EpisiotomyNCT07582302
Hybrid Episiotomy Training and Student Outcomes
A study testing Sponge-Based Episiotomy Repair Training, Chicken Tissue-Based Episiotomy Repair Training and Virtual Reality-Based Episiotomy Repair Training in people with Episiotomy and Midwifery Education, run by Atlas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Midwifery Education, Simulation Training
- What is being tested?
- Sponge-Based Episiotomy Repair Training, Chicken Tissue-Based Episiotomy Repair Training and Virtual Reality-Based Episiotomy Repair Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Istanbul, 34408
About this study
Official title: 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?
Read more
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.
- Conditions
- Episiotomy, Midwifery Education, Simulation Training, Self- Efficacy
- Being tested
- Sponge-Based Episiotomy Repair Training, Chicken Tissue-Based Episiotomy Repair Training, Virtual Reality-Based Episiotomy Repair Training
- Keywords
- Episiotomy, Simulation training, Midwifery education, Self-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponge-Based Episiotomy Repair TrainingBehavioural
Standardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills.
Chicken Tissue-Based Episiotomy Repair TrainingBehavioural
Hands-on episiotomy repair training using chicken tissue to provide realistic tactile practice under instructor supervision.
Virtual Reality-Based Episiotomy Repair TrainingBehavioural
Non-interactive virtual reality-based video training demonstrating episiotomy repair procedures to support cognitive and visual learning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sponge-Based Episiotomy Repair Training; Behavioral: 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. Receives: Behavioral: Sponge-Based Episiotomy Repair Training; Behavioral: Virtual Reality-Based Episiotomy Repair Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episiotomy Skills Self-Efficacy
Scores range from 19 to 76, with higher scores indicating greater self-efficacy in episiotomy repair skills.
Measured: Baseline and immediately after training
Secondary outcomes (2)
Anxiety (STAI)
Scores range from 20 to 80 for each subscale, with higher scores indicating higher levels of anxiety.
Measured: Baseline and immediately after training
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.
Measured: Baseline and immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Dec 2025
- Primary completion28 Jan 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ece NİLÜFER, MSc Candidate, Principal investigator, Atlas UniversityMeserret ASLAN, PhD Candidate, Study director, Atlas UniversityGülay RATHFISCH, Study chair, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582302
- Sponsor's protocol ID
- E-22686390-050.99-87329
- Status last verified
- Jan 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hybrid Episiotomy Repair Training Model on Midwifery Students' Self-Efficacy, Anxiety and Cognitive Load
- ClinicalTrials.gov ID
- NCT07582302
- Acronym / sponsor ID
- E-22686390-050.99-87329
- Conditions
- Episiotomy, Midwifery Education, Simulation Training, Self- Efficacy
- Keywords
- Episiotomy, Simulation training, Midwifery education, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chicken Tissue-Based Episiotomy Repair Training | Experimental | Behavioral: Sponge-Based Episiotomy Repair Training, Behavioral: Chicken Tissue-Based Episiotomy Repair TrainingParticipants 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. |
| Virtual Reality-Based Episiotomy Repair Training | Experimental | Behavioral: Sponge-Based Episiotomy Repair Training, Behavioral: Virtual Reality-Based Episiotomy Repair TrainingParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sponge-Based Episiotomy Repair TrainingStandardized theoretical and practical training on episiotomy repair using sponge models to establish baseline psychomotor skills. | Behavioural | Chicken Tissue-Based Episiotomy Repair Training, Virtual Reality-Based Episiotomy Repair Training |
| Chicken Tissue-Based Episiotomy Repair TrainingHands-on episiotomy repair training using chicken tissue to provide realistic tactile practice under instructor supervision. | Behavioural | Chicken Tissue-Based Episiotomy Repair Training |
| Virtual Reality-Based Episiotomy Repair TrainingNon-interactive virtual reality-based video training demonstrating episiotomy repair procedures to support cognitive and visual learning. | Behavioural | Virtual Reality-Based Episiotomy Repair Training |
Primary outcome
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.
2 secondary outcomes
Anxiety (STAI)
Time frame: Baseline and immediately after training
Cognitive Load (DTCLS)
Time frame: Baseline and immediately after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ece NİLÜFER, MSc Candidate principal investigator
Atlas University
Meserret ASLAN, PhD Candidate study director
Atlas University
Gülay RATHFISCH study chair
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sponge-Based Episiotomy Repair Training, Chicken Tissue-Based Episiotomy Repair Training and Virtual Reality-Based Episiotomy Repair Training in people with Episiotomy and Midwifery Education, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy Skills Self-Efficacy (time frame: Baseline and immediately after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.