The Effect of Music Therapy on Sleep Quality in Patients with Multiple Sclerosis: A Randomized Controlled Trial

The Effect of Music Therapy on Sleep Quality in Patients with Multiple Sclerosis: A Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The Effect of Music Therapy on Sleep Quality in Patients with Multiple Sclerosis: A Randomized Controlled Trial Hamid Reza Zendehtalab, Samira Mohajer, Mohammad Ali Nahayati, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7156351/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system. Conventional treatments often fail to adequately address symptoms such as sleep disturbances. Objective: To investigate the efficacy of music therapy as a complementary intervention in improving sleep quality among patients with multiple sclerosis. Methods: This randomized controlled trial enrolled 60 patients with MS from the Comprehensive MS Center in Mashhad. Participants were randomly assigned to either an intervention group (music therapy plus standard care) or a control group (standard care only). The intervention group received music therapy sessions three times daily for two weeks. Sleep quality was assessed at baseline and post-intervention using the Pittsburgh Sleep Quality Index (PSQI). Data were analyzed using SPSS version 26. Results: Baseline PSQI scores did not differ significantly between groups (10.5 ± 2.8 vs. 11.8 ± 3.3, P = 0.118). After the intervention, the intervention group showed a significant improvement in sleep quality compared to the control group (9.4 ± 2.6 vs. 10.9 ± 3.0, P = 0.047). Conclusion: Music therapy is a safe, accessible, and cost-effective complementary intervention that significantly improves sleep quality in patients with MS. Music therapy Sleep quality Multiple sclerosis Complementary therapies Figures Figure 1 Introduction Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system (CNS), characterized by inflammation, demyelination, gliosis, and neuronal loss primarily affecting myelinated axons [1]. Although its exact etiology remains unclear, various risk factors—including genetic predisposition, environmental influences, vitamin D deficiency, and smoking—have been identified. MS predominantly affects young adults aged 20 to 40 years, with a higher prevalence among women (female-to-male ratio approximately 2–3:1) [2–4]. The global prevalence of MS is increasing, with an estimated 2.3 million individuals affected worldwide. Iran has one of the highest prevalence rates, with over 70,000 diagnosed cases, notably concentrated in Isfahan Province [5–9]. MS manifests with diverse clinical symptoms such as motor impairments, fatigue, visual disturbances, spasticity, pain, cognitive deficits, and psychological conditions including depression and anxiety [10, 11]. Among these, sleep disturbances are highly prevalent, affecting nearly half of MS patients, yet remain significantly underdiagnosed and undertreated [12, 13]. Poor sleep quality in this population is strongly associated with increased fatigue, mood disorders, and decreased overall quality of life [14]. While disease-modifying therapies (DMTs) effectively reduce inflammatory activity and relapse rates, they do not directly improve sleep quality or psychological well-being. Therefore, there is a growing need to explore non-pharmacological approaches to manage these symptoms [15]. Complementary and alternative medicine (CAM) is widely used by patients with chronic illnesses including MS, providing various therapeutic options for symptoms inadequately controlled by conventional treatments [16–18]. Among these, music therapy (MT) has emerged as a promising mind–body intervention, defined by the American Music Therapy Association (AMTA) as “the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional” [19]. Music therapy has been shown to evoke emotional responses, regulate mood, and modulate neurophysiological processes involved in sleep regulation [20]. Previous studies indicate that music therapy can improve sleep quality by reducing physiological arousal, enhancing relaxation, and promoting emotional regulation. As a cost-effective, low-risk, and accessible intervention, it is particularly suitable for managing chronic neurological conditions such as MS [21]. Most previous studies have combined music therapy with other interventions or have focused on populations other than MS patients. Consequently, there is a paucity of research investigating the isolated effects of music therapy on sleep quality specifically in patients with MS. Therefore, this study aims to address this research gap by evaluating the efficacy of a structured music therapy program on sleep quality in patients with relapsing-remitting MS, underscoring the novelty and clinical significance of this investigation. Methods Study Design This randomized controlled trial was conducted over a two-week period. Participants in the intervention group listened to the prescribed music three times daily—morning, afternoon, and night. Sleep quality outcomes were assessed at baseline and immediately post-intervention. The control group received standard care, which included adherence to prescribed medications under physician supervision, while the intervention group received music therapy in addition to standard care. The two-week intervention duration was selected based on prior research demonstrating its effectiveness in alleviating sleep disturbances in patients with multiple sclerosis (MS) [22, 23]. The trial was registered in the Iranian Registry of Clinical Trials (IRCT) under registration code IRCT20231001059576N1. The study protocol received ethical approval from the Ethics Committee of Mashhad University of Medical Sciences (Approval No. IR.MUMS.NURSE.REC.1402.089). Participants A total of 60 patients with relapsing-remitting MS (11 males, 49 females) attending the Comprehensive MS Center at Ghaem Hospital in Mashhad between July and September 2024 were recruited. Inclusion criteria were: neurologist-confirmed MS diagnosis, Expanded Disability Status Scale (EDSS) score between 0 and 6, age 20–50 years, and a Pittsburgh Sleep Quality Index (PSQI) score greater than 6, indicating poor sleep quality. Only patients in remission were enrolled. Exclusion criteria included severe psychiatric disorders or neurological conditions affecting motor coordination. Randomization and Blinding Participants were randomly assigned to the intervention (n = 30; 5 males, 25 females) or control group (n = 30; 6 males, 24 females) using stratified block randomization by