or TTM includes a set of stretching movements that helps improve individuals’ body flexibility, range of motion, and function [9, 10]. A Thai massage is defined as manual work on the body, including using pressure, rubbing, and kneading on the soft body tissues with adjustable levels of intensity, directions, rates, and rhythms [11]. The focus of this intervention is to provide holistic care for patients; Therefore, Thai massage therapists tend to help improve psychological and social aspects of health in addition to physical health [12]. Thai massage is more dynamic than other types of massage, and the body is stretched during the massage. This massage is easy compared to other massages, and it has no side effects for the patient [11, 12].
Due to the high prevalence of sleep disorders in HD patients, the side effects related to sedatives and hypnotic’s medications, as well as the convenience of massage as a non-invasive procedure, massage therapy is recommended for the management of sleep disorders in chronic diseases [13]. The effects of massage on sleep quality have been investigated among different groups of patients [14, 15]. These studies have been shown contradictory results regarding the effectiveness of massage on the quality of sleep [14, 15]. For example, in a clinical trial, researchers assessed the effect of a foot massage on the quality of sleep during the night among HD patients. The results showed that a 60-minute foot massage twice a week for four weeks effectively improved the quality of sleep among these patients [16]. Another research reported that 12 massage therapy sessions using hot stones could improve the total score sleep quality and the subscales, except sleep disorders subscale among HD male patients. It has been suggested that other studies with larger sample sizes on both genders apply a placebo intervention in the control group be conducted [17]. However, another clinical trial showed that a full body massage before bedtime for three nights was not effective on the quality of sleep among patients after coronary artery bypass graft surgery [18].
Due to the increasing interest in using complementary and alternative therapies in managing chronic diseases, no study examined the effect of Thai massage therapy on the quality of sleep among HD patients. The purpose of the present study was to investigate the effect of Thai massage on the quality of sleep among HD patients.
Materials and Methods
Trial design
The present study was a single-blinded randomized controlled clinical trial that was conducted from September to December 2020. The study was registered in the Iranian Registry of Clinical Trials (code: IRCT20111210008348N43).
Participants
This clinical trial was performed on 80 hemodialysis (HD) patients referred to the Hemodialysis Center in Kashan, Iran.
Inclusion criteria of the study were as follows: Ages over 18 years, willingness to participate in the study, no diseases in the limbs, having three sessions of 3-4-hour hemodialysis per week, having a history of at least three months of hemodialysis; consent to participate in the study, obtaining a score of 5 or higher from the Pittsburgh sleep quality index. Exclusion criteria included: Exacerbation of the patient’s symptoms during the study, absence in at least two sessions of massage therapy, a simultaneous use of other complementary therapies, such as laser therapy, music therapy, motion therapy, and hydrotherapy.
Sample size calculation
The sample size in each group was calculated based on Pocock's formula (α=0.05, β=0.2, d=0.65) [19]. Based on the formula and Sahraei et al. study [13], the optimal sample size of each group was estimated to be 37 participants. So, 40 participants were considered for each group, considering 10% of the sample loss.
Randomization
At the beginning of this study, 150 HD patients were selected according to convenience methods and were assessed for eligibility. 56 out of 150 patients did not meet the criteria for this study, and 14 patients declined to complete the consent form for participation. After the baseline assessment, a total of 80 HD patients were randomly assigned into intervention (n=40) and control (n=40) groups using the block randomization method (8 groups of ten).
Intervention and data collection
Intervention of the study was Thai massage. At the beginning of the study, the first author explained the methods and procedures related to Thai massage therapy to the participants in the intervention group. The intervention environment was set based on the recommendations by American College of Sports Medicine [20]. The intervention was performed in a room next to the Hemodialysis Center with proper ventilation, light, and temperature. Thai massage performed for the female by the first author and for the male by assistant researcher in the intervention group, who had the certificate in Thai massage. To perform a Thai massage, the participants were placed in a supine position on a foam floor mat while their privacy was respected [12]. The massage sessions were set individually. A weekly schedule was prepared to list the day and time of the massage for each participant in the intervention group. This weekly schedule was set based on the participants’ convenience for morning (8-9 am) or afternoon (3-4 pm) massage. Thai massage was performed before HD sessions, three times a week, for four consecutive weeks. In total, Thai massage were performed in 12 sixty-minute sessions [21]. The participants were asked to report to the Hemodialysis Center about 75 minutes earlier. They had about 15 minutes to change their clothes and get prepared for the massage intervention. Then, a Thai massage was performed for 60 minutes.
