Resilience and Acute Stress in Simulation

Resilience Clinical Trial

— SimStress  

Official title:

Resilience and Acute Stress in Simulation : "SimStress"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353621
• Other study ID #: IRB 00010254 - 2022 - 052
• Status: Completed
• Start date: May 18, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 15, 2022
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Accepts Healthy Volunteers

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anaesthesiology
• Occupational Stress
• Resilience
• Simulation
• Stress, Professional

Intervention

Behavioral:
• VAS reported Stress
VAS reported Stress measurement during simulation

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resilience	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
Primary	Self-reported stress	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 )
Secondary	Performance	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)
Secondary	resilience of anesthetists	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
Secondary	resilience of Resident in anaesthesia	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
Secondary	resilience of nurse anesthetist	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
Secondary	resilience of the student nurse anesthetist	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
Secondary	Self-reported stress	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 )