- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07235800
VR Episiotomy Simulation: Impact on Midwifery Students' Skills and Self-Efficacy (VESES) (VESES)
The Effect of Virtual Reality-Based Episiotomy Simulation on Midwifery Students' Skills and Self-Efficacy Levels
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aims to develop and evaluate a virtual reality (VR)-supported episiotomy simulation training program for midwifery students. The unique contribution of this study lies in assessing skills acquisition, learning processes, and satisfaction differences in VR-based episiotomy training, a field where no previous VR applications for episiotomy skills training have been identified in the literature.
A randomized controlled parallel-group design will be employed. The study will take place at Van Yuzuncu Yıl University Faculty of Health Sciences (YYU FHS) between April 2025 and April 2026. The episiotomy topic is covered theoretically and practically within the Risky Birth and Postpartum Course for third-year midwifery students at YYU FHS. Currently, mannequin models are used for episiotomy practice.
The study population will consist of third-year midwifery students at YYU FHS, totaling 90 students. The sample will be composed of students who voluntarily agree to participate and meet inclusion criteria. Sample size was calculated using G*Power 3.1.9.2 software based on the primary dependent variable-mean self-efficacy scores-yielding a minimum of 38 students per group (VR intervention and control groups), with an effect size of 0.50, power of 0.95, and alpha of 0.05. Participants will be randomized equally into two groups using the Random.org platform to prevent selection bias.
Inclusion criteria are: proficiency in Turkish, no prior episiotomy training, and no medical contraindications for VR use (e.g., epilepsy).
Data collection tools include:
Demographic Information Form
Skill Evaluation Form
Episiotomy Skills Self-Efficacy Scale (EBÖÖ)
Student Satisfaction Survey
Data collection will be performed by an independent researcher who is not involved in the intervention delivery or study design. Due to the visible nature of the intervention (VR headset vs. mannequin), full blinding of the outcome assessor is not feasible. However, all evaluations will be conducted using standardized assessment tools to reduce observer bias and ensure objectivity. Assessments will occur pre-training, immediately post-training, and one month after training.
The intervention includes a two-day training program. On the first day, all students receive four hours of theoretical instruction on episiotomy. On the second day, the control group practices on traditional mannequins for four hours, while the intervention group trains using the VR simulation for the same duration. The VR simulation immerses students in a virtual delivery room where they perform episiotomy and repair using virtual surgical tools and equipment.
The VR setup includes VR goggles, two control handles, motion sensors, and a high-performance computer. The episiotomy mannequin used in the control group realistically simulates perineal anatomy for skill practice.
Dependent variables are students' skill performance and self-efficacy scores; the independent variable is the VR-supported episiotomy training.
Study limitations include the single-center design with only YYU third-year students and the high cost of VR software and equipment.
Data will be analyzed using SPSS 25. Descriptive statistics (mean, standard deviation) and inferential tests (independent and paired sample t-tests) will be conducted to evaluate group differences and within-group changes.
This study is expected to demonstrate the feasibility and effectiveness of VR technology in enhancing midwifery education and propose an innovative training tool for episiotomy skills development.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuba Uçar, Professor
- Phone Number: +90 536 761 80 76
- Email: tubaucar@inonu.edu.tr
Study Locations
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Van, Turkey (Türkiye)
- Van Yüzüncü Yıl University Faculty of Health Sciences
-
Contact:
- Sibel AKGÜL KARTAL, Lecturer
- Phone Number: +905019999999
- Email: sibelakgulkartal@yyu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak and understand Turkish
Have not received previous episiotomy training
No medical conditions preventing the use of virtual reality (e.g., epilepsy)
Enrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences
Exclusion Criteria:
- Individuals who do not speak or understand Turkish
Those who have previously received episiotomy training
Participants with medical conditions contraindicating the use of virtual reality (e.g., epilepsy)
Not enrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Simulation Group
Participants in this group will receive episiotomy skills training using a virtual reality (VR) simulation environment.
The training will include a theoretical session followed by hands-on practice in a simulated virtual birth room using VR equipment.
|
This intervention is a virtual reality (VR)-based episiotomy simulation designed for midwifery students.
The training is conducted in an immersive virtual delivery room, where participants perform the steps of episiotomy incision and suturing using VR headsets, motion sensors, and hand controllers.
The simulation includes virtual surgical tools and interactive elements that replicate a clinical environment.
This VR-based training differs from traditional model-based education by providing a more engaging and realistic experience, aiming to improve students' psychomotor skills and self-efficacy in performing episiotomy.
Other Names:
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|
Active Comparator: Control Group
Participants in this group will receive episiotomy skills training using traditional silicone-based episiotomy mannequins.
The training includes the same theoretical content as the intervention group, followed by hands-on practice using anatomical models.
|
This intervention consists of a traditional episiotomy training session using physical anatomical models (manikins) in a classroom environment.
The training includes hands-on practice of episiotomy incision and suturing on silicone-based or synthetic perineal models, supervised by the instructor.
This method reflects standard educational practices in midwifery training and does not involve virtual reality or simulation technology.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Episiotomy Self-Efficacy Score
Time Frame: Baseline (before training), immediately after training, and 1 month after training
|
Participants' episiotomy-related self-efficacy will be assessed using the Episiotomy Skills Self-Efficacy Scale (EBÖÖ), a validated 19-item Likert-type instrument.
Each item is scored from 1 (strongly disagree) to 4 (strongly agree), with total scores ranging from 19 to 76. Higher scores indicate greater self-efficacy.
|
Baseline (before training), immediately after training, and 1 month after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Episiotomy Skill Performance Score
Time Frame: Immediately after training
|
Participants' practical episiotomy skills will be evaluated through a researcher-developed checklist.
This checklist covers key steps in the episiotomy procedure.
Each step is observed and scored, providing a total
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Immediately after training
|
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Student Satisfaction with Training Method
Time Frame: Immediately after training and 1 month after training
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Participants' satisfaction with the training method (VR or traditional mannequin) will be assessed using a researcher-developed satisfaction questionnaire.
This includes Likert-scale questions evaluating the perceived usefulness, engagement, and satisfaction with the training.
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Immediately after training and 1 month after training
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sibel AKGÜL KARTAL, Lecturer, Yuzuncu Yil University, Faculty of Health Sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/17627
- TDK-2020-2165 (Other Grant/Funding Number: Inonu University Scientific Research Projects Coordination Unit (BAP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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