CClinicalTrials.gg
CompletedNCT02758119Updated Jul 5, 2019Results posted

Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.

An interventional study of Serious Game and Online course in Education, Medical, Undergraduate, Out-of-Hospital Cardiac Arrest and Simulation Training, sponsored by Ilumens. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Ilumens · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to compare two forms of pre-training (an online narrative presentation and a serious game) to prepare 2nd year medical students for a hands-on training with physical simulators about out-of-hospital cardiac arrest management.

Read the detailed description

Technology-enhanced simulation allows mastery learning. Mastery learning is a variety of competency-based education which has demonstrated its efficacy for skills acquisition and their transfer to actual settings. While traditional education defines fixed learning time and allows outcomes to vary, in mastery learning, all trainees must achieve a predefined level of proficiency while their learning time can vary. The main limitation of mastery learning is that it takes more time than non-mastery learning. This is of concern because the main barrier to simulation-based training is the lack of faculty time. Thus, new solutions should emerge to conciliate mastery learning and time constraints on physical simulators.

Pre-training with a "simulation game" may be a mean to reach this objective. Simulation games are serious games which are at the cross roads between (1) educational games which are "applications using the characteristics of video and computer games to create engaging and immersive learning experiences", and (2) simulation, the imitation of situations which can be encountered in real-life. They combine the advantages of educational games (active, personalized learning) and simulation (realistic and safe environment for experiential learning). By contrast, pre-training with an online course using a PowerPoint presentation with voiceover narration lecture is both passive and abstract.

The objective of this study is to evaluate the time-efficiency of pre-training using a simulation game versus an online course to reach mastery learning in the management of an adult out-of-hospital cardiac arrest.

02

Conditions studied

  • Education, Medical, Undergraduate
  • Out-of-Hospital Cardiac Arrest
  • Simulation Training
03

In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 225 are open to participants now.

This study's enrollment of 82 is below the median of 100 across 556 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Ilumens is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Second-year medical students from the medical schools of Paris Descartes and Paris Diderot University who are not opposed to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Opposition to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Serious Game

    Participants in the "serious game" group will be pre-trained before the hands-on sessions with the serious game "Staying Alive", available at http://www.stayingalive.fr/index_us.html This game aims at teaching the management of an out-of-hospital cardiac arrest to the general public and health professionals. In this game, the player faces a man who has experienced sudden cardiac arrest and learns the appropriate behavior, movements and techniques that can contribute to saving his life. The first level of the game lasts 4-5 minutes, depending on the skills of the player. It is a point and click game, displayed on a PC computer.

    Other: Serious Game

  • Active comparator
    Online course

    Participants in the lecture group will watch individually a 4-min video of a PowerPoint presentation with voiceover narration, given in the medical school of Paris Descartes University. The video is edited to contain the same informations on out-of-hospital cardiac management than the serious game, with the same duration.

    Other: Online course

Interventions

  • OtherSerious Game
  • OtherOnline course
06

What researchers measure

Primary outcomes

  1. Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.

    Following the 2015 European Resuscitation Council guidelines, a checklist was developed for this study. This checklist allows the assessors to evaluate the participant's compliance with guidelines, and to determine if he/she needs to practice again on the scenario or if he/she reached the minimum passing score and can stop the training. The quality of the chest compressions provided is recorded automatically through the ResusciAnne Skill Reporter Software (Laerdal, Norways), and is integrated in the checklist.

    Time frame: The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more

Secondary outcomes

  1. Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator

    Evaluation of skill retention.

    Time frame: 4 months after the hands-on session.

  2. Score (on the Checklist) on the First Attempt During the hands-on Session

    Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

    Time frame: The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more

  3. Score (on the Checklist) on the First Attempt During the hands-on Session

    Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

    Time frame: 4 months after the hands-on session.

07

Results

Posted Jul 5, 2019

Participant flow

Participant flow — Overall Study
MilestoneOnline CourseSerious Game
Started4141
Completed3940
Not completed21

Outcome measures

PrimaryMedian Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.

Following the 2015 European Resuscitation Council guidelines, a checklist was developed for this study. This checklist allows the assessors to evaluate the participant's compliance with guidelines, and to determine if he/she needs to practice again on the scenario or if he/she reached the minimum passing score and can stop the training. The quality of the chest compressions provided is recorded automatically through the ResusciAnne Skill Reporter Software (Laerdal, Norways), and is integrated in the checklist.

