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The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial
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Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/burns
The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial Mehdi Harorani a, * , Fahimeh Davodabady a , Behnam Masmouei b , Niloofar Barati c a
Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran b Faculty of Nursing, Department of Nursing, School of Nursing Hazrat Zahra(P.B.U.H) Abadeh, Shiraz University of Medical Sciences, Shiraz, Iran c Student Research Committee, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran
article info
abstract
Article history:
Background and objectives: Burn patients experience a high level of anxiety and poor sleep quality
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due to their special physical and psychological conditions. The presentstudy aimed to investigate the effect of progressive muscle relaxation on anxiety and sleep quality in burn patients. Methodology and participants: In this randomized controlled clinical trial, a total of 80 patients
Keywords:
admitted to burn ward were enrolled using convenient sampling and randomly assigned to
Burn
one of the experimental or control groups. In the experimental group, patients were
Anxiety
intervened using Jacobson’s relaxation technique 20 30min daily for three consecutive
Sleep quality
days. During this period, the control group received only routine care and treatment.
Relaxation
Patients' anxiety and their sleep quality were measured and recorded before and after the intervention using the Spielberger State-Trait Anxiety Inventory (STAI) and St Mary’s Hospital Sleep Quality Questionnaire (SMHSQ) respectively. Eventually, data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA). Results: The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05). Conclusion: Relaxation as a complementary method can be used along with modern medicine to reduce anxiety and improve sleep quality in burn patients. © 2019 Elsevier Ltd and ISBI. All rights reserved.
1.
Introduction
Burn remains a serious problem in today’s modern society that causes many irreparable damages and side effects to the burn
patient and his/her family [1,2]. It is estimated that a burnrelated injury occurs every 30min [3]. World Health Organization statistics also indicate that an estimated 180,000 deaths are caused by burns every year [4]. Extensive burns, even if they do not lead to death, imposes hospitalization, infection,
* Corresponding author. E-mail address: [email protected] (M. Harorani). https://doi.org/10.1016/j.burns.2019.11.021 0305-4179/© 2019 Elsevier Ltd and ISBI. All rights reserved.
Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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scarring, surgeries, expensive medical treatments, significant physical and psychological injuries, and financial burdens on the patient and his/her family [5,6]. Based on studies conducted, there is a high level of anxiety in burn patients [7]. Numerous studies have reported that anxiety causes decreased physical and emotional performance as well as increased pain intensity in these patients [8]. Anxiety as a psychological stress can trigger a cascade of physiological events that impair wound healing [9]. In a study conducted in the United States, it was found that burn patients with a higher level of anxiety experience a greater pain during treatment [10]. Increased pain and anxiety along with other problems such as itchy skin, can also lead to sleep deprivation in these patients [5,11]. Pazar has stated that more than 85% of burn patients have sleep disorder throughout the course of treatment [12]. Sleep deprivation can cause many side effects in patients including decreased immune function, impaired wound healing, increased cardiac contractility, increased blood pressure, and increased secretion of stress-induced hormones in the body [13,14]. Healthy sleep as a vital function affects the patients' treatment and their recovery [15]. In a study conducted, it was found that those burn patients who have not had a good night’s sleep showed a lower pain tolerance during the day [16]. Many pharmacological and non-pharmacological methods are utilized to control and relieve the aforementioned complications. These pharmacological methods have numerous side effects and impose high costs of healthcare on health systems [17]. Non-pharmacological methods are safe and without any side effects in most cases. Many of these methods are parts of complementary medicine [18]. Progressive muscle relaxation is one of these non-pharmacological and complementary methods of deep muscle relaxation based on the principle that muscle tension is the body’s psychological response to anxiety-provoking thoughts. This technique was developed by Jacobsen in 1938 in which both the body and the mind are deeply relieved from any tension and anxiety [19]. In the study of Gao et al. relaxation reduces stress and improve well-being [20], in the study by Aksu et al. Progressive muscle relaxation has improved the sleep quality of patients with lung resection [21]. Also, this technique in Park’s study relieves tension and anxiety in dental patients [22]. Learning this technique is very easy and doing it can cause distraction, relief of tension and muscle contractions, reduction of stress and anxiety, improvement of sleep, and decrease in sensitivity to pain and fatigue [23]. In addition, Progressive muscle relaxation does not need to be done in a specific time and place and requires no special technology and equipment; most importantly, relaxation strengthens the health care personnelpatient relationship. Regarding the importance of anxiety reduction and sleep quality improvement in burn patients as well as the non-invasive relaxation in this technique, the present study was conducted to investigate the effect of relaxation on sleep quality and anxiety in burn patients.