We performed Thai massage based on a standardized protocol and using energy lines [12, 21]. In each hand, there are two energy lines on the inner and outer surfaces of the limbs. So, there are four lines in the spine and back, in each foot six lines, and in each leg two lines.
Initially, the therapist applied pressure on the participant’s plantar muscles along the 6 energy lines of each foot for 10 minutes (5 minutes per foot) using the palms and thumbs [12, 21]. Second, the therapist squeezed the femoral artery to stop blood flow to the legs and then released the pressure so that the blood could return to the legs. Then, the therapist applied pressure using the heel of the hand along the energy lines on the inner and outer sides of the thigh for 10 minutes (5 minutes per foot). Third, massage was performed using the thumbs of the therapist on the external surfaces of the participant’s foot from the top of the ankle to the leg (both sides of the tibia), the thigh, and groin for 10 minutes (5 minutes per foot). Also, the massage was performed for the inner surface of the foot for 10 minutes (5 minutes per foot). Fourth, the therapist applied pressure on both sides of the participant’s spine (lumbar, waist, and upper back up to the shoulder along the energy lines) for 30 minutes using the thumbs. For the participants who had limited mobility and could not be in the supine position, this stage was done in the sitting position.
For the control group, routine care including fistula care, weight and blood pressure measurement and diet training was provided.
The two groups completed the Pittsburgh Sleep Quality Index (PSQI) immediately after the last session and one month after the last session of the intervention. The first author contacted the participants frequently to ensure they did not receive any kind of complementary treatments over the course of the study.
Instruments
To collect data, a sociodemographic questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were completed. The sociodemographic questionnaire included gender, age, marital status, level of education, and history of hemodialysis (HD). The PSQI was used to evaluate the sleep quality. The PSQI is a standardized self-report questionnaire that includes 18 items. Each item is scored 0 to 3, higher scores represent poorer sleep quality. Total score ranges from 0 to 21 and a total score >5 indicates poor sleep quality. Lower scores indicate a better sleep quality. Scores between 0 and 4 indicate a good sleep quality. Scores of 5 or more indicate a poor sleep quality [22]. The PSQI measures different aspects of sleep and consists of seven subscales; These subscales include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Validity and reliability of the PSQI were confirmed in different studies [23, 24]. Ağargün et al. reported Cronbach’s alpha of 78-82% for the scale [23]. Hosseinabadi et al. reported Cronbach’s alpha of 88% for the Persian version of the PSQI [24]. In the present study, the Cronbach’s alpha of the Persian version of the instrument was 0.831.
Blinding
This was a randomized single-blinded clinical trial study. The patient did not know whether he/she was in the intervention group or the control group.
Outcome
Primary outcome was the quality of sleep in patients with thalassemia. Secondary outcomes were the subscales of quality of sleep including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction based on PSQI. The data was measured immediately and one month after the last session of the intervention.
Statistical analysis
Data was analyzed using the Statistical Package for Social Sciences 22.0 software (SPSS Inc., Chicago, IL, USA). Kolmogorov Smirnov test was used to determine whether the data had a normal distribution (all data were normal p>0.05). To mitigate non-random attrition of participants in the study, the intention-to-treat (ITT) analysis was used. Mean scores and standard deviations were calculated. Chi-square tests were used to compare the two groups in terms of nominal variables. The independent t-tests were used to compare the two groups’ mean scores. The two-way analysis of variance with repeated measures test was used to perform within- and between-group comparisons over time. The level of significance was set at 0.05.
Findings
Over the course of the study, three participants were excluded from the control group due to a partial completion of the survey. Additionally, four participants in the intervention group were excluded due to their acute medical conditions (n=1) and a lack of cooperation to perform the massage (n=3).
The results indicated that most participants in the intervention (50%) and control (51.35%) groups were 45-65 years old. Most participants in the intervention (72.2%) and control (67.6%) groups were female. The education level of 41.65% of the participants in the intervention group and 56.75% in the control group was an elementary degree. No significant difference was observed between the two groups in terms of the sociodemographic characteristics, including age, gender, level of education, marital status, and the history of HD (p>0.05; Table 1).
