MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)

Study Overview
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Brief Summary
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The purpose of this pilot study is to investigate the effects of a 6-session music therapy protocol on the pain, mood, quality of life, coping skills, and self-efficacy of adult patients with sickle cell disease (SCD) as compared to adult patients with SCD who receive standard care alone. The investigators will also determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management and quality of life.

Official Title
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MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS): A Pilot Study

Conditions
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Sickle Cell Disease, Chronic Pain

Intervention / Treatment
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* Other: Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years or older Subject has a SCD diagnosis Subject fits chronic pain criteria in SCD Subject has a working email address Subject has access to a mobile device with email and internet capabilities Subject is able to speak and understand English Subject has attended at least 50% of his/her scheduled outpatient visits to the Adult SCD Clinic in the last 12 months Exclusion Criteria: Subject has a significant visual impairment that has not been corrected Subject has a significant hearing impairment that has not been corrected Subject has a significant cognitive impairment that would prevent subject from participating in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy Group<br>Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home. | Other: Music Therapy<br>* Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home.<br>|
| No Intervention: Wait-List Control Group<br>Patient receives standard care alone. Patient will receive music therapy sessions following completion of the post-test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a | Physical function (4 questions) | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) | A patient-reported outcome measurement system that addresses the physical, social, and emotional impact of SCD. ASCQ-Me scores are calculated in the direction of overall health, with higher ASCQ-Me scores indicating better health. | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a | Anxiety (4 questions) | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a | Depression (4 questions) | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a | Fatigue (4 questions) | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a | Ability to participate in social roles and activities (4 questions) | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a | Pain interference (4 questions) | Pre-test at baseline and post-test at 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES) | A nine-item Likert scale originally developed for adults with SCD to assess patients' beliefs in their ability to manage their own SCD. | Pre-test at baseline and post-test at 10 weeks | 
| Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD) | 80-item questionnaire that assesses coping strategies relevant to SCD | Pre-test at baseline and post-test at 10 weeks | 
| Electronic Sickle Cell Disease Pain Diary | A multidimensional pain diary assessing daily pain intensity, location, description, cause, and interference with daily activities | Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention | 
| Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a | Sleep disturbance (4 questions) | Pre-test at baseline and post-test at 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain