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NCT Number: NCT06956833

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Jette Led Sørensen, MD, MMEd, PhD, Professor

CONTACT

[email protected]

26711484 ext. +45

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amalie M Andersen, MD, PhD student

CONTACT

[email protected]

25344610 ext. +45

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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