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

NCT07562451 | Not Yet Recruiting

• 1 other identifier: 2025P012013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Keywords

Music therapy; Pain control; Sickle cell disease

Outcome Measures

Primary Outcomes (2)

• Change in Pain characteristics

  The Brief Pain Inventory (BPI) is a validated self-report questionnaire that measures both the severity of pain and the degree to which pain interferes with daily activities. Pain intensity is rated on a 0-10 numeric scale (0 = no pain, 10 = worst pain imaginable). Pain interference items are also scored 0-10 (0 = does not interfere, 10 = completely interferes). Greater scores indicate more severe pain and greater interference with daily activities.

  Baseline, Week 5

• Change in Health-related quality of life (HRQoL)

  Parents will complete the Pediatric Quality of Life Inventory (PedsQL) at baseline and Week 5. This parent-proxy measure assesses physical, emotional, social, and school functioning. Changes in HRQoL scores will be analyzed to determine whether music therapy improves overall well-being compared to control. Scoring: Items are scored on a 0-100 scale, with higher scores reflecting better quality of life (less impairment). Lower scores indicate poorer functioning across physical, emotional, social, and school domains.

  Baseline, Week 5

Secondary Outcomes (5)

• Change in Depressive Symptoms

  Baseline, Week 5

• Change in General Anxiety Disorder scale scores

  Baseline, Week 5

• Change in Psychological Stress

  Baseline, Week 5

• Change in Physical stress

  Baseline, Week 5

• Hospital utilization

  4 weeks

Other Outcomes (1)

• Gene expression changes in immune cells

  Baseline, Week 5

Study Arms (2)

Music Therapy group

EXPERIMENTAL

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).

Other: Music Therapy

Control group

SHAM COMPARATOR

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)

Other: Standard of Care

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).

Also known as: MT

Music Therapy group

Standard of Care OTHER

Routinely available educational material on sickle cell disease management and a healthy lifestyle.

Control group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Major hearing deficiency or medical condition in which listening to music may be contraindicated (e.g., reflex epilepsy).

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30324, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Agnosia

Interventions

Music Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Manoj Bhasin

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Bhasin, PhD

CONTACT

404-712-9849; manoj.bhasin@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following publication
• Access Criteria: Investigators whose proposed use of the data is provided in a formal written request, has been approved by the IRB, and receives explicit PI approval. Proposals may be submitted up to 36 months following publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)