The Effect of Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis
NCT Number: NCT06468241
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis|Fatigue|Sleep
Interventions: OTHER: Progressive relaxation exercise|OTHER: Listening to music
Sponsor: Ondokuz Mayıs University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-15
Completion Date: 2024-04-15
Locations: Ondokuz Mayıs University, Samsun, Turkey

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.

Primary Outcome Measures: 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