[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611070":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":32,"studyPopulation":22,"armGroups":33,"interventions":46,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":89,"collaborators":92,"id":95,"slug":22,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":22,"enrollmentInfo":105,"targetDuration":22,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":116,"whyStopped":22,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Yuzuncu Yil University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline (before training), immediately after training, and 1 month after training",[14,18],{"measure":15,"description":16,"timeFrame":17},"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","Immediately after training",{"measure":19,"description":20,"timeFrame":21},"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.","Immediately after training and 1 month after training",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":6,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","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":28,"maskingDescription":29,"whoMasked":30},"SINGLE","No blinding (masking) was applied in this study. Participants were unaware of their group allocation only during the initial training session, but by the time of the one-month follow-up data collection, they were aware of their group assignment. Instructors and outcome assessors were aware of group assignments throughout the study.\"",[31],"PARTICIPANT","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.\n\nA 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.\n\nThe 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.\n\nInclusion criteria are: proficiency in Turkish, no prior episiotomy training, and no medical contraindications for VR use (e.g., epilepsy).\n\nData collection tools include:\n\nDemographic Information Form\n\nSkill Evaluation Form\n\nEpisiotomy Skills Self-Efficacy Scale (EBÖÖ)\n\nStudent Satisfaction Survey\n\nData 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.\n\nThe 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.\n\nThe 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.\n\nDependent variables are students' skill performance and self-efficacy scores; the independent variable is the VR-supported episiotomy training.\n\nStudy limitations include the single-center design with only YYU third-year students and the high cost of VR software and equipment.\n\nData 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.\n\nThis 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.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"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.",[39],"Behavioral: Virtual Reality Simulation Training",{"label":41,"type":42,"description":43,"interventionNames":44},"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.",[45],"Behavioral: Traditional Episiotomy Training",[47,56],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"BEHAVIORAL","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.",[35],[53,54,55],"VR Episiotomy Simulation","Virtual Reality-Based Episiotomy Training","VR Episiotomy Skills Training",{"type":48,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"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.",[41],[61,62],"Conventional Episiotomy Education","Episiotomy Model Training",[64],{"name":65,"affiliation":66,"role":67},"Sibel AKGÜL KARTAL, Lecturer","Yuzuncu Yil University, Faculty of Health Sciences","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":22,"email":73},"Tuba Uçar, Professor","CONTACT","+90 536 761 80 76","tubaucar@inonu.edu.tr",[75],{"facility":76,"status":22,"city":77,"state":22,"zip":22,"country":78,"countryCode":22,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Van Yüzüncü Yıl University Faculty of Health Sciences","Van","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],43.38323,38.49457,{"lat":83,"lon":82},[86],{"name":65,"role":71,"phone":87,"phoneExt":22,"email":88},"+905019999999","sibelakgulkartal@yyu.edu.tr",{"type":67,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Sibel Akgül Kartal","Lecturer",[93],{"name":94,"class":6},"Inonu University","100611070",false,"NCT07235800","VR Episiotomy Simulation: Impact on Midwifery Students' Skills and Self-Efficacy (VESES)","The Effect of Virtual Reality-Based Episiotomy Simulation on Midwifery Students' Skills and Self-Efficacy Levels","VESES","Inclusion Criteria:\n\n* Able to speak and understand Turkish\n\nHave not received previous episiotomy training\n\nNo medical conditions preventing the use of virtual reality (e.g., epilepsy)\n\nEnrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences\n\nExclusion Criteria:\n\n* Individuals who do not speak or understand Turkish\n\nThose who have previously received episiotomy training\n\nParticipants with medical conditions contraindicating the use of virtual reality (e.g., epilepsy)\n\nNot enrolled as a third-year midwifery student at Van Yüzüncü Yıl University Faculty of Health Sciences",true,"FEMALE","18 Years",{"count":106,"type":107},87,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.",[113],"Use of Virtual Reality Simulation in Midwifery Training",[115],"Midwifery Virtual Reality Simulation Episiotomy Learning Process","NOT_YET_RECRUITING","2025-11-14",{"date":119,"type":120},"2025-11-19","ACTUAL",{"date":122,"type":107},"2025-12-21",{"date":124,"type":107},"2026-04",{"name":5,"class":6},1]