gender to ensure balanced baseline characteristics. Allocation was performed using sealed opaque envelopes prepared by an independent researcher. Due to the nature of the intervention, participant blinding was not feasible; however, outcome assessors remained blinded to group assignments. Music Therapy Intervention The intervention followed the Standley model, combining passive listening and active reflective discussion components. In an initial face-to-face session at the MS center, participants were instructed to listen to music using headphones or phone speakers in a quiet setting. They were asked to sit comfortably, close their eyes, take four deep breaths, and listen to instrumental, wordless music provided by the research team. Music files were delivered through commonly used platforms (e.g., WhatsApp, Telegram) according to participant preference. Participants engaged in three daily sessions lasting 10–15 minutes each, scheduled in the morning (7–9 a.m.), afternoon (4–6 p.m.), and evening (9–11 p.m.). To enhance adherence and emotional engagement, a virtual group was created for participants to share their experiences and perceived effects, serving as motivational reinforcement (Fig. 1 ). Materials and Measurement Tools Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 18-item self-report questionnaire developed by Buysse et al. (1989). The PSQI comprises seven components scored from 0 to 3, with higher scores indicating poorer sleep quality. Total scores range from 0 to 21; scores above 6 indicate poor sleep quality. The Persian version of the PSQI, psychometrically validated in Iranian populations, was used in this study. The Cronbach’s alpha coefficient for the PSQI in the present sample was 0.86, indicating good internal consistency. The PSQI was administered at baseline and after the two-week intervention in both groups. Statistical Analysis Data were analyzed using SPSS version 26.0 for Windows. A two-tailed p-value < 0.05 was considered statistically significant. Descriptive statistics summarized demographic and clinical characteristics. Between-group comparisons for continuous variables were conducted using independent t-tests, while paired t-tests assessed within-group changes. For non-normally distributed data (assessed via the Shapiro–Wilk test), non-parametric tests such as the Mann–Whitney U and Wilcoxon signed-rank tests were applied. CONSORT Flow Diagram The study flow is presented in the CONSORT diagram (Fig. 1 ), detailing the number of participants assessed for eligibility, randomized, and included in the final analysis. Results A total of 60 patients who met the inclusion criteria participated in the study. The mean age of patients was 36.6 ± 7.8 years in the intervention group and 35.3 ± 6.3 years in the control group. The mean disease duration was 8.7 ± 5.3 years in the intervention group and 9.1 ± 5.8 years in the control group. The Mann–Whitney U test indicated no significant difference between groups regarding age distribution (P = 0.402) or disease duration (P = 0.959). Additionally, the chi-square test showed no significant differences in other demographic variables between the groups (Table 1 ). Overall, these results indicate that the intervention and control groups were homogeneous and comparable at baseline. Table 1 Demographic characteristics of patients Variable Group P value* Intervention (n = 30) Control (n = 30) Number Percentage Number Percentage Gender Female 25 83.3 24 80.0 0.739 Male 5 16.7 6 20.0 Marital status Married 20 66.7 16 53.3 0.292 Single 10 33.3 14 46.7 Employment status Unemployed 18 60.0 13 43.3 0.213 Employed 11 36.7 17 56.7 Retired 1 3.3 0 0.0 Housing status Yes 16 53.3 22 73.3 0.108 No 14 46.7 8 26.7 Family history of MS Yes 5 16.7 6 20.0 0.111 No 25 83.3 24 80.0 * Statistical comparisons were performed using the Chi-square test for categorical variables. A p-value less than 0.05 was considered statistically significant. Prior to the intervention, there was no significant difference in sleep quality scores between the intervention (10.5 ± 2.8) and control groups (11.8 ± 3.3) (P = 0.093, Mann–Whitney U test). Post-intervention, sleep quality scores significantly improved in the intervention group compared to the control group (9.4 ± 2.6 vs. 10.9 ± 3.0; P = 0.047, independent t-test). The mean change in scores did not differ significantly between groups (P = 0.833). Within-group analysis using the Wilcoxon signed-rank test showed no statistically significant changes in sleep quality scores for either the intervention (P = 0.088) or control group (P = 0.335). Table 2 Overall sleep quality scores of the participants in the study Variable Group P Value* Intervention (n = 30) Control (n = 30) Mean ± standard deviation Mean ± standard deviation Overall sleep quality score Before intervention 10.5 ± 2.8 11.8 ± 3.3 0.093 After intervention 9.4 ± 2.6 10.9 ± 3.0 0.047 Change (After - Before) -1.1 ± 3.2 -0.9 ± 5.0 0.321 Within-group test result P** = 0.088 P** = 0.335 * P-values for between-group comparisons were calculated using the Mann–Whitney U test before the intervention and the independent t-test after the intervention and for change scores. Within-group comparisons were performed using the Wilcoxon signed-rank test. Discussion This study aimed to evaluate the effect of music therapy on sleep quality in patients with multiple sclerosis (MS). Our results showed no significant difference in sleep quality between the intervention and control groups at baseline. However, after two weeks of music therapy, the intervention group demonstrated a significant improvement in overall sleep quality compared to the control group. These findings are consistent with prior research supporting the positive effects of music therapy on sleep. For instance, Chang et al. (2024) reported improved sleep quality in breast cancer patients undergoing a combined intervention of music therapy and aerobic exercise [24]. While both studies employed music therapy, our study uniquely focuses on MS patients and isolates the effect of music therapy alone. Similarly, Koolaee et al. (2018) found that elderly women who listened to Arnd Stein’s instrumental music experienced enhanced sleep quality and mood, aligning with our use of the same musical selections [25]. Other research, such as Amrollahi et al. (2016), demonstrated that music therapy was more effective than aromatherapy in improving sleep among burn patients, despite a shorter intervention duration [26]. Variations in patient populations, intervention length, and