Music Intervention for Preterm Birth

Sponsor

Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05945264

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

142

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will test a music intervention versus a control 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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Behavioral: Music Intervention (MI) Behavioral: Verbal Intervention (VI)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music Intervention Group Music therapist will meet individually with each participant to provide music therapy by asking women to sing a song meaningful to them.	Behavioral: Music Intervention (MI) The intervention will be to sing a song or songs, that are meaningful to the subject.
Active Comparator: Verbal Intervention Only Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy).	Behavioral: Verbal Intervention (VI) The intervention will be to support a woman to talk about anything she wants that is important to her.

Arm

Intervention/Treatment

Experimental: Music Intervention Group

Music therapist will meet individually with each participant to provide music therapy by asking women to sing a song meaningful to them.

Behavioral: Music Intervention (MI)

The intervention will be to sing a song or songs, that are meaningful to the subject.

Active Comparator: Verbal Intervention Only

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

Behavioral: Verbal Intervention (VI)

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

Outcome Measures

Primary Outcome Measures

Score on the Perceived Stress Scale (PSS) [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) [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) [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.
Mean Gestational Age [Up to 43 weeks]
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louis Armstrong Center for Music and Medicine at Mount Sinai Health System	New York	New York	United States	10003
2	Columbia University Irving Medical Center/NYP	New York	New York	United States	10032