Table 1. The intervention and control groups’ sociodemographic characteristics
At the beginning of the study, there was no significant difference between the two groups in terms of the sleep quality (p>0.05). Over the course of the study, the results of Repeated Measures ANOVA test showed that there were within and between group differences in terms of the groups’ quality of sleep scores. In the intervention group, the mean scores of the sleep quality and three subscales, including use of sleeping medication, sleep latency, and subjective sleep quality changed over time, before, immediately after last session, and one month after the last session of the intervention (p<0.05). The results showed that in the intervention group, the total score of sleep quality before, immediately after and one month after the intervention was 9.62±3.67, 7.53±2.29 and 8.15±2.52 respectively, which was statistically significant (p<0.001). The mean scores of the sleep quality and two subscales, including the use of sleeping medication and sleep latency decreased over time (p<0.05). The Bonferroni test showed that the comparison of the mean sleep quality before and after the intervention was significant (p<0.05); Additionally, the difference was significant (p<0.05) before the intervention and one month afterward, but not significant (p>0.05) after the intervention and one month later. The mean scores of the subjective sleep quality subscale significantly increased (p<0.05). However, this difference was not significant for other subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders (p>0.05). In the control group, no significant difference was observed between the scores of the sleep quality and the subscales before, immediately after, and one month after the intervention (p>0.05; Table 2).
The results of the independent t-test showed that the two groups had significant differences in terms of the mean scores of overall sleep quality as well as subjective sleep quality, sleep latency, and the use of sleeping medication subscales immediately after and one month after the last session of the intervention (p<0.05). However, the differences between the two groups were not significant in terms of sleep duration, habitual sleep efficiency, and sleep disturbances (p>0.05). The results showed that the total sleep quality score one month after the intervention was 8.15±2.52 in the intervention group and 10.09±3.01 in the control group. The independent t-test showed a statistically significant difference between the two groups (p=0.004; Table 2).
Table 2. Comparing mean scores of the two groups in the sleep quality before, immediately, and one month after the end of the intervention
Discussion
In this study, we examined the effects of Thai massage on the sleep quality in patients undergoing HD. Our findings indicated that between the intervention and control groups, there were significant differences in terms of the total scores of overall sleep quality and several subscales, including subjective sleep quality, sleep latency, and the use of sleeping medication subscales, immediately after the last session and one month after the intervention. In the intervention group, the total scores of sleep quality as well as the scores related to the use of sleeping medication, sleep latency, and subjective sleep quality subscales significantly changed over time. The mean scores of the total sleep quality as well as the use of sleeping medication and sleep latency and subjective sleep quality significantly decreased. However, this difference was not significant for other subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders.
Several studies agreed our findings in terms of the significance of massage in improving the sleep quality among different populations [17, 25]. However, there was a study that showed no significant effect of massage on the sleep quality after coronary artery bypass graft surgery [18]. The number of studies using Thai massage is limited; Therefore, we discuss studies using different types of massage in this section.
In a clinical trial, Ghavami et al. use the PSQI to measure the quality of sleep before and after massage. They show that 12 sessions of hot stone massage in HD patients were effective in improving the scores of the sleep quality and the subscales, except sleep disorders subscale [17]. Another research has investigated the effects of foot and facial massages on sleep, blood pressure, respiratory rate, and pulse rate among healthy adults. Massages are performed for 20 minutes on the feet. Moreover, a 20-minute facial massage using peach-kernel base oil Prunus persica is performed. Their results show that massage can shorten the length of the time needed for a patient to fall asleep. Some of their participants report that they started to feel sleepy during the intervention [25].
A clinical trial shows that foot massage twice a week for a month can improve the quality of sleep and its subscales in patients with HD [16]. However, in the present study, massage was not effective on four subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders. Other studies also show that massage therapy can improve the sleep quality in different populations of patients [26, 27].
