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临床试验/NCT07235800
NCT07235800尚未招募不适用

The Effect of Virtual Reality-Based Episiotomy Simulation on Midwifery Students' Skills and Self-Efficacy Levels

Yuzuncu Yil University1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2025年12月21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
发起方
入组人数
87
试验地点
1
主要终点
Change in Episiotomy Self-Efficacy Score

研究概览

简要总结

This study aims to develop and evaluate a virtual reality (VR)-based episiotomy training simulation for midwifery students. Episiotomy is a surgical procedure performed during childbirth, and incorrect application may lead to serious psychological and physiological consequences. While traditional training methods often use animal tissues or synthetic materials, recent advances in technology have introduced simulation-based learning. VR technology has shown potential to enhance learning outcomes, confidence, and satisfaction among healthcare students. Despite its growing use in medical education, there is currently no VR training model specifically designed for teaching episiotomy skills. This study will design a VR episiotomy simulation, assess its effectiveness in skill acquisition and learning, and propose it as a new educational method in midwifery training.

详细描述

This study aims to develop and evaluate a virtual reality (VR)-supported episiotomy simulation training program for midwifery students. The unique contribution of this study lies in assessing skills acquisition, learning processes, and satisfaction differences in VR-based episiotomy training, a field where no previous VR applications for episiotomy skills training have been identified in the literature.

A randomized controlled parallel-group design will be employed. The study will take place at Van Yuzuncu Yıl University Faculty of Health Sciences (YYU FHS) between April 2025 and April 2026. The episiotomy topic is covered theoretically and practically within the Risky Birth and Postpartum Course for third-year midwifery students at YYU FHS. Currently, mannequin models are used for episiotomy practice.

The study population will consist of third-year midwifery students at YYU FHS, totaling 90 students. The sample will be composed of students who voluntarily agree to participate and meet inclusion criteria. Sample size was calculated using G*Power 3.1.9.2 software based on the primary dependent variable-mean self-efficacy scores-yielding a minimum of 38 students per group (VR intervention and control groups), with an effect size of 0.50, power of 0.95, and alpha of 0.05. Participants will be randomized equally into two groups using the Random.org platform to prevent selection bias.

Inclusion criteria are: proficiency in Turkish, no prior episiotomy training, and no medical contraindications for VR use (e.g., epilepsy).

Data collection tools include:

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)

盲法说明

No blinding (masking) was applied in this study. Participants were unaware of their group allocation only during the initial training session, but by the time of the one-month follow-up data collection, they were aware of their group assignment. Instructors and outcome assessors were aware of group assignments throughout the study."

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Able to speak and understand Turkish
  • •Have not received previous episiotomy training
  • •No medical conditions preventing the use of virtual reality (e.g., epilepsy)
  • •Enrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences

排除标准

  • •Individuals who do not speak or understand Turkish
  • •Those who have previously received episiotomy training
  • •Participants with medical conditions contraindicating the use of virtual reality (e.g., epilepsy)
  • •Not enrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences

研究组 & 干预措施

VR Simulation Group

Experimental

Participants in this group will receive episiotomy skills training using a virtual reality (VR) simulation environment. The training will include a theoretical session followed by hands-on practice in a simulated virtual birth room using VR equipment.

干预措施: Virtual Reality Simulation Training (Behavioral)

Control Group

Active Comparator

Participants in this group will receive episiotomy skills training using traditional silicone-based episiotomy mannequins. The training includes the same theoretical content as the intervention group, followed by hands-on practice using anatomical models.

干预措施: Traditional Episiotomy Training (Behavioral)

结局指标

主要结局

Change in Episiotomy Self-Efficacy Score

时间窗: Baseline (before training), immediately after training, and 1 month after training

Participants' episiotomy-related self-efficacy will be assessed using the Episiotomy Skills Self-Efficacy Scale (EBÖÖ), a validated 19-item Likert-type instrument. Each item is scored from 1 (strongly disagree) to 4 (strongly agree), with total scores ranging from 19 to 76. Higher scores indicate greater self-efficacy.

次要结局

  • Episiotomy Skill Performance Score(Immediately after training)
  • Student Satisfaction with Training Method(Immediately after training and 1 month after training)

研究者

发起方
Yuzuncu Yil University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Akgül Kartal

Lecturer

Yuzuncu Yil University

研究点 (1)

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