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Идёт набор NCT05400382

Maternal Mindfulness: Depression and Postpartum Pain

Без фазы С лечением Depression, Unipolar Pain, Postoperative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mindfulness.
Кому может быть актуально
Состояния в реестре: Depression, Unipolar, Pain, Postoperative. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention

Обзор

This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.

Подробное описание

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.

Вмешательства

  • Поведенческое Mindfulness
    Meditation training to help reduce stress and reactivity to pain and other stressors.

Первичные конечные точки

  • Post-operative pain [Срок оценки: 1 week postpartum and 8 weeks postpartum]
Вторичные конечные точки (1)
  • Postpartum depression [Срок оценки: 1 week postpartum and 8 weeks postpartum]

Критерии участия

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Illinois Urbana-Champaign — Champaign

Идентификаторы

NCT: NCT05400382 · MaMiDaPP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