Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06468241 |
| Other study ID # |
OMU-AHSENTASTANGURKAN-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2023 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
