NCT05905263

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

May 31, 2023

Last Update Submit

July 3, 2023

Conditions

Keywords

Virtual RealityEducationalSelf-ConfidenceAnxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Study Arms (1)

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.

Other: Application group with virtual reality

Interventions

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.

Also known as: Calf tongue group
Application group with virtual reality

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a 3rd year student of the Midwifery Department,
  • Not having received episiotomy training,
  • Volunteer to participate in the study.

You may not qualify if:

  • Not voluntarily participating in the study,
  • Dizziness, nausea, etc. during the application. symptom development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Barjon K, Vadakekut ES, Mahdy H. Episiotomy. 2024 Oct 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546675/

    PMID: 31536281BACKGROUND
  • 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.

    PMID: 26958827BACKGROUND
  • 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.

    PMID: 30060763BACKGROUND
  • 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.

    PMID: 33846148BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hüsniy Dınc Kaya, Ph.D

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Demet Güney, MSc.

CONTACT

Tülay Yılmaz, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc., Research Assist

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 15, 2023

Study Start

January 1, 2024

Primary Completion

April 30, 2024

Study Completion

August 30, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD avalilable.

Available IPD Datasets

Clinical Study Report Access