Education, Medical, UndergraduateNCT02758119
Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.
A study testing Serious Game and Online course in people with Education, Medical, Undergraduate and Out-of-Hospital Cardiac Arrest, run by Ilumens at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Undergraduate, Out-of-Hospital Cardiac Arrest, Simulation Training
- What is being tested?
- Serious Game and Online course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Second-year medical students from the medical schools of Paris Descartes and Paris Diderot University who are not opposed to participate in the study.
Who cannot join
- Opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Simulation iLumens, Université Paris Descartes
Paris, 75006
About this study
Official title: Conciliating Mastery Learning and Time Constraints on High-fidelity Simulators: Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.
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.
- Being tested
- Serious Game, Online course
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious GameOther
Online courseOther
| Study group | Role | What they receive |
|---|---|---|
| Serious Game | Experimental | 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. Receives: Other: Serious Game |
| Online course | Active comparator | 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. Receives: Other: Online course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 4 months after the hands-on session.
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.
Measured: 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
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.
Measured: 4 months after the hands-on session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Education, Medical, UndergraduateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilumens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Drummond, MD, Principal investigator, University Paris René Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758119
- Sponsor's protocol ID
- Ilumens0002
- Status last verified
- Mar 2019
- First submitted
- 29 Apr 2016
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 23624247Wayne 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 16637824Cook 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 23807104Creutzfeldt 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 23217084Drummond 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conciliating Mastery Learning and Time Constraints on High-fidelity Simulators: Serious Game Versus Online Course to Pre-train Medical Students on the Management of an Adult Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT02758119
- Acronym / sponsor ID
- Ilumens0002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- IlumensUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious Game | Experimental | Other: Serious GameParticipants 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. |
| Online course | Active comparator | Other: Online courseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Second-year medical students from the medical schools of Paris Descartes and Paris Diderot University who are not opposed to participate in the study.
Key exclusion criteria (1 listed)
- Opposition to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious Game | Other | Serious Game |
| Online course | Other | Online course |
Primary outcome
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.
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
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.
3 secondary outcomes
Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator
Time frame: 4 months after the hands-on session.
Score (on the Checklist) on the First Attempt During the hands-on Session
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
Score (on the Checklist) on the First Attempt During the hands-on Session
Time frame: 4 months after the hands-on session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23624247Mundell 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.
- Background: PubMed 16637824Wayne 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.
- Background: PubMed 23807104Cook 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.
- Background: PubMed 23217084Creutzfeldt 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.
- Derived from this study: PubMed 28731928Drummond 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Drummond, MD principal investigator
University Paris René Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game and Online course in people with Education, Medical, Undergraduate and Out-of-Hospital Cardiac Arrest, run by Ilumens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02758119, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.