Effect of Music Therapy on Pain in People With Multiple Sclerosis

Effect of Telerehabilitation-Based Heart Rate-Synchronized Motor Imagery Music Therapy on Pain, Autonomic Function and Psychosocial Parameters in People With Multiple Sclerosis

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, MS
• Intervention / Treatment: Behavioral: Heart rate synchronized motor imagery music therapy; Behavioral: Heart rate synchronized music therapy

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilal Karakas; Phone Number: 05466017860; Email: hilalkrkas58@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye)
      • Recruiting
      • Istanbul Bilgi University
      • Contact: Phone Number: 05466017860

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart rate synchronized motor imagery music therapy; Participants included in this group will imagine the movements presented to them with a metronome sound in a rhythm synchronized with their heart rate.	Behavioral: Heart rate synchronized motor imagery music therapy; Participants included in this group will listen a metronome sound in a rhythm synchronized with their heart rate.
Active Comparator: Heart rate synchronized music therapy; Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate.	Behavioral: Heart rate synchronized music therapy; Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate.
No Intervention: Control group; Participants included in this group will continue their routine treatment and will only be evaluated three times: at the beginning, after 8 weeks and after 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	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.	Baseline, week 8 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PainDETECT	'PainDETECT' will be used to assess neuropathic pain in people with MS participating in the study.	Baseline, week 8 and week 12
Nordic Musculoskeletal Questionnaire	The 'Nordic Musculoskeletal Questionnaire' will be used to assess the pain of MS patients participating in the study according to their body regions.	Baseline, week 8 and week 12
Central Sensitization Questionnaire- Short Form	The Central Sensitization Questionnaire-Short Form is a participant-reported measurement tool designed to assess the presence of central sensitization and its associated symptoms.	Baseline, week 8 and week 12
Modified Fatigue Impact Scale	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.	Baseline, week 8 and week 12
Hospital Anxiety and Depression Scale	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.	Baseline, week 8 and week 12
Preference Based MS Index	The Preference-Based MS Index will be used to assess patient-reported health-related quality of life.	Baseline, week 8 and week 12
Pittsburgh Sleep Quality Index	The subjective sleep quality of individuals with MS participating in the study will be evaluated using the 'Pittsburg Sleep Quality Index (PSQI)'.	Baseline, week 8 and week 12
Heart Rate Variability	Heart rate variability is an important parameter of cardiac autonomic modulation and provides information about the autonomic nervous system functions of individuals.	Baseline, week 8 and week 12
Paced Auditory Serial Addition Test	Paced Auditory Serial Addition Test (PASAT) will be used to assessment the cognitive functions of the participants included in the study.	Baseline, week 8 and week 12

Collaborators and Investigators

• Sponsor: Istanbul Bilgi University
• Collaborators: Scientific and Technological Research Council of Turkey (TÜBİTAK)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Music Therapy in Multiple Sclerosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: MusicTherapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No