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临床试验/NCT06453811
NCT06453811已完成不适用

The Effect of a Self-Efficacy Theory-Based Spouse Participation Childbirth Preparation Program on Fear of Childbirth, Self-Efficacy, Mode of Delivery and Birth Outcomes: A Randomized Controlled Trial

Lokman Hekim University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
The Childbirth Self-Efficacy Inventory Short Form

研究概览

简要总结

The research is designed as a pre-test, post-test, parallel-group, randomized controlled study to examine the effect of a spouse-participated childbirth preparation program based on self-efficacy theory on fear of childbirth, self-efficacy, mode of delivery and outcomes. Participants will be allocated to experimental and control groups through block randomization. Participants in the experimental group will be enrolled in a two-session spouse-participated childbirth preparation program based on self-efficacy theory once a week, in addition to receiving routine care at the hospital. Participants in the control group will not receive any intervention, only routine care provided at the hospital.

详细描述

Nulliparous pregnant women and their spouses who apply to the obstetrics and gynecology clinic and outpatient clinic of the hospital where the research will be conducted will be assessed for eligibility according to the inclusion criteria, and informed consent will be obtained. Subsequently, prospective fathers will be given a Personal Information Form and the Fathers' Fear of Childbirth Scale; prospective mothers will be given a Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale as pre-tests. Couples will be allocated to the experimental or control group according to a block randomization list. Couples assigned to the experimental group will be included in a three-week program, attending a self-efficacy theory-based childbirth preparation program in groups of 3-4 couples, scheduled according to their availability. At the end of the sessions, the training guide reflecting the content of the training will be given to the couples and they will be asked to read it at home and do their homework by using the relevant parts of the guide. At the same time, these couples will continue routine pregnancy controls in the hospital. Routine pregnancy check-ups at the hospital include standard antenatal follow-ups, and pregnant women and their partners receive information about the pregnancy and labour process only during the medical examination. It is planned to complete the trainings once a week, twice in total and for two weeks. After the trainings are completed, it is planned to send at least three reminders by text message until the calculated delivery date. Brochures and text message contents related to the training content will be used in the reminder. After completing the training, the Fathers' Fear of Childbirth Scale, the Childbirth Self-Efficacy Inventory Short Form, and the Perception of Spousal Support in Pregnancy Scale will be administered again. Following childbirth, the Wijma Delivery Expectancy/Experience Questionnaire Version B will be completed by the mothers, and the birth process information form will be filled out by the researcher. Couples in the control group will undergo the same pre-test and post-test assessments as the experimental group. However, no additional intervention will be provided to these couples, and they will receive the same routine care as the experimental group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Couples must be 18 years of age or older,
  • Couples should be able to read and write Turkish,
  • The pregnant woman has never given birth before,
  • The pregnant woman is at 28-30 weeks of gestation,
  • The pregnancy is viable and singular,
  • The pregnant woman does not have an established indication for caesarean section,
  • Routine controls during pregnancy are carried out in the hospital where the study is conducted.

排除标准

  • Pregnancy achieved by assisted reproductive techniques,
  • Participating in a birth preparation programme other than the routine pregnancy check-ups at the hospital,
  • Failure to attend any of the sessions in the childbirth preparation programme,
  • Failure to communicate in the postnatal period (no response to at least 3 telephone calls)
  • Development of any indication for caesarean section during pregnancy,
  • The birth takes place in a health institution different from the hospital where the research will be conducted.

结局指标

主要结局

The Childbirth Self-Efficacy Inventory Short Form

时间窗: The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).

Measures the level of self-efficacy of expectant mothers in childbirth. The lowest score that can be obtained from the overall scale is 32 and the highest score is 320. The highest score obtained from the overall scale means that women's self-efficacy levels in childbirth are high (Ersoy \& Kukulu, 2011).

Birth Process Information Form

时间窗: It will be applied two hours after the expectant mother gives birth.

This form inquires about the mode of delivery and intervention at birth. One of the primary outcomes of the research is mode of delivery.

次要结局

  • The Perception of Spousal Support in Pregnancy Scale(The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).)
  • The Fathers' Fear of Childbirth Scale(The pre-test will be administered before randomisation and the post-test will be administered 15 minutes after the training is completed (on the same day).)
  • The Wijma Delivery Expectancy/Experience Questionnaire Version A-B(The pre-test will be administered before randomisation and the post-test 2 hours after the delivery.)

研究者

发起方
Lokman Hekim University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fatma Nur Duman

Research Assistant

Lokman Hekim University

研究点 (2)

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