- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03729037
Cardiopulmonary Resuscitation Self-training
Comparative Evaluation of Video-based On-line Course vs. Serious Game for Training Medical Students in Cardiopulmonary Resuscitation: a Randomized Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
A prospective, simulation-based, randomised controlled trial was conducted. Participants were randomised to the video group watched a video-recorded lecture on the management of adult cardiac arrest, while participants randomised to the game group played a serious game on the same topic.
The video was developed based on a previously recorded Keynote presentation (version 6.6.2, Apple Inc.) with the addition of voice-over narration of the events. The video was edited to contain the same information as provided in the serious game. The learning environment simulated an urban public space where the player should identify a victim of cardiac arrest and perform CPR manoeuvres. The game was designed to be a CPR self-learning tool for both health professionals and the lay public. The game involved only one rescuer without access to a portable defibrillator. During the game, the player should identify the victim, diagnose cardiac arrest correctly and initiate CPR as early as possible. The actions of the player were guided throughout the game by step-by-step instructions that should be followed to save the victim's life and to score on the game. Whenever the manoeuvres were not performed correctly, the victim died and the game automatically restarted from the beginning.
After exposure to the self-learning methods, participants were reassessed individually for their theoretical knowledge on a written, 10-question, multiple-choice test (theoretical post-test) and for their practical performance by three examiners, blinded to group assignment, who independently rated the participants' actions on a 10-min simulated scenario of cardiac arrest using a CPR training manikin (practical post-test).
Simulated scenario The same simulated scenario was used for pre-exposure and post-exposure practical evaluation. When the student entered the simulation room, a manikin was lying on the floor, simulating a person lying on the street, unconscious, not responding to stimulation and with no respiratory effort or pulse. The student was alone without access to medical equipment such as a defibrillator. Participants were expected to recognise the cardiac arrest, call the emergency services, and initiate chest compressions and ventilations as soon as possible for at least two cycles. A 10-min time limit was set for each simulation session.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being a medical student;
- Voluntary participation;
- No previous participation in CPR training.
Exclusion Criteria:
- Previous participation in CPR training.
- Refusal to participate.
- Not being enrolled in medical school.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Serious game
Intervention: CPR self-training with serious game.
|
|
ACTIVE_COMPARATOR: Training video
Intervention: CPR self-training with Keynote presentation with the addition of voice-over narration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American Heart Association (AHA) Guidelines for CPR
Time Frame: 2 hours
|
Mean performance score of students on each (theoretical and practical) test for each study arm.
|
2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: David P Sena, MD, PhD, Pontificia Universidade Católica do Rio Grande do Sul (PUCRS)
Publications and helpful links
General Publications
- Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
- Thorne CJ, Lockey AS, Bullock I, Hampshire S, Begum-Ali S, Perkins GD; Advanced Life Support Subcommittee of the Resuscitation Council (UK). E-learning in advanced life support--an evaluation by the Resuscitation Council (UK). Resuscitation. 2015 May;90:79-84. doi: 10.1016/j.resuscitation.2015.02.026. Epub 2015 Mar 9.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1818537
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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