NCT06468241Completed
The Effect of Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis
The Effect of Listening to Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis: A Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 1 Aug 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Ondokuz Mayıs University
- Diseases
- Multiple sclerosis
- NCT number
- NCT06468241
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 15 Aug 2023 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.),
Other
- Using a regular non-pharmacological method (Yoga, psychotherapy, etc.) for sleep and fatigue
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ondokuz Mayıs University Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.