VR Episiotomy Simulation: Impact on Midwifery Students' Skills and Self-Efficacy (VESES)

NCT ID: NCT07235800

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-21
• Study Completion Date: 2026-04-30

Brief 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. 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.

Conditions

Use of Virtual Reality Simulation in Midwifery Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Simulation Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Episiotomy Training

Intervention Type: BEHAVIORAL

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.

Interventions

Virtual Reality Simulation 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.

Intervention Type: BEHAVIORAL

Traditional Episiotomy 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

VR Episiotomy Simulation; Virtual Reality-Based Episiotomy Training; VR Episiotomy Skills Training; Conventional Episiotomy Education; Episiotomy Model Training

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: collaborator

Yuzuncu Yil University

OTHER

Sponsor Role: lead

Responsible Party

Sibel Akgül Kartal

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibel AKGÜL KARTAL, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yil University, Faculty of Health Sciences

Locations

Van Yüzüncü Yıl University Faculty of Health Sciences

Van, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tuba Uçar, Professor

Role: CONTACT

tubaucar@inonu.edu.tr

+90 536 761 80 76

Facility Contacts

Sibel AKGÜL KARTAL, Lecturer

Role: primary

sibelakgulkartal@yyu.edu.tr

+905019999999

Related Links

https://tez.yok.gov.tr/UlusalTezMerkezi/tezDetay.jsp?id=63801

Related Info

Other Identifiers

TDK-2020-2165

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025/17627

Identifier Type: -

Identifier Source: org_study_id