combination therapies may explain differences in outcomes. Recent studies also reinforce the beneficial role of music therapy in improving sleep and mental health across diverse clinical groups [27–31]. Sleep is a vital biological function essential for physical and mental health. Sleep disturbances are prevalent in MS and contribute to fatigue, cognitive impairment, and reduced quality of life [32, 33]. Given that standard treatments may inadequately address sleep problems in MS, non-pharmacological interventions such as music therapy offer a safe, accessible, and cost-effective alternative. Music therapy has been shown to reduce anxiety, enhance social engagement, and alleviate neurological and psychological symptoms in MS [5, 21, 22, 34–37]. This study contributes to the literature by specifically examining the isolated effect of music therapy on sleep quality in patients with relapsing-remitting MS—a clinical population that has received limited attention in this context. Unlike prior studies that employed music therapy alongside other interventions (e.g., aerobic exercise, relaxation training, or pharmacologic treatment), our research uniquely evaluates music therapy as a stand-alone modality. This design enables a clearer interpretation of its specific efficacy on MS-related sleep disturbances. Furthermore, the intervention was delivered via a virtual platform and included not only passive listening but also interactive group discussions, creating a hybrid model of engagement. This innovative approach may have enhanced motivation, compliance, and therapeutic impact, particularly during the post-pandemic era when remote interventions are increasingly relevant. The rigorous randomized controlled design, use of validated sleep quality measures, and careful participant selection criteria reinforce the internal validity of our results. Taken together, these findings support the integration of music therapy as a safe, cost-effective, and engaging adjunctive treatment for improving sleep quality in patients with MS. Conclusion This study investigated the efficacy of a music therapy intervention on sleep quality in patients with multiple sclerosis (MS). The findings, supporting the initial hypotheses, indicate that music therapy can significantly improve sleep quality and help manage symptoms in this population. These results emphasize the potential of complementary and alternative therapies as effective, accessible, and affordable approaches to reduce healthcare costs and improve patient care. Given their safety, low cost, and growing acceptance, complementary therapies such as music therapy hold promise for diverse patient groups, including those with MS. Therefore, it is recommended that such interventions be integrated into clinical practice, hospital settings, and home care programs involving patients, caregivers, and healthcare providers. Research limitations This study has several limitations. First, the relatively short duration of the intervention (two weeks) may limit the generalizability of the findings to the long-term effects of music therapy on sleep quality in patients with multiple sclerosis. Second, the sample size was relatively small, consisting of 60 participants from a single center, which may affect the external validity of the results. Third, the use of self-reported measures such as the Pittsburgh Sleep Quality Index may introduce subjective bias. Finally, factors such as medication use, lifestyle habits, and psychological status were not controlled for, which could have influenced the outcomes. Future research with larger sample sizes, longer follow-up periods, and objective sleep assessments is recommended to strengthen the evidence base. Future Directions Future studies should consider extending the duration of music therapy interventions to assess long-term benefits on sleep quality and other MS-related symptoms. Incorporating objective sleep measurement tools such as polysomnography or actigraphy could provide more robust and unbiased data. Multicenter trials with larger and more diverse samples would improve the generalizability of findings. Additionally, exploring the combined effects of music therapy with other non-pharmacological approaches, such as cognitive-behavioral therapy or physical exercise, may uncover synergistic benefits. Finally, investigating the impact of music therapy on broader aspects of quality of life and neurological function in MS patients will help establish its comprehensive therapeutic value. Declarations Ethics approval and consent to participate The study was approved by the Ethics Committee of Mashhad University of Medical Sciences (Approval No. IR.MUMS.NURSE.REC.1402.089). Written informed consent was obtained from all participants after providing detailed information about the study objectives, procedures, confidentiality assurances, and their right to withdraw at any stage. Consent for publication Not applicable. Availability of data and materials All data generated or analyzed during this study are included in this published article and its supplementary files. Competing interests The authors declare that they have no competing interests. Funding This study was funded by Mashhad University of Medical Sciences (MUMS) as part of a student thesis project. The funding covered research-related expenses including participant recruitment and materials. The funding body had no role in the study design, data collection, analysis, interpretation, or manuscript preparation. Author Contributions Statement M.R. conceptualized and designed the study, conducted data collection, performed data analysis, and wrote the initial draft of the manuscript. H.R.Z. contributed to study design, supervised the research process, and reviewed the manuscript. S.M assisted in data collection and contributed to manuscript revision. M.A.N. provided statistical consultation and reviewed the analysis. S.R.M. contributed to the interpretation of results and critical revision of the manuscript. All authors read and approved the final manuscript. Acknowledgements The authors would like to thank Mashhad University of Medical Sciences for its financial and institutional support. 