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
3 other identifiers
interventional
142
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 29, 2027
February 10, 2026
February 1, 2026
1.4 years
July 6, 2023
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Score on the Perceived Stress Scale (PSS)
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.
Week 1
Score on the Perceived Stress Scale (PSS)
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.
Week 5
Score on the Perceived Stress Scale (PSS)
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.
Week 10
Mean Gestational Age
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Up to 43 weeks
Study Arms (2)
Music Intervention (MI) Group
EXPERIMENTALMusic therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.
Sham Control (SC) Group
ACTIVE COMPARATORMusic/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).
Interventions
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.
The intervention will be to support a woman to talk about anything she wants that is important to her.
Eligibility Criteria
You may qualify if:
- Aged 18 to 40 years
- Generally healthy pregnant women in the first trimester of pregnancy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Emory Universitycollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- National Institute on Minority Health and Health Disparities (NIMHD)collaborator
Study Sites (2)
Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
New York, New York, 10003, United States
Columbia University Irving Medical Center/NewYork Presbyterian
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacquelyn Taylor, PhD
Columbia University
- PRINCIPAL INVESTIGATOR
Joanne V. Loewy, DA, LCAT, MT-BC
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Helen F. Pettit Professor of Nursing; Executive Director of Columbia Nursing's Center for Research of People of Color
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 14, 2023
Study Start
March 12, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
August 29, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared, but de-identified composite data with be shared with authorized recipients at the end of the study.