- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07584863
Virtual Reality-Based Simulation Versus High-Fidelity Simulation for Emergency Management Training in Medical Interns
A Randomized Controlled Study Comparing Virtual Reality-Based Simulation With High-fidelity Simulation for Training Novice Physicians in Emergency Management
This study is a two-arm parallel randomized controlled non-inferiority trial designed to compare the educational effectiveness of virtual reality (VR)-based simulation with high-fidelity simulation (HFS) for emergency management training in medical interns.
Participants will be randomized 1:1 to either VR-based training or HFS-based training for managing desaturation and anaphylaxis scenarios. After training and structured debriefing, all participants will undergo objective structured clinical examinations (OSCEs) and complete pre- and post-training surveys.
The primary outcome is OSCE performance score. Secondary outcomes include confidence improvement, participant satisfaction, usability (UEQ-S).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Seoul
-
Seoul, Seoul, South Korea, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Medical interns enrolled in the 2026 internship program at Seoul National University Hospital
- Provided written informed consent
Exclusion Criteria
- Did not complete pre-training survey
- Declined participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Group
Participants use an immersive VR platform to manage simulated patients with oxygen desaturation and anaphylaxis.
|
Participants use an immersive VR platform to manage simulated patients with oxygen desaturation and anaphylaxis.
|
|
Active Comparator: HFS Group
Participants use a high-fidelity simulator (Sim-Man) to manage the same emergency scenarios.
|
Participants use a high-fidelity simulator (Sim-Man) to manage the same emergency scenarios.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OSCE Performance Score
Time Frame: Immediately after training
|
Mean total score of two Objective Structured Clinical Examination (OSCE) stations (desaturation and anaphylaxis).
Scores range from 0 to 20, with higher scores indicating better clinical performance.
|
Immediately after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confidence Improvement
Time Frame: Immediately before and immediately after training
|
Self-reported confidence in emergency management measured using a 10-point Likert scale ranging from 1 to 10, with higher scores indicating greater confidence.
|
Immediately before and immediately after training
|
|
Participant Satisfaction
Time Frame: Immediately after training
|
Participant satisfaction measured using a 7-point Likert scale ranging from 1 to 7, with higher scores indicating greater satisfaction.
|
Immediately after training
|
|
Usability (UEQ-S)
Time Frame: Immediately after training
|
Usability assessed using the User Experience Questionnaire-Short Version (UEQ-S).
Scores range from 1 to 7, with higher scores indicating a more positive user experience.
|
Immediately after training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Task Completion Time
Time Frame: Immediately after training
|
Time required to complete VR emergency scenarios, measured in seconds.
|
Immediately after training
|
|
Critical Action Completion Rate
Time Frame: Immediately after training
|
Percentage of predefined critical actions successfully completed during VR scenarios.
|
Immediately after training
|
|
Task Sequence Accuracy
Time Frame: Immediately after training
|
Accuracy of procedural task sequence during VR emergency scenarios based on predefined scenario flow.
|
Immediately after training
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sun Jung Myung, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-2602-161-1723
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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