NCT04487353

Brief Summary

With the virtual birth application,

  • Learning the physiology and mechanism of birth,
  • To monitor the progress of birth and to understand deviations from normal,
  • Learning normal birth,
  • It will provide the opportunity to see all the emergencies that may be encountered at birth and besides these, the information will be remembered for a long time. In this way, the effectiveness of virtual birth in midwifery education will be evaluated. Teaching the birth, which is one of the cornerstones of midwifery education and where the students find the opportunity to practice clinically, with virtual reality application, will minimize clinical application errors and will provide early diagnosis of adverse conditions such as fetal presentation and placental anomalies that may occur at birth. It is an up-to-date and important subject that will enable them to see the stages of birth in three dimensions with the virtual delivery application without any obstacle in midwifery education, the birth process, the birth mechanisms of the baby from the birth canal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

July 11, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

July 11, 2020

Last Update Submit

February 16, 2022

Conditions

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

  • Labor Evaluation Information Scale (LEIS)

    To measure the knowledge level of both groups about the mechanism of labor. To compare the changes in the knowledge level of students who have experienced VRT-LMA and students who have only theory education.

    within 6 weeks

Secondary Outcomes (2)

  • Cognitive Load Scale

    within 6 weeks

  • Availability Sensitivity Scale

    within 6 weeks

Study Arms (2)

Experiment Group

EXPERIMENTAL

The Labor Evaluation Information Scale (LEIS) was administered as a pre-test before applying to 30 students who had taken a course on childbirth. After the pre-test, the application was carried out with the "Labor mechanism application developed with virtual reality technology (VRT-LMA)". Immediately after the application, data were collected with the "LEIS", "sense of presence scale" and "cognitive load scale". Post-test was performed again with the Labor Evaluation Information Scale (LEIS) 5 weeks after the application.

Other: Labor mechanism application developed with virtual reality technology (VRT-LMA)

Control Group

NO INTERVENTION

Before the theory training, the Assessment Knowledge Scale (LEIS) was administered as a pre-test to 31 students in the control group who had taken a course on obstetrics. After the pre-test, theory training including birth knowledge was given. "Labor mechanism application developed with virtual reality technology (VRT-LMA)" was not applied to the control group. After 4 hours of theoretical training, the final test was performed using LEIS. After 5 weeks, the last test was repeated.

Interventions

In phase I: VRT-LMA application was developed. (Female in lithotomy position, bony pelvis, flexion of the coccyx back about 2 cm and the Hodge plane were modeled as lines. The theory training to be given to the control group was prepared in accordance with the curriculum. II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered. II. In the first stage: Pre-test was applied to both groups. After the pretest, theory training was given to the control group and the posttest was applied. VRT-LMA was applied to the experimental group, and the posttest, sense of presence scale, and cognitive load scale were administered. III. In the second stage: the post-test and analyzes were performed after 5 weeks in both groups.

Experiment Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Gülhane Faculty of Health Sciences

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (2)

  • Cooper S, Cant R, Porter J, Bogossian F, McKenna L, Brady S, Fox-Young S. Simulation based learning in midwifery education: a systematic review. Women Birth. 2012 Jun;25(2):64-78. doi: 10.1016/j.wombi.2011.03.004. Epub 2011 Apr 13.

    PMID: 21489894BACKGROUND
  • Bjerrum AS, Hilberg O, van Gog T, Charles P, Eika B. Effects of modelling examples in complex procedural skills training: a randomised study. Med Educ. 2013 Sep;47(9):888-98. doi: 10.1111/medu.12199.

    PMID: 23931538BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The sample will consist of 105 midwifery students, 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated from 0.95 power, among the midwifery students who took the birth mechanism 4 hours theoretically in their curriculum within the scope of normal birth lesson.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prelector (principal investigator)

Study Record Dates

First Submitted

July 11, 2020

First Posted

July 27, 2020

Study Start

June 15, 2021

Primary Completion

January 25, 2022

Study Completion

February 12, 2022

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

I'm undecided now. I want to decide in the future

Locations