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CompletedNCT07582302Updated May 12, 2026

Hybrid Episiotomy Training and Student Outcomes

An interventional study of Sponge-Based Episiotomy Repair Training and Chicken Tissue-Based Episiotomy Repair Training in Episiotomy, Midwifery Education and Simulation Training, sponsored by Atlas University. Completed at 1 site in Turkey (Türkiye). Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Atlas University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Episiotomy
  • Midwifery Education
  • Simulation Training
  • Self- Efficacy

Keywords

  • Episiotomy
  • Simulation training
  • Midwifery education
  • Self-efficacy
03

In context

Lead sponsor

Atlas University is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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 · Behavioral: Chicken Tissue-Based Episiotomy Repair Training

  • 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 · Behavioral: Virtual Reality-Based Episiotomy Repair Training

Interventions

  • BehavioralSponge-Based Episiotomy Repair Training

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

  • BehavioralChicken Tissue-Based Episiotomy Repair Training

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

  • BehavioralVirtual Reality-Based Episiotomy Repair Training

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

06

What researchers measure

Primary outcomes

  1. Episiotomy Skills Self-Efficacy

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

    Time frame: Baseline and immediately after training

Secondary outcomes

  1. Anxiety (STAI)

    Scores range from 20 to 80 for each subscale, with higher scores indicating higher levels of anxiety.

    Time frame: Baseline and immediately after training

  2. Cognitive Load (DTCLS)

    The scale assesses intrinsic, extraneous, and germane cognitive load using a Likert-type format, with higher scores indicating higher perceived cognitive load.

    Time frame: Baseline and immediately after training

07

Study locations

1 site
  • Istanbul Atlas University
    Istanbul, Istanbul 34408, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07582302
Lead sponsor
Atlas University
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Dec 30, 2025
Primary completion
Jan 28, 2026
Completion
Feb 25, 2026
Last update
May 12, 2026

Study contacts

Ece NİLÜFER, MSc Candidate
principal investigator · Atlas University
Meserret ASLAN, PhD Candidate
study director · Atlas University
Gülay RATHFISCH
study chair · Atlas University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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