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

July 19, 2018 updated by: Daphne Michelet, Ilumens

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75006
        • Recruiting
        • Ilumens, Paris Descartes University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ilumens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Maccoy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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