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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Behavioral: Music Intervention (MI); Other: Sham Control (SC)

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 Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne V. Loewy, DA, LCAT, MT-BC; Phone Number: 212-420-3484; Email: joanne.loewy@mountsinai.org
• Study Contact Backup: Name: Jacquelyn Taylor, PhD; Phone Number: 347-978-2871; Email: jyt2116@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Active, not recruiting
      • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center/NewYork Presbyterian
      • Contact: Jacquelyn Taylor, PhD; Phone Number: 347-978-2871; Email: jyt2116@cumc.columbia.edu
      • Principal Investigator: Jacquelyn Taylor, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria

• Aged 18 to 40 years
• Generally healthy pregnant women in the first trimester of pregnancy

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Intervention (MI) Group; Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.	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.
Active Comparator: Sham Control (SC) Group; Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).	Other: Sham Control (SC); The intervention will be to support a woman to talk about anything she wants that is important to her.; Other Names: Verbal intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Icahn School of Medicine at Mount Sinai; Emory University
• Investigators: Principal Investigator: Joanne V. Loewy, DA, LCAT, MT-BC, Icahn School of Medicine at Mount Sinai; Principal Investigator: Jacquelyn Taylor, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2026
• Last Update Submitted That Met QC Criteria: October 14, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Chronic stress; Preterm birth; Music intervention; Black women stress; Metabolomics of chronic stress; Music and medicine
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: ACYY0271; AAAU6262 (Other Identifier: Columbia University Irving Medical Center Institutional Review Board); R01MD016899 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No