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NCT07562451
Assessing Molecular Mechanisms and Effects of Music Therapy in Youth With Sickle Cell Disease Using Single-cell RNA-sequencing
Conditions: Sickle Cell Disease
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Emory University
Location: Children's Healthcare of Atlanta Atlanta Georgia
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 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).
Source: ClinicalTrials.gov (NCT07562451). StuddyBuddy aggregates publicly available trial information.