Hybrid Episiotomy Training and Student Outcomes

May 6, 2026 updated by: Atlas University

Effects of a Hybrid Episiotomy Repair Training Model on Midwifery Students' Self-Efficacy, Anxiety and Cognitive Load

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized comparative educational intervention designed to evaluate the effects of a hybrid episiotomy repair training model on midwifery students' self-efficacy, anxiety levels, and cognitive load. Episiotomy repair is a technically demanding clinical skill that is difficult to practice in real clinical settings due to its invasive nature and limited opportunities for hands-on experience. Therefore, simulation-based training methods are essential to support skill acquisition in a safe and controlled learning environment.

The study was conducted with third-year midwifery students enrolled in the Department of Midwifery at Istanbul Atlas University during the 2025-2026 academic year. A total of 51 students who met the inclusion criteria and provided informed consent participated in the study. All participants first received standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor competence.

Following this initial phase, participants were randomly assigned in a 1:1 ratio to one of two advanced training groups using a computer-generated randomization sequence. The first group received hands-on training using chicken tissue, which provides a more realistic tactile simulation of human perineal tissue. The second group received non-interactive virtual reality-based video training, designed to enhance cognitive and visual understanding of the episiotomy repair procedure.

Data were collected at three time points: before the training (baseline), after the standardized sponge-based training, and after completion of the assigned advanced training intervention. The primary outcomes included episiotomy skills self-efficacy, anxiety levels, and cognitive load. Self-efficacy was assessed using the Episiotomy Skills Self-Efficacy Scale (ESSES), anxiety levels were measured using the State-Trait Anxiety Inventory (STAI), and cognitive load was evaluated using the Different Types of Cognitive Load Scale (DTCLS).

The study aims to determine whether standardized sponge-based training improves students' learning outcomes and to compare the effectiveness of chicken tissue-based training and virtual reality-based training in reinforcing these outcomes. The findings are expected to contribute to the development of evidence-based educational strategies in midwifery education by identifying effective and feasible simulation-based training models for teaching episiotomy repair skills.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34408
        • Istanbul Atlas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chicken Tissue-Based Episiotomy Repair Training
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 Training
Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.
Behavioral: Chicken Tissue-Based Episiotomy Repair Training
Hands-on episiotomy repair training using chicken tissue to provide realistic tactile practice under instructor supervision.
Experimental: Virtual Reality-Based Episiotomy Repair Training
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 Training
Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.
Behavioral: Virtual Reality-Based Episiotomy Repair Training
Non-interactive virtual reality-based video training demonstrating episiotomy repair procedures to support cognitive and visual learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episiotomy Skills Self-Efficacy
Time Frame: Baseline and immediately after training
Scores range from 19 to 76, with higher scores indicating greater self-efficacy in episiotomy repair skills.
Baseline and immediately after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety (STAI)
Time Frame: Baseline and immediately after training
Scores range from 20 to 80 for each subscale, with higher scores indicating higher levels of anxiety.
Baseline and immediately after training
Cognitive Load (DTCLS)
Time Frame: Baseline and immediately after training
The scale assesses intrinsic, extraneous, and germane cognitive load using a Likert-type format, with higher scores indicating higher perceived cognitive load.
Baseline and immediately after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Investigators

  • Principal Investigator: Ece NİLÜFER, MSc Candidate, Atlas University
  • Study Director: Meserret ASLAN, PhD Candidate, Atlas University
  • Study Chair: Gülay RATHFISCH, Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2025

Primary Completion (Actual)

January 28, 2026

Study Completion (Actual)

February 25, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-22686390-050.99-87329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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