- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03844009
Computer Debriefing and Screen-based Simulation
Impact of Computer Debriefing During Screen-based Simulation of Neonatal Resuscitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Simulation, including screen-based simulation, is employed in medicine to enhance competency and improve care. It has been practiced for centuries in its primitive form as uses of wax Venus or obstetrics dolls to teaching anatomical knowledge or know-how/gestures. Many benefits come from simulations as the capacity to practiced procedures without any risk to the patient, the possibility of trainees to commit errors and learn from these errors, the repeatability of scenario that can be different or presented to learners many times, and then the opportunity to improved technical and non-technical skills among learners. Specifically, screen-based simulation has many advantages as portability (easy to move), distribution and replicability (usable by many learners at differences places in the world), repeatability (people not faced frequently in their regular practice), even be remotely usable. Screen-based simulation appears in literature to be a complement of mannequin simulation. Indeed, since last years the development of computer science has made it possible to create new kind of simulators in the medical field for the acquisition of knowledge, know-how and technical gestures, more realistic and interactively rich.
Debriefing is considered as a part of simulation-based training and cannot be separated of simulators. Debriefing improve professional practice, clinical skills and competences. It exists different debriefing methods: post simulation debriefing, in-simulation debriefing, verbal instructor debriefing, video-assisted instructor debriefing, self-debriefing or also multimedia debriefing. However, debriefing is considered by many as a communication between student/learner and teacher, after a situation (e.g. simulation), and about this experience. It is not just a feedback on performance but also a communication process about the impact of the experience or performance explanation.
This study aims to evaluate the impact of a computer integrated debriefing of technical and non-technical skills on retention and performance of neonatal resuscitation management by trainee's midwives.
Thirty student in midwifery in fourth year will participate. The study protocol is the following:
Baseline knowledge questionnaire, randomization of the participants. Day one: Tutorial of the simulator, First scenario (+/- debriefing depending of the allocation group), second scenario (+/- debriefing depending of the allocation group).
Day two (two month later): knowledge questionnaire, tutorial of the simulator, one scenario (+/- debriefing depending of the allocation group).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Paris, France, 75006
- Ilumens, Paris Descartes University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Student in midwifery in fourth year in france (penultimate year of the midwifery studies)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Debriefing
Participant's of the debriefing group had a computer integrated debriefing at the end of each scenario of the computer-based simulator
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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.
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No Intervention: No debriefing
Participant's of the debriefing group had no computer integrated debriefing at the end of each scenario of the computer-based simulator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
knowledge retention
Time Frame: two months
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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)
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two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-technical skills assesment
Time Frame: two months
|
Evaluation of the Anesthetist Non technical skills score at T1 (first session) and T2 (second session, two month later)
|
two months
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Technical skills assessment
Time Frame: two months
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Evaluation of the Modified Neonatal Resuscitation Program Evaluation score at T1 (first session) and T2 (second session, two month later)
|
two months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Antoine Tesnière, PhD, Ilumens
Publications and helpful links
General Publications
- 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.
- 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.
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RNN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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