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Набор скоро начнётся NCT07323459

A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women

Без фазы С лечением Pregnancy-Related Anxiety (PrA) Fear of Childbirth

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: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women.
Кому может быть актуально
Состояния в реестре: Pregnancy-Related Anxiety (PrA), Fear of Childbirth. 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
Польша
Следующий шаг
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Официальное название

Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women

Обзор

The goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. The main questions it aims to answer are: * Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire? * Does this intervention improve women's sense of control, competence, and readiness for childbirth? * Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women? Participants will: * Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks * Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels * Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures * Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness * Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel * Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth

Вмешательства

  • Другое A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
    Individual program by midwife in 2nd/3rd trimester: 4-6 sessions (\~60min), every 1-2 weeks. Session 1: PRAQ-R2 assessment, identifying fears, building trust. Session 2: Labor stages education, myth verification, visual aids. For multiparous: previous birth discussion. Session 3: Pain management - breathing, relaxation, massage, hydrotherapy, epidural, nitrous oxide. Practical exercises. Session 4: Birth plan development, assertive communication training, role-playing. Session 5: Mindfulness

Первичные конечные точки

  • Pregnancy-Related Anxiety Level [Срок оценки: Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)]

Критерии участия

Критерии включения

  • Pregnant women in the second or third trimester of pregnancy
  • Elevated level of pregnancy-related anxiety (PrA)
  • Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery)
  • Consent to participate in individual psychoeducational sessions
  • Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions

Критерии исключения

  • Pregnant women with severe mental disorders requiring urgent psychiatric intervention
  • Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization)
  • Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety
  • Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons)
  • Pregnant women whose pregnancy-related anxiety is not the primary concern, with other dominant anxiety disorders (e.g., GAD unrelated to pregnancy) or other priority health needs

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Польша · 1 центр
  • Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Inst — Gdansk

Публикации

  • Krawczyk A, Czerwinska-Osipiak A, Wojcicka L, Michalik A, Gruszecka A. Study protocol for a midwife-led psychoeducational intervention to reduce pregnancy-related anxiety in low-risk pregnant women. Front Public Health. 2026 Jun 3;14:1832201. doi: 10.3389/fpubh.2026.1832201. eCollection 2026. PMID 42317977

Идентификаторы

NCT: NCT07323459 · KB/367/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