Use of Virtual Reality Simulation in Midwifery TrainingVESESNCT07235800
VR Episiotomy Simulation: Impact on Midwifery Students' Skills and Self-Efficacy (VESES)
A study testing Virtual Reality Simulation Training and Traditional Episiotomy Training in people with Use of Virtual Reality Simulation in Midwifery Training, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to develop and evaluate a virtual reality (VR)-based episiotomy training simulation for midwifery students. Episiotomy is a surgical procedure performed during childbirth, and incorrect application may lead to serious psychological and physiological consequences. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Use of Virtual Reality Simulation in Midwifery Training
- What is being tested?
- Virtual Reality Simulation Training and Traditional Episiotomy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Faculty of Health Sciences
Van
Sibel AKGÜL KARTAL, Lecturer, +905019999999, sibelakgulkartal@yyu.edu.tr
About this study
Official title: The Effect of Virtual Reality-Based Episiotomy Simulation on Midwifery Students' Skills and Self-Efficacy Levels
This study aims to develop and evaluate a virtual reality (VR)-based episiotomy training simulation for midwifery students. Episiotomy is a surgical procedure performed during childbirth, and incorrect application may lead to serious psychological and physiological consequences. While traditional training methods often use animal tissues or synthetic materials, recent advances in technology have introduced simulation-based learning. VR technology has shown potential to enhance learning outcomes, confidence, and satisfaction among healthcare students. Despite its growing use in medical education, there is currently no VR training model specifically designed for teaching episiotomy skills. This study will design a VR episiotomy simulation, assess its effectiveness in skill acquisition and learning, and propose it as a new educational method in midwifery training.
Read the 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.
- Being tested
- Virtual Reality Simulation Training, Traditional Episiotomy Training
- Keywords
- Midwifery Virtual Reality Simulation Episiotomy Learning Process
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Simulation TrainingBehavioural
Also called VR Episiotomy Simulation, Virtual Reality-Based Episiotomy Training, VR Episiotomy Skills Training
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.
Traditional Episiotomy TrainingBehavioural
Also called Conventional Episiotomy Education, Episiotomy Model Training
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Simulation Group | Experimental | 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. Receives: Behavioral: Virtual Reality Simulation Training |
| Control Group | Active comparator | 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. Receives: Behavioral: Traditional Episiotomy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Episiotomy Self-Efficacy Score
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.
Measured: Baseline (before training), immediately after training, and 1 month after training
Secondary outcomes (2)
Episiotomy Skill Performance Score
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
Measured: Immediately after training
Student Satisfaction with Training Method
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.
Measured: Immediately after training and 1 month after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start21 Dec 2025 (estimated)
- Primary completion22 Jan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Virtual Reality Simulation in Midwifery TrainingStudies 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
- Model description
- Participants will be randomly assigned to either the virtual reality simulation group or the traditional mannequin training group. Both groups receive the same theoretical education, followed by their respective practical training interventions in parallel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Sibel Akgül Kartal, Yuzuncu Yil University
- Investigators
- Sibel AKGÜL KARTAL, Lecturer, Principal investigator, Yuzuncu Yil University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235800
- Sponsor's protocol ID
- 2025/17627
- Other IDs
- TDK-2020-2165, 2025
- Acronym
- VESES
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data is still under consideration and will depend on institutional policies and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality-Based Episiotomy Simulation on Midwifery Students' Skills and Self-Efficacy Levels
- ClinicalTrials.gov ID
- NCT07235800
- Acronym / sponsor ID
- VESES / 2025/17627
- Keywords
- Midwifery Virtual Reality Simulation Episiotomy Learning Process
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 21 Dec 2025 (estimated)
- Primary completion
- 22 Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
This study aims to develop and evaluate a virtual reality (VR)-based episiotomy training simulation for midwifery students. Episiotomy is a surgical procedure performed during childbirth, and incorrect application may lead to serious psychological and physiological consequences. While traditional training methods often use animal tissues or synthetic materials, recent advances in technology have introduced simulation-based learning. VR technology has shown potential to enhance learning outcomes, confidence, and satisfaction among healthcare students. Despite its growing use in medical education, there is currently no VR training model specifically designed for teaching episiotomy skills. This study will design a VR episiotomy simulation, assess its effectiveness in skill acquisition and learning, and propose it as a new educational method in midwifery training.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the virtual reality simulation group or the traditional mannequin training group. Both groups receive the same theoretical education, followed by their respective practical training interventions in parallel.
| Arm | Type | Receives |
|---|---|---|
| VR Simulation Group | Experimental | Behavioral: Virtual Reality Simulation TrainingParticipants 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. |
| Control Group | Active comparator | Behavioral: Traditional Episiotomy TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Virtual Reality Simulation TrainingAlso: VR Episiotomy Simulation, Virtual Reality-Based Episiotomy Training, VR Episiotomy Skills TrainingThis 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. | Behavioural | VR Simulation Group |
| Traditional Episiotomy TrainingAlso: Conventional Episiotomy Education, Episiotomy Model TrainingThis 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. | Behavioural | Control Group |
Primary outcome
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.
2 secondary outcomes
Episiotomy Skill Performance Score
Time frame: Immediately after training
Student Satisfaction with Training Method
Time frame: Immediately after training and 1 month after training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data is still under consideration and will depend on institutional policies and participant consent.
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.
Sibel AKGÜL KARTAL, Lecturer principal investigator
Yuzuncu Yil University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Simulation Training and Traditional Episiotomy Training in people with Use of Virtual Reality Simulation in Midwifery Training, run by Yuzuncu Yil 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Uçar, Professor (+90 536 761 80 76, tubaucar@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Episiotomy Self-Efficacy Score (time frame: Baseline (before training), immediately after training, and 1 month 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 19 Nov 2025.