Using music therapy to improve quality of life in sickle cell disease

MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease (MULTI-MUSIQOLS)

This study is testing if music therapy can help improve the quality of life for teenagers and adults with sickle cell disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Locations: 2 sites (Cleveland, Ohio and 1 other locations)
• Trial ID: NCT06853158 on ClinicalTrials.gov

What this trial studies

This clinical trial examines the feasibility of music therapy as an intervention for adolescents and adults with sickle cell disease. Participants will be randomly assigned to one of three groups: in-person music therapy, a hybrid of in-person and virtual music therapy, or hybrid health education. The study aims to evaluate the implementation of these interventions through both quantitative and qualitative data collection over a period of 6 to 8 weeks. The primary focus is on assessing the feasibility of the study based on various metrics such as participant recruitment and retention.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 14 years or older with a confirmed diagnosis of sickle cell disease and chronic pain.

Not a fit: Patients without a diagnosis of sickle cell disease or those who do not experience chronic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life for patients with sickle cell disease through innovative therapeutic approaches.

How similar studies have performed: While the specific approach of using music therapy for sickle cell disease is novel, similar studies in other conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Be aged \>=14 years old
2. Have a diagnosis of SCD present in their electronic health record (EHR);
3. Meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain which includes:

3a. A diagnosis of SCD confirmed by laboratory testing (present in EHR per eligibility criteria 2)

3b. Reports of ongoing pain present on most days over the past 6 months either in a single location or in multiple locations (to be obtained at screening)

3c. Displaying at least one of the following signs on clinical exam (to be obtained from providers' clinical notes in the EHR

* Palpation of the region of reported pain elicits focal pain or tenderness;
* Movement of the region of reported pain elicits focal pain;
* Decreased range of motion or weakness in the region of reported pain;
* Evidence of skin ulcer in the region of reported pain;
* Evidence of hepatobiliary or splenic imaging abnormalities (e.g., splenic infarct, chronic pancreatitis) consistent with the region of reported pain; or
* Evidence of imaging abnormalities consistent with bone infarction or avascular necrosis in the region of reported;

  3d. There is no other diagnosis that better explains the signs and symptoms (to be obtained from providers following referral and pre-screening)

  4\. Be able to speak and understand English;

  5\. Have an email address and access to mobile device with a functioning data plan

  6\. Reporting that pain interfered with daily activities at least 1-2 days in the past week.

Exclusion Criteria:

1. Have a significant visual, hearing, or cognitive impairment
2. Have previously participated in the MUSIQOLS single-site pilot study at University Hospitals in 2018
3. Are currently engaging in mind-body therapies under the supervision of a healthcare professional specifically for pain management
4. Have a planned major medical event in the next 14 weeks such as (but not limited to) childbirth, orthopedic surgery, gene therapy, or stem cell transplant (These criteria do not include blood transfusions, exchange transfusions, or other pharmacologic pain treatment).

Qualitative interviews will be conducted with \~24 participants who received the interventions (with equal numbers across the InMT, HybMT and HybHE groups). Participants will be purposively sampled to include equal distribution across sites in proportion to recruitment.

Stakeholder surveys and qualitative interviews will be conducted among \~20 relevant staff stakeholders (\~10 per site), including healthcare providers \& staff, music therapists and HybHE interventionists.

Where this trial is running

Cleveland, Ohio and 1 other locations

• UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center — Cleveland, Ohio, United States (Recruiting)
• Prisma Health Lifespan Comprehensive SCD Program — Greenville, South Carolina, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Jeffery A Dusek, PhD — University of California, Irvine
• Study coordinator: Jeffery A Dusek, PhD

Conditions Sickle Cell Disease; feasibility, music therapy, QoL, Sickle cell