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早产的音乐干预

2026年10月14日 更新者：Jacquelyn Taylor、Columbia University

基于文化的现场音乐干预对黑人女性慢性压力和早产风险相关代谢物和代谢途径的影响

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

142

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • New York
      • New York、New York、美国、10003
        • 主动，不招人
        • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
      • New York、New York、美国、10032
        • 招聘中
        • Columbia University Irving Medical Center/NewYork Presbyterian
        • 接触：
        • 首席研究员：
          • Jacquelyn Taylor, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 40年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Music Intervention (MI) Group

Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.
行为的：Music Intervention (MI)

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.
有源比较器：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).
其他：Sham Control (SC)

The intervention will be to support a woman to talk about anything she wants that is important to her.

其他名称：
  • 口头干预

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Score on the Perceived Stress Scale (PSS)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：Up to 43 weeks

Number of completed weeks/days of pregnancy will be collected and the mean will be calculated.
Up to 43 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

合作者

National Institute on Minority Health and Health Disparities (NIMHD)
Icahn School of Medicine at Mount Sinai
Emory University

调查人员

  • 首席研究员：Joanne V. Loewy, DA, LCAT, MT-BC、Icahn School of Medicine at Mount Sinai
  • 首席研究员：Jacquelyn Taylor, PhD、Columbia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月29日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2023年7月6日

首先提交符合 QC 标准的

2023年7月6日

首次发布 (实际的)

2023年7月14日

研究记录更新

最后更新发布 (实际的)

2026年10月19日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACYY0271
  • AAAU6262 (其他标识符：Columbia University Irving Medical Center Institutional Review Board)
  • R01MD016899 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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