NCT04444258

Brief Summary

In this study, it was aimed to design virtual pregnancy for pregnancy formation, fetal and placental development in the virtual reality environment and to evaluate the effectiveness of the designed virtual pregnancy on midwifery education. Our study, which will be the first in our second country in the world, aims to reduce the application errors and determine deviations from normal by examining the formation of pregnancy, maternal, fetal and placental changes, which form the basis of midwifery profession, before having clinical experience. In this direction, the objectives of our study are;

  • Development of the virtual pregnancy application, which will be designed for the first time in our country,
  • Ensuring the effective use of virtual pregnancy practice in midwifery education,
  • Visualizing fetal and placental development with virtual pregnancy that will form the basis of midwifery education,
  • To minimize the application errors experienced in clinical practices of midwifery students,
  • To increase educational effectiveness, clinical and academic success by visualizing the formation of pregnancy.
  • Measuring cognitive loadings of students after education
  • Measuring students' sense of readiness

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

June 18, 2020

Last Update Submit

September 26, 2021

Conditions

Keywords

virtual realitymidwifery student educationvirtual pregnancy

Outcome Measures

Primary Outcomes (1)

  • To provide midwifery students to learn fetal development week by week

    All three groups will be developed by researchers after 4 hours of theoretical training; "Fetal Development Assessment Information Form (FEGBF)" will be applied to evaluate fetal development and fetal physiology knowledge.

    Within 6 weeks after the fetal development virtual reality application is developed and applied.

Other Outcomes (1)

  • Ensuring that virtual reality application in the teaching of Fetal Development focuses students' attention and mental potential on related stimuli, activities or events

    Within 6 weeks after the fetal development virtual reality application is developed and applied.

Study Arms (2)

Experimental I Group

EXPERIMENTAL

After the Fetal Development Assessment Information Form (FEGBF), a computer-aided and guided virtual reality application prepared by the researchers including the phases of the fetus week by week will be watched and then FEGBF will be applied again by changing the locations of the questions.

Other: Application of computer aided virtual reality glassesOther: Teaching fetal development theoretically

Control Group

NO INTERVENTION

FEGBF will be applied after 4 hours of theory training. Virtual pregnancy application will not be watched.

Interventions

Experimental I Group: After the Fetal Development Assessment Information Form (FEGBF), a computer-aided and guided virtual reality application prepared by the researchers including the phases of the fetus week by week will be watched and then FEGBF will be applied again by changing the locations of the questions.

Experimental I Group

Control Group: FEGBF will be applied after 4 hours of theory training. Virtual pregnancy application will not be watched.

Experimental I Group

Eligibility Criteria

Age24 Months+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being at least a 4nd year student at the Midwifery Department of
  • I. Karabuk University,
  • II. 84 midwifery students will be volunteering to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78500, Turkey (Türkiye)

Location

Related Publications (5)

  • Fealy S, Jones D, Hutton A, Graham K, McNeill L, Sweet L, Hazelton M. The integration of immersive virtual reality in tertiary nursing and midwifery education: A scoping review. Nurse Educ Today. 2019 Aug;79:14-19. doi: 10.1016/j.nedt.2019.05.002. Epub 2019 May 4.

    PMID: 31078869BACKGROUND
  • Williams J, Jones D, Walker R. Consideration of using virtual reality for teaching neonatal resuscitation to midwifery students. Nurse Educ Pract. 2018 Jul;31:126-129. doi: 10.1016/j.nepr.2018.05.016. Epub 2018 May 28.

  • 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.

  • Ohmaru T, Fujita Y, Sugitani M, Shimokawa M, Fukushima K, Kato K. Placental elasticity evaluation using virtual touch tissue quantification during pregnancy. Placenta. 2015 Aug;36(8):915-20. doi: 10.1016/j.placenta.2015.06.008. Epub 2015 Jun 24.

  • Verwoerd-Dikkeboom CM, Koning AH, Hop WC, Rousian M, Van Der Spek PJ, Exalto N, Steegers EA. Reliability of three-dimensional sonographic measurements in early pregnancy using virtual reality. Ultrasound Obstet Gynecol. 2008 Dec;32(7):910-6. doi: 10.1002/uog.5390.

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, including 35 control, 35 experiment I and 35 experiment II, as a result of the G-power analysis calculated by 0.95 power, among the midwifery students who took theoretical 4 hours in their curriculum within the scope of the week of week, including fetal development.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prelector

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 23, 2020

Study Start

March 15, 2020

Primary Completion

July 15, 2021

Study Completion

September 10, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

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

Locations