Music Intervention for Preterm Birth

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05945264
Status
Not Yet Recruiting

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Conditions

  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Music Intervention (MI) — 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) — OTHER
    The intervention will be to support a woman to talk about anything she wants that is important to her.

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
May 2026
Primary completion
Jul 30, 2027
Completion
Aug 29, 2027

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Music Intervention (MI) Group
    Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.
  • Active Comparator: 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).

Primary Outcome Measure

Score on the Perceived Stress Scale (PSS) [ Time Frame: Week 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NewYork PresbyterianNew YorkNew York10032
Jacquelyn Taylor, PhD
[email protected]
347-978-2871
Jacquelyn Taylor, PhD (PRINCIPAL_INVESTIGATOR)
Louis Armstrong Center for Music and Medicine at Mount Sinai Health SystemNew YorkNew York10003-

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By research site
Columbia University Irving Medical Center/NewYork Presbyterian· New York, NYLouis Armstrong Center for Music and Medicine at Mount Sinai Health System· New York, NY

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