CClinicalTrials.gg
CompletedNCT06711198Updated Jan 16, 2025

Virtual Reality Simulation in Episiotomy Training

An interventional study of virtual reality simulation in Episiotomy and Virtual Simulation, sponsored by Sakarya University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Sakarya University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The correct application and repair of episiotomy, which is a frequently used intervention in labor, is important for the psychological and physiological health of the mother after birth. Therefore, it is very important to provide students with the skill of performing episiotomy with the most effective education methods, to reduce their anxiety in this regard and to increase their self-efficacy. Trying to teach suture techniques on sponge, chicken, calf tongue or a soft material is quite limited when the integrity of episiotomy education is considered. Developments in simulation techniques, especially virtual reality glasses that help users experience sensory information such as visual, auditory and movement with real-like experiences, reveal the importance of using technology in health education. Since it does not require additional materials such as calf tongue, sponge, needle holder, etc., it is important for midwifery education to be economical. In addition, the fact that the application can be repeated many times without harming the person affects the anxiety and self-efficacy levels of students before real clinical experience. Within the scope of the study, in order to evaluate the effect of using virtual reality in teaching episiotomy application and repair on students' episiotomy self-efficacy and anxiety levels, midwifery students taking the Normal Birth and Postpartum period course will be divided into three groups during the episiotomy teaching application; one group will practice on calf tongue, one group will practice only with virtual reality, and one group will practice using both. The study data will be collected through the Student Identification Form, State Anxiety Inventory, and Episiotomy Self-Efficacy Scale. The analysis of the data obtained from the research will be done with the SPSS program. It is thought that the study will make a significant contribution to the literature in terms of evaluating the effect of virtual reality glasses on episiotomy teaching.

Read the detailed description

Episiotomy, which is among the duties of midwives, is an important surgical incision made in the vagina and perineum to widen the vaginal opening during birth (Hersh \& Emeis, 2020). In many countries, especially those classified as low or middle income; the majority of women who give birth vaginally undergo routine episiotomy (Silf et al. 2015). Although the use of routine episiotomy is no longer recommended, a midwife or obstetrician must perform the procedure expertly (Güler et al. 2018). Correct application and repair of episiotomy is important for the psychological and physiological health of the mother after birth. If this process is not managed correctly, it can reduce the quality of life of women (Güler et al. 2018, Demir Kaymak et al., 2024). For this reason, it is very important to provide students with the skill of performing episiotomy with the most effective training methods and to increase their self-efficacy in this regard (Bick et al., 2010; Güler et al. 2018). Virtual reality is a simulation technology that allows people to feel like they are in a real world through technological tools using three-dimensional images made in a computer environment, and allows them to interact with objects in the environment by including visual screens and sounds (Bani Mohammadi and Ahmad, 2019). Virtual reality can be defined as a digital simulation created by a computer that allows users to explore a virtual environment and interact with a virtual environment, providing a sense of reality with three-dimensional (3D) images (Bevilacqua et al., 2019). The computer-generated environment helps users experience sensory information such as visual, auditory and movement with experiences close to reality. An important feature of all virtual reality applications is interaction. Virtual environments are created and allow the user to interact not only with the virtual environment, but also with virtual objects in the environment (Bevilacqua et al., 2019; Chirico et al., 2016). Virtual reality, which places people in a central role by using motor skills, decision-making skills, and communication skills with virtual procedures in various clinical environments, is also used as a teaching strategy today (Berman, Durning, Fischer, Huwendiek, \& Triola, 2016; Padilha, Machado, Ribeiro, Ramos, \& Costa, 2019). Virtual reality simulators are preferred because they increase knowledge retention, clinical reasoning, increased learning satisfaction, and improved motor control, decision-making, and communication skills of individuals and increased self-efficacy (Nassar, Al-Manaseer, Knowlton, \& Tuma, 2021; Padilha et al., 2019). Innovations in simulation technologies necessitate the integration of technological developments into health education (Berman et al., 2016). In parallel, the use of high-quality simulators in education strengthens the acquisition of knowledge and skills in students' practices and increases the quality of education (Berman et al., 2016; Padilha et al., 2019).

02

Conditions studied

  • Episiotomy
  • Virtual Simulation

Keywords

  • virtual simulation
  • midwifery
  • episiotomy
  • anxiety
  • Self-Efficacy
03

In context

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Registered in the midwifery department,
  • Attending the normal birth and postpartum period course,
  • Agreeing to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Having previously taken the normal birth and postpartum period course and failed the course,
  • Not attending the episiotomy laboratory course,
  • Not agreeing to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
95 participants (actual)

Study arms

  • No intervention
    Control group (application with calf tongue)

    Control group (application with calf tongue): In Sakarya University Midwifery Department, while teaching episiotomy application within the scope of Normal birth and postpartum period course, laboratory application is routinely performed on calf tongue. Therefore, the application group to be performed on calf tongue was accepted as the control group. The instructor will first provide theoretical training on episiotomy to the group coming to the laboratory. The theoretical training period will consist of 50 minutes. The content of the training will include the importance of episiotomy, risks, indications, contraindications, episiotomy application time, materials used, episiotomy types, episiotomy repair and time, suture techniques and midwifery care in episiotomy. While explaining suture techniques within the scope of this course, videos about suture techniques on social media platforms will be watched by students. Immediately after the training, episiotomy repair (suture techniques) ap

  • Experimental
    1. Experimental group (Application with virtual reality simulation)

