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Resilience and Acute Stress in Simulation (SimStress)

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ClinicalTrials.gov Identifier: NCT05353621
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment
Stress, Professional Resilience Anaesthesiology Simulation Behavioral: VAS reported Stress

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). Translated with www.DeepL.com/Translator (free version)

Study Design
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Study Type : Observational
Estimated Enrollment : 85 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Resilience and Acute Stress in Simulation : "SimStress"
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: VAS reported Stress
    VAS reported Stress measurement during simulation

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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%).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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%).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
physician anesthesiologist or anesthesia intern or nurse anesthetist or student nurse anesthetist
Criteria

Inclusion Criteria:

  • Accepts Healthy Volunteers

Exclusion Criteria:

  • Participants who object to the use of their data for research purposes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05353621


Contacts
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Contact: Pierre Albaladejo +33 (0)4 76 76 92 88 PAlbaladejo@chu-grenoble.fr
Contact: Julien Picard +33 (0)4 76 76 92 88 JPicard@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
Grenoble, France, 38043
Contact: Pierre Albaladejo, M.D, Ph.D.         
Contact: Julien Picard, M.D, Ph.D.         
Principal Investigator: Yoann Zafiriou         
Principal Investigator: Julien Picard, M.D, Ph.D.         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Yoann Zafiriou University Hospital, Grenoble
Principal Investigator: Julien Picard University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT05353621    
Other Study ID Numbers: IRB 00010254 - 2022 - 052
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Occupational Stress
Occupational Diseases
Stress, Psychological
Behavioral Symptoms