Effect of Music Therapy on Pain in People With Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis, MS

• Registration Number: NCT06800144
• Lead Sponsor: Istanbul Bilgi University

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and progressive neurological disease of the central nervous system, often seen between the ages of 20-30. Pain is a very common symptom in people with MS, with a prevalence of 63%. Pain in MS is a symptom that negatively affects individuals' fatigue, anxiety and depression levels, quality of life and sleep quality. In addition, chronic pain affects individuals' autonomic and cognitive functions. Music therapy is defined as the systematic use of music in a therapeutic relationship that aims to improve, maintain and develop emotional, physical and mental health. Music therapy protocols synchronized with heart rate can be effective on chronic pain through the regulation of the autonomic nervous system and activation of the parasympathetic nervous system. Studies indicate that music therapy, regardless of the population applied, is effective in the management of symptoms such as pain, depression and anxiety. Motor imagery training is a method that regulates cerebral cortex activity by exposing the brain to visual information and imagination, reduces abnormal cortical activation, and thus restores the brain's ability to change. Research indicates that the most effective motor imagery training in reducing pain is motor imagery training presented in a protocol graded from simple to complex motor tasks.

The grading principle applied in motor imagery training in the form of imagining movements from simple to complex and music therapy training presented in a rhythm matched with heart rate rhythm are effective approaches on chronic pain. It is thought that the treatment protocol in which these two methods are combined and their therapeutic effects are combined in MS rehabilitation may be more effective on pain and related factors in MS. The aim of the study is to show the effects of telerehabilitation-based heart rate-synchronized music therapy protocols on pain, heart rate, fatigue, anxiety, depression, quality of life, sleep quality, and information processing speed compared to MS individuals who continue their routine treatments.

45 MS people with chronic pain will be included in the planned randomized controlled trial. The included participants will be randomized into 3 groups with 15 participants in each group. The evaluations will be performed three times before treatment, at 8th (post-treatment evaluation) and 12th weeks (follow-up evaluation). The participants' general pain intensity in the last 2 and 7 days, the presence of neuropathic pain, fatigue level, anxiety and depression levels, sleep quality, health-related quality of life and information processing speed will be evaluated. In addition, heart rate variability will be evaluated in order to evaluate the participants' autonomic functions. Telerehabilitation-based music therapy application will be given to the participants 2 days a week for 8 weeks using a videoconferencing platform under the guidance of a physiotherapist. The heart rates of the participants will be monitored throughout the session. The participants included in the first group will visualize the movements presented with the metronome sound in a rhythm matched to their heart rates, while the participants included in the second group will listen to relaxing/relaxing music without lyrics in a rhythm matched to their heart rates. When synchronization is achieved between the music rhythm and the heart rate in both groups, the music rhythm will be reduced. Participants included in the 3rd group will continue their routine treatment and will be evaluated only three times: at the beginning, after the 8th week and after the 12th week. The results obtained from this study will examine the effects of heart rate synchronized music therapy protocols on pain, autonomic function and psychosocial parameters in individuals with chronic pain and MS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Study Start: 2025-07-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Being between the ages of 18-65.
• Having a definite MS diagnosis according to the 2017 McDonald criteria.
• Having a pain level of at least 3 and above on the numerical pain scale for at least 3 months.
• Not having had an attack in the last 3 months.
• Having a tablet or computer with an active internet connection that is suitable for videoconferencing.
• Having a smartphone to which the heart rate monitor can be connected with the Bluetooth feature so that the heart rate synchronized music therapy training can be given.
• Having sufficient smartphone/tablet or computer knowledge to participate in the study or having a relative who can help in this regard.
• No change in the medications used for pain in the last 2 months.
• Not receiving any additional treatment other than routine treatments.
• Being able to read and understand Turkish.

Exclusion Criteria

• Having a serious musculoskeletal, cardiovascular, pulmonary, metabolic or other disease that would prevent participation in the study.
• Having a condition other than MS that can cause pain, such as cancer, diabetes, significant osteoarthritis or rheumatoid arthritis, based on laboratory or imaging findings
• Having a psychiatric disease (such as active psychotic disorders, severe depression, anxiety disorders) that would prevent participation in the study and having a serious cognitive disorder determined by a physician that would prevent testing
• Having a serious vision or hearing problem.
• Being pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Baseline, week 8 and week 12	The general pain intensity felt by people with MS participating in the study in the last 2 and 7 days will be assessed using the Visual Analogue Pain Scale. The scale ranges from 0 mm to 100 mm, with higher values indicating greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
PainDETECT	Baseline, week 8 and week 12	'PainDETECT' will be used to assess neuropathic pain in people with MS participating in the study.
Nordic Musculoskeletal Questionnaire	Baseline, week 8 and week 12	The 'Nordic Musculoskeletal Questionnaire' will be used to assess the pain of MS patients participating in the study according to their body regions.
Central Sensitization Questionnaire- Short Form	Baseline, week 8 and week 12	The Central Sensitization Questionnaire-Short Form is a participant-reported measurement tool designed to assess the presence of central sensitization and its associated symptoms.
Modified Fatigue Impact Scale	Baseline, week 8 and week 12	The 'Modified Fatigue Impact Scale', which is frequently used in clinical and experimental studies, will be used to determine the fatigue level of people with MS participating in the study. The scale ranges from 0 to 84, with higher values representing increased levels of fatigue.
Hospital Anxiety and Depression Scale	Baseline, week 8 and week 12	The 'Hospital Anxiety and Depression Scale' will be used to evaluate the anxiety and depression levels of people with MS participating in the study. The questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Preference Based MS Index	Baseline, week 8 and week 12	The Preference-Based MS Index will be used to assess patient-reported health-related quality of life.
Heart Rate Variability	Baseline, week 8 and week 12	Heart rate variability is an important parameter of cardiac autonomic modulation and provides information about the autonomic nervous system functions of individuals.
Paced Auditory Serial Addition Test	Baseline, week 8 and week 12	Paced Auditory Serial Addition Test (PASAT) will be used to assessment the cognitive functions of the participants included in the study.
Pittsburgh Sleep Quality Index	Baseline, week 8 and week 12	The subjective sleep quality of individuals with MS participating in the study will be evaluated using the 'Pittsburg Sleep Quality Index (PSQI)'.