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Recruiting NCT06956833

Immersive Virtual Reality Simulation-Effects of Self-Guided Versus Facilitator-Guided Debriefing

No phase Interventional Virtual Reality Simulation Simulation-based Medical Education Pediatric Emergency Medicine Immersive Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ìmmersive virtual reality simulation with self-guided debriefing, Ìmmersive virtual reality simulation with facilitator-guided debriefing.
Who it may be relevant to
Registry conditions: Virtual Reality Simulation, Simulation-based Medical Education, Pediatric Emergency Medicine, Immersive Virtual Reality. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Ìmmersive virtual reality simulation with self-guided debriefing
    * Familiarization with immersive virtual reality simulation (1 hour) * Video tutorial introducing paediatric Airway, Breathing, Circulation, Disability, Exposure (ABCDE) assessment, emergency teamwork and communication, and core elements in debriefing (1 hour) * Three immersive virtual reality simulation-based pediatric emergency team training scenarios with self-guided debriefing (2 hours)
  • Other Ìmmersive virtual reality simulation with facilitator-guided debriefing
    * Familiarization with immersive virtual reality simulation (1 hour) * Video tutorial introducing paediatric ABCDE assessment, emergency teamwork and communication, and core elements in debriefing (1 hour) * Three immersive virtual reality simulation-based pediatric emergency team training scenarios with facilitator-guided debriefing (2 hours)

Primary outcome measures

  • Clinical Teamwork Scale [Time frame: 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 outcome measures (7)
  • ABCDE checklist [Time frame: 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.]
  • Time to critical action [Time frame: 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.]
  • Debriefing Assessment for Simulation in Healthcare Student Version [Time frame: Medical students will complete the DASH-SV questionnaire at Day 1 (the intervention day) after each debriefing.]
  • Intrinsic Motivation Inventory [Time frame: Medical students will complete the IMI questionnaire at Day 1 (intervention day) after completion of the intervention.]
  • System Usability Scale [Time frame: Medical students will complete the SUS questionnaire at Day 1 (intervention day) after completion of the intervention.]
  • NASA Task Load Index [Time frame: Medical students will complete the NASA-TLX at Day 1 (intervention day) after completion of the intervention.]
  • Virtual Reality Sickness Questionnaire [Time frame: Medical students will complete the VRSQ questionnaire at Day 1 (intervention day) after completion of the intervention.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Denmark · 1 center
  • Copenhagen University Hospital, Rigshospitalet — Copenhagen

Publications

  • Brooke J. SUS: A 'Quick and Dirty' Usability Scale. In: Jordan PW, Thomas B, Weerdmeester BA, McClelland IL, editors. Usability Evaluation In Industry. London: Taylor & Francis; 1996. p. 189-94.
  • https://doi.org/10.1016/j.apergo.2017.12.016
  • Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): Results of Empirical and Theoretical Research. Advances in Psychology. 1988 Jan 1;52(C):139-83.
  • Brett-Fleegler M, Rudolph J, Eppich W, Monuteaux M, Fleegler E, Cheng A, Simon R. Debriefing assessment for simulation in healthcare: development and psychometric properties. Simul Healthc. 2012 Oct;7(5):288-94. doi: 10.1097/SIH.0b013e3182620228. PMID 22902606
  • https://doi.org/10.1016/j.resuscitation.2021.02.015
  • Hultin M, Jonsson K, Hargestam M, Lindkvist M, Brulin C. Reliability of instruments that measure situation awareness, team performance and task performance in a simulation setting with medical students. BMJ Open. 2019 Sep 12;9(9):e029412. doi: 10.1136/bmjopen-2019-029412. PMID 31515425
  • Guise JM, Deering SH, Kanki BG, Osterweil P, Li H, Mori M, Lowe NK. Validation of a tool to measure and promote clinical teamwork. Simul Healthc. 2008 Winter;3(4):217-23. doi: 10.1097/SIH.0b013e31816fdd0a. PMID 19088666
  • Abulfaraj MM, Jeffers JM, Tackett S, Chang T. Virtual Reality vs. High-Fidelity Mannequin-Based Simulation: A Pilot Randomized Trial Evaluating Learner Performance. Cureus. 2021 Aug 11;13(8):e17091. doi: 10.7759/cureus.17091. eCollection 2021 Aug. PMID 34527478

Identifiers

NCT: NCT06956833 · P-2023-167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