Resilience and Acute Stress in Simulation (SimStress)

November 29, 2022 updated by: University Hospital, Grenoble

Resilience and Acute Stress in Simulation : "SimStress"

The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.

Study Overview

Detailed Description

This trial will take place at the Grenoble Alpes University Hospital. Volunteer anaesthetists, nurse anaesthetists, professionals or students will perform a simulation scenario. This scenario generates a high level of stress and focuses on medication errors, which is a good educational tool for the participants.

The simulation is performed in an available operating room with a dedicated anesthesia cart. In this environment, 17 error opportunities were created, i.e., factors that could contribute to the occurrence of a medication error. A person playing the role of the anesthesiologist will give instructions, leave the room, and return to interrupt the participant several times, which will contribute to the intensity of the stressor. The simulation will proceed as follows:

Briefing:

Welcome and explanation of the session. Collection of age, gender, number of years in anesthesia, number of previous simulation sessions, participation or not in stress management training. Presentation of the context and the anesthesiologist, then the participants evaluate their stress using the VAS (visual analog scale) Stress, which triggers the beginning of the scenario. Introduction of the setting and the anesthesiologist, then participants rate their stress using the VAS Stress scale, triggering the start of the scenario.

Scenario:

10 minutes in length. After the briefing, the anesthesiologist announces the imminent arrival of a patient with a suspected abdominal aortic aneurysm. The participant must quickly prepare a tray of medications. The scenario ends just prior to the patient's arrival, with the anesthesiologist presenting the stress VAS again for further evaluation.

Debriefing:

The participant completes a questionnaire about opportunities for detected errors, followed by a 15-minute debriefing after the simulation session.

For each participant, data regarding stress VAS, CD-RISC, PSS-10 and number of errors detected will be compared.

The primary objective is to analyze an association between resilience developed by anesthesia professionals and acute stress level.

The secondary objectives are to study the association between the resilience developed by the anesthesia professionals and the level of acute stress present immediately at the end of the simulation.

immediately at the end of the simulation. Measure the association between resilience (CDRISC 10) and performance (number of potential errors detected). Compare resilience and acute stress between different statuses (anesthesiologist, intern, nurse anesthetist, student nurse anesthetist).

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Grenoble, France, 38043
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

physician anesthesiologist or anesthesia intern or nurse anesthetist or student nurse anesthetist

Description

Inclusion Criteria:

  • Accepts Healthy Volunteers

Exclusion Criteria:

  • Participants who object to the use of their data for research purposes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported stress
Time Frame: just Before the scenario (at 0 minute )
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
just Before the scenario (at 0 minute )
Resilience
Time Frame: 15 Days after simulation
Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants. A high score indicates better resilience.
15 Days after simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance
Time Frame: just after the end of scenario (at 10 minute)
Number of potential errors detected by participants on a post-simulation questionnaire with 23 questions. 18 potential errors are present on the 23 questions. Each correct answer counts as one point and each error removes one point. The maximum score is 18. (performance 0-18); a higher score indicates better performance.
just after the end of scenario (at 10 minute)
resilience of anesthetists
Time Frame: 15 Days after simulation
Average measure of physician anesthesiologists' resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40). Higher scores indicate greater resilience.
15 Days after simulation
resilience of Resident in anaesthesia
Time Frame: 15 Days after simulation
Average measure of Resident in anaesthesia resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40). Higher scores indicate greater resilience.
15 Days after simulation
resilience of nurse anesthetist
Time Frame: 15 Days after simulation
Average measure of nurse anesthetist resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40). Higher scores indicate greater resilience.
15 Days after simulation
resilience of the student nurse anesthetist
Time Frame: 15 Days after simulation
Average measure of the student nurse anesthetist resilience by the Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40). Higher scores indicate greater resilience.
15 Days after simulation
Self-reported stress
Time Frame: just after the end of scenario (at 10 minute )
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
just after the end of scenario (at 10 minute )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julien Picard, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Actual)

October 4, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRB 00010254 - 2022 - 052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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