Music Intervention (MI)
BehavioralThe 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.
Not Yet Recruiting
NCT Number: NCT05945264
Music Intervention for Preterm Birth
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–40 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Columbia University Irving Medical Center/NewYork Presbyterian, New York, United States
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sham Control (SC)
OtherThe intervention will be to support a woman to talk about anything she wants that is important to her.
Other names: Verbal intervention
Primary outcomes
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Score on the Perceived Stress Scale (PSS)
Time frame: Week 1
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.
-
Score on the Perceived Stress Scale (PSS)
Time frame: Week 5
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.
-
Score on the Perceived Stress Scale (PSS)
Time frame: 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.
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Mean Gestational Age
Time frame: Up to 43 weeks
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Study contacts
Contact information is provided by the study sponsor or research team.
Jacquelyn Taylor, PhD
CONTACT
Joanne V. Loewy, DA, LCAT, MT-BC
CONTACT
Sponsors and collaborators
Lead sponsor
Columbia University
Other
Collaborators
- Emory University
- Icahn School of Medicine at Mount Sinai
- National Institute on Minority Health and Health Disparities (NIMHD)
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 14, 2023
- Registry last updated
- Jul 6, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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