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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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