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Assessing Molecular Mechanisms and Effects of Music Therapy in Youth With Sickle Cell Disease Using Single-cell RNA-sequencing

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate whether a 4-week music therapy (MT) intervention can reduce chronic pain and improve psychosocial outcomes in youth with sickle cell disease (SCD). The main questions it aims to answer are: * Does MT reduce pain intensity, frequency of pain episodes, and improve health-related quality of life (HRQoL)? * Does MT alter immune cell composition and gene expression in inflammatory pathways, as measured by single-cell RNA sequencing (scRNA-seq)? Researchers will compare participants randomized to music therapy versus a control condition to see if MT produces superior improvements in pain and psychosocial outcomes, and distinct molecular changes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with SCD

• English fluency (for survey completion)

• Have access to a personal electronic device (e.g., phone, tablet) with access to the internet

• Meet the criteria for chronic pain defined by the International Association for the Study of Pain (IASP). IASP defines chronic pain as pain that is both:

‣ Persistent or recurrent for ≥ 3 months

⁃ is associated with significant emotional distress or functional disability.30

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Contact Information
Primary
Manoj Bhasin, PhD
manoj.bhasin@emory.edu
404-712-9849
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 25
Treatments
Experimental: Music Therapy group
The MT group will engage in 20-minute daily virtual music therapy sessions for 4 weeks, using the freely available Music Care© app (manufactured by MUSIC CARE) to independently participate in electronic music therapy following the U sequence. This app is voluntarily downloaded onto a participant's personal device, and participants will be instructed to complete daily MT sessions under optimal conditions (i.e., lying down, eyes closed, low lighting).
Sham_comparator: Control group
The control group will be asked to engage with educational material for 20 minutes daily. There will be no restrictions for research subjects in regards to listening to music under other conditions (e.g., phone, radio, concert, etc)
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Emory University

This content was sourced from clinicaltrials.gov