Computer SimulationNCT03844009
Computer Debriefing and Screen-based Simulation
A study testing Computer integrated debriefing in people with Computer Simulation and Neonatal Resuscitation, run by Ilumens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Computer Simulation, Neonatal Resuscitation
- What is being tested?
- Computer integrated debriefing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student in midwifery in fourth year in france (penultimate year of the midwifery studies)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Computer Debriefing During Screen-based Simulation of Neonatal Resuscitation
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.
Read the 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).
- Conditions
- Computer Simulation, Neonatal Resuscitation
- Being tested
- Computer integrated debriefing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer integrated debriefingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Debriefing | Experimental | Participant's of the debriefing group had a computer integrated debriefing at the end of each scenario of the computer-based simulator Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: two months
Secondary outcomes (2)
Non-technical skills assesment
Evaluation of the Anesthetist Non technical skills score at T1 (first session) and T2 (second session, two month later)
Measured: two months
Technical skills assessment
Evaluation of the Modified Neonatal Resuscitation Program Evaluation score at T1 (first session) and T2 (second session, two month later)
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start7 Dec 2018
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Computer SimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study comparing two groups, one intervention group (debriefing) and one control group (no debriefing)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilumens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Michelet, Ilumens
- Investigators
- Antoine Tesnière, PhD, Study director, Ilumens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844009
- Sponsor's protocol ID
- RNN
- Status last verified
- Aug 2021
- First submitted
- 7 Feb 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16987590Donoghue 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.
PubMed 20047787Michelet 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.
PubMed 32780021
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computer Debriefing During Screen-based Simulation of Neonatal Resuscitation
- ClinicalTrials.gov ID
- NCT03844009
- Acronym / sponsor ID
- RNN
- Conditions
- Computer Simulation, Neonatal Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IlumensUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study comparing two groups, one intervention group (debriefing) and one control group (no debriefing)
| Arm | Type | Receives |
|---|---|---|
| Debriefing | Experimental | Other: Computer integrated debriefingParticipant's of the debriefing group had a computer integrated debriefing at the end of each scenario of the computer-based simulator |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Student in midwifery in fourth year in france (penultimate year of the midwifery studies)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer integrated debriefingAt 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. | Other | Debriefing |
Primary outcome
knowledge retention
Time frame: two months
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)
2 secondary outcomes
Non-technical skills assesment
Time frame: two months
Technical skills assessment
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 16987590van 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.
- Background: PubMed 20047787Donoghue 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.
- Derived from this study: PubMed 32780021Michelet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Tesnière, PhD study director
Ilumens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer integrated debriefing in people with Computer Simulation and Neonatal Resuscitation, run by Ilumens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge retention (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844009, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.