2.
Material & methodology
2.1.
Design
The present study is a randomized controlled clinical trial approved by Arak University of Medical Sciences, Iran in
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2017 with registration number of IRCT20130424013110N4.After obtaining approval from the Ethics Committee of Arak University of Medical Sciences (with ethics number of IR. ARAKMU.REC.1396.134), the researcher enrolled the subjects. The minimum sample size was calculated to be 70 patients considering a significance level (a) of 0.05, statistical power of 0.8 according to the Pocock’s formula, and the results of Dayapoglo and Tan study. A total of 80 patients were enrolled regarding the sample attrition and divided into two groups of experimental and control. Then 40 patients were assigned to each group [24]. Randomized blocks were used to randomize patients into two (experimental and control) groups. Initially, 20 blocks of 4 were formed and written on the identical pieces of paper and placed in a sealed envelope. Then the pieces of paper were randomly extracted to determine the sequence of participants’ assignment to the groups so that the participants were intervened based on the specified sequence.
2.2.
Participants
The target population included all patients admitted to the burn ward of Valiasr Hospital affiliated to Arak University of Medical Sciences in 2017. Inclusion criteria consisted of 15 65% TBSA (total body surface area) burns, being aged over 15 years old, having no mental disorders by doctor's diagnosis and passing the acute phase of the burn. In contrast, exclusion criteria consisted of inability to continue the study by the patient, patients who use cigarettes and drugs, occurrence of unforeseen events or circumstances for the patient such as death or sepsis, or his/her willingness to withdraw from the study.
2.3.
Data collection tools
Data were collected using a demographic questionnaire, information about patient’s disease, Spielberger State-Trait Anxiety Inventory (STAI), and St Mary’s Hospital Sleep Quality Questionnaire (SMHSQ).
2.4.
STAI questionnaire
Standardization and cross-cultural adaptation of the STAI was done by Mehram (1994) and its reliability was 94%. This inventory is scored ranging from 20 to 80 divided into four groups: no anxiety [20], mild [21 39], moderate (40 59) and severe anxiety (60 80) (25 28).
2.5.
SMHSQ questionnaire
The SMHSQ was designed to assess the sleep quality of hospitalized patients. It contains 11 questions to assess the previous night's sleep of the patient using a 4-point Likert scale with 1=never to 4=high. The total score ranges from 11 to 44 divided into three groups: mild [11 21], moderate [22 32], and severe sleep disorder [33 44]. This instrument has validity and reliability and has been used and assessed in many studies. The reliability of its Persian version, as measured by Cronbach's alpha coefficient, was 0.91 [29,30]. This questionnaire was completed by the participants before and after the intervention.
Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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2.6.
Data collection procedures and relaxation technique
Prior to beginning of the study, the researcher provided an explanation about the objectives and methodology. All participants were included in the study with full awareness and personal consent. They were also free to leave the study at any stage and assured that the data collected would be regarded as strictly confidential and in this regard the names of participants were not presented in the results. The intervention began after justifying the study objectives and obtaining written informed consent from the patients. First, the questionnaires were completed by both experimental and control groups and collected. Then the researcher instructed the experimental group how to do relaxation using Jacobson’s relaxation technique (PMR and deep breathing), and after making certain they have learned how to do so, the technique was performed by the patients in a session of 20 30 min daily for three consecutive days. every training session was performed under the supervision of the researcher and consisted of providing an environment without any disturbance, making the body comfortable on the bed, instructing how to tighten and relax the specific muscle groups in
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sequence from upper body to the lower parts or vice versa, answering patients' questions about the relaxation technique and how to apply the technique correctly [31,32]. Patients were asked to first tense the muscles tightly and hold for slow count of 5 s and then relax them quickly and completely for 10 s until all the tightness and pain flow out of the muscles and feeling of relaxation in whole body. Meanwhile, the patients took deep breaths inhaling through nose and exhaling through mouth. The position of choice for relaxation was supine. Patients in the control group received routine care during this period. The level of anxiety and sleep quality in both groups were measured at the end of the intervention (Fig. 1).
2.7.
Data analysis
Data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA) as well as descriptive and inferential statistical methods. Furthermore, the statistical significance level was set at P<0.05. Chi-square and t-test were used to compare the nominal data and the mean score of anxiety and sleep quality respectively.
Fig. 1 – The CONSORT follows diagram of the patients’ recruitment. Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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Table 1 – Comparison of demographic characteristics in the control and intervention groups, using the Chi-square test. Variable Sex Age category (year)
Marital status
Job status
Burn depth (degree) Burn extent (%TBSA)
History of received sedation
History of received analgesic injections
3.
Results
3.1.
Follow-up
Male Female 25 15 26 35 36 45 46 60 Single Married Divorced Widow Jobless Employed Housewife Retired II II & III 35 15 50 36 65 51 Midazolam Alprazolam None Morphine Pethidine None
Experimental group (N=40) No%
Control group (N=40) No%
P-value
31 (77.5) 9 (22.5) 9 (22.5) 11 (27.5) 13 (32.5) 7 (17.5) 7 (17.5) 29 (72.5) 3 (7.5) 1 (2.5) 8 (20) 21 (52.5) 5 (12.5) 6 (15) 22 (55) 18 (45) 21 (52.5) 14 (35) 5 (12.5) 3 (7.5) 23 (57.5) 14 (35) 23 (57.5) 6 (15) 11 (27.5)
32 (80) 8 (20) 13 (32.5) 11 (27.5) 7 (17.5) 9 (22.5) 7 (17.5) 29 (72.5) 2 (5) 2 (5) 9 (22.5) 20 (50) 5 (12.5) 6 (15) 23 (57.5) 17 (42.5) 16 (40) 17 (42.5) 7 (17.5) 4 (10) 22 (55) 14 (35) 22 (55) 5 (12.5) 13 (32.5)
0.78 0.56
0.91
0.99
0.82 0.14
0.92
0.86
Of the 80 randomized patients, all completed the study and were included in the final analysis
3.2.
Demographic and clinical variables
In the present study, the majority of participants in both experimental (77.5%) and control (80%) groups were men. The mean age of the patients was 36.3510.28 years. The educational level of the majority of patients participated in the study was primary and secondary (75%). Flame burn was the most common type of burn in patient included in the study (76.25%). The mean of the total body surface area affected by burn in the patients of the experimental group was 29.97.5% and in the control group was 32.59.6%. There was no significant difference between the two groups in terms of all demographic variables that may affect the results and these demographics were homogeneous (P>0.05) (Table 1). The mean score of sleep quality in the two groups before the intervention was not statistically significant (P=0.854), while there was a significant difference after the intervention (P<0.05). The results of the ttest also indicated that the mean score of anxiety in the two groups was not statistically significant before the intervention (P=0.647), while the difference was statistically significant after the intervention (P<0.05) (Figs. 2 and 3) (Table 2). In the present study, the intervention led to a decrease in anxiety level and improvement in sleep quality in the experimental group compared with the control group after three days (Figs. 2 and 3).
Fig. 2 – Sleep quality.
Fig. 3 – Anxiety level.
Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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Table 2 – Comparison of the anxiety and quality of sleep score in the control and intervention groups before and after of the intervention. Variable Anxiety Sleep quality
4.
Experimental group MeanSD
Control group MeanSD
P-value
57.90 10.02 44.99 11.02 24 3.44 16.77 2.90
56.909.44 57.179.44 23.853.40 23.223.14
0.647 <0.01 0.845 <0.01
Before intervention After intervention Before intervention After intervention
Discussion
The present study aimed to investigate the effect of relaxation on anxiety and sleep quality in burn patients. The results of our study revealed that relaxation is an effective way to reduce the level of anxiety in burn patients. The results of studies conducted to investigate the effect of progressive muscle relaxation on the level of anxiety in students taking clinical simulation exam [33], parents of hospitalized children with malignancies [34], female breast cancer patients after radical mastectomy [35] and surgical patients [36] are consistent with our study. Other relaxation techniques in burn patients showed that the use of jaw relaxation [37] and Benson relaxation technique [38] can be effective in reducing patients’ anxiety level. Moreover, the findings of our study showed that relaxation can also affect the sleep quality in burn patients. The effect of this technique on other patients' sleep quality has also been studied so that in a study, it was found that relaxation can reduce the complications of pulmonary resection and improve patients' sleep quality. Chegeni and et al., also showed that relaxation reduces fatigue and improves sleep quality in patients with COPD [39]. Relaxation has also been effective in post cesarean section pain intensity and sleep quality [40]. Although the efficacy of this method of complementary medicine has been confirmed in many studies, the emphasis is still on conducting more studies to clarify all dimensions of this technique [41,42]. The reason for the reduction of patients’ anxiety after performing the relaxation technique can be the balance between the anterior and posterior hypothalamic nuclei which through reducing sympathetic nervous system activity prevents side effects of stress and anxiety and increases relaxation in both the body and mind. Similar to the other studies, the patients in the present study achieved relaxation by learning how to tighten and relax their muscles regularly as well as identifying stress symptoms [43]. In numerous aforementioned studies, the effect of progressive muscle relaxation on various dimensions of patients’ health has been investigated, in which the effect of this method of relaxation has been shown in alleviating patients’ symptoms. However, some studies have revealed that this technique have no significant effect on improving patients' problems or have less positive effects than other rehabilitation methods. The results of Hadadian et al. study on the effect of progressive muscle relaxation on sleep quality in hemodialysis patients are inconsistent with the results of the present study, although there was a significant difference between the scores of sleep quality before and after the intervention in the experimental group and there was no significant difference
