Music Intervention for Preterm Birth

NCT ID: NCT05945264

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2029-08-29

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Music Intervention (MI) Group

Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.

Group Type EXPERIMENTAL

Music Intervention (MI)

Intervention Type BEHAVIORAL

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.

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).

Group Type ACTIVE_COMPARATOR

Sham Control (SC)

Intervention Type OTHER

The intervention will be to support a woman to talk about anything she wants that is important to her.

Interventions

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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.

Intervention Type BEHAVIORAL

Sham Control (SC)

The intervention will be to support a woman to talk about anything she wants that is important to her.

Intervention Type OTHER

Other Intervention Names

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Verbal intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Corwin

Professor of Nursing and Vice Dean for Research Innovation & Strategy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth J. Corwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Joanne V. Loewy, DA, LCAT, MT-BC

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Louis Armstrong Center for Music and Medicine at Mount Sinai Health System

New York, New York, United States

Site Status

Columbia University Irving Medical Center/NYP

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01MD016899

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU6262

Identifier Type: -

Identifier Source: org_study_id

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