SimStress: Resilience and Acute Stress in Simulation

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT05353621
Collaborator
(none)
85
1
5.5
15.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Resilience [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Accepts Healthy Volunteers
Exclusion Criteria:
  • Participants who object to the use of their data for research purposes.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Grenoble Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Yoann Zafiriou, University Hospital, Grenoble
  • Principal Investigator: Julien Picard, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT05353621
Other Study ID Numbers:
  • IRB 00010254 - 2022 - 052
First Posted:
Apr 29, 2022
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022