NCT05604924

Brief Summary

The goal of this is to determine the effectiveness of virtual reality training simulator for cesarean section. Evaluate the effect of using VR surgery on the self-confidence and knowledge of cesarean section procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

October 26, 2022

Last Update Submit

April 12, 2023

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (2)

  • improvement on the knowledge of cesarean section procedures.

    After using VR training, the test scores cesarean section procedures.

    1 month after examination

  • improvement on the self-confidence of cesarean section procedures.

    After using VR training, the self-assessment scores of trainee confidence via questionnaire

    1 month after examination

Study Arms (2)

Participants who received virtual reality training

EXPERIMENTAL
Other: virtual reality training for cesarean section

Participants who received similar contents in a standard PowerPoint presentation on a laptop

PLACEBO COMPARATOR
Other: virtual reality training for cesarean section

Interventions

virtual reality training for cesarean sectionOTHER

Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.

Participants who received similar contents in a standard PowerPoint presentation on a laptopParticipants who received virtual reality training

Eligibility Criteria

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

You may qualify if:

  • Residents and fellows receiving training at Seoul National University Bundang Hospital and who wish to participate in this study

You may not qualify if:

  • If trainee refuse to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeong-gi Do, 13620, South Korea

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in osbtetrics

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 3, 2022

Study Start

September 10, 2022

Primary Completion

November 15, 2022

Study Completion

November 30, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

KR(1)