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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05073445
Other study ID # IRB 02021 - 097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 18, 2021
Est. completion date November 15, 2021

Study information

Verified date March 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.


Description:

This trial will be carried out at the simulation center of the training institute for health professionals of the CHU Grenoble Alpes. Volunteer anesthesia professionals and students will perform a scenario simulating a pediatric laryngospasm during a surgical incision. Each scenario will be performed by a medical and paramedical anesthesia pair and supervised by simulation trainers. Stress and resilience measures will be taken at various times during the study. Participants will be debriefed at the end of the simulation. The primary objective is to analyze the correlation between anesthesia professionals' resilience and measured stress.Secondary objectives are to study the association between: SDNN-measured stress and VAS-reported stress, age and SDNN-measured stress, CD RISC 10 resilience and PSS10-reported stress, CD RISC resilience and VAS-reported stress, the effect of experience on SDNN-measured stress, multiple correlation of the different secondary criteria. secondary criteria.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 15, 2021
Est. primary completion date October 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - volunteer in anesthesia Exclusion Criteria: - Rhythm disorders - Endocrine pathology - High blood pressure - Pregnancy or breastfeeding in progress - Taking anti-inflammatory or psychotropic drugs that interfere with the heart rate - Interruption of professional practice in anesthesia > 2 years

Study Design


Intervention

Behavioral:
SDNN measurement
SDNN measurement during pediatric simulation

Locations

Country Name City State
France University Hospital 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 Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants during the laryngospasm (during 3 minutes at 6 minutes)
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. 5 days before scenario
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%). 5 days before scenario
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 Before the scenario (at 0 minute )
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 briefing (at 3 minutes)
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 9 minutes)
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 debriefing (at 30 minutes)
Secondary Perceived Stress Scale The Perceived Stress Scale (PSS10 from 10 To 50) measures the degree to which respondents feel their lives are unpredictable, uncontrollable, and overloaded. A high score indicates more stress. 5 days before scenario
Secondary Age of anesthesia professionals Age of anesthesia professionals: (quantitative variable) 5 days before scenario
Secondary Experience in anesthesia: Experience in anesthesia: number of years since the beginning of specialized training training (quantitative variable) 5 days before scenario
Secondary Pediatric experience: Pediatric experience: qualitative variable (yes, no) 5 days before scenario
Secondary Pediatric laryngospasm experience Pediatric laryngospasm experience: qualitative variable: (yes, no) 5 days before scenario
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants 5 days before scenario (during 3 minutes)
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants Before the scenario (during 3 minutes)
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants during briefing (during 3 minutes at 0 minutes)
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants during the scenario before the laryngospasm (during 3 minutes at 3 minutes)
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants during the debriefing (3 minutes at 9 minutes)
Secondary Heart rate variability Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants after the debriefing (3 minutes at 30 minutes)
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