Simulation TrainingNCT03592953
Are Serious Games Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenarios in Soft Skills Training
A study testing Serious game simulation training sessions in people with Simulation Training, run by Ilumens at 1 site in France.
Trial summary
The aim of the study is to assess if a training on post-partum hemorrhage management with serious game scenarios specifically designed to teach non technical skills improve non technical skills scoring in a high-fidelity simulation session. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Training
- What is being tested?
- Serious game simulation training sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Students in midwifery in 4th or 5th year (last year of the french curriculum)
Who cannot join
- Midwifery students who did not receive theoretical training on postpartum hemorrhage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ilumens, Paris Descartes University
Paris, 75006
Daphné Michelet, MD, +33617861084, daphnemichelet@gmail.com
About this study
Official title: Serious Games and Non Technical Skills Training: Are Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenario
The aim of the study is to assess if a training on post-partum hemorrhage management with serious game scenarios specifically designed to teach non technical skills improve non technical skills scoring in a high-fidelity simulation session.
Read the detailed description
This study aims to answer the following problematic: How to improve the learning of Non Technical Skills (communication, teamwork, leadership ...) in simulation. This study tests non technical skills learning in a serious game on Postpartum Hemorrhage (PPH) management and the interest of specifically designed scenarios.
36 students in midwifery in 5th (and last) year will participate in the experiment. They will be randomized into 3 groups:
- Serious game Control group (12 participants): The participants spend on three different scenarios from the game "PerinatSims"; basic scenarios designed to train Technical Skills (management of post partum hemorrhage according to the algorithm).
- Serious game Experimental group (12 participants): The participants spend on three "PerinatSims" scenarios in which "critical situations" have been implemented, aiming to mobilize some of the non-technical skills of the learners: situation awareness, decision making, communication...
- Classical teaching group (12 participants): the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high-fidelity simulation session.
For the serious games groups, at the end of each scenario the participant has access to a debriefing of his technical skills, integrated into the game. At the end of the 3 scenarios, the participant has a debriefing with a simulation teacher.
Finally, each participant of the three groups will be asked to participate to a post partum hemorrhage scenario in High Fidelity simulation. This final award will enable us to validate the investigator's working hypothesis: to check if the non-technical skills mobilized during the sessions on the serious game PerinatSims have been acquired and are beneficial for the participants. A debriefing will be done at the end of the simulation.
The objective of this experiment is to assess if the type of scenario (with or without critical events) improves non-technical skills learning.
The evaluation tools will be the following:
- 3 hetero evaluation scales: Anesthetist's Non Technical Skills (ANTS), Observational Teamwork Assessment for Surgery (OTAS) and a checklist specially developped.
- Electrophysiology: Eye tracking (for the screen-based simulation), Heart rate monitor
- Auto evaluation scales: Flow scale, Stress scale (DASS), Leadership scale (BAT), Mental load scale (NASA TLX), Scale of technological acceptability (SUS)
The High Fidelity simulation will be evaluated according to the same tools outside the eye-tracking.
- Conditions
- Simulation Training
- Being tested
- Serious game simulation training sessions
- Keywords
- Serious game, Post partum hemorrhage, Non technical skills
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game simulation training sessionsOther
Each participant of the Serious game groups played 3 scenarios of "Perinatsims", a screen-based simulation on the management of a post partum hemorrhage. The serious game control group played basic scenarios and the experimental group played specific scenarios.
| Study group | Role | What they receive |
|---|---|---|
| Serious game Control group | Experimental | The participants spend on three different scenarios from the game PerinatSims; basic scenarios designed to train Technical Skills (management of post partum hemorrhage according to the algorithm). Receives: Other: Serious game simulation training sessions |
| Serious game Experimental group | Experimental | The participants spend on three "PerinatSims" scenarios in which "critical situations" have been implemented, aiming to mobilize some of the non-technical skills of the learners: situation awareness, decision making, communication... Receives: Other: Serious game simulation training sessions |
| Classical teaching group | No intervention | the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high fidelity simulation session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non technical skills scoring with OTAS score
3 raters will evaluate participant on the video recording of the High fidelity simulation session with the help of the OTAS score (Observational Teamwork Assessment for Surgery). The total score is 30 points and is composed of 5 categories (/6 points each): communication, coordination, cooperation, leadership, situation awareness.
