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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
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 31, 2018
    Last Updated
    October 31, 2018
    Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul
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    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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