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临床试验/NCT03654079
NCT03654079尚未招募不适用

Patient Centered Simulation For Labor and Delivery

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Childbirth Experience Questionnaire (CEQ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Group assignment will be removed from the data set prior to analysis.

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Nulliparous pregnant women
  • In third trimester

排除标准

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

研究组 & 干预措施

Simulation Arm

Active Comparator

Subjects in this arm will participate in Interventions (In- Utero Simulation, Cesarean Section Simulation, and Pushing Simulation).

干预措施: Simulation (Other)

Control Arm

No Intervention

Subjects in this arm will not participate in any simulations.

结局指标

主要结局

Childbirth Experience Questionnaire (CEQ)

时间窗: After delivery, up to 2 weeks

Childbirth Experience Satisfaction will be measured by the CEQ a 24 item questionnaire. For 19 of the items the response format is a 4-point Likert Scale and three of the items are assessed using a visual analogue scale (VAS). The VAS-scales scores were transformed to categorical values, 0-40 = 1, 41-60 = 2, 61-80 = 3 and 81-100 = 4. Total score 24-92. Higher scores indicate better childbirth experience

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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