The studies are different in terms of their intervention designs and length and types of massage. However, all the studies are in line with our results regarding the effectiveness of massage therapy on the sleep quality in patients [14, 15]. This consistency can be interpreted as a significant influence of massage in improving the sleep quality in different health conditions. In all reviewed studies as well as the present study, the PSQI is used to measure sleep quality. These studies do not include any follow-up assessment for patients’ quality of sleep. However, in the present study, we assessed the sleep quality a month after the end of the intervention. This follow-up assessment indicated the persistence of the Thai massage effectiveness in improving the sleep quality among HD patients a few weeks after the intervention. Studies reported that massage can lead to muscle relaxation. Muscle relaxation can improve muscular flexibility and reduce pain caused by dry muscles; Thus, the relaxation can be effective in the management of sleep disorders [16, 28].
Another study indicates that massage therapy can boost the person’s energy level through the release of neurotransmitters and neurohormones. They state that massage increases body energy, comfort and relaxation, and relieves muscle cramps in HD patients. As a result, massage can reduce fatigue and improve the sleep quality [29]. Hsu et al. also report that back massage before bedtime for three consecutive days improved the scores of sleep quality and the subscales in intensive-care-unit patients [30]. However, in the present study, the scores of four subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders, did not increase after the intervention. In a clinical trial, Nerbass et al. state that full-body massage before bedtime for three consecutive days are not significantly effective in improving the quality of sleep among patients after coronary artery bypass graft surgery [18].
The Bonferroni test showed that the comparison of the mean sleep quality, after the intervention and one month later, was not significant (p>0.05). Perhaps the reason was the occurrence of intervening factors such as anemia and hemodynamic disorders that were beyond the researcher's control.
The conflicting results between studies on the effectiveness of massage may be due to differences in the type of massage, the number of massage sessions, session duration, intervals between sessions, and the method of massage. It will be valuable to consider these factors in the design of future studies.
We could not control some confounding factors, such as medications and routine treatments for HD patients, which can influence the participants’ quality of sleep. To confirm the results of the present study, we recommend further studies on the effects of Thai massage on the sleep quality among HD patients.
Conclusion
Thai massage therapy effectively improved the participants’ quality of sleep.
Acknowledgments: The authors thank Kashan University of Medical Sciences and the Clinical Research Development Unit of Shahid Beheshti Hospital for supporting this study.
Ethical Permissions: This study was approved by Kashan University of Medical Sciences (KAUMS), the Institutional Review Board and the Ethics Committee (code: IR.KAUMS.NUHEPM.REC.1399.008). The purposes methods, and voluntary nature of the study were explained to the participants. The participants were ensured about confidentiality of data and the right to withdraw from the study at any time without any penalty. The participants completed written informed consents. The study was conducted in accordance with the Declaration of Helsinki.
Conflicts of Interests: The authors declare no conflicts of interest.
Authors' Contribution: Mohammadi M (First Author), Main Researcher (20%); Rahemi Z (Second Author), Introduction Writer (20%); Mirbagher Ajorpaz N (Third Author), Methodologist/Discussion Writer (30%); Mousavi SMS (Fourth Author), Introduction Writer (20%); Sadat Z (Fifth Author), Statistical Analyst (10%)
Funding/Support: This work was financially supported by the Kashan University of Medical Sciences, Iran.
End-stage renal disease (ESRD) is one of the top leading causes of death in the world. This disease is defined as the irreversible destruction of kidneys. In this stage of renal disease, the patient needs to undergo hemodialysis (HD) [1]. In the United States, there are about 675,000 ESRD patients, from which more than 400,000 patients are under HD treatment [2]. In Iran, the number of patients undergoing HD is increasing; the number of ESRD patients in 2014 was 24,000 and is projected to be 90,000 in 2022 [3].
Long-term treatments using HD can lead to a set of medical conditions known as uremic syndrome. One of the frequent problems associated with this syndrome in HD patients is sleep disorders [3, 4]. Additionally, bone pain, itching, anxiety, immobility, and napping during HD can lead to nighttime sleep disturbances [2]. Sleep disorder is a significant complication associated with HD and is diagnosed through disturbed and interrupted sleep patterns [3]. More than 80% of patients with chronic renal failure reported complaints related to sleep [4]. Most common sleep complaints in these patients are related to initiating and maintaining sleep, leading to sleep inadequacy, increased fall risk, concentration difficulty, and memory problems [3, 4]. However, despite the importance and rates of sleep disorders in patients, healthcare professionals frequently overlook sleep disorders [2].