    The instructor will first provide theoretical training to the group coming to the laboratory on episiotomy. The theoretical training will consist of 50 minutes. The content of the training will include the importance of episiotomy, risks, indications, contraindications, episiotomy application time, materials used, episiotomy types, episiotomy repair and time, suture techniques and midwifery care in episiotomy. While explaining suture techniques within the scope of this course, videos on suture techniques on social media platforms will be watched by the students. Immediately after the training, the episiotomy repair (suture techniques) application will be started. Students will be taken to the laboratory one by one. The student who is taken to the application will be put on the Meta Quest 3 virtual reality glasses and the episiotomy application will be started via the computer integrated with the glasses. The episiotomy application will start with the image of a woman who has given bir

    Other: virtual reality simulation

  • Experimental
    2. Experimental group (Both calf tongue and virtual reality simulation)

    Students in this group will first receive theoretical training as in other groups. The theoretical training will consist of 50 minutes. The content of the training will include the importance of episiotomy, risks, indications, contraindications, episiotomy application time, materials used, episiotomy types, episiotomy repair and time, suture techniques and midwifery care in episiotomy. While suture techniques are explained in this course, videos about suture techniques on social media platforms will be watched by students. Immediately after the training, an application will be made in a virtual reality simulation for episiotomy repair, and then the application will be repeated on the calf tongue.

    Other: virtual reality simulation

Interventions

  • Othervirtual reality simulation

    The student will be put on the Meta Quest 3 virtual reality glasses and the episiotomy application will be started via the computer integrated with the glasses. The episiotomy application will start with the image of a woman who has given birth in the delivery room on the delivery table. The student is expected to select the appropriate materials and complete the episiotomy repair of the woman with the correct steps.

06

What researchers measure

Primary outcomes

  1. State Anxiety Inventory (STAI)

    The State Anxiety Inventory consists of 20 items and requires the individual to answer how he or she feels at a certain moment and under certain conditions, taking into account his feelings about the situation he is in. The scale is likert type and is a four-degree scale ranging from "Not at all" to "Totally". The maximum score that can be obtained from the scale is 80, and the minimum score is 20. High scores indicate high anxiety, low scores indicate low anxiety.

    Time frame: 1 hours

  2. Episiotomy Self-Efficacy Scale

    The scale developed by the researchers consists of 17 items. The scale is a 5-point Likert type and consists of 4 sub-dimensions. These sub-dimensions are cognitive (5 items), affective (5 items), motivation (3 items) and psychomotor (4 items). The Cronbach Alpha coefficient of this scale developed by the authors is 0.955.

    Time frame: 1 hours

07

Study locations

1 site
  • Sakarya University
    Sakarya, Turkey
08

References and documents

Publications

  • Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical Virtual Simulation in Nursing Education: Randomized Controlled Trial. J Med Internet Res. 2019 Mar 18;21(3):e11529. doi: 10.2196/11529. Erratum In: J Med Internet Res. 2019 Jun 27;21(6):e14155. doi: 10.2196/14155. PubMed 30882355 ↗
  • Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov. PubMed 34840738 ↗
  • Berman NB, Durning SJ, Fischer MR, Huwendiek S, Triola MM. The Role for Virtual Patients in the Future of Medical Education. Acad Med. 2016 Sep;91(9):1217-22. doi: 10.1097/ACM.0000000000001146. PubMed 26959224 ↗
  • Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117. PubMed 26238976 ↗
  • Bevilacqua R, Maranesi E, Riccardi GR, Donna VD, Pelliccioni P, Luzi R, Lattanzio F, Pelliccioni G. Non-Immersive Virtual Reality for Rehabilitation of the Older People: A Systematic Review into Efficacy and Effectiveness. J Clin Med. 2019 Nov 5;8(11):1882. doi: 10.3390/jcm8111882. PubMed 31694337 ↗
  • Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10. PubMed 30198451 ↗
  • Demir-Kaymak Z, Turan Z, Cit G, Akyaman S. Midwifery students' opinions about episiotomy training and using virtual reality: A qualitative study. Nurse Educ Today. 2024 Jan;132:106013. doi: 10.1016/j.nedt.2023.106013. Epub 2023 Oct 31. PubMed 37926004 ↗
  • Bick DE, Kettle C, Macdonald S, Thomas PW, Hills RK, Ismail KM. PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial. BMC Pregnancy Childbirth. 2010 Feb 25;10:10. doi: 10.1186/1471-2393-10-10. PubMed 20184764 ↗
  • Silf K, Woodhead N, Kelly J, Fryer A, Kettle C, Ismail KM. Evaluation of accuracy of mediolateral episiotomy incisions using a training model. Midwifery. 2015 Jan;31(1):197-200. doi: 10.1016/j.midw.2014.08.009. Epub 2014 Sep 2. PubMed 25261381 ↗
  • Guler H, Cetin P, Yurtsal ZB, Cesur B, Bekar M, Ucar T, Evcili F, Cetin A. Effect of episiotomy training with beef tongue and sponge simulators on the self-confidence building of midwifery students. Nurse Educ Pract. 2018 May;30:1-6. doi: 10.1016/j.nepr.2018.02.004. Epub 2018 Feb 9. PubMed 29452943 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06711198
Lead sponsor
Sakarya University
Responsible party
yasemin hamlacı başkaya (Assoc. prof., Sakarya University) — Principal investigator
First posted
Dec 2, 2024
Start date
Dec 20, 2024
Primary completion
Jan 10, 2025
Completion
Jan 15, 2025
Last update
Jan 16, 2025

Study contacts

Yasemin Hamlaci Baskaya
study director · Sakarya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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