Preterm Birth
Conditions
Keywords
Chronic stress, Preterm birth, Black women stress, Metabolomics of chronic stress, Music and medicine, Music intervention
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.
Interventions
BEHAVIORALMusic Intervention (MI)
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.
OTHERSham Control (SC)
The intervention will be to support a woman to talk about anything she wants that is important to her.
Sponsors
Columbia University
National Institute on Minority Health and Health Disparities (NIMHD)
Emory University
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Mean Gestational Age | Up to 43 weeks | Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Countries
United States
Contacts
CONTACTJacquelyn Taylor, PhD
CONTACTJoanne V. Loewy, DA, LCAT, MT-BC
PRINCIPAL_INVESTIGATORJacquelyn Taylor, PhD
Columbia University
PRINCIPAL_INVESTIGATORJoanne V. Loewy, DA, LCAT, MT-BC
Icahn School of Medicine at Mount Sinai
Outcome results
None listed