between the two groups after the intervention despite relative improvement in patients' sleep quality [44]. In Jensen et al. study on patients with chronic pain, two methods of muscle relaxation and hypnosis were used to reduce pain and their results demonstrated that both methods were ineffective, although hypnosis was more effective than relaxation [45]. This inconsistency between the results of our study and the above can be attributed to the study population, the variables studied and the progressive course of some chronic diseases. In Golmakani et al. study, the effects of progressive muscle relaxation and guided imagery on sleep quality in primigravida women were compared in which guided imagery had a greater effect compared to relaxation although both methods improved patients' sleep quality. This may be due to the easier learning and application of the guided imagery technique in comparison to progressive muscle relaxation in this patient group [46]. Based on the results of the present study, progressive muscle relaxation has a positive effect on improving sleep quality and reducing the level of anxiety in burn patients. So, this technique is recommended to be applied for other cases such as pain, stress, depression, and other disturbing sleep and anxiety disorders. The point that should be considered is the importance of using this technique along with modern medicine to control anxiety and improve the sleep quality in these patients. The results of our study suggest this strategy to the medical staff as a non-pharmacological method for controlling anxiety and improving sleep quality.
5.
Conclusion
Burn treatment as well as its effect on patients increases their level of anxiety and sleep disturbance. The results of our study revealed that PMR as a complementary therapy and costeffective treatment can be used along with other medical treatments to reduce the level of anxiety and sleep disorders in these patients. According to the results of this study, teaching this technique to nurses and doing it by patients with burns and also comparison with other complementary therapies Such as massage therapy and aromatherapy is suggested.
6.
Limitations
Limitations of our study consisted of the individual differences and mental condition of the samples, the effect of environmental and cultural factors on the individuals, and patients’ preoccupation during hospitalization. Also, in this study did not control for the amount of time and attention given to the intervention group.
Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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Authors’ contribution MH, FH, and NB: Study conception and design, data collection, data interpretation, and critical revision of the paper; MH, NB and MD (clinical supervision (Surgeon)): study conception and design; MH and BM: study conception and design, and critical revision of the paper; MH, BM: study conception and design, data analysis(Statistics specialist) and interpretation, manuscript preparation, and critical revision of the paper. All the authors read and approved the final manuscript for submission.
Conflicts of interest The authors report no declaration of interest
Funding information This study was supported by Arak University of Medical Sciences, Arak, Iran (No 2816).
Ethical confirmation The Ethics Committee of Arak University of Medical Sciences, Arak, Iran, approved this study (No: IR.ARAKMU.REC.1396.134).
Trial registration This trial was registered in the Iranian Registry of Clinical Trials (No: IRCT20130424013110N4
Acknowledgements The authors would like to appreciate the patients and colleagues in Burn unit of Valiasr hospital in Arak city, as well as the assistant of the Vice Chancellor for Research and Technology of Arak University of Medical Sciences. REFERENCES
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[39] Chegeni PS, Gholami M, Azargoon A, Pour AHH, Birjandi M, Norollahi H. The effect of progressive muscle relaxation on the management of fatigue and quality of sleep in patients with chronic obstructive pulmonary disease: a randomized controlled clinical trial. Complement Ther Clin Pract 2018;31:64 70. [40] Ismail NIAA, Elgzar WTI. The effect of progressive muscle relaxation on post cesarean section pain, quality of sleep and physical activities limitation. Int J Stud Nurs 2018;3(3):14. [41] De Paolis G, Naccarato A, Cibelli F, D’Alete A, Mastroianni C, Surdo L, et al. The effectiveness of progressive muscle relaxation and interactive guided imagery as a pain-reducing intervention in advanced cancer patients: a multicentre randomised controlled non-pharmacological trial. Complement Ther Clin Pract 2018;34:280 7. [42] Usmani S, Aldana SI, Ortega E, Kasianko C, Weiss Z, Balcer L, et al. One-month feasibility of progressive muscle relaxation (PMR) via smartphone application for post traumatic headache (PTH) patients (P5. 10-025). AAN Enterprises; 2019. [43] Safi Z, Moein L, Sahami S. Effectiveness of applying progressive muscle relaxation technique on quality of life of patients with multiple sclerosis. 2011. [44] Hadadian F, Jalalvandi F, Ghobadi A, Taimazy , Panahifar S. Effect of progressive muscle relaxation technique on sleep quality in hemodialysis patients in Kermanshah, 2011. J Clin Res Paramed Sci 2015;4:120 7. [45] Jensen MP, Barber J, Romano JM, Molton IR, Raichle KA, Osborne TL, et al. A comparison of self-hypnosis versus progressive muscle relaxation in patients with multiple sclerosis and chronic pain. Intl J Clin Exp Hypnosis 2009;57 (2):198 221. [46] Golmakani N, Seyed Ahmadi Nejad FS, Shakeri MT, Asghari Pour N. Comparing the effects of progressive muscle relaxation and guided imagery on sleep quality in primigravida women referring to Mashhad health care centers-1393. J Midwifery Reprod Health 2015;3(2):335 42.
