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The Effect of Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis

The Effect of Listening to Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06468241
Enrollment
30
Registered
2024-06-21
Start date
2023-08-15
Completion date
2024-04-15
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Fatigue, Sleep

Keywords

Multiple Sclerosis, Progressive relaxation exercise, listening to music, sleep, fatigue

Brief summary

Multiple Sclerosis (MS) is a chronic complex neurodegenerative disease that targets the central nervous system and is autoimmune. The prevalence of fatigue in individuals diagnosed with MS varies between 50% and 81%. It is one of the most common, disabling and complex symptoms of MS. Another common symptom in MS patients is sleep problems. Sleep problems are seen in approximately 70% of MS patients. Non-pharmacological interventions have been used in recent years for the management of fatigue and sleep problems in MS. The effects of Progressive relaxation exercises (PGE), one of the non-pharmacological methods, on sleep and fatigue symptoms in MS patients have been reported. It has been reported that the implementation of progressive relaxation exercises in MS is a supportive intervention for sleep quality and fatigue and is recommended for future research. Another initiative that is planned to be used within the scope of this research proposal is listening to music. Although rhythm and music have recently become a topic of interest in the field of neurological rehabilitation, their value in practice has not yet been fully discovered. Suggestions are given to objectively define sleep disorders in MS and to focus on this symptom of MS. It has been determined that music shows promise in improving sleep, but more research is needed on improved techniques for sleep measurement. The main purpose of this research is to reveal the effects of listening to music and progressive relaxation exercise on fatigue and sleep in Multiple Sclerosis. The research was planned as a randomized controlled experimental study in a three-measure design with three groups (music listening, progressive relaxation exercise, and control group). The sample of the project consists of 30 individuals with MS diagnosis and meeting the inclusion criteria. In data collection, it is planned to use of the Introductory Information Form, which includes the sociodemographic characteristics of the patients, the characteristics of the disease and sleep habits, the Fatigue Severity Scale, the Fatigue Impact Scale and the Pittsburgh Sleep Quality Index and wearable technology. Data were analysed with Statistical Package for the Social Sciences (SPSS) V23 and R software. In addition to descriptive analyses, In addition to descriptive analyses, multiple comparisons by group and time were performed using generalised linear model analyses.

Detailed description

Multiple Sclerosis (MS) is a chronic complex neurodegenerative disease that targets the central nervous system and is autoimmune. The prevalence of fatigue in individuals diagnosed with MS varies between 50% and 81%. It is one of the most common, disabling and complex symptoms of MS. Another common symptom in MS patients is sleep problems. Sleep problems are seen in approximately 70% of MS patients. It has been reported that sleep disorders affect the course of MS negatively. Non-pharmacological interventions have been used in recent years for the management of fatigue and sleep problems in MS. The effects of Progressive relaxation exercises (PGE), one of the non-pharmacological methods, on sleep and fatigue symptoms in MS patients have been reported. It has been reported that the implementation of progressive relaxation exercises in MS is a supportive intervention for sleep quality and fatigue and is recommended for future research. Another initiative that is planned to be used within the scope of this research proposal is listening to music. Although rhythm and music have recently become a topic of interest in the field of neurological rehabilitation, their value in practice has not yet been fully discovered. Suggestions are given to objectively define sleep disorders in MS and to focus on this symptom of MS. It has been determined that music shows promise in improving sleep, but more research is needed on improved techniques for sleep measurement. Polysomnography (PSG) is used for the objective measurement of sleep. However, it may cause poorer quality sleep as it requires participants to sleep in a laboratory environment. For this reason, it is important to use objective measurement tools that patients can do in their own environment. The main purpose of this research is to reveal the effects of listening to music and progressive relaxation exercise on fatigue and sleep in Multiple Sclerosis. The research was planned as a randomized controlled experimental study in a three-measure design with three groups (music listening, progressive relaxation exercise, and control group). The sample of the project consists of 30 individuals with MS diagnosis and meeting the inclusion criteria. In data collection, it is planned to use of the Introductory Information Form, which includes the sociodemographic characteristics of the patients, the characteristics of the disease and sleep habits, the Fatigue Severity Scale, the Fatigue Impact Scale and the Pittsburgh Sleep Quality Index and wearable technology. Data were analysed with Statistical Package for the Social Sciences (SPSS) V23 and R software. In addition to descriptive analyses, In addition to descriptive analyses, multiple comparisons by group and time were performed using generalised linear model analyses.

Interventions

OTHERProgressive relaxation exercise

For the progressive relaxation exercise group, a progressive relaxation exercise session will be applied to the participants 3 times a week for four weeks.

For the music listening group, the participants will listen to the Turkish music makams (uşşak and rast) three times a week for four weeks.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Being between the ages of 18-65, * Having a diagnosis of MS for at least six months and being in remission * To be between 0-3.5 points on the Expanded Disability Status Scale (EDSS), * Having the disease type Relapsing Remitting (RRMS), * Having a score of 4 or more on the Fatigue Severity Scale, (In the Fatigue Severity Scale, 4 points is the cut-off value and scores of 4 and above indicate pathological fatigue.) * Having a score above 5 on the Pittsburgh Sleep Quality Index, (A total score of \>5 indicates that the sleep quality of the individual is inadequate.) * To be residing in Samsun,Turkey, * Having the ability to use technology with computer/phone and internet facilities, * To voluntarily accept participation in research.

Exclusion criteria

* Having a chronic disease other than MS, * Having a sleep disorder diagnosed for different reasons, * To be diagnosed with a psychiatric disorder that may prevent obtaining a healthy result from the study and affect sleep (Major depressive disorder, serious anxiety disorders, severe psychiatric conditions, etc.), * Using a regular non-pharmacological method (Yoga, psychotherapy, etc.) for sleep and fatigue

Design outcomes

Primary

MeasureTime frameDescription
The effect of progressive relaxation exercise and listening to music on sleep qualitytwo and four weeks after starting the interventionIt will be measured with the Pittsburgh Sleep Quality Index
The effect of progressive relaxation exercise and listening to music on fatiguetwo and four weeks after starting the interventionIt will be measured with the Fatigue Severity Scale
The effect of progressive relaxation exercise and listening to music on fatigue effecttwo and four weeks after starting the interventionIt will be measured with the Fatigue Impact Scale
The effect of progressive relaxation exercise and listening to music on sleeptwo and four weeks after starting the interventionIt will be measured with the Wearable Tecnology

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026