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

Not Applicable
Completed
Conditions
Fatigue
Sleep
Multiple Sclerosis
Interventions
Other: Progressive relaxation exercise
Other: Listening to music
Registration Number
NCT06468241
Lead Sponsor
Ondokuz Mayıs University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Progressive relaxation exercise groupProgressive relaxation exerciseprogressive relaxation exercise intervention and measurement with scales and wearable technology
Music groupListening to musicmusic listening intervention and measurement with scales and wearable technology
Primary Outcome Measures
NameTimeMethod
The effect of progressive relaxation exercise and listening to music on sleeptwo and four weeks after starting the intervention

It will be measured with the Wearable Tecnology

The effect of progressive relaxation exercise and listening to music on sleep qualitytwo and four weeks after starting the intervention

It will be measured with the Pittsburgh Sleep Quality Index

The effect of progressive relaxation exercise and listening to music on fatigue effecttwo and four weeks after starting the intervention

It will be measured with the Fatigue Impact Scale

The effect of progressive relaxation exercise and listening to music on fatiguetwo and four weeks after starting the intervention

It will be measured with the Fatigue Severity Scale

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ondokuz Mayıs University

🇹🇷

Samsun, Turkey

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