Musikintervention til for tidlig fødsel
Virkningen af en kulturbaseret livemusikintervention på metabolitter og metaboliske veje forbundet med kronisk stress og risikoen for for tidlig fødsel hos sorte kvinder
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Joanne V. Loewy, DA, LCAT, MT-BC
- Telefonnummer: 212-420-3484
- E-mail: joanne.loewy@mountsinai.org
Undersøgelse Kontakt Backup
- Navn: Jacquelyn Taylor, PhD
- Telefonnummer: 347-978-2871
- E-mail: jyt2116@cumc.columbia.edu
Studiesteder
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New York
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New York, New York, Forenede Stater, 10003
- Aktiv, ikke rekrutterende
- Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University Irving Medical Center/NewYork Presbyterian
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Kontakt:
- Jacquelyn Taylor, PhD
- Telefonnummer: 347-978-2871
- E-mail: jyt2116@cumc.columbia.edu
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Ledende efterforsker:
- Jacquelyn Taylor, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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. |
|
Aktiv komparator: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Score on the Perceived Stress Scale (PSS)
Tidsramme: Week 1
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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
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Score on the Perceived Stress Scale (PSS)
Tidsramme: Week 5
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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
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Score on the Perceived Stress Scale (PSS)
Tidsramme: 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
|
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Mean Gestational Age
Tidsramme: Up to 43 weeks
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Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Up to 43 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joanne V. Loewy, DA, LCAT, MT-BC, Icahn School of Medicine at Mount Sinai
- Ledende efterforsker: Jacquelyn Taylor, PhD, Columbia University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACYY0271
- AAAU6262 (Anden identifikator: Columbia University Irving Medical Center Institutional Review Board)
- R01MD016899 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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