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Набор скоро начнётся NCT03654079

Patient Centered Simulation For Labor and Delivery

Без фазы С лечением Pregnancy Related

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: Simulation.
Кому может быть актуально
Состояния в реестре: Pregnancy Related. Базовые параметры: 18 лет — 44 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 →

Обзор

Patient satisfaction is an important outcome in the evaluation and development of healthcare services. Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care. Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes. Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries. Often fear is worsened by a lack of knowledge of what to expect during labor. Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery.

Подробное описание

Patient satisfaction is an important outcome in the evaluation and development of healthcare services. Studies have identified tools that successfully measure women's childbirth experiences, and have shown that multidimensional measures of women's satisfaction in labor and delivery provides a richer and diverse perspective on women's experiences of intrapartum care. Childbirth experience can have significant effects, both positive and negative, on women's immediate and long term health outcomes. Patients with negative experiences surrounding childbirth have been shown to have significant fear surrounding the labor and delivery experience that negatively impact subsequent deliveries. Often fear is worsened by a lack of knowledge of what to expect during labor. Women enrolled in this study will simulate some of the potentially stressful experiences that commonly occur during labor to determine if doing so decreases a woman's fear and anxiety about labor and delivery. Women in Centering Pregnancy groups will be approached and assigned to either the intervention or control arm by Centering Pregnancy group. Those in the intervention arm will participate in simulations in the following areas: 1) In-Utero Resuscitation Simulation: the process that may occur if a baby has a significant drop in heart rate during labor, 2) Cesarean Section Simulation: the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a laboring woman needs a cesarean delivery, 3) Pushing Simulation: the pushing process after a laboring woman becomes completely dilated. Those in the control arm will not receive this education. All patient will complete a modified Childbirth Experience Questionnaire the day after delivery. Responses will be compared between the woman that participated in the simulations to women who did not participate in simulations.

Вмешательства

  • Другое Simulation
    Participants assigned to the intervention group will participate in the following simulations: 1) the process that may occur if a baby has a significant drop in heart rate during labor, 2) the process of moving from the labor bed to the transport stretcher and on to the operating room in the event that a woman needs a cesarean delivery, 3) the pushing process after a woman becomes completely dilated

Первичные конечные точки

  • Childbirth Experience Questionnaire (CEQ) [Срок оценки: After delivery, up to 2 weeks]

Критерии участия

Критерии включения

  • Nulliparous pregnant women
  • In third trimester

Критерии исключения

  • Not planning on delivering with Wake Forest School of Medicine OB/GYN

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Wake Forest Baptist Health Downtown Health Plaza — Winston-Salem

Публикации

  • Rudman A, El-Khouri B, Waldenstrom U. Women's satisfaction with intrapartum care - a pattern approach. J Adv Nurs. 2007 Sep;59(5):474-87. doi: 10.1111/j.1365-2648.2007.04323.x. Epub 2007 Jul 20. PMID 17645495
  • Nilver H, Begley C, Berg M. Measuring women's childbirth experiences: a systematic review for identification and analysis of validated instruments. BMC Pregnancy Childbirth. 2017 Jun 29;17(1):203. doi: 10.1186/s12884-017-1356-y. PMID 28662645
  • Nilsson C, Lundgren I, Karlstrom A, Hildingsson I. Self reported fear of childbirth and its association with women's birth experience and mode of delivery: a longitudinal population-based study. Women Birth. 2012 Sep;25(3):114-21. doi: 10.1016/j.wombi.2011.06.001. Epub 2011 Jul 20. PMID 21764400
  • World Health Organization . WHO Statment: The prevention and elimiation of disrespect and abuse during facility-based childbirth. 2014.
  • Finnbogason, Christine. "Experiences and Satisfaction with Intrapartum Care: A Comparison of Normal Weight Women and Obese Women." University of Manitoba, University of Manitoba, 2016, pp. 149-154.

Идентификаторы

NCT: NCT03654079 · IRB00052749

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