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

May 13, 2025 updated by: Amalie Middelboe Andersen, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital, Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Self-guided debriefing
Immersive virtual reality simulation-based pediatric emergency training with self-guided debriefing
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)
Active Comparator: Facilitator-guided debriefing
Immersive virtual reality simulation-based pediatric emergency training with facilitator-guided debriefing
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

The investigators will assess medical students' adherence to the Airways, Breathing, Circulation, Disability, Exposure (ABCDE) approach using the ABCDE checklist. Modified from an ABCDE checklist for adult life support, this checklist assesses adherence to the European Paediatric Advanced Life Support guidelines for ABCDE assessment and ranges from 0 = not initiated to 3 = performed consistently during the whole simulation.

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 blinded to group allocation will assess each team's collective performance based on the videos, using the 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
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.

The investigators will assess medical students' time to critical actions measured as time in seconds to administration of oxygen (pneumonia case) or beta2 agonist (asthma case), administration of a fluid bolus (10 mL/kg body weight), and completion of the ABCDE assessment. If the team does not perform the action, they will be assigned a time of 900 seconds.

Medical students will be video recorded before and after the intervention while managing a mannequin-based pediatric emergency in teams of two. Two independent raters blinded to group allocation will assess each team's time to predefined critical actions based on the videos.
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.
This validated questionnaire is designed for learners to evaluate a debriefing on a 7-point Likert scale ranging from 1 = extremely ineffective to 7 = extremely effective. In consultation with the Debriefing Assessment for Simulation in Healthcare Student Version (DASH-SV©) developers, the investigators have replaced 'The facilitator' with 'We' in the self-guided debriefing group to fit the context. DASH-SV has been translated into Danish using a forward-backward translation process by two professional translators.
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.
This validated questionnaire measures the subjective motivation related to a specific activity on a 7-point Likert scale ranging from 1 = not at all true to 7 = very true. Intrinsic Motivation Inventory (IMI) consists of 22 items across four domains: interest/enjoyment (seven items), perceived competence (five items), perceived choice (five items), and pressure/tension (five items). In this study, the investigatorswill use the seven-item Interest/Enjoyment domain, which is considered the direct measure of intrinsic motivation. IMI has previously been translated professionally to Danish and tested in a Danish context.
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.
This validated questionnaire measures the subjective usability of a product on a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree. The System Usability Scale (SUS) item scores are subsequently converted into a single SUS score on a scale from 0 to 100 (0 = lowest, 100 = highest). SUS has previously been translated professionally to Danish and validated in a Danish context.
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.
This validated scale measures subjective workload related to a specific activity. The scale ranges from 0 to 21, and the item scores are subsequently converted into a single score from 0 to 100 (0 = lowest, 100 = highest). National Aeronautics and Space Administration Task Load Index (NASA-TLX) has been translated into Danish using a forward-backward translation process by two professional translators.
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.
Virtual Reality Sickness Questionnaire(VRSQ) is a validated questionnaire designed to measure symptoms of cybersickness experienced during immersive virtual reality use. It evaluates nine symptoms on a Likert-type scale ranging from 0 = none to 3 = severe.
Medical students will complete the VRSQ questionnaire at Day 1 (intervention day) after completion of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-2023-167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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