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Supplementary Files Attachment1InclusionExclusionChecklist.docx Attachment2DemographicQuestionnaire.docx Attachment3PSQIQuestionnaire.docx RawData.csv Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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08:01:27","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":15587,"visible":true,"origin":"","legend":"","description":"","filename":"Attachment2DemographicQuestionnaire.docx","url":"https://assets-eu.researchsquare.com/files/rs-7156351/v1/4cd14ff3cbeefb6445af3e11.docx"},{"id":88223396,"identity":"011bbfd3-6b17-4d49-8265-dea8e5309254","added_by":"auto","created_at":"2025-08-04 08:09:27","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":15346,"visible":true,"origin":"","legend":"","description":"","filename":"Attachment3PSQIQuestionnaire.docx","url":"https://assets-eu.researchsquare.com/files/rs-7156351/v1/93bfebf7e728008e40e1021d.docx"},{"id":88221753,"identity":"dd40383d-3d8e-471f-ad87-4ea8978d9440","added_by":"auto","created_at":"2025-08-04 08:01:27","extension":"csv","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":10601,"visible":true,"origin":"","legend":"","description":"","filename":"RawData.csv","url":"https://assets-eu.researchsquare.com/files/rs-7156351/v1/52dd8f03ac4bba02f3c75b26.csv"}],"financialInterests":"No competing interests reported.","formattedTitle":"The Effect of Music Therapy on Sleep Quality in Patients with Multiple Sclerosis: A Randomized Controlled Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMultiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system (CNS), characterized by inflammation, demyelination, gliosis, and neuronal loss primarily affecting myelinated axons [1]. Although its exact etiology remains unclear, various risk factors—including genetic predisposition, environmental influences, vitamin D deficiency, and smoking—have been identified. MS predominantly affects young adults aged 20 to 40 years, with a higher prevalence among women (female-to-male ratio approximately 2–3:1) [2–4].\u003c/p\u003e\u003cp\u003eThe global prevalence of MS is increasing, with an estimated 2.3\u0026nbsp;million individuals affected worldwide. Iran has one of the highest prevalence rates, with over 70,000 diagnosed cases, notably concentrated in Isfahan Province [5–9].\u003c/p\u003e\u003cp\u003eMS manifests with diverse clinical symptoms such as motor impairments, fatigue, visual disturbances, spasticity, pain, cognitive deficits, and psychological conditions including depression and anxiety [10, 11]. Among these, sleep disturbances are highly prevalent, affecting nearly half of MS patients, yet remain significantly underdiagnosed and undertreated [12, 13]. Poor sleep quality in this population is strongly associated with increased fatigue, mood disorders, and decreased overall quality of life [14].\u003c/p\u003e\u003cp\u003eWhile disease-modifying therapies (DMTs) effectively reduce inflammatory activity and relapse rates, they do not directly improve sleep quality or psychological well-being. Therefore, there is a growing need to explore non-pharmacological approaches to manage these symptoms [15].\u003c/p\u003e\u003cp\u003eComplementary and alternative medicine (CAM) is widely used by patients with chronic illnesses including MS, providing various therapeutic options for symptoms inadequately controlled by conventional treatments [16–18]. Among these, music therapy (MT) has emerged as a promising mind–body intervention, defined by the American Music Therapy Association (AMTA) as “the clinical and evidence-based use of music interventions to accomplish individualized goals within a therapeutic relationship by a credentialed professional” [19]. Music therapy has been shown to evoke emotional responses, regulate mood, and modulate neurophysiological processes involved in sleep regulation [20].\u003c/p\u003e\u003cp\u003ePrevious studies indicate that music therapy can improve sleep quality by reducing physiological arousal, enhancing relaxation, and promoting emotional regulation. As a cost-effective, low-risk, and accessible intervention, it is particularly suitable for managing chronic neurological conditions such as MS [21].\u003c/p\u003e\u003cp\u003eMost previous studies have combined music therapy with other interventions or have focused on populations other than MS patients. Consequently, there is a paucity of research investigating the isolated effects of music therapy on sleep quality specifically in patients with MS.\u003c/p\u003e\u003cp\u003eTherefore, this study aims to address this research gap by evaluating the efficacy of a structured music therapy program on sleep quality in patients with relapsing-remitting MS, underscoring the novelty and clinical significance of this investigation.\u003c/p\u003e\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cb\u003eStudy Design\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis randomized controlled trial was conducted over a two-week period. Participants in the intervention group listened to the prescribed music three times daily—morning, afternoon, and night. Sleep quality outcomes were assessed at baseline and immediately post-intervention.\u003c/p\u003e\u003cp\u003eThe control group received standard care, which included adherence to prescribed medications under physician supervision, while the intervention group received music therapy in addition to standard care. The two-week intervention duration was selected based on prior research demonstrating its effectiveness in alleviating sleep disturbances in patients with multiple sclerosis (MS) [22, 23].\u003c/p\u003e\u003cp\u003eThe trial was registered in the Iranian Registry of Clinical Trials (IRCT) under registration code IRCT20231001059576N1. The study protocol received ethical approval from the Ethics Committee of Mashhad University of Medical Sciences (Approval No. IR.MUMS.NURSE.REC.1402.089).\u003c/p\u003e\u003cp\u003e\u003cb\u003eParticipants\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA total of 60 patients with relapsing-remitting MS (11 males, 49 females) attending the Comprehensive MS Center at Ghaem Hospital in Mashhad between July and September 2024 were recruited. Inclusion criteria were: neurologist-confirmed MS diagnosis, Expanded Disability Status Scale (EDSS) score between 0 and 6, age 20–50 years, and a Pittsburgh Sleep Quality Index (PSQI) score greater than 6, indicating poor sleep quality. Only patients in remission were enrolled. Exclusion criteria included severe psychiatric disorders or neurological conditions affecting motor coordination.