Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05353621 |
Other study ID # |
IRB 00010254 - 2022 - 052 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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).