NCT07235800

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

Midwifery Virtual Reality Simulation Episiotomy Learning Process

Outcome Measures

Primary Outcomes (1)

  • Change in Episiotomy Self-Efficacy Score

    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.

    Baseline (before training), immediately after training, and 1 month after training

Secondary Outcomes (2)

  • Episiotomy Skill Performance Score

    Immediately after training

  • Student Satisfaction with Training Method

    Immediately after training and 1 month after training

Study Arms (2)

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.

Behavioral: Virtual Reality Simulation Training

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.

Behavioral: Traditional Episiotomy Training

Interventions

This intervention is a virtual reality (VR)-based episiotomy simulation designed for midwifery students. The training is conducted in an immersive virtual delivery room, where participants perform the steps of episiotomy incision and suturing using VR headsets, motion sensors, and hand controllers. The simulation includes virtual surgical tools and interactive elements that replicate a clinical environment. This VR-based training differs from traditional model-based education by providing a more engaging and realistic experience, aiming to improve students' psychomotor skills and self-efficacy in performing episiotomy.

Also known as: VR Episiotomy Simulation, Virtual Reality-Based Episiotomy Training, VR Episiotomy Skills Training
VR Simulation Group

This intervention consists of a traditional episiotomy training session using physical anatomical models (manikins) in a classroom environment. The training includes hands-on practice of episiotomy incision and suturing on silicone-based or synthetic perineal models, supervised by the instructor. This method reflects standard educational practices in midwifery training and does not involve virtual reality or simulation technology.

Also known as: Conventional Episiotomy Education, Episiotomy Model Training
Control Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University Faculty of Health Sciences

Van, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Sibel AKGÜL KARTAL, Lecturer

    Yuzuncu Yil University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Uçar, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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."
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the virtual reality simulation group or the traditional mannequin training group. Both groups receive the same theoretical education, followed by their respective practical training interventions in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

December 21, 2025

Primary Completion

January 22, 2026

Study Completion

April 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations