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临床试验/NCT07479524
NCT07479524Enrolling By Invitation不适用

Effect of Induction Admission of Shared Decision-Making on First Time Expectant Mothers', Self-efficacy, Anxiety, Birth Outcomes and Birth Satisfaction

Lee Wan1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
130
试验地点
1
主要终点
Childbirth Self-Efficacy Inventory

研究概览

简要总结

Women's childbirth is regarded as a natural, normal and healthy process, and no interventional measures are required unless medically necessary. However, the proportion of routine induction of labor among Taiwanese women is currently on the rise. This study intends to use the medical-patient shared decision-making program for induction of labor to explore the impact of this program on the delivery efficiency, anxiety, delivery results, and delivery satisfaction of first-time pregnant women. In addition, we also want to explore the feelings and thoughts of this group of women who underwent induced labor under the Shared Medical Decision-Making Program in the postpartum period after participating in this program. It can be used as an improvement reference for the future implementation of shared decision-making between doctors and clients.

This research adopts a qualitative and quantitative mixed research method to conduct this research. The quantitative research will adopt an experimental research design. Those who meet the criteria will be randomly assigned to collect the experimental group and the control group. In addition to receiving general routine care, the experimental group also receive a shared decision-making plan for delaying admission to the hospital. The control group received regular care. The results of measurement include knowledge about birth scale, anxiety scale, birth outcomes and birth satisfaction scale. The qualitative study is the application of one-to-one and in-depth interviews and semi-structured interview guidelines will be used to collect data, and the application of content analysis to analyze the data.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The first pregnancy and the gestation period is more than 32 weeks, the fetus is a singleton, and the fetal position is cephalad.
  • There are no obstetric complications and the fetus is normal during prenatal examination.
  • Can communicate in Mandarin and Taiwanese
  • Natural delivery is expected
  • Complete the consent form to participate in this study

排除标准

  • Those whose delivery method expected Cesarean Section
  • Early water breaker
  • Obstetric emergency
  • Newborns have abnormal conditions

研究组 & 干预措施

control group

No Intervention

routine education

shared decision making

Experimental

indcution of labor with shared decision making

干预措施: decision aid (Device)

结局指标

主要结局

Childbirth Self-Efficacy Inventory

时间窗: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum

There are a total of 62 questions, and the scoring method is based on Likert 10 points.

State-Trait Anxiety Inventory; STAI

时间窗: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum

The Situational Anxiety Scale consists of 20 items; a higher score indicates a higher level of anxiety, and vice versa. This scale measures the subject's anxiety level using a 4-point scale: 1 point represents "not at all", 2 points represent "somewhat", 3 points represent "quite a bit", and 4 points represent "very much".

次要结局

未报告次要终点

研究者

发起方
Lee Wan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lee Wan

National Taipei University of Nursing and Health Sciences

National Taipei University of Nursing and Health Sciences

研究点 (1)

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