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Music Intervention for Preterm Birth

Primary Purpose

Preterm Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Intervention (MI)
Sham Control (SC)
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
  • Columbia University Irving Medical Center/NYP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Intervention (MI) Group

Sham Control (SC) Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Score on the Perceived Stress Scale (PSS)
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)
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)
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
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2023
Last Updated
October 17, 2023
Sponsor
Columbia University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05945264
Brief Title
Music Intervention for Preterm Birth
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Intervention (MI) Group
Arm Type
Experimental
Arm Description
Music therapist will meet individually with each participant to provide music therapy by asking women to sing a song meaningful to them.
Arm Title
Sham Control (SC) Group
Arm Type
Active Comparator
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Music Intervention (MI)
Intervention Description
The intervention will be to sing a song or songs, that are meaningful to the subject.
Intervention Type
Other
Intervention Name(s)
Sham Control (SC)
Other Intervention Name(s)
Verbal intervention
Intervention Description
The intervention will be to support a woman to talk about anything she wants that is important to her.
Primary Outcome Measure Information:
Title
Score on the Perceived Stress Scale (PSS)
Description
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.
Time Frame
Week 1
Title
Score on the Perceived Stress Scale (PSS)
Description
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.
Time Frame
Week 5
Title
Score on the Perceived Stress Scale (PSS)
Description
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.
Time Frame
Week 10
Title
Mean Gestational Age
Description
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Time Frame
Up to 43 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth J. Corwin, PhD
Phone
212-305-3983
Email
ejc2202@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne V. Loewy, DA, LCAT, MT-BC
Phone
212-420-3484
Email
joanne.loewy@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J. Corwin, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Irving Medical Center/NYP
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth J. Corwin
Phone
212-305-3983
Email
ejc2202@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth J. Corwin, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared, but de-identified composite data with be shared with authorized recipients at the end of the study.

Learn more about this trial

Music Intervention for Preterm Birth

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