An observational study in Healthy, sponsored by Claude Bernard University. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by Claude Bernard University · Observational
High-fidelity simulation (HFS) is a learning method extensively used for training of surgical specialty (including anesthesia) and nurses. It has a beneficial effect on knowledge of algorithms, team working, early warning scores, and communication. Various skills can be learned using a standardized simulation programs.
The complexity of instructional design may produce cognitive overload, high stress level and anxiety. This may increase fatigue, facilitate errors, and is associated with inferior task performance which may impede memorization of learned skills resulting in inefficient learning/simulation failure. Subjectively reported scales can accurately identify the level of perceived workload and mental demand in individuals during simulation tasks. One example is the National Aeronautics and Space Administration (NASA)-TLX - the most accepted subjective measure of human workload in various industries including medicine.
Surgical specialty (including anesthesia) and nurses training curriculum in Lyon, France, includes several HFS scenarios with a large panel of critical events. The investigators aim to evaluate the effect of burden of workload and stress perceived by surgical specialty (including anesthesia) residents and nurses during HFS on the learning performance, and to grade different learning scenarios by their difficulty.
In this observational study investigators aim to measure anesthesiology, surgeon residents and nurses' workload, stress level, and performance on high-fidelity simulation scenarios used routinely in the current anesthesiology, nurse and surgical training curriculum. A NASA TLX scale, 100 points numeric scale for anxiety (0 - no anxiety; 100 - maximal anxiety), automated quantitative pupillometry, Team Emergency Assessment Measure scale will be used to evaluate a workload, anxiety, stress, and performance. Age, sex, previous experience of HFS will be noted. All data will be anonymized. The participation in this study is voluntary and one can withdraw from this study at any time prior to or after the completion of any interview without any penalty.
Two investigators will independently evaluate the performance of HFS by direct observation and video record if necessary. NASA TLX questionnaire will be administrated immediately after HFS scenario and before the debriefing. Anxiety scale and pupillometry will be administrated before the beginning of HFS scenario and upon its completion.
Claude Bernard University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All medical students/nurse students enrolled in anesthesia/ surgeon simulation training and participating in the HFS training sessions of June 2017
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Exclusion Criteria:
surgical specialty ( including anesthesia) residents and nurses undergoing High Fidelity Simulation scenarios.
Task Load
NASA TLX scale questionnaire
Time frame: immediately after the scenario
Anxiety scale
100 points numeric scale for anxiety (0 - no anxiety; 100 - maximal anxiety)
Time frame: at baseline, at 20 minutes and at 60 minutes
Pupillometry
automated quantitative pupillometry
Time frame: at baseline, at 20 minutes and at 60 minutes
HFS performance
Technical and Team Emergency Assessment Measure scale scores
Time frame: at 20 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Dec 2017, 6 months.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Claude Bernard University