- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711198
Virtual Reality Simulation in Episiotomy Training
January 14, 2025 updated by: yasemin hamlacı başkaya, Sakarya University
The Effect of Virtual Reality Simulation on Self-Efficacy and Anxiety Levels of Students in Episiotomy Education: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sakarya, Turkey
- Sakarya University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Registered in the midwifery department,
- Attending the normal birth and postpartum period course,
- Agreeing to participate in the study
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
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
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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
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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.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State Anxiety Inventory (STAI)
Time Frame: 1 hours
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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.
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1 hours
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Episiotomy Self-Efficacy Scale
Time Frame: 1 hours
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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.
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1 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yasemin Hamlaci Baskaya, Sakarya University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2024
Primary Completion (Actual)
January 10, 2025
Study Completion (Actual)
January 15, 2025
Study Registration Dates
First Submitted
November 26, 2024
First Submitted That Met QC Criteria
November 26, 2024
First Posted (Actual)
December 2, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 14, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 16112024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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