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Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/burns
The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial Mehdi Harorani a, * , Fahimeh Davodabady a , Behnam Masmouei b , Niloofar Barati c a
Faculty of Nursing, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran b Faculty of Nursing, Department of Nursing, School of Nursing Hazrat Zahra(P.B.U.H) Abadeh, Shiraz University of Medical Sciences, Shiraz, Iran c Student Research Committee, Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran
article info
abstract
Article history:
Background and objectives: Burn patients experience a high level of anxiety and poor sleep quality
Available online xxx
due to their special physical and psychological conditions. The presentstudy aimed to investigate the effect of progressive muscle relaxation on anxiety and sleep quality in burn patients. Methodology and participants: In this randomized controlled clinical trial, a total of 80 patients
Keywords:
admitted to burn ward were enrolled using convenient sampling and randomly assigned to
Burn
one of the experimental or control groups. In the experimental group, patients were
Anxiety
intervened using Jacobson’s relaxation technique 20 30min daily for three consecutive
Sleep quality
days. During this period, the control group received only routine care and treatment.
Relaxation
Patients' anxiety and their sleep quality were measured and recorded before and after the intervention using the Spielberger State-Trait Anxiety Inventory (STAI) and St Mary’s Hospital Sleep Quality Questionnaire (SMHSQ) respectively. Eventually, data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA). Results: The findings of the present study showed a statistically significant decrease in anxiety and improvement in sleep quality in the experimental group compared to the control group (P<0.05). Conclusion: Relaxation as a complementary method can be used along with modern medicine to reduce anxiety and improve sleep quality in burn patients. © 2019 Elsevier Ltd and ISBI. All rights reserved.
1.
Introduction
Burn remains a serious problem in today’s modern society that causes many irreparable damages and side effects to the burn
patient and his/her family [1,2]. It is estimated that a burnrelated injury occurs every 30min [3]. World Health Organization statistics also indicate that an estimated 180,000 deaths are caused by burns every year [4]. Extensive burns, even if they do not lead to death, imposes hospitalization, infection,
* Corresponding author. E-mail address: [email protected] (M. Harorani). https://doi.org/10.1016/j.burns.2019.11.021 0305-4179/© 2019 Elsevier Ltd and ISBI. All rights reserved.
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scarring, surgeries, expensive medical treatments, significant physical and psychological injuries, and financial burdens on the patient and his/her family [5,6]. Based on studies conducted, there is a high level of anxiety in burn patients [7]. Numerous studies have reported that anxiety causes decreased physical and emotional performance as well as increased pain intensity in these patients [8]. Anxiety as a psychological stress can trigger a cascade of physiological events that impair wound healing [9]. In a study conducted in the United States, it was found that burn patients with a higher level of anxiety experience a greater pain during treatment [10]. Increased pain and anxiety along with other problems such as itchy skin, can also lead to sleep deprivation in these patients [5,11]. Pazar has stated that more than 85% of burn patients have sleep disorder throughout the course of treatment [12]. Sleep deprivation can cause many side effects in patients including decreased immune function, impaired wound healing, increased cardiac contractility, increased blood pressure, and increased secretion of stress-induced hormones in the body [13,14]. Healthy sleep as a vital function affects the patients' treatment and their recovery [15]. In a study conducted, it was found that those burn patients who have not had a good night’s sleep showed a lower pain tolerance during the day [16]. Many pharmacological and non-pharmacological methods are utilized to control and relieve the aforementioned complications. These pharmacological methods have numerous side effects and impose high costs of healthcare on health systems [17]. Non-pharmacological methods are safe and without any side effects in most cases. Many of these methods are parts of complementary medicine [18]. Progressive muscle relaxation is one of these non-pharmacological and complementary methods of deep muscle relaxation based on the principle that muscle tension is the body’s psychological response to anxiety-provoking thoughts. This technique was developed by Jacobsen in 1938 in which both the body and the mind are deeply relieved from any tension and anxiety [19]. In the study of Gao et al. relaxation reduces stress and improve well-being [20], in the study by Aksu et al. Progressive muscle relaxation has improved the sleep quality of patients with lung resection [21]. Also, this technique in Park’s study relieves tension and anxiety in dental patients [22]. Learning this technique is very easy and doing it can cause distraction, relief of tension and muscle contractions, reduction of stress and anxiety, improvement of sleep, and decrease in sensitivity to pain and fatigue [23]. In addition, Progressive muscle relaxation does not need to be done in a specific time and place and requires no special technology and equipment; most importantly, relaxation strengthens the health care personnelpatient relationship. Regarding the importance of anxiety reduction and sleep quality improvement in burn patients as well as the non-invasive relaxation in this technique, the present study was conducted to investigate the effect of relaxation on sleep quality and anxiety in burn patients.
