Cardiopulmonary Resuscitation Self-training
Primary Purpose
Cardiopulmonary Arrest With Successful Resuscitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPR self-training
Sponsored by
About this trial
This is an interventional other trial for Cardiopulmonary Arrest With Successful Resuscitation focused on measuring Virtual learning, Educational technology, Medical education
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Serious game
Training video
Arm Description
Intervention: CPR self-training with serious game.
Intervention: CPR self-training with Keynote presentation with the addition of voice-over narration.
Outcomes
Primary Outcome Measures
American Heart Association (AHA) Guidelines for CPR
Mean performance score of students on each (theoretical and practical) test for each study arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT03729037
First Posted
October 31, 2018
Last Updated
October 31, 2018
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03729037
Brief Title
Cardiopulmonary Resuscitation Self-training
Official Title
Comparative Evaluation of Video-based On-line Course vs. Serious Game for Training Medical Students in Cardiopulmonary Resuscitation: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
August 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants were 45 first-year medical students randomly assigned to cardiopulmonary resuscitation (CPR) self-training using either a video-based presentation or a serious game developed in a 3D learning environment for up to 20 min. Each participant was evaluated on a written, multiple-choice test (theoretical test) and then on a scenario of cardiac arrest (practical test) before and after exposure to the self-learning methods.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest With Successful Resuscitation
Keywords
Virtual learning, Educational technology, Medical education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (outcomes assessor)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serious game
Arm Type
Experimental
Arm Description
Intervention: CPR self-training with serious game.
Arm Title
Training video
Arm Type
Active Comparator
Arm Description
Intervention: CPR self-training with Keynote presentation with the addition of voice-over narration.
Intervention Type
Other
Intervention Name(s)
CPR self-training
Primary Outcome Measure Information:
Title
American Heart Association (AHA) Guidelines for CPR
Description
Mean performance score of students on each (theoretical and practical) test for each study arm.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Sena, MD, PhD
Organizational Affiliation
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26473002
Citation
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.
Results Reference
background
PubMed Identifier
25766092
Citation
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.
Results Reference
background
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Cardiopulmonary Resuscitation Self-training
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