\u003c/p\u003e\u003cp\u003e\u003cb\u003eRandomization and Blinding\u003c/b\u003e\u003c/p\u003e\u003cp\u003eParticipants were randomly assigned to the intervention (n = 30; 5 males, 25 females) or control group (n = 30; 6 males, 24 females) using stratified block randomization by gender to ensure balanced baseline characteristics. Allocation was performed using sealed opaque envelopes prepared by an independent researcher. Due to the nature of the intervention, participant blinding was not feasible; however, outcome assessors remained blinded to group assignments.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMusic Therapy Intervention\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe intervention followed the Standley model, combining passive listening and active reflective discussion components. In an initial face-to-face session at the MS center, participants were instructed to listen to music using headphones or phone speakers in a quiet setting. They were asked to sit comfortably, close their eyes, take four deep breaths, and listen to instrumental, wordless music provided by the research team.\u003c/p\u003e\u003cp\u003eMusic files were delivered through commonly used platforms (e.g., WhatsApp, Telegram) according to participant preference. Participants engaged in three daily sessions lasting 10–15 minutes each, scheduled in the morning (7–9 a.m.), afternoon (4–6 p.m.), and evening (9–11 p.m.). To enhance adherence and emotional engagement, a virtual group was created for participants to share their experiences and perceived effects, serving as motivational reinforcement (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cb\u003eMaterials and Measurement Tools\u003c/b\u003e\u003c/p\u003e\u003cp\u003eSleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 18-item self-report questionnaire developed by Buysse et al. (1989). The PSQI comprises seven components scored from 0 to 3, with higher scores indicating poorer sleep quality. Total scores range from 0 to 21; scores above 6 indicate poor sleep quality.\u003c/p\u003e\u003cp\u003eThe Persian version of the PSQI, psychometrically validated in Iranian populations, was used in this study. The Cronbach’s alpha coefficient for the PSQI in the present sample was 0.86, indicating good internal consistency. The PSQI was administered at baseline and after the two-week intervention in both groups.\u003c/p\u003e\u003ch2\u003eStatistical Analysis\u003c/h2\u003e\u003cp\u003eData were analyzed using SPSS version 26.0 for Windows. A two-tailed p-value \u0026lt; 0.05 was considered statistically significant. Descriptive statistics summarized demographic and clinical characteristics. Between-group comparisons for continuous variables were conducted using independent t-tests, while paired t-tests assessed within-group changes. For non-normally distributed data (assessed via the Shapiro–Wilk test), non-parametric tests such as the Mann–Whitney U and Wilcoxon signed-rank tests were applied.\u003c/p\u003e\u003cp\u003e\u003cb\u003eCONSORT Flow Diagram\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study flow is presented in the CONSORT diagram (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), detailing the number of participants assessed for eligibility, randomized, and included in the final analysis.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 60 patients who met the inclusion criteria participated in the study. The mean age of patients was 36.6\u0026thinsp;\u0026plusmn;\u0026thinsp;7.8 years in the intervention group and 35.3\u0026thinsp;\u0026plusmn;\u0026thinsp;6.3 years in the control group. The mean disease duration was 8.7\u0026thinsp;\u0026plusmn;\u0026thinsp;5.3 years in the intervention group and 9.1\u0026thinsp;\u0026plusmn;\u0026thinsp;5.8 years in the control group. The Mann\u0026ndash;Whitney U test indicated no significant difference between groups regarding age distribution (P\u0026thinsp;=\u0026thinsp;0.402) or disease duration (P\u0026thinsp;=\u0026thinsp;0.959). Additionally, the chi-square test showed no significant differences in other demographic variables between the groups (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Overall, these results indicate that the intervention and control groups were homogeneous and comparable at baseline.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eDemographic characteristics of patients\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c2\" namest=\"c1\" rowspan=\"3\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eP value*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003eIntervention (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u003cp\u003eControl (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNumber\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePercentage\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNumber\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003ePercentage\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eGender\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e83.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e80.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e0.739\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e16.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e20.0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eMarital status\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMarried\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e66.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e53.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e0.292\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSingle\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e33.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e46.7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eEmployment status\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" 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colname=\"c5\"\u003e\u003cp\u003e22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e73.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e0.108\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e46.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e26.7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eFamily history of MS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e16.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e20.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003e0.111\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e83.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e80.0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e* \u003cem\u003eStatistical comparisons were performed using the Chi-square test for categorical variables. A p-value less than 0.05 was considered statistically significant.