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Completed

NCT Number: NCT07582302

Hybrid Episiotomy Training and Student Outcomes

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Atlas University

Istanbul, 34408, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sponge-Based Episiotomy Repair Training

Behavioral

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

Chicken Tissue-Based Episiotomy Repair Training

Behavioral

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

Virtual Reality-Based Episiotomy Repair Training

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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