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

NCT06956833 | Recruiting

• 1 other identifier: P-2023-167
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Clinical Teamwork Scale

  The investigators will assess medical students' teamwork skills using the Clinical Teamwork Scale (CTS). This validated scale assesses fifteen teamwork skills across five main domains: overall teamwork, communication, situational awareness, decision-making, and role responsibility, on an 11-point Likert scale ranging from 1 = unacceptable to 11 = perfect. The CTS has been translated into Danish using a forward-backward translation process by two professional translators. Medical students will be videorecorded immediately before and after the intervention while managing a mannequin-based pediatric emergency in teams of two. Two independent raters will assess each team's collective performance based on the videos, using the CTS.

  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 (7)

• ABCDE checklist

  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

  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

  Medical students will complete the DASH-SV questionnaire at Day 1 (the intervention day) after each debriefing.

• Intrinsic Motivation Inventory

  Medical students will complete the IMI questionnaire at Day 1 (intervention day) after completion of the intervention.

• System Usability Scale

  Medical students will complete the SUS questionnaire at Day 1 (intervention day) after completion of the intervention.

Study Arms (2)

Self-guided debriefing

EXPERIMENTAL

Immersive virtual reality simulation-based pediatric emergency training with self-guided debriefing

Other: Ìmmersive virtual reality simulation with self-guided debriefing

Facilitator-guided debriefing

ACTIVE COMPARATOR

Immersive virtual reality simulation-based pediatric emergency training with facilitator-guided debriefing

Other: Ìmmersive virtual reality simulation with facilitator-guided debriefing

Interventions

Ìmmersive virtual reality simulation with self-guided debriefing OTHER

* 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)

Self-guided debriefing

Ìmmersive virtual reality simulation with facilitator-guided debriefing OTHER

* 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)

Facilitator-guided debriefing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Lack of informed consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (15)

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  BACKGROUND

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  BACKGROUND

• 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 BACKGROUND

• https://doi.org/10.1016/j.resuscitation.2021.02.015

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Umoren R, Bucher S, Hippe DS, Ezenwa BN, Fajolu IB, Okwako FM, Feltner J, Nafula M, Musale A, Olawuyi OA, Adeboboye CO, Asangansi I, Paton C, Purkayastha S, Ezeaka CV, Esamai F. eHBB: a randomised controlled trial of virtual reality or video for neonatal resuscitation refresher training in healthcare workers in resource-scarce settings. BMJ Open. 2021 Aug 25;11(8):e048506. doi: 10.1136/bmjopen-2020-048506.

  PMID: 34433598 BACKGROUND

• Farra S, Hodgson E, Miller ET, Timm N, Brady W, Gneuhs M, Ying J, Hausfeld J, Cosgrove E, Simon A, Bottomley M. Effects of Virtual Reality Simulation on Worker Emergency Evacuation of Neonates. Disaster Med Public Health Prep. 2019 Apr;13(2):301-308. doi: 10.1017/dmp.2018.58. Epub 2018 Oct 8.

  PMID: 30293544 BACKGROUND

• Zackoff MW, Real FJ, Sahay RD, Fei L, Guiot A, Lehmann C, Tegtmeyer K, Klein M. Impact of an Immersive Virtual Reality Curriculum on Medical Students' Clinical Assessment of Infants With Respiratory Distress. Pediatr Crit Care Med. 2020 May;21(5):477-485. doi: 10.1097/PCC.0000000000002249.

  PMID: 32106189 BACKGROUND

• Foronda CL, Gonzalez L, Meese MM, Slamon N, Baluyot M, Lee J, Aebersold M. A Comparison of Virtual Reality to Traditional Simulation in Health Professions Education: A Systematic Review. Simul Healthc. 2024 Jan 1;19(1S):S90-S97. doi: 10.1097/SIH.0000000000000745. Epub 2023 Aug 31.

  PMID: 37651101 BACKGROUND

• Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.

  PMID: 21900138 BACKGROUND

• Thim S, Henriksen TB, Laursen H, Schram AL, Paltved C, Lindhard MS. Simulation-Based Emergency Team Training in Pediatrics: A Systematic Review. Pediatrics. 2022 Apr 1;149(4):e2021054305. doi: 10.1542/peds.2021-054305.

  PMID: 35237809 BACKGROUND

• Sohlin AM, Poulsen A, Hoffmann IM, Gjaerde LK, Lund S, Overbeck G, Paulsen L, Chang TP, Lee JY, Sorensen JL, Kjaergaard J. Self-guided versus facilitator-guided debriefing in immersive virtual reality simulation: Protocol for a randomized controlled non-inferiority trial assessing teamwork skills in medical students. PLoS One. 2025 Sep 12;20(9):e0332309. doi: 10.1371/journal.pone.0332309. eCollection 2025.

  PMID: 40938855 DERIVED

Central Study Contacts

Amalie M Andersen, MD, PhD student

CONTACT

25344610; amalie.middelboe.andersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: May 6, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)