Clinical trial NCT06711198: Virtual Reality Simulation in Episiotomy Training
Official title: The Effect of Virtual Reality Simulation on Self-Efficacy and Anxiety Levels of Students in Episiotomy Education: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy
Virtual Simulation
Keywords: virtual simulation
midwifery
episiotomy
anxiety
Self-Efficacy
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group, the calf tongue group, will have an episiotomy on the calf tongue. The virtual reality group will have an episiotomy with virtual reality glasses. The mixed group will first have an episiotomy on the calf tongue with virtual reality glasses and then have an episiotomy on the calf tongue.
Primary purpose: OTHER

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: State Anxiety Inventory (STAI)
timeFrame: 1 hours
measure: Episiotomy Self-Efficacy Scale
timeFrame: 1 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
affiliation: Sakarya University
name: Yasemin Hamlaci Baskaya
role: STUDY_DIRECTOR
References:
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citation: 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.
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