Viewing Study NCT06468241



Ignite Creation Date: 2024-07-17 @ 10:59 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06468241
Status: COMPLETED
Last Update Posted: 2024-06-21
First Post: 2023-08-01

Brief Title: The Effect of Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis
Sponsor: Ondokuz Mayıs University
Organization: Ondokuz Mayıs University

Study Overview

Official Title: The Effect of Listening to Music and Progressive Relaxation Exercise on Fatigue and Sleep in Multiple Sclerosis A Randomized Controlled Study
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None