Are Serious Games Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenarios in Soft Skills Training

• ClinicalTrials.gov Identifier: NCT03592953
• Recruitment Status: Unknown
• First Posted: July 19, 2018
• Last Update Posted: July 23, 2018
• Sponsor: Ilumens
• Information provided by (Responsible Party): Daphne Michelet, Ilumens

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Simulation Training	Other: Serious game simulation training sessions	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized trial with 3 groups: classical teaching, serious game with classical scenarios, serious game with specific scenarios
• Masking: Single (Outcomes Assessor)
• Masking Description: the primary endpoint is the scoring of non-technical skills on the video recording of the high fidelity simulation session. The raters are blinded of the allocation group of the participant.
• Primary Purpose: Other
• Official Title: Serious Games and Non Technical Skills Training: Are Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenario
• Actual Study Start Date: December 1, 2017
• Estimated Primary Completion Date: September 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

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).	Other: Serious game simulation training sessions; 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...	Other: Serious game simulation training sessions; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

France

Ilumens, Paris Descartes University; Recruiting

Paris, France, 75006

Contact: Daphné Michelet, MD +33617861084 daphnemichelet@gmail.com

Sponsors and Collaborators

Ilumens

More Information

• Responsible Party: Daphne Michelet, Principal Investigator, Ilumens
• ClinicalTrials.gov Identifier: NCT03592953
• Other Study ID Numbers: Maccoy
• First Posted: July 19, 2018
• Last Update Posted: July 23, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daphne Michelet, Ilumens:

Serious game; Post partum hemorrhage; Non technical skills