Music Therapy for Sickle Cell Disease (MULTI-MUSIQOLS Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByJeffery A Dusek, PhD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adolescents and adults aged 14 or older with sickle cell disease. It's designed to see if music therapy can improve their quality of life. Participants will be split into groups, some getting in-person music therapy, others a mix of in-person and virtual sessions, or health education as a comparison.

Inclusion Criteria

I am 14 years old or older.

My electronic health record shows I have sickle cell disease.

Exclusion Criteria

I have a major issue with my sight, hearing, or thinking.

I have a major medical event planned within the next 14 weeks, not including blood transfusions or pain treatments.

Participant Groups

The study tests the feasibility of music therapy versus health education for sickle cell patients through three different setups: all in-person sessions, a hybrid of one in-person followed by virtual sessions, and one in-person plus virtual health education. Success is measured by six specific goals like attendance and data collection.

3Treatment groups

Experimental Treatment

Active Control

Group I: InMTExperimental Treatment1 Intervention

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).

Group II: HybMTExperimental Treatment1 Intervention

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).

Group III: HybHEActive Control1 Intervention

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).