Music Intervention for Preterm Birth

Not Applicable

Suspended

• Conditions: Preterm Birth
• Interventions: Other: Sham Control (SC); Behavioral: Music Intervention (MI)

• Registration Number: NCT05945264
• Lead Sponsor: Columbia University

Brief 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.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2025-01-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-05-30
• Study Completion: 2029-08-29

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

Not provided

Exclusion Criteria

• Non-pregnant women
• Women with a chronic medical condition that could impact pregnancy health or duration
• Women regularly taking any medications other than prenatal vitamins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control (SC) Group	Sham Control (SC)	Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).
Music Intervention (MI) Group	Music Intervention (MI)	Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.

Primary Outcome Measures

Name	Time	Method
Score on the Perceived Stress Scale (PSS)	Week 10	The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Mean Gestational Age	Up to 43 weeks	Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.

Trial Locations

Locations (2)

Louis Armstrong Center for Music and Medicine at Mount Sinai Health System; 🇺🇸 New York City, New York, United States

Columbia University Irving Medical Center/NYP; 🇺🇸 New York, New York, United States