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NCT06853158 · ClinicalTrials.gov registry record · NA
MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease
A NA study of Sickle Cell Disease, sponsored by University of California, Irvine.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT06853158: Recruiting NA study of Sickle Cell Disease, sponsored by University of California, Irvine.
NCT06853158 is a NA study of Sickle Cell Disease that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 90 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06853158, a NA study of Sickle Cell Disease, is actively recruiting participants, sponsored by University of California, Irvine.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
There are 6 feasibility metrics: (1) Data quality (90%), (2) Screening rate (35%), (3) Recruitment rate (90%), (4) Retention rate (70%), (5) Individual attendance (70%) and (6) Home practice (70%). A final determination of "feasibility" for the study will be met if any 4 of the 6 metrics are met.
Conditions Studied
Interventions
- BEHAVIORAL Music therapy
- OTHER Health education
Study Locations (2)
Ohio
- UH Seidman Cancer Center Adult SCD Clinic or UH Rainbow Babies and Children's Hospital Sickle Cell Anemia Center - Cleveland
South Carolina
- Prisma Health Lifespan Comprehensive SCD Program - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-04-02 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What NCT06853158 shows while recruiting
NCT06853158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Music therapy is the first listed.
NCT06853158 reports a single indexed study location in Ohio, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06853158 about?
NCT06853158 is a clinical study titled "MULTIsite Feasibility of MUSIc Therapy to Address Quality Of Life in Sickle Cell Disease". 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 visit...
What is the current status of trial NCT06853158?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2025-04-02. Estimated completion is 2027-01-31.
What conditions does trial NCT06853158 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06853158?
The interventions under investigation include: Music therapy (BEHAVIORAL), Health education (OTHER).
Who is sponsoring clinical trial NCT06853158?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06853158 being conducted?
This trial has 2 study locations across Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06853158's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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