Evidence indicates that sleep disorders are disturbances related to the disruption of sleep patterns or the quality and quantity of sleep that can negatively affect a person’s daily functions [3, 4]. Pharmacological treatments are the most common interventions in the management of sleep disorders. However, pharmacological treatments can cause multiple side effects, including changes in sleep patterns, tolerance and resistance to drugs, withdrawal syndrome, daily sleepiness, falls, and deterioration of medical conditions. Despite these side effects, sedatives and hypnotic medications are frequently used to manage sleep disorders [5].
Due to the side effects of pharmacological treatments, complementary medicine methods are currently recommended as a more efficient method in managing sleep disorders. Complementary medicine interventions by nurses that are shown to improve the quality of sleep include acupressure, acupuncture, aromatherapy, massage therapy, reflexology, and therapeutic touch [6, 7]. Massage may help improve sleep in two primary ways. The first is by alleviating stress. Stress is known to affect sleep. Massage reduces stress by decreasing cortisol (a stress hormone) and increasing serotonin and dopamine (neurotransmitters that help stabilize mood). Using massage to decrease stress and to promote relaxation may help sleep better [6]. There are about 80 different types of massage in practice, such as Swedish massage, exercise massage, traditional Thai massage (TTM), reflexology, Yumeiho massage, Japanese massage, and Chinese massage [8]. A Thai massage or TTM includes a set of stretching movements that helps improve individuals’ body flexibility, range of motion, and function [9, 10]. A Thai massage is defined as manual work on the body, including using pressure, rubbing, and kneading on the soft body tissues with adjustable levels of intensity, directions, rates, and rhythms [11]. The focus of this intervention is to provide holistic care for patients; Therefore, Thai massage therapists tend to help improve psychological and social aspects of health in addition to physical health [12]. Thai massage is more dynamic than other types of massage, and the body is stretched during the massage. This massage is easy compared to other massages, and it has no side effects for the patient [11, 12].
Due to the high prevalence of sleep disorders in HD patients, the side effects related to sedatives and hypnotic’s medications, as well as the convenience of massage as a non-invasive procedure, massage therapy is recommended for the management of sleep disorders in chronic diseases [13]. The effects of massage on sleep quality have been investigated among different groups of patients [14, 15]. These studies have been shown contradictory results regarding the effectiveness of massage on the quality of sleep [14, 15]. For example, in a clinical trial, researchers assessed the effect of a foot massage on the quality of sleep during the night among HD patients. The results showed that a 60-minute foot massage twice a week for four weeks effectively improved the quality of sleep among these patients [16]. Another research reported that 12 massage therapy sessions using hot stones could improve the total score sleep quality and the subscales, except sleep disorders subscale among HD male patients. It has been suggested that other studies with larger sample sizes on both genders apply a placebo intervention in the control group be conducted [17]. However, another clinical trial showed that a full body massage before bedtime for three nights was not effective on the quality of sleep among patients after coronary artery bypass graft surgery [18].
Due to the increasing interest in using complementary and alternative therapies in managing chronic diseases, no study examined the effect of Thai massage therapy on the quality of sleep among HD patients. The purpose of the present study was to investigate the effect of Thai massage on the quality of sleep among HD patients.
Materials and Methods
Trial design
The present study was a single-blinded randomized controlled clinical trial that was conducted from September to December 2020. The study was registered in the Iranian Registry of Clinical Trials (code: IRCT20111210008348N43).
Participants
This clinical trial was performed on 80 hemodialysis (HD) patients referred to the Hemodialysis Center in Kashan, Iran.
Inclusion criteria of the study were as follows: Ages over 18 years, willingness to participate in the study, no diseases in the limbs, having three sessions of 3-4-hour hemodialysis per week, having a history of at least three months of hemodialysis; consent to participate in the study, obtaining a score of 5 or higher from the Pittsburgh sleep quality index. Exclusion criteria included: Exacerbation of the patient’s symptoms during the study, absence in at least two sessions of massage therapy, a simultaneous use of other complementary therapies, such as laser therapy, music therapy, motion therapy, and hydrotherapy.
Sample size calculation
The sample size in each group was calculated based on Pocock's formula (α=0.05, β=0.2, d=0.65) [19]. Based on the formula and Sahraei et al. study [13], the optimal sample size of each group was estimated to be 37 participants. So, 40 participants were considered for each group, considering 10% of the sample loss.
