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Completed

NCT Number: NCT03175484

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CLESS

Lyon, Auvergne-Rhône-Alpes, 69007, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Task Load

    Time frame: immediately after the scenario

    NASA TLX scale questionnaire

Secondary outcomes

  1. Anxiety scale

    Time frame: at baseline, at 20 minutes and at 60 minutes

    100 points numeric scale for anxiety (0 - no anxiety; 100 - maximal anxiety)

  2. Pupillometry

    Time frame: at baseline, at 20 minutes and at 60 minutes

    automated quantitative pupillometry

  3. HFS performance

    Time frame: at 20 minutes

    Technical and Team Emergency Assessment Measure scale scores

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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