Muziekinterventie voor vroeggeboorte
De impact van een op cultuur gebaseerde livemuziekinterventie op de metabolieten en metabole routes die verband houden met chronische stress en het risico van vroeggeboorte bij zwarte vrouwen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Joanne V. Loewy, DA, LCAT, MT-BC
- Telefoonnummer: 212-420-3484
- E-mail: joanne.loewy@mountsinai.org
Studie Contact Back-up
- Naam: Jacquelyn Taylor, PhD
- Telefoonnummer: 347-978-2871
- E-mail: jyt2116@cumc.columbia.edu
Studie Locaties
-
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New York
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New York, New York, Verenigde Staten, 10003
- Actief, niet wervend
- Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University Irving Medical Center/NewYork Presbyterian
-
Contact:
- Jacquelyn Taylor, PhD
- Telefoonnummer: 347-978-2871
- E-mail: jyt2116@cumc.columbia.edu
-
Hoofdonderzoeker:
- Jacquelyn Taylor, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Music Intervention (MI) Group
Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. |
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. |
|
Actieve vergelijker: Sham Control (SC) Group
Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only). |
The intervention will be to support a woman to talk about anything she wants that is important to her.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
Tijdsspanne: 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. |
Week 1
|
|
Score on the Perceived Stress Scale (PSS)
Tijdsspanne: 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. |
Week 5
|
|
Score on the Perceived Stress Scale (PSS)
Tijdsspanne: 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. |
Week 10
|
|
Mean Gestational Age
Tijdsspanne: Up to 43 weeks
|
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Up to 43 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joanne V. Loewy, DA, LCAT, MT-BC, Icahn School of Medicine at Mount Sinai
- Hoofdonderzoeker: Jacquelyn Taylor, PhD, Columbia University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACYY0271
- AAAU6262 (Andere identificatie: Columbia University Irving Medical Center Institutional Review Board)
- R01MD016899 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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