Randomization
At the beginning of this study, 150 HD patients were selected according to convenience methods and were assessed for eligibility. 56 out of 150 patients did not meet the criteria for this study, and 14 patients declined to complete the consent form for participation. After the baseline assessment, a total of 80 HD patients were randomly assigned into intervention (n=40) and control (n=40) groups using the block randomization method (8 groups of ten).
Intervention and data collection
Intervention of the study was Thai massage. At the beginning of the study, the first author explained the methods and procedures related to Thai massage therapy to the participants in the intervention group. The intervention environment was set based on the recommendations by American College of Sports Medicine [20]. The intervention was performed in a room next to the Hemodialysis Center with proper ventilation, light, and temperature. Thai massage performed for the female by the first author and for the male by assistant researcher in the intervention group, who had the certificate in Thai massage. To perform a Thai massage, the participants were placed in a supine position on a foam floor mat while their privacy was respected [12]. The massage sessions were set individually. A weekly schedule was prepared to list the day and time of the massage for each participant in the intervention group. This weekly schedule was set based on the participants’ convenience for morning (8-9 am) or afternoon (3-4 pm) massage. Thai massage was performed before HD sessions, three times a week, for four consecutive weeks. In total, Thai massage were performed in 12 sixty-minute sessions [21]. The participants were asked to report to the Hemodialysis Center about 75 minutes earlier. They had about 15 minutes to change their clothes and get prepared for the massage intervention. Then, a Thai massage was performed for 60 minutes.
We performed Thai massage based on a standardized protocol and using energy lines [12, 21]. In each hand, there are two energy lines on the inner and outer surfaces of the limbs. So, there are four lines in the spine and back, in each foot six lines, and in each leg two lines.
Initially, the therapist applied pressure on the participant’s plantar muscles along the 6 energy lines of each foot for 10 minutes (5 minutes per foot) using the palms and thumbs [12, 21]. Second, the therapist squeezed the femoral artery to stop blood flow to the legs and then released the pressure so that the blood could return to the legs. Then, the therapist applied pressure using the heel of the hand along the energy lines on the inner and outer sides of the thigh for 10 minutes (5 minutes per foot). Third, massage was performed using the thumbs of the therapist on the external surfaces of the participant’s foot from the top of the ankle to the leg (both sides of the tibia), the thigh, and groin for 10 minutes (5 minutes per foot). Also, the massage was performed for the inner surface of the foot for 10 minutes (5 minutes per foot). Fourth, the therapist applied pressure on both sides of the participant’s spine (lumbar, waist, and upper back up to the shoulder along the energy lines) for 30 minutes using the thumbs. For the participants who had limited mobility and could not be in the supine position, this stage was done in the sitting position.
For the control group, routine care including fistula care, weight and blood pressure measurement and diet training was provided.
The two groups completed the Pittsburgh Sleep Quality Index (PSQI) immediately after the last session and one month after the last session of the intervention. The first author contacted the participants frequently to ensure they did not receive any kind of complementary treatments over the course of the study.
Instruments
To collect data, a sociodemographic questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were completed. The sociodemographic questionnaire included gender, age, marital status, level of education, and history of hemodialysis (HD). The PSQI was used to evaluate the sleep quality. The PSQI is a standardized self-report questionnaire that includes 18 items. Each item is scored 0 to 3, higher scores represent poorer sleep quality. Total score ranges from 0 to 21 and a total score >5 indicates poor sleep quality. Lower scores indicate a better sleep quality. Scores between 0 and 4 indicate a good sleep quality. Scores of 5 or more indicate a poor sleep quality [22]. The PSQI measures different aspects of sleep and consists of seven subscales; These subscales include subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Validity and reliability of the PSQI were confirmed in different studies [23, 24]. Ağargün et al. reported Cronbach’s alpha of 78-82% for the scale [23]. Hosseinabadi et al. reported Cronbach’s alpha of 88% for the Persian version of the PSQI [24]. In the present study, the Cronbach’s alpha of the Persian version of the instrument was 0.831.
Blinding
This was a randomized single-blinded clinical trial study. The patient did not know whether he/she was in the intervention group or the control group.
Outcome
Primary outcome was the quality of sleep in patients with thalassemia. Secondary outcomes were the subscales of quality of sleep including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction based on PSQI. The data was measured immediately and one month after the last session of the intervention.
Statistical analysis
Data was analyzed using the Statistical Package for Social Sciences 22.0 software (SPSS Inc., Chicago, IL, USA). Kolmogorov Smirnov test was used to determine whether the data had a normal distribution (all data were normal p>0.05). To mitigate non-random attrition of participants in the study, the intention-to-treat (ITT) analysis was used. Mean scores and standard deviations were calculated. Chi-square tests were used to compare the two groups in terms of nominal variables. The independent t-tests were used to compare the two groups’ mean scores. The two-way analysis of variance with repeated measures test was used to perform within- and between-group comparisons over time. The level of significance was set at 0.05.
Findings
Over the course of the study, three participants were excluded from the control group due to a partial completion of the survey. Additionally, four participants in the intervention group were excluded due to their acute medical conditions (n=1) and a lack of cooperation to perform the massage (n=3).
The results indicated that most participants in the intervention (50%) and control (51.35%) groups were 45-65 years old. Most participants in the intervention (72.2%) and control (67.6%) groups were female. The education level of 41.65% of the participants in the intervention group and 56.75% in the control group was an elementary degree. No significant difference was observed between the two groups in terms of the sociodemographic characteristics, including age, gender, level of education, marital status, and the history of HD (p>0.05; Table 1).
Table 1. The intervention and control groups’ sociodemographic characteristics
At the beginning of the study, there was no significant difference between the two groups in terms of the sleep quality (p>0.05). Over the course of the study, the results of Repeated Measures ANOVA test showed that there were within and between group differences in terms of the groups’ quality of sleep scores. In the intervention group, the mean scores of the sleep quality and three subscales, including use of sleeping medication, sleep latency, and subjective sleep quality changed over time, before, immediately after last session, and one month after the last session of the intervention (p<0.05). The results showed that in the intervention group, the total score of sleep quality before, immediately after and one month after the intervention was 9.62±3.67, 7.53±2.29 and 8.15±2.52 respectively, which was statistically significant (p<0.001). The mean scores of the sleep quality and two subscales, including the use of sleeping medication and sleep latency decreased over time (p<0.05). The Bonferroni test showed that the comparison of the mean sleep quality before and after the intervention was significant (p<0.05); Additionally, the difference was significant (p<0.05) before the intervention and one month afterward, but not significant (p>0.05) after the intervention and one month later. The mean scores of the subjective sleep quality subscale significantly increased (p<0.05). However, this difference was not significant for other subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders (p>0.05). In the control group, no significant difference was observed between the scores of the sleep quality and the subscales before, immediately after, and one month after the intervention (p>0.05; Table 2).
The results of the independent t-test showed that the two groups had significant differences in terms of the mean scores of overall sleep quality as well as subjective sleep quality, sleep latency, and the use of sleeping medication subscales immediately after and one month after the last session of the intervention (p<0.05). However, the differences between the two groups were not significant in terms of sleep duration, habitual sleep efficiency, and sleep disturbances (p>0.05). The results showed that the total sleep quality score one month after the intervention was 8.15±2.52 in the intervention group and 10.09±3.01 in the control group. The independent t-test showed a statistically significant difference between the two groups (p=0.004; Table 2).
Table 2. Comparing mean scores of the two groups in the sleep quality before, immediately, and one month after the end of the intervention
Discussion
In this study, we examined the effects of Thai massage on the sleep quality in patients undergoing HD. Our findings indicated that between the intervention and control groups, there were significant differences in terms of the total scores of overall sleep quality and several subscales, including subjective sleep quality, sleep latency, and the use of sleeping medication subscales, immediately after the last session and one month after the intervention. In the intervention group, the total scores of sleep quality as well as the scores related to the use of sleeping medication, sleep latency, and subjective sleep quality subscales significantly changed over time. The mean scores of the total sleep quality as well as the use of sleeping medication and sleep latency and subjective sleep quality significantly decreased. However, this difference was not significant for other subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders.
Several studies agreed our findings in terms of the significance of massage in improving the sleep quality among different populations [17, 25]. However, there was a study that showed no significant effect of massage on the sleep quality after coronary artery bypass graft surgery [18]. The number of studies using Thai massage is limited; Therefore, we discuss studies using different types of massage in this section.