\u003c/em\u003e\u003c/p\u003e\u003cp\u003ePrior to the intervention, there was no significant difference in sleep quality scores between the intervention (10.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8) and control groups (11.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.3) (P\u0026thinsp;=\u0026thinsp;0.093, Mann\u0026ndash;Whitney U test).\u003c/p\u003e\u003cp\u003ePost-intervention, sleep quality scores significantly improved in the intervention group compared to the control group (9.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.6 vs. 10.9\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0; P\u0026thinsp;=\u0026thinsp;0.047, independent t-test).\u003c/p\u003e\u003cp\u003eThe mean change in scores did not differ significantly between groups (P\u0026thinsp;=\u0026thinsp;0.833).\u003c/p\u003e\u003cp\u003eWithin-group analysis using the Wilcoxon signed-rank test showed no statistically significant changes in sleep quality scores for either the intervention (P\u0026thinsp;=\u0026thinsp;0.088) or control group (P\u0026thinsp;=\u0026thinsp;0.335).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOverall sleep quality scores of the participants in the study\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c2\" namest=\"c1\" rowspan=\"3\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eP Value*\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIntervention (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eControl (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eOverall sleep quality score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBefore intervention\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.093\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAfter intervention\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e9.4\u0026thinsp;\u0026plusmn;\u0026thinsp;2.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e10.9\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.047\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eChange (After - Before)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-1.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-0.9\u0026thinsp;\u0026plusmn;\u0026thinsp;5.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.321\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003eWithin-group test result\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eP** = 0.088\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP** = 0.335\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e* \u003cem\u003eP-values for between-group comparisons were calculated using the Mann\u0026ndash;Whitney U test before the intervention and the independent t-test after the intervention and for change scores. Within-group comparisons were performed using the Wilcoxon signed-rank test.\u003c/em\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study aimed to evaluate the effect of music therapy on sleep quality in patients with multiple sclerosis (MS). Our results showed no significant difference in sleep quality between the intervention and control groups at baseline. However, after two weeks of music therapy, the intervention group demonstrated a significant improvement in overall sleep quality compared to the control group.\u003c/p\u003e\u003cp\u003eThese findings are consistent with prior research supporting the positive effects of music therapy on sleep. For instance, Chang et al. (2024) reported improved sleep quality in breast cancer patients undergoing a combined intervention of music therapy and aerobic exercise [24]. While both studies employed music therapy, our study uniquely focuses on MS patients and isolates the effect of music therapy alone. Similarly, Koolaee et al. (2018) found that elderly women who listened to Arnd Stein\u0026rsquo;s instrumental music experienced enhanced sleep quality and mood, aligning with our use of the same musical selections [25].\u003c/p\u003e\u003cp\u003eOther research, such as Amrollahi et al. (2016), demonstrated that music therapy was more effective than aromatherapy in improving sleep among burn patients, despite a shorter intervention duration [26]. Variations in patient populations, intervention length, and combination therapies may explain differences in outcomes. Recent studies also reinforce the beneficial role of music therapy in improving sleep and mental health across diverse clinical groups [27\u0026ndash;31].\u003c/p\u003e\u003cp\u003eSleep is a vital biological function essential for physical and mental health. Sleep disturbances are prevalent in MS and contribute to fatigue, cognitive impairment, and reduced quality of life [32, 33]. Given that standard treatments may inadequately address sleep problems in MS, non-pharmacological interventions such as music therapy offer a safe, accessible, and cost-effective alternative. Music therapy has been shown to reduce anxiety, enhance social engagement, and alleviate neurological and psychological symptoms in MS [5, 21, 22, 34\u0026ndash;37].\u003c/p\u003e\u003cp\u003eThis study contributes to the literature by specifically examining the isolated effect of music therapy on sleep quality in patients with relapsing-remitting MS\u0026mdash;a clinical population that has received limited attention in this context. Unlike prior studies that employed music therapy alongside other interventions (e.g., aerobic exercise, relaxation training, or pharmacologic treatment), our research uniquely evaluates music therapy as a stand-alone modality. This design enables a clearer interpretation of its specific efficacy on MS-related sleep disturbances.\u003c/p\u003e\u003cp\u003eFurthermore, the intervention was delivered via a virtual platform and included not only passive listening but also interactive group discussions, creating a hybrid model of engagement. This innovative approach may have enhanced motivation, compliance, and therapeutic impact, particularly during the post-pandemic era when remote interventions are increasingly relevant.\u003c/p\u003e\u003cp\u003eThe rigorous randomized controlled design, use of validated sleep quality measures, and careful participant selection criteria reinforce the internal validity of our results. Taken together, these findings support the integration of music therapy as a safe, cost-effective, and engaging adjunctive treatment for improving sleep quality in patients with MS.