Music Intervention for Preterm Birth

Columbia University

Status: Enrolling

Conditions: Preterm Birth

Treatments: Other: Sham Control (SC); Behavioral: Music Intervention (MI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05945264

AAAU6262

R01MD016899 (U.S. NIH Grant/Contract)

ACYY0271

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Music Intervention (MI) Group

Experimental group

Description:

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

Treatment:

Behavioral: Music Intervention (MI)

Sham Control (SC) Group

Active Comparator group

Description:

Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).

Treatment:

Other: Sham Control (SC)