Music Intervention for Preterm Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music Intervention (MI), Sham Control (SC).
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Score on the Perceived Stress Scale (PSS) [Time frame: Week 1]
- Score on the Perceived Stress Scale (PSS) [Time frame: Week 5]
- Score on the Perceived Stress Scale (PSS) [Time frame: Week 10]
- Mean Gestational Age [Time frame: Up to 43 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Louis Armstrong Center for Music and Medicine at Mount Sinai Health System — New York
- Columbia University Irving Medical Center/NewYork Presbyterian — New York
Identifiers
NCT: NCT05945264 · ACYY0271 · R01MD016899 · AAAU6262