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

July 13, 2024 updated by: Ahsen Taştan Gürkan, Ondokuz Mayıs University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Ondokuz Mayıs University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive relaxation exercise group
progressive relaxation exercise intervention and measurement with scales and wearable technology
Other: Progressive 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.
Experimental: Music group
music listening intervention and measurement with scales and wearable technology
Other: Listening to music
For the music listening group, the participants will listen to the Turkish music makams ("uşşak" and "rast") three times a week for four weeks.
No Intervention: Control group
No intervention and measurement with scales and wearable technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of progressive relaxation exercise and listening to music on sleep quality
Time Frame: two and four weeks after starting the intervention
It will be measured with the Pittsburgh Sleep Quality Index
two and four weeks after starting the intervention
The effect of progressive relaxation exercise and listening to music on fatigue
Time Frame: two and four weeks after starting the intervention
It will be measured with the Fatigue Severity Scale
two and four weeks after starting the intervention
The effect of progressive relaxation exercise and listening to music on fatigue effect
Time Frame: two and four weeks after starting the intervention
It will be measured with the Fatigue Impact Scale
two and four weeks after starting the intervention
The effect of progressive relaxation exercise and listening to music on sleep
Time Frame: two and four weeks after starting the intervention
It will be measured with the Wearable Tecnology
two and four weeks after starting the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMU-AHSENTASTANGURKAN-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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