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

The Influence of the Perceived Workload on Performance During High Fidelity Simulation in Surgical Specialty ( Including Anesthesia) and Nurses

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• France
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69007
      • CLESS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All medical students/nurse students enrolled in anesthesia/ surgeon simulation training and participating in the HFS training sessions of June 2017

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observation TLX; surgical specialty ( including anesthesia) residents and nurses undergoing High Fidelity Simulation scenarios.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task Load	NASA TLX scale questionnaire	immediately after the scenario

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Claude Bernard University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): December 22, 2017

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Prospective Studies; Students, Medical; Cognitive Load; High Fidelity Simulation; Simulation Training/methods*; Task Performance and Analysis*
• Other Study ID Numbers: HFS-TLX-Lyon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No