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Идёт набор NCT06824480

The Effect of Postpartum Debriefing on the Psychological Outcomes

Без фазы С лечением Well-Being, Psychological

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: debriefing group, control group.
Кому может быть актуально
Состояния в реестре: Well-Being, Psychological. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of Debriefing of Childbirth in the Early Postpartum Period on the Psychological Outcomes

Обзор

This study was planned to determine the effect of re-signification of birth in the early postpartum period on postpartum fear of childbirth, postpartum depression and birth trauma.

Подробное описание

This study was contucted between february 2024 and June 2025 in Turkey , as a single-blind randomized controlled experimental study to determine the effect of reinterpretation of birth on postpartum fear of childbirth, postpartum depression and birth trauma.During data collection, participants were informed about the purpose of the study and those who volunteered to participate in the research were accepted into the study by signing an informed consent form.Data; When the study was approved, it was planned to be collected face to face within the first 12-24 hours after birth and by telephone within 6-8 weeks after birth. CONSORT directive was followed in the research planning.

Вмешательства

  • Поведенческое debriefing group
    Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.
  • Поведенческое control group
    he women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.

Первичные конечные точки

  • Personal Information Form [Срок оценки: the first 12-24 hours after birth]
  • Birth Process Evaluation Form [Срок оценки: the first 12-24 hours after birth]
  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: [Срок оценки: the first 12-24 hours after birth]
  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (ANNEX-3) [Срок оценки: first 6-8 weeks after birth]
  • City Birth Trauma Scale (CityBiTS) [Срок оценки: first 6-8 weeks after birth]
  • Edinburgh Postpartum Depression Scale (EDPS) [Срок оценки: first 6-8 weeks after birth]

Критерии участия

Критерии включения

Women who volunteer to participate in the study, Whose mother tongue is Turkish, Who are between the ages of 18-45, Who are at least primary school graduates, Who are 37-42 weeks pregnant, Who are nulliparous, Who have a healthy pregnancy, Who do not have a psychological condition or psychiatric disorder, Who are monitored and cared for in the first 24 hours after birth at the Tarsus State Hospital Maternity Department, Who approve of the reinterpretation of birth application to be carried out by the researcher will be included in the sample.

Критерии исключения

Those who did not volunteer to participate in the study, Those who gave birth before the 37th week of pregnancy, Those who were multiparous, Those who had abnormal medical conditions during pregnancy (placental disorder, preeclampsia, premature birth threat, etc.),

Those whose native language is not Turkish, Those who have visual, speech and hearing impairments, Those who had an emergency cesarean section, Those who stayed in the hospital for less than 12 hours after birth, Those who received a psychiatric diagnosis during the postpartum period (except those diagnosed with postpartum depression and post-traumatic stress disorder related to birth), Those who could not be reached by phone during the follow-up of the study, Women who developed complications in the first 24 hours after birth and required intensive care, Those whose babies required neonatal intensive care during the postpartum period, Those who experienced another life event that traumatized the woman during the postpartum period (harassment, rape, earthquake, accident, loss of a loved one) etc.) Those who want to withdraw from the study at any stage of the study will not be included in the sample.

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
Простое слепое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 2 центра
  • Mersin university — Mersin
  • Mersin University — Mersin

Идентификаторы

NCT: NCT06824480 · VBalci

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