Clinical trial NCT06956833: Immersive Virtual Reality Simulation-Effects of Self-Guided Versus Facilitator-Guided Debriefing
Official title: Self-Guided Versus Facilitator-Guided Debriefing in Immersive Virtual Reality Simulation: Protocol for a Randomized Controlled Non-Inferiority Trial As-sessing Teamwork Skills in Medical Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality Simulation
Simulation-based Medical Education
Pediatric Emergency Medicine
Immersive Virtual Reality
Debriefing
Keywords: Immersive Virtual Reality
Virtual Reality simulation
Simulation-based medical education
Pediatric emergencies
Debriefing
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to find out whether self-guided and facilitator-guided virtual reality (VR) simulations are equally effective in helping medical students learn how to manage and treat critically ill children. The study will also investigate how medical students feel about the two training methods and examine how many experience cybersickness. The main questions it aims to answer are:

* Does self-guided VR simulation work as well as facilitator-guided VR simulation in teaching medical students how to manage critically ill children?
* How do medical students experience the ease of use, workload, reflection on learning, and motivation in each training method?
* How many students experience cybersickness? To answer these questions, researchers will compare the two training methods to evaluate if self-guided VR simulation is an effective way to teach medical students how to manage critically ill children.

Participants will:

* Work through three VR cases to practice managing critically ill children in a safe environment.
* Be tested before and after the VR simulation to assess changes in their skills managing critically ill children.
* Complete surveys about their experience of the VR simulation, the training sessions, and any cybersickness symptoms they might have.


Eligibility criteria: Inclusion Criteria:

* Eligible participants will be medical students enrolled at medical schools in Denmark who are within two years of graduation.

Exclusion Criteria:

* Lack of informed consent

Primary outcomes:
measure: Clinical Teamwork Scale
timeFrame: The medical students will be videorecorded at Day 1 (intervention day) immediately before and after the intervention. Two raters will assess the videos once all data collection for the trial has been completed.
Secondary outcomes:
measure: ABCDE checklist
timeFrame: The medical students will be videorecorded at Day 1 (intervention day) immediately before and after the intervention. Two raters will assess the videos once all data collection for the trial has been completed.
measure: Time to critical action
timeFrame: The medical students will be videorecorded at Day 1 (intervention day) immediately before and after the intervention. Two raters will assess the videos once all data collection for the trial has been completed.
measure: Debriefing Assessment for Simulation in Healthcare Student Version
timeFrame: Medical students will complete the DASH-SV questionnaire at Day 1 (the intervention day) after each debriefing.
measure: Intrinsic Motivation Inventory
timeFrame: Medical students will complete the IMI questionnaire at Day 1 (intervention day) after completion of the intervention.
measure: System Usability Scale
timeFrame: Medical students will complete the SUS questionnaire at Day 1 (intervention day) after completion of the intervention.
measure: NASA Task Load Index
timeFrame: Medical students will complete the NASA-TLX at Day 1 (intervention day) after completion of the intervention.
measure: Virtual Reality Sickness Questionnaire
timeFrame: Medical students will complete the VRSQ questionnaire at Day 1 (intervention day) after completion of the intervention.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
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