Music Intervention for Preterm Birth

Study Overview
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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.

Official Title
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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

Conditions
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Preterm Birth

Intervention / Treatment
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* Behavioral: Music Intervention (MI)
* Other: Sham Control (SC)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Intervention (MI) Group<br>Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. | Behavioral: Music Intervention (MI)<br>* 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.<br>|
| Active Comparator: Sham Control (SC) Group<br>Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only). | Other: Sham Control (SC)<br>* The intervention will be to support a woman to talk about anything she wants that is important to her.<br>* Other names: Verbal intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 1 | 
| 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. | Week 5 | 
| 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. | Week 10 | 
| Mean Gestational Age | Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. | Up to 43 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention