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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03592953
Other study ID # Maccoy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date September 2018

Study information

Verified date July 2018
Source Departement de simulation en Santé de l'Université Paris Descartes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Ilumens, Paris Descartes University Paris

Sponsors (1)

Lead Sponsor Collaborator
Departement de simulation en Santé de l'Université Paris Descartes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One year
Secondary 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 One year
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