- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03592953
Are Serious Games Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenarios in Soft Skills Training
Serious Games and Non Technical Skills Training: Are Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenario
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75006
- Recruiting
- Ilumens, Paris Descartes University
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Contact:
- Daphné Michelet, MD
- Phone Number: +33617861084
- Email: daphnemichelet@gmail.com
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Students in midwifery in 4th or 5th year (last year of the french curriculum)
Exclusion Criteria:
- Midwifery students who did not receive theoretical training on postpartum hemorrhage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Serious game Control group
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).
|
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.
|
|
EXPERIMENTAL: Serious game Experimental group
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...
|
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.
|
|
NO_INTERVENTION: Classical teaching group
the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high fidelity simulation session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non technical skills scoring with a specific checklist for the assessment of non technical skills in post partum hemorrhage situation
Time Frame: One year
|
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
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Maccoy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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