NCT03844009

Brief Summary

Debriefing after simulation plays a crucial role in student learning and medical practice. This paper focuses on impact of computer debriefing technique on knowledge retention of midwives during screen-based simulation of neonatal resuscitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

February 7, 2019

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • knowledge retention

    Knowledge assesment based on a validated questionnaire created from International Liaison Committee On Resuscitation guidelines at T0 (before simulation), T1 (after the first simulation session) and T2 (after the second simulation session, two month later)

    two months

Secondary Outcomes (2)

  • Non-technical skills assesment

    two months

  • Technical skills assessment

    two months

Study Arms (2)

Debriefing

EXPERIMENTAL

Participant's of the debriefing group had a computer integrated debriefing at the end of each scenario of the computer-based simulator

Other: Computer integrated debriefing

No debriefing

NO INTERVENTION

Participant's of the debriefing group had no computer integrated debriefing at the end of each scenario of the computer-based simulator

Interventions

At the end of each computer-based simulation, the participant had a computer integrated debriefing of his performance during the neonatal resuscitation simulation and a debriefing based on an auto-evaluation of his non-technical skills.

Debriefing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Student in midwifery in fourth year in france (penultimate year of the midwifery studies)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilumens, Paris Descartes University

Paris, 75006, France

Location

Related Publications (3)

  • van der Heide PA, van Toledo-Eppinga L, van der Heide M, van der Lee JH. Assessment of neonatal resuscitation skills: a reliable and valid scoring system. Resuscitation. 2006 Nov;71(2):212-21. doi: 10.1016/j.resuscitation.2006.04.009. Epub 2006 Sep 20.

    PMID: 16987590BACKGROUND
  • Donoghue A, Nishisaki A, Sutton R, Hales R, Boulet J. Reliability and validity of a scoring instrument for clinical performance during Pediatric Advanced Life Support simulation scenarios. Resuscitation. 2010 Mar;81(3):331-6. doi: 10.1016/j.resuscitation.2009.11.011. Epub 2010 Jan 4.

    PMID: 20047787BACKGROUND
  • Michelet D, Barre J, Truchot J, Piot MA, Cabon P, Tesniere A. Effect of Computer Debriefing on Acquisition and Retention of Learning After Screen-Based Simulation of Neonatal Resuscitation: Randomized Controlled Trial. JMIR Serious Games. 2020 Aug 11;8(3):e18633. doi: 10.2196/18633.

Study Officials

  • Antoine Tesnière, PhD

    Ilumens

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor (questionnaire) was blinded of the allocation group of the participant.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled study comparing two groups, one intervention group (debriefing) and one control group (no debriefing)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 18, 2019

Study Start

December 7, 2018

Primary Completion

February 28, 2019

Study Completion

March 31, 2019

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations