早産に対する音楽介入
黒人女性の慢性ストレスと早産のリスクに関連する代謝物と代謝経路に対する、文化に基づいたライブ音楽介入の影響
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Joanne V. Loewy, DA, LCAT, MT-BC
- 電話番号：212-420-3484
- メール：joanne.loewy@mountsinai.org
研究連絡先のバックアップ
- 名前：Jacquelyn Taylor, PhD
- 電話番号：347-978-2871
- メール：jyt2116@cumc.columbia.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10003
- 積極的、募集していない
- Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
-
New York、New York、アメリカ、10032
- 募集
- Columbia University Irving Medical Center/NewYork Presbyterian
-
コンタクト：
- Jacquelyn Taylor, PhD
- 電話番号：347-978-2871
- メール：jyt2116@cumc.columbia.edu
-
主任研究者：
- Jacquelyn Taylor, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Music Intervention (MI) Group
Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states. |
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. |
|
アクティブコンパレータ：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Up to 43 weeks
|
Number of completed weeks/days of pregnancy will be collected and the mean will be calculated. |
Up to 43 weeks
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Joanne V. Loewy, DA, LCAT, MT-BC、Icahn School of Medicine at Mount Sinai
- 主任研究者：Jacquelyn Taylor, PhD、Columbia University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ACYY0271
- AAAU6262 (その他の識別子：Columbia University Irving Medical Center Institutional Review Board)
- R01MD016899 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。