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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD016899 | U.S. NIH Grant/Contract | View source | |
| AAAU6262 | Other Identifier | Columbia University Irving Medical Center Institutional Review Board |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Emory University | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Intervention (MI) Group | Experimental | Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. |
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| Sham Control (SC) Group | Active Comparator | Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacquelyn Taylor, PhD | Contact | 347-978-2871 | jyt2116@cumc.columbia.edu | |
| Joanne V. Loewy, DA, LCAT, MT-BC | Contact | 212-420-3484 | joanne.loewy@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn Taylor, PhD | Columbia University | Principal Investigator |
| Joanne V. Loewy, DA, LCAT, MT-BC | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Armstrong Center for Music and Medicine at Mount Sinai Health System | New York | New York | 10003 | United States | ||
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.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Sham Control (SC) | Other | The intervention will be to support a woman to talk about anything she wants that is important to her. |
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| Columbia University Irving Medical Center/NewYork Presbyterian |
| New York |
| New York |
| 10032 |
| United States |
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| D000091642 | Urogenital Diseases |