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study investigated the efficacy of a music therapy intervention on sleep quality in patients with multiple sclerosis (MS). The findings, supporting the initial hypotheses, indicate that music therapy can significantly improve sleep quality and help manage symptoms in this population. These results emphasize the potential of complementary and alternative therapies as effective, accessible, and affordable approaches to reduce healthcare costs and improve patient care.\u003c/p\u003e\u003cp\u003eGiven their safety, low cost, and growing acceptance, complementary therapies such as music therapy hold promise for diverse patient groups, including those with MS. Therefore, it is recommended that such interventions be integrated into clinical practice, hospital settings, and home care programs involving patients, caregivers, and healthcare providers.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResearch limitations\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study has several limitations. First, the relatively short duration of the intervention (two weeks) may limit the generalizability of the findings to the long-term effects of music therapy on sleep quality in patients with multiple sclerosis. Second, the sample size was relatively small, consisting of 60 participants from a single center, which may affect the external validity of the results. Third, the use of self-reported measures such as the Pittsburgh Sleep Quality Index may introduce subjective bias. Finally, factors such as medication use, lifestyle habits, and psychological status were not controlled for, which could have influenced the outcomes. Future research with larger sample sizes, longer follow-up periods, and objective sleep assessments is recommended to strengthen the evidence base.\u003c/p\u003e\u003cp\u003e\u003cb\u003eFuture Directions\u003c/b\u003e\u003c/p\u003e\u003cp\u003eFuture studies should consider extending the duration of music therapy interventions to assess long-term benefits on sleep quality and other MS-related symptoms. Incorporating objective sleep measurement tools such as polysomnography or actigraphy could provide more robust and unbiased data. Multicenter trials with larger and more diverse samples would improve the generalizability of findings. Additionally, exploring the combined effects of music therapy with other non-pharmacological approaches, such as cognitive-behavioral therapy or physical exercise, may uncover synergistic benefits. Finally, investigating the impact of music therapy on broader aspects of quality of life and neurological function in MS patients will help establish its comprehensive therapeutic value.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the Ethics Committee of Mashhad University of Medical Sciences (Approval No. IR.MUMS.NURSE.REC.1402.089). Written informed consent was obtained from all participants after providing detailed information about the study objectives, procedures, confidentiality assurances, and their right to withdraw at any stage.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data generated or analyzed during this study are included in this published article and its supplementary files.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by Mashhad University of Medical Sciences (MUMS) as part of a student thesis project. The funding covered research-related expenses including participant recruitment and materials. The funding body had no role in the study design, data collection, analysis, interpretation, or manuscript preparation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eM.R. conceptualized and designed the study, conducted data collection, performed data analysis, and wrote the initial draft of the manuscript. H.R.Z. contributed to study design, supervised the research process, and reviewed the manuscript. S.M assisted in data collection and contributed to manuscript revision. M.A.N. provided statistical consultation and reviewed the analysis. S.R.M. contributed to the interpretation of results and critical revision of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank Mashhad University of Medical Sciences for its financial and institutional support. We also sincerely thank all the patients who participated in this study for their valuable cooperation and time.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eHaki M, et al. Review of multiple sclerosis: epidemiology, etiology, pathophysiology, and treatment. Medicine (Baltimore). 2024;103(8):e37297.\u003c/li\u003e\n \u003cli\u003eSesel AL, et al. The evaluation of an online mindfulness program for people with multiple sclerosis: study protocol. BMC Neurol. 2019;19(1):129.\u003c/li\u003e\n \u003cli\u003eThompson AJ, et al. Multiple sclerosis. Lancet. 2018;391(10130):1622\u0026ndash;1636.\u003c/li\u003e\n \u003cli\u003eWeerasinghe-Mudiyanselage PDE, et al. Understanding the spectrum of non-motor symptoms in multiple sclerosis: insights from animal models. Neural Regen Res. 2024;19(1):84\u0026ndash;91.\u003c/li\u003e\n \u003cli\u003eLopes J, Keppers II. Music-based therapy in rehabilitation of people with multiple sclerosis: a systematic review of clinical trials. Arq Neuropsiquiatr. 2021;79(6):527\u0026ndash;535.\u003c/li\u003e\n \u003cli\u003eSalehi Kalate Sadat MAS, Stiri Z, Shahabi Kasab MR. The effect of six weeks of pilates exercises with music on balance and concentration in women with multiple sclerosis. Sports Biomot Sci. 2022;14(27):53\u0026ndash;63.\u003c/li\u003e\n \u003cli\u003eStratton C, et al. Interim guidelines for the assessment and treatment of pain in children with multiple sclerosis. Front Neurosci. 2023;17:1235945. https://doi.org/10.3389/fnins.2023.1235945\u003c/li\u003e\n \u003cli\u003eParapari S, Letafatkar A, Moradi B. The effect of resistance training on control of posture and gait ability in patients with multiple sclerosis: a narrative review. J Exerc Rehabil. 2021;13:1.\u003c/li\u003e\n \u003cli\u003eRostami S, Ismailian M, Asghari Hasuri F. The effect of a dynamic neuromuscular stabilization exercise program on balance and ankle proprioception in patients with multiple sclerosis. Trials. 2022;23:69. https://doi.org/10.1186/s13063-022-06015-3\u003c/li\u003e\n \u003cli\u003eTafti D, Ehsan M, Xixis KL. Multiple sclerosis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024.\u003c/li\u003e\n \u003cli\u003eChen MH, et al. Real-time associations among MS symptoms and cognitive dysfunction using ecological momentary assessment. Front Med (Lausanne). 2022;9:1049686. https://doi.org/10.3389/fmed.2022.1049686\u003c/li\u003e\n \u003cli\u003eMotavakel N, et al. The effect of spiritual care on sleep quality in patients with multiple sclerosis referred to the MS Society of Hamadan city in 2018. 