NCT05945264

Music Intervention for Preterm Birth

The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Detailed description

Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
BEHAVIORAL	Music Intervention (MI)	The intervention will involve listening, playing and/or singing melodies or songs, that are meaningful to the participant, with interpretation/reflection on their relevance/capacity to alter stress.
OTHER	Sham Control (SC)	The intervention will be to support a woman to talk about anything she wants that is important to her.

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-07-30
• Completion: 2027-08-29
• First posted: 2023-07-14
• Last updated: 2026-02-10

Locations

2 sites across 1 country: United States