Меню
Набор скоро начнётся NCT07660471

Mindfulness-Based Intervention in Primiparous Pregnant Women

Без фазы С лечением Pregnancy Fear of Childbirth Childbirth Self-efficacy Self-Compassion

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-Based Intervention.
Кому может быть актуально
Состояния в реестре: Pregnancy, Fear of Childbirth, Childbirth Self-efficacy, Self-Compassion. Базовые параметры: от 18 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.

Подробное описание

Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.

This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.

Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.

Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.

Вмешательства

  • Поведенческое Mindfulness-Based Intervention
    A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.

Первичные конечные точки

  • Childbirth Self-Efficacy [Срок оценки: Baseline and 4 weeks after intervention]
  • Fear of Childbirth [Срок оценки: Baseline and 4 weeks after intervention]
  • Self-Compassion [Срок оценки: Baseline and 4 weeks after intervention]

Критерии участия

Критерии включения

  • Pregnant women aged 18 years and older
  • Primiparous women
  • Singleton pregnancy
  • Gestational age between 28 and 32 weeks
  • No known obstetric complications
  • Ability to read and understand Turkish
  • Attendance at the Pregnancy School of the Healthy Life Center
  • Willingness to participate and provide written informed consent
  • Willingness to participate in the mindfulness-based intervention program

Критерии исключения

  • Multiple pregnancy
  • High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
  • Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
  • Substance or alcohol dependence
  • Previous participation in a structured mindfulness, meditation, or similar awareness-based program
  • Inability to attend intervention sessions regularly

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
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Healthy Life Center Pregnancy School — Ağrı

Публикации

  • Feli R, Heydarpour S, Yazdanbakhsh K, Heydarpour F. The effect of mindfulness-based counselling on the anxiety levels and childbirth satisfaction among primiparous pregnant women: a randomized controlled trial. BMC Psychiatry. 2024 Dec 31;24(1):964. doi: 10.1186/s12888-024-06442-3. PMID 39741245

Идентификаторы

NCT: NCT07660471 · PMI-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