NCT07582302

Brief Summary

The goal of this clinical trial is to evaluate the effects of a hybrid episiotomy repair training model on self-efficacy, anxiety, and cognitive load in third-year midwifery students. The main questions it aims to answer are: Does standardized sponge-based training improve students' episiotomy skills self-efficacy and cognitive load? Is there a difference between chicken tissue-based training and virtual reality-based training in terms of self-efficacy, anxiety, and cognitive load outcomes? Researchers will compare chicken tissue-based training and virtual reality-based training to determine whether there are differences in educational outcomes between these two advanced simulation methods. Participants will:

  • complete baseline assessments of anxiety, self-efficacy, and cognitive load,
  • receive standardized episiotomy repair training using a sponge model,
  • be randomly assigned to either chicken tissue-based hands-on training or virtual reality-based video training,
  • complete post-training assessments following each training phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 30, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

January 1, 2026

Enrollment Period

29 days

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

EpisiotomySimulation trainingMidwifery educationSelf-efficacy

Outcome Measures

Primary Outcomes (1)

  • Episiotomy Skills Self-Efficacy

    Scores range from 19 to 76, with higher scores indicating greater self-efficacy in episiotomy repair skills.

    Baseline and immediately after training

Secondary Outcomes (2)

  • Anxiety (STAI)

    Baseline and immediately after training

  • Cognitive Load (DTCLS)

    Baseline and immediately after training

Study Arms (2)

Chicken Tissue-Based Episiotomy Repair Training

EXPERIMENTAL

Participants in this arm received standardized episiotomy repair training using sponge models, followed by hands-on episiotomy repair practice on chicken tissue under instructor supervision. Final assessments of self-efficacy, anxiety, and cognitive load were conducted after completion of the training.

Behavioral: Sponge-Based Episiotomy Repair TrainingBehavioral: Chicken Tissue-Based Episiotomy Repair Training

Virtual Reality-Based Episiotomy Repair Training

EXPERIMENTAL

Participants in this arm received standardized episiotomy repair training using sponge models, followed by non-interactive virtual reality-based video training demonstrating episiotomy repair procedures. Final assessments of self-efficacy, anxiety, and cognitive load were conducted after completion of the training.

Behavioral: Sponge-Based Episiotomy Repair TrainingBehavioral: Virtual Reality-Based Episiotomy Repair Training

Interventions

Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.

Chicken Tissue-Based Episiotomy Repair TrainingVirtual Reality-Based Episiotomy Repair Training

Non-interactive virtual reality-based video training demonstrating episiotomy repair procedures to support cognitive and visual learning.

Virtual Reality-Based Episiotomy Repair Training

Hands-on episiotomy repair training using chicken tissue to provide realistic tactile practice under instructor supervision.

Chicken Tissue-Based Episiotomy Repair Training

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a third-year midwifery student
  • Having completed theoretical education on episiotomy and perineal repair
  • Voluntary agreement to participate in the study
  • Providing written informed consent

You may not qualify if:

  • Having previously performed episiotomy repair actively in a clinical setting
  • Having any physical condition that may affect surgical hand skills
  • Not attending any of the training sessions during the study
  • Not completing the data collection process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Istanbul, 34408, Turkey (Türkiye)

Location

Study Officials

  • Ece NİLÜFER, MSc Candidate

    Atlas University

    PRINCIPAL INVESTIGATOR
  • Meserret ASLAN, PhD Candidate

    Atlas University

    STUDY DIRECTOR
  • Gülay RATHFISCH

    Atlas University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

December 30, 2025

Primary Completion

January 28, 2026

Study Completion

February 25, 2026

Last Updated

May 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations