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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart rate synchronized motor imagery music therapy | Experimental | Participants included in this group will imagine the movements presented to them with a metronome sound in a rhythm synchronized with their heart rate. |
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| Heart rate synchronized music therapy | Active Comparator | Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate synchronized motor imagery music therapy | Behavioral | Participants included in this group will listen a metronome sound in a rhythm synchronized with their heart rate. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hilal Karakas | Contact | 05466017860 | hilalkrkas58@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Bilgi University | Recruiting | Istanbul | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41791797 | Derived | Karakas H, Ertekin O, Yavas I, Gozubatik-Celik RG, Kazdagli H, Seebacher B, Kahraman T. Effect of Telerehabilitation-Based Music Therapy and Motor Imagery on Pain, Autonomic Function, and Psychosocial Outcomes in People With Multiple Sclerosis: A Randomized Controlled Trial Protocol. Physiother Res Int. 2026 Apr;31(2):e70186. doi: 10.1002/pri.70186. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Heart rate synchronized music therapy | Behavioral | Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate. |
|
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |