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

CompletedNot a drug-phase studyRelapsing MSNCT06468241

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Progressive relaxation exercise
  • Listening to music

What it measured

Main measures

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

    two and four weeks after starting the intervention

    Physical functionMood and sleep
  • The effect of progressive relaxation exercise and listening to music on fatigue

    two and four weeks after starting the intervention

    FatiguePhysical function
  • The effect of progressive relaxation exercise and listening to music on fatigue effect

    two and four weeks after starting the intervention

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

    two and four weeks after starting the intervention

    Physical functionMood and sleep

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Aug 2023

    2. Main results due

      Dec 2023

    3. Finished

      Apr 2024

    Assembled by software from public sources.