조산을 위한 음악 중재
흑인 여성의 만성 스트레스 및 조산 위험과 관련된 대사 산물 및 대사 경로에 대한 문화 기반 라이브 음악 개입의 영향
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Joanne V. Loewy, DA, LCAT, MT-BC
- 전화번호: 212-420-3484
- 이메일: joanne.loewy@mountsinai.org
연구 연락처 백업
- 이름: Jacquelyn Taylor, PhD
- 전화번호: 347-978-2871
- 이메일: jyt2116@cumc.columbia.edu
연구 장소
-
-
New York
-
New York, New York, 미국, 10003
- 모집하지 않고 적극적으로
- Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
-
New York, New York, 미국, 10032
- 모병
- Columbia University Irving Medical Center/NewYork Presbyterian
-
연락하다:
- Jacquelyn Taylor, PhD
- 전화번호: 347-978-2871
- 이메일: jyt2116@cumc.columbia.edu
-
수석 연구원:
- Jacquelyn Taylor, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
기간: 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)
기간: 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)
기간: 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
기간: Up to 43 weeks
|
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Up to 43 weeks
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Joanne V. Loewy, DA, LCAT, MT-BC, Icahn School of Medicine at Mount Sinai
- 수석 연구원: Jacquelyn Taylor, PhD, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ACYY0271
- AAAU6262 (기타 식별자: Columbia University Irving Medical Center Institutional Review Board)
- R01MD016899 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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