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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Emory University • ClinicalTrials.gov ID: NCT07562451

Registry updated: 2026-09-10
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Description

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.

Interventions

  • Music Therapy (Other)
    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 participants personal device and participants will be instructed to complete daily MT sessions under optimal conditions (i.e., lying down, eyes closed, low lighting).
  • Standard of Care (Other)
    Routinely available educational material on sickle cell disease management and a healthy lifestyle.

Eligibility criteria

Inclusion Criteria: * 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: 1. Persistent or recurrent for ≥ 3 months 2. is associated with significant emotional distress or functional disability.30 Exclusion Criteria: * Major hearing deficiency or medical condition in which listening to music may be contraindicated (e.g., reflex epilepsy).

Conditions

Sickle Cell Disease

Locations

  • Children's Healthcare of Atlanta — Atlanta, Georgia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record