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Music tuned to 432 Hz versus music tuned to 440 Hz for improving sleep in patients with spinal cord injuries: a double-blind cross-over pilot study. Acta Biomed. 2020;91(12-s):e2020008.\u003c/li\u003e\n \u003cli\u003eZadbagherseyghalani M, Mohammadi A, Birashk B. The effectiveness of music therapy on depression and anxiety of patients with multiple sclerosis. Q J Psychol Stud. 2016;11(4):7\u0026ndash;22. [In Persian]\u003c/li\u003e\n \u003cli\u003eAskari P, Khayati A. The effectiveness of music therapy on pain intensity, perceived stress and happiness of teenagers with leukemia. Pos Psychol Res Pap. 2018;3(4):15\u0026ndash;28. [In Persian]\u003c/li\u003e\n \u003cli\u003eChang L, et al. Effect of music therapy combined with aerobic exercise on sleep quality among breast cancer patients undergoing chemotherapy after a radical mastectomy: a randomized controlled trial. BMC Womens Health. 2024;24(1):408. https://doi.org/10.1186/s12905-024-01234-5\u003c/li\u003e\n \u003cli\u003eKhodabakhshi-Koolaee A, Barzeghar Khezri R. The effect of relaxation and instrumental music by Arnd Stein on quality of sleep and happiness among aging women. J Torbat Heydarieh Univ Med Sci. 2018;5(4):46\u0026ndash;53. [In Persian]\u003c/li\u003e\n \u003cli\u003eAmrollahi A, et al. Comparison of the effects of aromatherapy with lavender essential oil and music therapy on sleep quality of burned patients. Complement Med J. 2016;6(2):1490\u0026ndash;1499. [In Persian]\u003c/li\u003e\n \u003cli\u003eRong Y, et al. Application of music therapy in improving sleep quality and psychological health of pregnant women with hypertension: a retrospective study. Noise Health. 2024;26(122):332\u0026ndash;337.\u003c/li\u003e\n \u003cli\u003eMao Y, et al. Effect of music therapy on negative psychology, sleep, and quality of life in elderly patients recovering from cerebral infarction with depression and anxiety: a retrospective analysis. Noise Health. 2024;26(122):430\u0026ndash;435.\u003c/li\u003e\n \u003cli\u003eAkhshabi M. Music therapy as a non-pharmacological treatment for the elderly: a systematic review. J Gerontol. 2023;8(2):1\u0026ndash;18.\u003c/li\u003e\n \u003cli\u003eAlijaniranani H, Noruzi Zamengani M, Amin Asnafi A. The effectiveness of aromatherapy with orange essential oil on improving sleep disturbances of school-aged children with leukemia. Complement Med J. 2023;13(3):67\u0026ndash;76. [In Persian]\u003c/li\u003e\n \u003cli\u003eKlocke C, et al. A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly-ELAMUS: study protocol. BMC Complement Med Ther. 2024;24(1):295. https://doi.org/10.1186/s12906-024-03674-1\u003c/li\u003e\n \u003cli\u003eParsai Manesh E, Mahdavi M, Moghadam S. The effect of self-care educational program on sleep quality in patients with multiple sclerosis. Educ Ethics Nurs. 2022;3(4):9\u0026ndash;13. [In Persian]\u003c/li\u003e\n \u003cli\u003eClark AJ, et al. Sleep disturbance in mid-life women. J Adv Nurs. 1995;22(3):562\u0026ndash;568.\u003c/li\u003e\n \u003cli\u003eScataglini S, et al. Effect of music based therapy rhythmic auditory stimulation (RAS) using wearable device in rehabilitation of neurological patients: a systematic review. Sensors (Basel). 2023;23(13). https://doi.org/10.3390/s23135980\u003c/li\u003e\n \u003cli\u003eImpellizzeri F, et al. An integrative cognitive rehabilitation using neurologic music therapy in multiple sclerosis: a pilot study. Medicine (Baltimore). 2020;99(4):e18866. https://doi.org/10.1097/MD.0000000000018866\u003c/li\u003e\n \u003cli\u003eSeebacher B, et al. Actual and imagined music-cued gait training in people with multiple sclerosis: a double-blind randomized parallel multicenter trial. Neurorehabil Neural Repair. 2024;38(8):555\u0026ndash;569. https://doi.org/10.1177/15459683231168241\u003c/li\u003e\n \u003cli\u003eTahan M, Evari MA, Ahangri E. The effect of music therapy on stress, anxiety, and depression in patients with cancer in Valiasr hospital in Birjand, 2017. J Multidiscip Care. 2018;7(3):186\u0026ndash;192.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Music therapy, Sleep quality, Multiple sclerosis, Complementary therapies","lastPublishedDoi":"10.21203/rs.3.rs-7156351/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7156351/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eMultiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system. Conventional treatments often fail to adequately address symptoms such as sleep disturbances.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003e To investigate the efficacy of music therapy as a complementary intervention in improving sleep quality among patients with multiple sclerosis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThis randomized controlled trial enrolled 60 patients with MS from the Comprehensive MS Center in Mashhad. Participants were randomly assigned to either an intervention group (music therapy plus standard care) or a control group (standard care only). The intervention group received music therapy sessions three times daily for two weeks. Sleep quality was assessed at baseline and post-intervention using the Pittsburgh Sleep Quality Index (PSQI). Data were analyzed using SPSS version 26.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Baseline PSQI scores did not differ significantly between groups (10.5 ± 2.8 vs. 11.8 ± 3.3, P = 0.118). After the intervention, the intervention group showed a significant improvement in sleep quality compared to the control group (9.4 ± 2.6 vs. 10.9 ± 3.0, P = 0.047).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eMusic therapy is a safe, accessible, and cost-effective complementary intervention that significantly improves sleep quality in patients with MS.\u003c/p\u003e","manuscriptTitle":"The Effect of Music Therapy on Sleep Quality in Patients with Multiple Sclerosis: A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-04 08:01:22","doi":"10.21203/rs.3.rs-7156351/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f180222a-11fd-4a9c-8a32-2a41d7a6a088","owner":[],"postedDate":"August 4th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-11T17:08:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-04 08:01:22","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7156351","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7156351","identity":"rs-7156351","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}