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

NCT06468241 | Completed DMC

• 1 other identifier: OMU-AHSENTASTANGURKAN-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Fatigue; Sleep

Keywords

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

Outcome Measures

Primary Outcomes (4)

• The effect of progressive relaxation exercise and listening to music on sleep quality

  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

  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

  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

  It will be measured with the Wearable Tecnology

  two and four weeks after starting the intervention

Study Arms (3)

Progressive relaxation exercise group

EXPERIMENTAL

progressive relaxation exercise intervention and measurement with scales and wearable technology

Other: Progressive relaxation exercise

Music group

EXPERIMENTAL

music listening intervention and measurement with scales and wearable technology

Other: Listening to music

Control group

NO INTERVENTION

No intervention and measurement with scales and wearable technology

Interventions

Progressive relaxation exercise OTHER

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

Progressive relaxation exercise group

Listening to music OTHER

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

Music group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: June 21, 2024
• Study Start: August 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: April 15, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

TU (1)