Musikkintervensjon for prematur fødsel
Virkningen av en kulturbasert levende musikkintervensjon på metabolitter og metabolske veier assosiert med kronisk stress og risikoen for for tidlig fødsel hos svarte kvinner
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Joanne V. Loewy, DA, LCAT, MT-BC
- Telefonnummer: 212-420-3484
- E-post: joanne.loewy@mountsinai.org
Studer Kontakt Backup
- Navn: Jacquelyn Taylor, PhD
- Telefonnummer: 347-978-2871
- E-post: jyt2116@cumc.columbia.edu
Studiesteder
-
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New York
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New York, New York, Forente 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, Forente stater, 10032
- Rekruttering
- Columbia University Irving Medical Center/NewYork Presbyterian
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Ta kontakt med:
- Jacquelyn Taylor, PhD
- Telefonnummer: 347-978-2871
- E-post: jyt2116@cumc.columbia.edu
-
Hovedetterforsker:
- Jacquelyn Taylor, PhD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
Tidsramme: 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)
Tidsramme: 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)
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
|
|
Mean Gestational Age
Tidsramme: Up to 43 weeks
|
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Up to 43 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joanne V. Loewy, DA, LCAT, MT-BC, Icahn School of Medicine at Mount Sinai
- Hovedetterforsker: Jacquelyn Taylor, PhD, Columbia University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACYY0271
- AAAU6262 (Annen identifikator: Columbia University Irving Medical Center Institutional Review Board)
- R01MD016899 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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