In a clinical trial, Ghavami et al. use the PSQI to measure the quality of sleep before and after massage. They show that 12 sessions of hot stone massage in HD patients were effective in improving the scores of the sleep quality and the subscales, except sleep disorders subscale [17]. Another research has investigated the effects of foot and facial massages on sleep, blood pressure, respiratory rate, and pulse rate among healthy adults. Massages are performed for 20 minutes on the feet. Moreover, a 20-minute facial massage using peach-kernel base oil Prunus persica is performed. Their results show that massage can shorten the length of the time needed for a patient to fall asleep. Some of their participants report that they started to feel sleepy during the intervention [25].
A clinical trial shows that foot massage twice a week for a month can improve the quality of sleep and its subscales in patients with HD [16]. However, in the present study, massage was not effective on four subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders. Other studies also show that massage therapy can improve the sleep quality in different populations of patients [26, 27].
The studies are different in terms of their intervention designs and length and types of massage. However, all the studies are in line with our results regarding the effectiveness of massage therapy on the sleep quality in patients [14, 15]. This consistency can be interpreted as a significant influence of massage in improving the sleep quality in different health conditions. In all reviewed studies as well as the present study, the PSQI is used to measure sleep quality. These studies do not include any follow-up assessment for patients’ quality of sleep. However, in the present study, we assessed the sleep quality a month after the end of the intervention. This follow-up assessment indicated the persistence of the Thai massage effectiveness in improving the sleep quality among HD patients a few weeks after the intervention. Studies reported that massage can lead to muscle relaxation. Muscle relaxation can improve muscular flexibility and reduce pain caused by dry muscles; Thus, the relaxation can be effective in the management of sleep disorders [16, 28].
Another study indicates that massage therapy can boost the person’s energy level through the release of neurotransmitters and neurohormones. They state that massage increases body energy, comfort and relaxation, and relieves muscle cramps in HD patients. As a result, massage can reduce fatigue and improve the sleep quality [29]. Hsu et al. also report that back massage before bedtime for three consecutive days improved the scores of sleep quality and the subscales in intensive-care-unit patients [30]. However, in the present study, the scores of four subscales, including sleep duration, habitual sleep efficiency, sleep disturbances, and daily functional disorders, did not increase after the intervention. In a clinical trial, Nerbass et al. state that full-body massage before bedtime for three consecutive days are not significantly effective in improving the quality of sleep among patients after coronary artery bypass graft surgery [18].
The Bonferroni test showed that the comparison of the mean sleep quality, after the intervention and one month later, was not significant (p>0.05). Perhaps the reason was the occurrence of intervening factors such as anemia and hemodynamic disorders that were beyond the researcher's control.
The conflicting results between studies on the effectiveness of massage may be due to differences in the type of massage, the number of massage sessions, session duration, intervals between sessions, and the method of massage. It will be valuable to consider these factors in the design of future studies.
We could not control some confounding factors, such as medications and routine treatments for HD patients, which can influence the participants’ quality of sleep. To confirm the results of the present study, we recommend further studies on the effects of Thai massage on the sleep quality among HD patients.
Conclusion
Thai massage therapy effectively improved the participants’ quality of sleep.
Acknowledgments: The authors thank Kashan University of Medical Sciences and the Clinical Research Development Unit of Shahid Beheshti Hospital for supporting this study.
Ethical Permissions: This study was approved by Kashan University of Medical Sciences (KAUMS), the Institutional Review Board and the Ethics Committee (code: IR.KAUMS.NUHEPM.REC.1399.008). The purposes methods, and voluntary nature of the study were explained to the participants. The participants were ensured about confidentiality of data and the right to withdraw from the study at any time without any penalty. The participants completed written informed consents. The study was conducted in accordance with the Declaration of Helsinki.
Conflicts of Interests: The authors declare no conflicts of interest.
Authors' Contribution: Mohammadi M (First Author), Main Researcher (20%); Rahemi Z (Second Author), Introduction Writer (20%); Mirbagher Ajorpaz N (Third Author), Methodologist/Discussion Writer (30%); Mousavi SMS (Fourth Author), Introduction Writer (20%); Sadat Z (Fifth Author), Statistical Analyst (10%)
Funding/Support: This work was financially supported by the Kashan University of Medical Sciences, Iran.
Keywords:
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