2.
Material & methodology
2.1.
Design
The present study is a randomized controlled clinical trial approved by Arak University of Medical Sciences, Iran in
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2017 with registration number of IRCT20130424013110N4.After obtaining approval from the Ethics Committee of Arak University of Medical Sciences (with ethics number of IR. ARAKMU.REC.1396.134), the researcher enrolled the subjects. The minimum sample size was calculated to be 70 patients considering a significance level (a) of 0.05, statistical power of 0.8 according to the Pocock’s formula, and the results of Dayapoglo and Tan study. A total of 80 patients were enrolled regarding the sample attrition and divided into two groups of experimental and control. Then 40 patients were assigned to each group [24]. Randomized blocks were used to randomize patients into two (experimental and control) groups. Initially, 20 blocks of 4 were formed and written on the identical pieces of paper and placed in a sealed envelope. Then the pieces of paper were randomly extracted to determine the sequence of participants’ assignment to the groups so that the participants were intervened based on the specified sequence.
2.2.
Participants
The target population included all patients admitted to the burn ward of Valiasr Hospital affiliated to Arak University of Medical Sciences in 2017. Inclusion criteria consisted of 15 65% TBSA (total body surface area) burns, being aged over 15 years old, having no mental disorders by doctor's diagnosis and passing the acute phase of the burn. In contrast, exclusion criteria consisted of inability to continue the study by the patient, patients who use cigarettes and drugs, occurrence of unforeseen events or circumstances for the patient such as death or sepsis, or his/her willingness to withdraw from the study.
2.3.
Data collection tools
Data were collected using a demographic questionnaire, information about patient’s disease, Spielberger State-Trait Anxiety Inventory (STAI), and St Mary’s Hospital Sleep Quality Questionnaire (SMHSQ).
2.4.
STAI questionnaire
Standardization and cross-cultural adaptation of the STAI was done by Mehram (1994) and its reliability was 94%. This inventory is scored ranging from 20 to 80 divided into four groups: no anxiety [20], mild [21 39], moderate (40 59) and severe anxiety (60 80) (25 28).
2.5.
SMHSQ questionnaire
The SMHSQ was designed to assess the sleep quality of hospitalized patients. It contains 11 questions to assess the previous night's sleep of the patient using a 4-point Likert scale with 1=never to 4=high. The total score ranges from 11 to 44 divided into three groups: mild [11 21], moderate [22 32], and severe sleep disorder [33 44]. This instrument has validity and reliability and has been used and assessed in many studies. The reliability of its Persian version, as measured by Cronbach's alpha coefficient, was 0.91 [29,30]. This questionnaire was completed by the participants before and after the intervention.
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2.6.
Data collection procedures and relaxation technique
Prior to beginning of the study, the researcher provided an explanation about the objectives and methodology. All participants were included in the study with full awareness and personal consent. They were also free to leave the study at any stage and assured that the data collected would be regarded as strictly confidential and in this regard the names of participants were not presented in the results. The intervention began after justifying the study objectives and obtaining written informed consent from the patients. First, the questionnaires were completed by both experimental and control groups and collected. Then the researcher instructed the experimental group how to do relaxation using Jacobson’s relaxation technique (PMR and deep breathing), and after making certain they have learned how to do so, the technique was performed by the patients in a session of 20 30 min daily for three consecutive days. every training session was performed under the supervision of the researcher and consisted of providing an environment without any disturbance, making the body comfortable on the bed, instructing how to tighten and relax the specific muscle groups in
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sequence from upper body to the lower parts or vice versa, answering patients' questions about the relaxation technique and how to apply the technique correctly [31,32]. Patients were asked to first tense the muscles tightly and hold for slow count of 5 s and then relax them quickly and completely for 10 s until all the tightness and pain flow out of the muscles and feeling of relaxation in whole body. Meanwhile, the patients took deep breaths inhaling through nose and exhaling through mouth. The position of choice for relaxation was supine. Patients in the control group received routine care during this period. The level of anxiety and sleep quality in both groups were measured at the end of the intervention (Fig. 1).
