MUSic Therapy to Improve Quality Of Life in Sickle Cell Disease (MUSIQOLS)
- Conditions
- Sickle Cell DiseaseChronic Pain
- Interventions
- Other: Music Therapy
- Registration Number
- NCT03556657
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Music Therapy Group Music Therapy 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.
- Primary Outcome Measures
Name Time Method Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a Pre-test at baseline and post-test at 10 weeks Physical function (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression - Short Form 4a Pre-test at baseline and post-test at 10 weeks Depression (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a Pre-test at baseline and post-test at 10 weeks Fatigue (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a Pre-test at baseline and post-test at 10 weeks Ability to participate in social roles and activities (4 questions)
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a Pre-test at baseline and post-test at 10 weeks Pain interference (4 questions)
Change from baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pre-test at baseline and post-test at 10 weeks 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.
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form 4a Pre-test at baseline and post-test at 10 weeks Anxiety (4 questions)
- Secondary Outcome Measures
Name Time Method Change from baseline in Sickle Cell Self-Efficacy Scale (SCSES) Pre-test at baseline and post-test at 10 weeks A nine-item Likert scale originally developed for adults with SCD to assess patients' beliefs in their ability to manage their own SCD.
Change from baseline in Coping Skills Questionnaire - Sickle Cell Disease (CSQ-SCD) Pre-test at baseline and post-test at 10 weeks 80-item questionnaire that assesses coping strategies relevant to SCD
Electronic Sickle Cell Disease Pain Diary Daily entries for 2 weeks at baseline and daily entries for 2 weeks post-intervention A multidimensional pain diary assessing daily pain intensity, location, description, cause, and interference with daily activities
Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a Pre-test at baseline and post-test at 10 weeks Sleep disturbance (4 questions)
Trial Locations
- Locations (1)
University Hospitals Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States