Maternal Mindfulness: Depression and Postpartum Pain (MaMiDaPP)
Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention
調査の概要
詳細な説明
Postpartum pain affects approximately 92% of women and is a risk factor for postpartum depression (PPD). Cesarean delivery is associated with elevated risk for both postpartum pain and PPD, and women who experience persistent postpartum pain are at increased risk of developing depressive symptoms. PPD may contribute to withdrawal, emotional detachment, and hostility, which can negatively affect mother-infant interactions, including breastfeeding. These risks underscore the urgent need for an effective non-pharmacologic intervention to reduce post-cesarean delivery pain and prevent PPD. The objective of this study is to optimize a mobile, self-guided 8-week Mindfulness-Based Stress Reduction (MBSR) intervention for non-depressed women at risk for PPD who have a planned cesarean delivery. The investigators will conduct a single-group open trial of women (N = 20), including Latinas (English- and Spanish-speaking), Asian, African American, and non-Hispanic White women. The study is testing two primary hypotheses: (1) the 8-week mobile MBI will demonstrate high feasibility and acceptability among a diverse sample of women, shown by meeting target recruitment, enrollment, and retention benchmarks and (2) participants will demonstrate reductions in reported pain scores and depressive symptoms from pre- to post-intervention. In addition, the study will evaluate recruitment, enrollment, dosage, safety, and retention metrics and survey participants about intervention features, facilitators, barriers, satisfaction, and recommendations.
Participants will be recruited through community partners, including the Champaign-Urbana Public Health District and the University YMCA, using flyers, partner-supported distribution of study information, and email announcements. Interested individuals will complete an online eligibility screener accessed through a QR code or URL on recruitment materials. Eligible participants will include women with an Edinburgh Postnatal Depression Scale score of 5-13 who have a planned singleton cesarean delivery, are within 18-45 years of age, and have no chronic pain condition. Individuals who meet initial eligibility criteria will be contacted by phone to confirm participant authenticity, then sent a REDCap link to complete electronic consent and a background questionnaire. After enrollment, participants will meet briefly with a trained research assistant to review access to the intervention platform and address any questions or concerns. Recruitment and enrollment will occur during the third trimester of pregnancy, and the intervention will begin during the first week following cesarean delivery.
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:Sandraluz Lara-Cinisomo, Ph.D.
- 電話番号:217-300-3512
- メール:laracini@illinois.edu
研究場所
-
-
Illinois
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Champaign、Illinois、アメリカ、61820
- 募集
- University of Illinois Urbana-Champaign
-
コンタクト:
- Sandraluz Lara-Cinisomo, Ph.D
- 電話番号:217-300-3512
- メール:laracini@illinois.edu
-
-
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
説明
- Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White.
- Scheduled to undergo a planned cesarean delivery.
- Be of 18-45 years of age
- Have a singleton pregnancy
- Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
- A history of depression
- Have no chronic pain condition (e.g., fibromyalgia)
- Own a computer, smartphone, or tablet
- Have a reliable internet access to complete the online surveys.
- Be proficient in English or Spanish.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Mindfulness
Receiving mobile, self-guided mindfulness intervention
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Meditation training to help reduce stress and reactivity to pain and other stressors.
他の名前:
|
|
介入なし:Treatment as usual with monitoring
Receiving treatment as usual with monitoring by study PI and investigators.
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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 |
|---|---|---|
|
Post-operative pain
時間枠:1 week postpartum and 8 weeks postpartum
|
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
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1 week postpartum and 8 weeks postpartum
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postpartum depression
時間枠:1 week postpartum and 8 weeks postpartum
|
Edinburgh Postnatal Depression Scale (EPDS); participant reported depressive symptoms.
Those who score above 13 are likely to be suffering from a depressive illness of varying severity.
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1 week postpartum and 8 weeks postpartum
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協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- MaMiDaPP
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
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
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