NCT06711198

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

21 days

First QC Date

November 26, 2024

Last Update Submit

January 14, 2025

Conditions

Keywords

virtual simulationmidwiferyepisiotomyanxietySelf-Efficacy

Outcome Measures

Primary Outcomes (2)

  • State Anxiety Inventory (STAI)

    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.

    1 hours

  • Episiotomy Self-Efficacy Scale

    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.

    1 hours

Study Arms (3)

Control group (application with calf tongue)

NO INTERVENTION

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

1. Experimental group (Application with virtual reality simulation)

EXPERIMENTAL

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

Other: virtual reality simulation

2. Experimental group (Both calf tongue and virtual reality simulation)

EXPERIMENTAL

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.

Other: virtual reality simulation

Interventions

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.

1. Experimental group (Application with virtual reality simulation)2. Experimental group (Both calf tongue and virtual reality simulation)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registered in the midwifery department,
  • Attending the normal birth and postpartum period course,
  • Agreeing to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Adapazarı, Sakarya, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 30882355BACKGROUND
  • 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.

    PMID: 34840738BACKGROUND
  • 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.

    PMID: 26959224BACKGROUND
  • 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.

    PMID: 26238976BACKGROUND
  • 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.

    PMID: 31694337BACKGROUND
  • 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.

    PMID: 30198451BACKGROUND
  • 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.

    PMID: 37926004BACKGROUND
  • 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.

    PMID: 20184764BACKGROUND
  • 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.

    PMID: 25261381BACKGROUND
  • 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.

    PMID: 29452943BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yasemin Hamlaci Baskaya

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. prof.

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 2, 2024

Study Start

December 20, 2024

Primary Completion

January 10, 2025

Study Completion

January 15, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations