Actively Recruiting
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
Led by University of California, Irvine · Updated on 2026-01-29
90
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-site, multi-visit feasibility RCT of music therapy (MT) among adolescent and adult patients (aged 14 and older) with sickle cell disease (SCD). Subjects will be randomized into one of three groups, either (1) 6 visits of in- person MT (InMT:); (2) 1 visit of in-person MT and 5 visits of virtual MT (HybMT); or (3) 1 visit of in-person health education and 5 visits of virtual health education (HybHE). Cohorts of 15 participants (10 at site 1 and 5 site 2) will be recruited each quarter for 6 quarters to reach 90 participants. Cohorts will maintain a semi-structured recruitment, consenting, assessment, and intervention schedule. The primary objective of the study is to examine the feasibility of study. This is defined by 6 metrics: (1) completeness of data collection, (2) participant screening, (3) participant recruitment, (4) participant retention, (5) Individual attendance and (6) Home practice. A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics described above are met. This study will also include a secondary objective of conducting qualitative interviews to assess feasibility of implementation.
CONDITIONS
Official Title
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be aged 14 years or older
- Have a diagnosis of sickle cell disease recorded in electronic health records
- Meet criteria for chronic sickle cell disease pain, including ongoing pain on most days over the past 6 months
- Show at least one clinical sign related to the pain area, such as tenderness, decreased motion, skin ulcers, or imaging abnormalities
- Have no other diagnosis better explaining the pain symptoms
- Be able to speak and understand English
- Have an email address and access to a mobile device with a working data plan
- Report pain interfering with daily activities at least 1-2 days in the past week
You will not qualify if you...
- Have a significant visual, hearing, or cognitive impairment
- Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
- Currently participate in mind-body therapies supervised for pain management
- Have a planned major medical event in the next 14 weeks such as childbirth, orthopedic surgery, gene therapy, or stem cell transplant (excluding blood transfusions or pharmacologic pain treatments)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
Prisma Health Lifespan Comprehensive SCD Program
Greenville, South Carolina, United States, 29605
Not Yet Recruiting
Research Team
J
Jeffery A Dusek, PhD
CONTACT
C
Coretta Jenerette, PhD, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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