Virtual Reality SimulationNCT06956833
Immersive Virtual Reality Simulation-Effects of Self-Guided Versus Facilitator-Guided Debriefing
A study testing Ìmmersive virtual reality simulation with self-guided debriefing and Ìmmersive virtual reality simulation with facilitator-guided debriefing in people with Virtual Reality Simulation and Simulation-based Medical Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Simulation, Simulation-based Medical Education, Pediatric Emergency Medicine
- What is being tested?
- Ìmmersive virtual reality simulation with self-guided debriefing and Ìmmersive virtual reality simulation with facilitator-guided debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible participants will be medical students enrolled at medical schools in Denmark who are within two years of graduation.
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Jette Led Sørensen, MD, MMEd, PhD, Professor, 26711484 ext. +45, jette.led.soerensen@regionh.dk
About this study
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
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.
Read more
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
- Being tested
- Ìmmersive virtual reality simulation with self-guided debriefing, Ìmmersive virtual reality simulation with facilitator-guided debriefing
- Keywords
- Immersive Virtual Reality, Virtual Reality simulation, Simulation-based medical education, Pediatric emergencies, Debriefing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ìmmersive virtual reality simulation with self-guided debriefingOther
- 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 debriefingOther
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Self-guided debriefing | Experimental | Immersive virtual reality simulation-based pediatric emergency training with self-guided debriefing Receives: 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 Receives: Other: Ìmmersive virtual reality simulation with facilitator-guided debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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
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.
Measured: Medical students will complete the DASH-SV questionnaire at Day 1 (the intervention day) after each debriefing.
Intrinsic Motivation Inventory
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.
Measured: Medical students will complete the IMI questionnaire at Day 1 (intervention day) after completion of the intervention.
System Usability Scale
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.
Measured: Medical students will complete the SUS questionnaire at Day 1 (intervention day) after completion of the intervention.
NASA Task Load Index
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.
Measured: Medical students will complete the NASA-TLX at Day 1 (intervention day) after completion of the intervention.
Virtual Reality Sickness Questionnaire
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.
Measured: Medical students will complete the VRSQ questionnaire at Day 1 (intervention day) after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start6 May 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Virtual Reality SimulationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amalie Middelboe Andersen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956833
- Sponsor's protocol ID
- P-2023-167
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22902606https://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.
PubMed 31515425Guise 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.
PubMed 19088666Abulfaraj 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.
PubMed 34527478Umoren 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.
PubMed 34433598Farra 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.
PubMed 30293544Zackoff 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.
PubMed 32106189Foronda 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.
PubMed 37651101Cook 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.
PubMed 21900138Thim 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.
PubMed 35237809Sohlin 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.
PubMed 40938855
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06956833
- Acronym / sponsor ID
- P-2023-167
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-guided debriefing | Experimental | Other: Ìmmersive virtual reality simulation with self-guided debriefingImmersive virtual reality simulation-based pediatric emergency training with self-guided debriefing |
| Facilitator-guided debriefing | Active comparator | Other: Ìmmersive virtual reality simulation with facilitator-guided debriefingImmersive virtual reality simulation-based pediatric emergency training with facilitator-guided debriefing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be medical students enrolled at medical schools in Denmark who are within two years of graduation.
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Self-guided debriefing |
| 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) | Other | Facilitator-guided debriefing |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- BackgroundBrooke 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.
- Backgroundhttps://doi.org/10.1016/j.apergo.2017.12.016
- BackgroundHart 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.
- Background: PubMed 22902606Brett-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.
- Backgroundhttps://doi.org/10.1016/j.resuscitation.2021.02.015
- Background: PubMed 31515425Hultin 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.
- Background: PubMed 19088666Guise 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.
- Background: PubMed 34527478Abulfaraj 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.
- Background: PubMed 34433598Umoren 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.
- Background: PubMed 30293544Farra 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.
- Background: PubMed 32106189Zackoff 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.
- Background: PubMed 37651101Foronda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ìmmersive virtual reality simulation with self-guided debriefing and Ìmmersive virtual reality simulation with facilitator-guided debriefing in people with Virtual Reality Simulation and Simulation-based Medical Education, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amalie M Andersen, MD, PhD student (25344610 ext. +45, amalie.middelboe.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956833, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.