- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05905263
The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels
The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels in Episiotomy Training
The study aims to develop a virtual reality application for episiotomy training and to determine the effect of the virtual reality application on student satisfaction, self-confidence, and anxiety levels.
It was found that there should be a total of at least 102 students, 51 of whom are Virtual Reality practice groups (experimental) and 51 Dana Language practice groups (control), who meet the inclusion criteria. Considering the losses, it was decided to include 110 students in the study.We are collected usıng a Personal Informatıon form, Student Satisfaction and Self-Confidence in Learning, State and Trait Anxiety Inventory- STAI I-II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study aims to develop a virtual reality application for episiotomy training and to determine the effect of the virtual reality application on student satisfaction, self-confidence, and anxiety levels.
As one of the most common surgical procedures in vaginal delivery, episiotomy or perineotomy is an incision procedure performed in the perineum. Episiotomy is a surgical incision made in the bulbocavernosus muscle in the perineum during the second stage of labor (Yıldız Karaahmet & Yazıcı, 2016). Episiotomy is often performed to ensure the easy, quick, and safe delivery of the baby's head, to prevent fetal hypoxia, to shorten the active phase of labor, to prevent lacerations, to protect the anal sphincter, and to prevent perineal problems after delivery (Durmaz & Buğdaycı, 2013, Kartal et al., 2014).
ACOG recommends episiotomy in case of maternal or infant risk, such as perineal tears that may occur during vaginal delivery, to facilitate or expedite labor, and to restrict its use when not necessary (ACOG, 2006). The prevalence of episiotomy varies between countries. For example, its prevalence is 3.7% in Denmark and 75% in Cyprus (Blondel et al., 2016). In Turkey, the prevalence of episiotomy is reported to be 64-88% (Karaahmet & Yazıcı, 2016). Episiotomy can cause perineal pain, puerperal infection, postpartum hemorrhage, and dyspareunia later in life (Yang & Bai, 2021). Considering the complications of episiotomy, it is extremely important to perform episiotomy correctly, and only when necessary. It is therefore essential that midwives responsible for this practice acquire the necessary knowledge and skills (Aytekin et al., 2022).
In midwifery education, training is provided both theoretically and in clinical practice to put into practice and reinforce theoretical knowledge. While providing psychomotor development and professional socialization of students, it is also necessary to support standard education and clinical practice with simulation methods (Uyar Hazar & Gültekin, 2019). The training by simulation method seems to be often used to provide effective and high-quality midwifery skills (Bingöl et al., 2020). This training is conducted in laboratory environments with realistic scenarios in the form of performing practices (Cofey, 2015). Various simulation materials (sponge, calf's tongue, chicken breast, episiotomy model) have been used to improve the episiotomy skills of midwifery students (Aytekin et al., 2022). Another simulation method is training with Virtual Reality (VR) method. The virtual reality method helps training by providing an environment that allows students to experience scenarios and situations instead of imagining them (Çapa, 2004). Virtual reality environments offer students the opportunity of detailed observations with new visualization methods and an environment without physical obstacles. VR also provides a learning experience on a platform where they can interact and learn independently (Torres et al., 2015). In the literature review, there were no studies on the application of virtual reality in episiotomy training.
In this regard, the primary aim of this study is to develop a virtual reality application in episiotomy training, and the secondary aim is to determine the effect of this virtual reality application on student satisfaction, self-confidence, and anxiety levels.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Demet Güney, MSc.
- Phone Number: +905456620057
- Email: demet909090@gmail.com
Study Contact Backup
- Name: Tülay Yılmaz, Ph.D
- Phone Number: +905333740208
- Email: tyilmaz@iuc.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a 3rd year student of the Midwifery Department,
- Not having received episiotomy training,
- Volunteer to participate in the study.
Exclusion Criteria:
- Not voluntarily participating in the study,
- Dizziness, nausea, etc. during the application. symptom development.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Application group with virtual reality
Each student will be introduced to the materials to be used for virtual reality and will be informed about the application.
After the introduction and information is given, the lens and pupil distances of the virtual reality glasses will be adjusted according to each student and students will be asked to wear them on their heads.
Students will then be required to wear gloves.
The application will be made one-on-one with each student.
The application will be carried out sitting in the laboratory.
If the student experiences symptoms such as dizziness and nausea during the application, the application will be terminated.
If the student wants to continue the practice after listening, it will be continued.
While the students are in the application, the interface will be introduced through the images projected to the computer simultaneously.
|
Each student will be introduced to the materials to be used for virtual reality and will be informed about the application.
After the introduction and information is given, the lens and pupil distances of the virtual reality glasses will be adjusted according to each student and students will be asked to wear them on their heads.
Students will then be required to wear gloves.
The application will be made one-on-one with each student.
The application will be carried out sitting in the laboratory.
If the student experiences symptoms such as dizziness and nausea during the application, the application will be terminated.
If the student wants to continue the practice after listening, it will be continued.
While the students are inside the application, the interface will be introduced through the images projected to the computer simultaneously.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction and Self-Confidence in Learning
Time Frame: Baseline
|
In the sub-dimension of satisfaction with learning; Five items measuring satisfaction with the teaching method, variety of learning materials, facilitation, motivation, and the suitability of simulation in general, self-confidence sub-dimension; The content adequacy includes eight items: self-confidence, content requirement, skill development, available resources, and information on how to get help to solve clinical problems in simulation.
Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 13-65.
|
Baseline
|
|
State and Trait Anxiety Inventory- STAI I-II
Time Frame: Baseline
|
It is a Likert-type scale that measures state and trait anxiety levels separately with 20 questions.
High scores indicate high anxiety levels, low scores indicate low anxiety levels.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hüsniy Dınc Kaya, Ph.D, Istanbul University - Cerrahpasa (IUC)
Publications and helpful links
General Publications
- Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.
- Barjon K, Mahdy H. Episiotomy. 2022 Sep 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546675/
- Blondel B, Alexander S, Bjarnadottir RI, Gissler M, Langhoff-Roos J, Novak-Antolic Z, Prunet C, Zhang WH, Hindori-Mohangoo AD, Zeitlin J; Euro-Peristat Scientific Committee. Variations in rates of severe perineal tears and episiotomies in 20 European countries: a study based on routine national data in Euro-Peristat Project. Acta Obstet Gynecol Scand. 2016 Jul;95(7):746-54. doi: 10.1111/aogs.12894. Epub 2016 Apr 5.
- Yang J, Bai H. Knowledge, attitude and experience of episiotomy practice among obstetricians and midwives: a cross-sectional study from China. BMJ Open. 2021 Apr 12;11(4):e043596. doi: 10.1136/bmjopen-2020-043596.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022/112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Clinical Study Report
Information comments: DEVELOPMENT AND USAGE OF VIRTUAL REALITY APPLICATION IN TEACHING FETAL DEVELOPMENT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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