Recruiting

MUSIc Therapy

Sponsor:

UCLA

Code:

NCT06853158

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Music therapy

Health education

Study Details

Brief summary:

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

Sickle Cell Disease

Study ID

NCT06853158

Start date

Apr 2, 2025

Status verified date

Jan, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: InMT

Participants in the InMT will receive 6 in-person MT sessions at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center).

experimental: HybMT

Individuals randomized to Hybrid MT will receive 1 in-person MT session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual MT sessions over secure telehealth platform (e.g. Zoom Health Professional).

active comparator: HybHE

Participants in the HybHE condition will receive 1 in-person health education session at the SCD center main campus, satellite campus, or another location preferred by the participant (e.g., community center) and 5 virtual sessions over secure telehealth platform (e.g. Zoom Health Professional).

Interventions

Music therapy

Participants in the 2 experimental MT conditions (In person MT (InMT) or hybrid (inperson.virtual (HybMT) will receive 6 MT sessions over 6 weeks. Each MT session will last no longer than one hour. This 6-week treatment period may be extended to up to 8 weeks if a scheduling conflict prevents a participant from receiving the 6 MT sessions over 6 consecutive weeks.

Health education

The content for the HybHE control was adapted from Project PEEP: Patients Empowered and Educated Providers. The Sickle Cell Community Consortium developed Project PEEP with a grant from Global Blood Therapeutics. Project PEEP addresses unmet needs directly identified and prioritized by a collective of patients with SCD, caregivers, and community-based organizations. The objective is to provide the tools and resources to improve communication and increase positive patient-provider interactions to receive quality, timely care. For the proposed study, we will use modules from the curriculum developed for patients living with SCD.

Primary outcome measure

  • Multi Musiqols Overall Feasibility (achieving 4/6 of the secondary outcomes). [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Jeffery A Dusek, PhD

949-824-8841jdusek@hs.uci.edu

Coretta Jenerette, PhD, RN

415-502-4242Coretta.Jenerette@ucsf.edu

Locations

UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Amma Owusu-Ansah, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • feasibility, music therapy, QoL, Sickle cell

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-01-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.