Time frame:
The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more
Reported as:
Median · minutes
Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.
minutesOnline CourseSerious Game
Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.23 (15 to 32)20.5 (15.8 to 30.3)
SecondaryMedian Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator

Evaluation of skill retention.

Time frame:
4 months after the hands-on session.
Reported as:
Median · Minutes
Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator
MinutesSerious GameOnline Course
Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator11.7 (10.7 to 17.0)12.1 (10.2 to 21.5)
Statistical analysis
  • Serious Game vs Online Course · Wilcoxon (Mann-Whitney) · p = <0.001
SecondaryScore (on the Checklist) on the First Attempt During the hands-on Session

Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

Time frame:
The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more
Reported as:
Median · units on a scale
Score (on the Checklist) on the First Attempt During the hands-on Session
units on a scaleSerious GameOnline Course
Score (on the Checklist) on the First Attempt During the hands-on Session6 (4 to 8)6 (5 to 7)
SecondaryScore (on the Checklist) on the First Attempt During the hands-on Session

Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score. Higher scores mean a better outcome.

Time frame:
4 months after the hands-on session.
Reported as:
Median · units on a scale
Score (on the Checklist) on the First Attempt During the hands-on Session
units on a scaleSerious GameOnline Course
Score (on the Checklist) on the First Attempt During the hands-on Session9 (8 to 10)9 (8 to 10)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Online Course—0/41 (0%)0/41 (0%)
Serious Game—0/41 (0%)0/41 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Serious GameOnline CourseTotal
Median21 (20 to 21)21 (21 to 21)21 (21 to 21)
Sex: Female, Male
Sex: Female, Male(Participants)Serious GameOnline CourseTotal
Female272956
Male141226
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Serious GameOnline CourseTotal
Count of participants——0
Last basic life support course taken,
Last basic life support course taken,(Participants)Serious GameOnline CourseTotal
Never122032
< 12 months459
> 12 months251641
Familiar with low-fidelity simulation
Familiar with low-fidelity simulation(Participants)Serious GameOnline CourseTotal
Count of participants111223
Familiar with high-fidelity simulation
Familiar with high-fidelity simulation(Participants)Serious GameOnline CourseTotal
Count of participants101
Previous participation in CPA management
Previous participation in CPA management(Participants)Serious GameOnline CourseTotal
Count of participants202
08

Study locations

1 site
  • Département de Simulation iLumens, Université Paris Descartes
    Paris, 75006, France
09

References and documents

Publications

  • Mundell WC, Kennedy CC, Szostek JH, Cook DA. Simulation technology for resuscitation training: a systematic review and meta-analysis. Resuscitation. 2013 Sep;84(9):1174-83. doi: 10.1016/j.resuscitation.2013.04.016. Epub 2013 Apr 23. PubMed 23624247 ↗
  • Wayne DB, Butter J, Siddall VJ, Fudala MJ, Wade LD, Feinglass J, McGaghie WC. Mastery learning of advanced cardiac life support skills by internal medicine residents using simulation technology and deliberate practice. J Gen Intern Med. 2006 Mar;21(3):251-6. doi: 10.1111/j.1525-1497.2006.00341.x. PubMed 16637824 ↗
  • Cook DA, Brydges R, Zendejas B, Hamstra SJ, Hatala R. Mastery learning for health professionals using technology-enhanced simulation: a systematic review and meta-analysis. Acad Med. 2013 Aug;88(8):1178-86. doi: 10.1097/ACM.0b013e31829a365d. PubMed 23807104 ↗
  • Creutzfeldt J, Hedman L, Fellander-Tsai L. Effects of pre-training using serious game technology on CPR performance--an exploratory quasi-experimental transfer study. Scand J Trauma Resusc Emerg Med. 2012 Dec 6;20:79. doi: 10.1186/1757-7241-20-79. PubMed 23217084 ↗
  • Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesniere A. Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study. Eur J Anaesthesiol. 2017 Dec;34(12):836-844. doi: 10.1097/EJA.0000000000000675. PubMed 28731928 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02758119
Lead sponsor
Ilumens
Responsible party
Sponsor
First posted
May 2, 2016
Start date
Jun 2016
Primary completion
Jun 2016
Completion
Oct 2016
Results posted
Jul 5, 2019
Last update
Jul 5, 2019

Study contacts

David Drummond, MD
principal investigator · University Paris René Descartes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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