Virtual RealityNCT05905263
The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels
A study testing Application group with virtual reality in people with Virtual Reality and Episiotomy, run by Istanbul University - Cerrahpasa.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Episiotomy
- What is being tested?
- Application group with virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a 3rd year student of the Midwifery Department,
- Not having received episiotomy training,
- Volunteer to participate in the study.
Who cannot join
- Not voluntarily participating in the study,
- Dizziness, nausea, etc. during the application. symptom development.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- Virtual Reality, Episiotomy
- Being tested
- Application group with virtual reality
- Keywords
- Virtual Reality, Educational, Self-Confidence, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application group with virtual realityOther
Also called Calf tongue group
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.
| Study group | Role | What they receive |
|---|---|---|
| Application group with virtual reality | Experimental | 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. Receives: Other: Application group with virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Satisfaction and Self-Confidence in Learning
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.
Measured: Baseline
State and Trait Anxiety Inventory- STAI I-II
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Guney, Istanbul University - Cerrahpasa
- Investigators
- Hüsniy Dınc Kaya, Ph.D, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905263
- Sponsor's protocol ID
- 2022/112
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD avalilable.
Publications
Barjon K, Vadakekut ES, Mahdy H. Episiotomy. 2024 Oct 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546675/
PubMed 31536281Blondel 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.
PubMed 26958827Grant 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.
PubMed 30060763Yang 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.
PubMed 33846148
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels in Episiotomy Training
- ClinicalTrials.gov ID
- NCT05905263
- Acronym / sponsor ID
- 2022/112
- Conditions
- Virtual Reality, Episiotomy
- Keywords
- Virtual Reality, Educational, Self-Confidence, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application group with virtual reality | Experimental | Other: Application group with virtual realityEach 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a 3rd year student of the Midwifery Department,
- Not having received episiotomy training,
- Volunteer to participate in the study.
Key exclusion criteria (2 listed)
- Not voluntarily participating in the study,
- Dizziness, nausea, etc. during the application. symptom development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application group with virtual realityAlso: Calf tongue groupEach 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 | Application group with virtual reality |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 31536281Barjon K, Vadakekut ES, Mahdy H. Episiotomy. 2024 Oct 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546675/
- Background: PubMed 26958827Blondel 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.
- Background: PubMed 30060763Grant 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.
- Background: PubMed 33846148Yang 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD avalilable.
Related trials for Virtual Reality
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain, Anxiety
Recruiting
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Anxiety
Not yet recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hüsniy Dınc Kaya, Ph.D principal investigator
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Application group with virtual reality in people with Virtual Reality and Episiotomy, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demet Güney, MSc. (+905456620057, demet909090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student Satisfaction and Self-Confidence in Learning (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05905263, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.