Virtual Reality Training Simulator for Cesarean Section

A Clinical Trial to Evaluate Effectiveness of Virtual Reality Training Simulator for Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Virtual Reality
• Intervention / Treatment: Other: virtual reality training for cesarean section

Detailed Description

A single center randomized controlled trial (RCT) was performed. The participants were obstetrics residents, fellows and residents in other majors with limited experience in performing cesarean section. The primary outcome measures were the self-assessment scores of trainee confidence using a virtual reality training and an objective assessment of the cognitive skills. The participants were randomly divided into a study group of VR training group and a control group. Participants in the study group used the VR application. The control group participants used similar content in a standard PowerPoint presentation on a laptop.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeong-gi Do
    • Seongnam-si, Gyeong-gi Do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• If trainee refuse to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants who received virtual reality training	Other: virtual reality training for cesarean section; Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.
Placebo Comparator: Participants who received similar contents in a standard PowerPoint presentation on a laptop	Other: virtual reality training for cesarean section; Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: B-2205-759-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No