NCT03592953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

July 5, 2018

Last Update Submit

July 19, 2018

Conditions

Keywords

Serious gamePost partum hemorrhageNon technical skills

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Non technical skills scoring with a specific checklist for the assessment of non technical skills in post partum hemorrhage situation

    One year

Study Arms (3)

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).

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...

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.

Interventions

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.

Serious game Control groupSerious game Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students in midwifery in 4th or 5th year (last year of the french curriculum)

You may not qualify if:

  • Midwifery students who did not receive theoretical training on postpartum hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilumens, Paris Descartes University

Paris, 75006, France

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized trial with 3 groups: classical teaching, serious game with classical scenarios, serious game with specific scenarios
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 19, 2018

Study Start

December 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations