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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-guided debriefing | Experimental | Immersive virtual reality simulation-based pediatric emergency training with self-guided debriefing |
|
| Facilitator-guided debriefing | Active Comparator | Immersive virtual reality simulation-based pediatric emergency training with facilitator-guided debriefing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ìmmersive virtual reality simulation with self-guided debriefing | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amalie M Andersen, MD, PhD student | Contact | 25344610 | +45 | amalie.middelboe.andersen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | https://doi.org/10.1016/j.apergo.2017.12.016 | ||
| Background | 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. | ||
| 22902606 | 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. |
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|
| Ìmmersive virtual reality simulation with facilitator-guided debriefing | Other |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | Medical students will complete the VRSQ questionnaire at Day 1 (intervention day) after completion of the intervention. |
| Background | https://doi.org/10.1016/j.resuscitation.2021.02.015 |
| 31515425 | 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. |
| 19088666 | 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. |
| 34527478 | 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. |
| 34433598 | 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. |
| 30293544 | 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. |
| 32106189 | 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. |
| 37651101 | 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. |
| 21900138 | 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. |
| 35237809 | 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. |
| 40938855 | Derived | 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. |