Measured: One year
Secondary outcomes (1)
Non technical skills scoring with a specific checklist for the assessment of non technical skills in post partum hemorrhage situation
3 raters will evaluate the participant on the video recording of the High fidelity simulation session with the help of a checklist specifically designed for the non-technical skills in the post partum hemorrhage. The total score is 24 and is divided in 6 categories (/4points each): communication, situation awareness, decision making,collaborative work, leadership, emotion management
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Dec 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies 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
- Model description
- Randomized trial with 3 groups: classical teaching, serious game with classical scenarios, serious game with specific scenarios
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilumens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Michelet, Ilumens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592953
- Sponsor's protocol ID
- Maccoy
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Games and Non Technical Skills Training: Are Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenario
- ClinicalTrials.gov ID
- NCT03592953
- Acronym / sponsor ID
- Maccoy
- Conditions
- Simulation Training
- Keywords
- Serious game, Post partum hemorrhage, Non technical skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IlumensUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess if a training on post-partum hemorrhage management with serious game scenarios specifically designed to teach non technical skills improve non technical skills scoring in a high-fidelity simulation session.
Detailed description
This study aims to answer the following problematic: How to improve the learning of Non Technical Skills (communication, teamwork, leadership ...) in simulation. This study tests non technical skills learning in a serious game on Postpartum Hemorrhage (PPH) management and the interest of specifically designed scenarios.
36 students in midwifery in 5th (and last) year will participate in the experiment. They will be randomized into 3 groups:
- Serious game Control group (12 participants): The participants spend on three different scenarios from the game "PerinatSims"; basic scenarios designed to train Technical Skills (management of post partum hemorrhage according to the algorithm).
- Serious game Experimental group (12 participants): The participants spend on three "PerinatSims" scenarios in which "critical situations" have been implemented, aiming to mobilize some of the non-technical skills of the learners: situation awareness, decision making, communication...
- Classical teaching group (12 participants): the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high-fidelity simulation session.
For the serious games groups, at the end of each scenario the participant has access to a debriefing of his technical skills, integrated into the game. At the end of the 3 scenarios, the participant has a debriefing with a simulation teacher.
Finally, each participant of the three groups will be asked to participate to a post partum hemorrhage scenario in High Fidelity simulation. This final award will enable us to validate the investigator's working hypothesis: to check if the non-technical skills mobilized during the sessions on the serious game PerinatSims have been acquired and are beneficial for the participants. A debriefing will be done at the end of the simulation.
The objective of this experiment is to assess if the type of scenario (with or without critical events) improves non-technical skills learning.
The evaluation tools will be the following:
- 3 hetero evaluation scales: Anesthetist's Non Technical Skills (ANTS), Observational Teamwork Assessment for Surgery (OTAS) and a checklist specially developped.
- Electrophysiology: Eye tracking (for the screen-based simulation), Heart rate monitor
- Auto evaluation scales: Flow scale, Stress scale (DASS), Leadership scale (BAT), Mental load scale (NASA TLX), Scale of technological acceptability (SUS)
The High Fidelity simulation will be evaluated according to the same tools outside the eye-tracking.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized trial with 3 groups: classical teaching, serious game with classical scenarios, serious game with specific scenarios
| Arm | Type | Receives |
|---|---|---|
| Serious game Control group | Experimental | Other: Serious game simulation training sessionsThe participants spend on three different scenarios from the game PerinatSims; basic scenarios designed to train Technical Skills (management of post partum hemorrhage according to the algorithm). |
| Serious game Experimental group | Experimental | Other: Serious game simulation training sessionsThe participants spend on three "PerinatSims" scenarios in which "critical situations" have been implemented, aiming to mobilize some of the non-technical skills of the learners: situation awareness, decision making, communication... |
| Classical teaching group | No intervention | –the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high fidelity simulation session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students in midwifery in 4th or 5th year (last year of the french curriculum)
Key exclusion criteria (1 listed)
- Midwifery students who did not receive theoretical training on postpartum hemorrhage
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 simulation training sessionsEach participant of the Serious game groups played 3 scenarios of "Perinatsims", a screen-based simulation on the management of a post partum hemorrhage. The serious game control group played basic scenarios and the experimental group played specific scenarios. | Other | Serious game Control group, Serious game Experimental group |
Primary outcome
Non technical skills scoring with OTAS score
Time frame: One year
3 raters will evaluate participant on the video recording of the High fidelity simulation session with the help of the OTAS score (Observational Teamwork Assessment for Surgery). The total score is 30 points and is composed of 5 categories (/6 points each): communication, coordination, cooperation, leadership, situation awareness.
1 secondary outcome
Non technical skills scoring with a specific checklist for the assessment of non technical skills in post partum hemorrhage situation
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Simulation Training
Active, not recruiting
Enhancing Male Nursing Students' Competence in Maternity Care: A Quasi-Experimental Study in Egypt
Maternity Nursing, Obstetric Nursing
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Enrolling by invitation
Virtual Reality-Based Simulation Training for Retrograde Anterior Column Acetabular Screw Placement in Orthopedic Residents
Virtual Reality Simulation
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.
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 simulation training sessions in people with Simulation Training, 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non technical skills scoring with OTAS score (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2018.