Music Intervention for Preterm Birth

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05945264
• Other study ID #: AAAU6262
• Secondary ID: R01MD016899
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center/NYP	New York	New York
United States	Louis Armstrong Center for Music and Medicine at Mount Sinai Health System	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Emory University, Icahn School of Medicine at Mount Sinai, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mean Gestational Age	Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.	Up to 43 weeks