Chronic Pain, Sickle Cell Disease
Conditions
Keywords
Music Therapy, Sickle Cell Disease, Quality of Life, Chronic Pain
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.
Interventions
OTHERMusic 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.
Sponsors
Kulas Foundation
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) Physical Function Short Form 4a | Pre-test at baseline and post-test at 10 weeks | Physical function (4 questions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Semi-structured interview | At post-test at 10 weeks | Interview questions will focus on the patient's current pain, his/her experience of the music therapy sessions, and whether anything could have been done differently to improve the music therapy sessions. |
Countries
United States
Outcome results
None listed