2.7.
Data analysis
Data analysis was conducted using SPSS version 20.0 software (IBM Corp., Armonk, N.Y., USA) as well as descriptive and inferential statistical methods. Furthermore, the statistical significance level was set at P<0.05. Chi-square and t-test were used to compare the nominal data and the mean score of anxiety and sleep quality respectively.
Fig. 1 – The CONSORT follows diagram of the patients’ recruitment. Please cite this article in press as: M. Harorani, et al., The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial, Burns (2019), https://doi.org/10.1016/j.burns.2019.11.021
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Table 1 – Comparison of demographic characteristics in the control and intervention groups, using the Chi-square test. Variable Sex Age category (year)
Marital status
Job status
Burn depth (degree) Burn extent (%TBSA)
History of received sedation
History of received analgesic injections
3.
Results
3.1.
Follow-up
Male Female 25 15 26 35 36 45 46 60 Single Married Divorced Widow Jobless Employed Housewife Retired II II & III 35 15 50 36 65 51 Midazolam Alprazolam None Morphine Pethidine None
Experimental group (N=40) No%
Control group (N=40) No%
P-value
31 (77.5) 9 (22.5) 9 (22.5) 11 (27.5) 13 (32.5) 7 (17.5) 7 (17.5) 29 (72.5) 3 (7.5) 1 (2.5) 8 (20) 21 (52.5) 5 (12.5) 6 (15) 22 (55) 18 (45) 21 (52.5) 14 (35) 5 (12.5) 3 (7.5) 23 (57.5) 14 (35) 23 (57.5) 6 (15) 11 (27.5)
32 (80) 8 (20) 13 (32.5) 11 (27.5) 7 (17.5) 9 (22.5) 7 (17.5) 29 (72.5) 2 (5) 2 (5) 9 (22.5) 20 (50) 5 (12.5) 6 (15) 23 (57.5) 17 (42.5) 16 (40) 17 (42.5) 7 (17.5) 4 (10) 22 (55) 14 (35) 22 (55) 5 (12.5) 13 (32.5)
0.78 0.56
0.91
0.99
0.82 0.14
0.92
0.86
Of the 80 randomized patients, all completed the study and were included in the final analysis
3.2.
Demographic and clinical variables
In the present study, the majority of participants in both experimental (77.5%) and control (80%) groups were men. The mean age of the patients was 36.3510.28 years. The educational level of the majority of patients participated in the study was primary and secondary (75%). Flame burn was the most common type of burn in patient included in the study (76.25%). The mean of the total body surface area affected by burn in the patients of the experimental group was 29.97.5% and in the control group was 32.59.6%. There was no significant difference between the two groups in terms of all demographic variables that may affect the results and these demographics were homogeneous (P>0.05) (Table 1). The mean score of sleep quality in the two groups before the intervention was not statistically significant (P=0.854), while there was a significant difference after the intervention (P<0.05). The results of the ttest also indicated that the mean score of anxiety in the two groups was not statistically significant before the intervention (P=0.647), while the difference was statistically significant after the intervention (P<0.05) (Figs. 2 and 3) (Table 2). In the present study, the intervention led to a decrease in anxiety level and improvement in sleep quality in the experimental group compared with the control group after three days (Figs. 2 and 3).
Fig. 2 – Sleep quality.
Fig. 3 – Anxiety level.
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Table 2 – Comparison of the anxiety and quality of sleep score in the control and intervention groups before and after of the intervention. Variable Anxiety Sleep quality
4.
Experimental group MeanSD
Control group MeanSD
P-value
57.90 10.02 44.99 11.02 24 3.44 16.77 2.90
56.909.44 57.179.44 23.853.40 23.223.14
0.647 <0.01 0.845 <0.01
Before intervention After intervention Before intervention After intervention
Discussion
The present study aimed to investigate the effect of relaxation on anxiety and sleep quality in burn patients. The results of our study revealed that relaxation is an effective way to reduce the level of anxiety in burn patients. The results of studies conducted to investigate the effect of progressive muscle relaxation on the level of anxiety in students taking clinical simulation exam [33], parents of hospitalized children with malignancies [34], female breast cancer patients after radical mastectomy [35] and surgical patients [36] are consistent with our study. Other relaxation techniques in burn patients showed that the use of jaw relaxation [37] and Benson relaxation technique [38] can be effective in reducing patients’ anxiety level. Moreover, the findings of our study showed that relaxation can also affect the sleep quality in burn patients. The effect of this technique on other patients' sleep quality has also been studied so that in a study, it was found that relaxation can reduce the complications of pulmonary resection and improve patients' sleep quality. Chegeni and et al., also showed that relaxation reduces fatigue and improves sleep quality in patients with COPD [39]. Relaxation has also been effective in post cesarean section pain intensity and sleep quality [40]. Although the efficacy of this method of complementary medicine has been confirmed in many studies, the emphasis is still on conducting more studies to clarify all dimensions of this technique [41,42]. The reason for the reduction of patients’ anxiety after performing the relaxation technique can be the balance between the anterior and posterior hypothalamic nuclei which through reducing sympathetic nervous system activity prevents side effects of stress and anxiety and increases relaxation in both the body and mind. Similar to the other studies, the patients in the present study achieved relaxation by learning how to tighten and relax their muscles regularly as well as identifying stress symptoms [43]. In numerous aforementioned studies, the effect of progressive muscle relaxation on various dimensions of patients’ health has been investigated, in which the effect of this method of relaxation has been shown in alleviating patients’ symptoms. However, some studies have revealed that this technique have no significant effect on improving patients' problems or have less positive effects than other rehabilitation methods. The results of Hadadian et al. study on the effect of progressive muscle relaxation on sleep quality in hemodialysis patients are inconsistent with the results of the present study, although there was a significant difference between the scores of sleep quality before and after the intervention in the experimental group and there was no significant difference
between the two groups after the intervention despite relative improvement in patients' sleep quality [44]. In Jensen et al. study on patients with chronic pain, two methods of muscle relaxation and hypnosis were used to reduce pain and their results demonstrated that both methods were ineffective, although hypnosis was more effective than relaxation [45]. This inconsistency between the results of our study and the above can be attributed to the study population, the variables studied and the progressive course of some chronic diseases. In Golmakani et al. study, the effects of progressive muscle relaxation and guided imagery on sleep quality in primigravida women were compared in which guided imagery had a greater effect compared to relaxation although both methods improved patients' sleep quality. This may be due to the easier learning and application of the guided imagery technique in comparison to progressive muscle relaxation in this patient group [46]. Based on the results of the present study, progressive muscle relaxation has a positive effect on improving sleep quality and reducing the level of anxiety in burn patients. So, this technique is recommended to be applied for other cases such as pain, stress, depression, and other disturbing sleep and anxiety disorders. The point that should be considered is the importance of using this technique along with modern medicine to control anxiety and improve the sleep quality in these patients. The results of our study suggest this strategy to the medical staff as a non-pharmacological method for controlling anxiety and improving sleep quality.
5.
Conclusion
Burn treatment as well as its effect on patients increases their level of anxiety and sleep disturbance. The results of our study revealed that PMR as a complementary therapy and costeffective treatment can be used along with other medical treatments to reduce the level of anxiety and sleep disorders in these patients. According to the results of this study, teaching this technique to nurses and doing it by patients with burns and also comparison with other complementary therapies Such as massage therapy and aromatherapy is suggested.
6.
Limitations
Limitations of our study consisted of the individual differences and mental condition of the samples, the effect of environmental and cultural factors on the individuals, and patients’ preoccupation during hospitalization. Also, in this study did not control for the amount of time and attention given to the intervention group.
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Authors’ contribution MH, FH, and NB: Study conception and design, data collection, data interpretation, and critical revision of the paper; MH, NB and MD (clinical supervision (Surgeon)): study conception and design; MH and BM: study conception and design, and critical revision of the paper; MH, BM: study conception and design, data analysis(Statistics specialist) and interpretation, manuscript preparation, and critical revision of the paper. All the authors read and approved the final manuscript for submission.
Conflicts of interest The authors report no declaration of interest
Funding information This study was supported by Arak University of Medical Sciences, Arak, Iran (No 2816).
Ethical confirmation The Ethics Committee of Arak University of Medical Sciences, Arak, Iran, approved this study (No: IR.ARAKMU.REC.1396.134).
Trial registration This trial was registered in the Iranian Registry of Clinical Trials (No: IRCT20130424013110N4
Acknowledgements The authors would like to appreciate the patients and colleagues in Burn unit of Valiasr hospital in Arak city, as well as the assistant of the Vice Chancellor for Research and Technology of Arak University of Medical Sciences. REFERENCES
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