Simulation to Assess Cognitive Workload and Task Load IndeX (TLX) Performance

Completed

• Conditions: Healthy

• Registration Number: NCT03175484
• Lead Sponsor: Claude Bernard University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-29
• Study Start: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Lyon University medical student status on the day of the study
• Enrolled in surgical specialty (including anesthesia) simulation training program

or

• Lyon Anesthesia Nurses School student status on the day of the study
• Enrolled in surgical specialty (including anesthesia) simulation training program
• voluntary

Exclusion Criteria

• denial to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Task Load	immediately after the scenario	NASA TLX scale questionnaire

Secondary Outcome Measures

Name	Time	Method
Anxiety scale	at baseline, at 20 minutes and at 60 minutes	100 points numeric scale for anxiety (0 - no anxiety; 100 - maximal anxiety)
Pupillometry	at baseline, at 20 minutes and at 60 minutes	automated quantitative pupillometry
HFS performance	at 20 minutes	Technical and Team Emergency Assessment Measure scale scores

Trial Locations

Locations (1)

CLESS; 🇫🇷 Lyon, Rhône-Alpes, France