- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05073445
Stress and Resilience in Anesthesia Professionals (ResiStress)
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38000
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Anaesthetic teams composed with :
- 1 resident in anaesthesiology and critical care OR Anesthesiologist AND
- 1 anaesthetic nursing student OR 1 anaesthetic nurse graduated
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability
Time Frame: during the laryngospasm (during 3 minutes at 6 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
during the laryngospasm (during 3 minutes at 6 minutes)
|
|
Resilience
Time Frame: 5 days before scenario
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported stress
Time Frame: 5 days before scenario
|
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
|
|
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%).
|
just Before the scenario (at 0 minute )
|
|
Self-reported stress
Time Frame: just after briefing (at 3 minutes)
|
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)
|
|
Self-reported stress
Time Frame: just after the end of scenario (at 9 minutes)
|
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)
|
|
Self-reported stress
Time Frame: just after the debriefing (at 30 minutes)
|
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)
|
|
Perceived Stress Scale
Time Frame: 5 days before scenario
|
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
|
|
Age of anesthesia professionals
Time Frame: 5 days before scenario
|
Age of anesthesia professionals: (quantitative variable)
|
5 days before scenario
|
|
Experience in anesthesia:
Time Frame: 5 days before scenario
|
Experience in anesthesia: number of years since the beginning of specialized training training (quantitative variable)
|
5 days before scenario
|
|
Pediatric experience:
Time Frame: 5 days before scenario
|
Pediatric experience: qualitative variable (yes, no)
|
5 days before scenario
|
|
Pediatric laryngospasm experience
Time Frame: 5 days before scenario
|
Pediatric laryngospasm experience: qualitative variable: (yes, no)
|
5 days before scenario
|
|
Heart rate variability
Time Frame: 5 days before scenario (during 3 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
5 days before scenario (during 3 minutes)
|
|
Heart rate variability
Time Frame: Before the scenario (during 3 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
Before the scenario (during 3 minutes)
|
|
Heart rate variability
Time Frame: during briefing (during 3 minutes at 0 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
during briefing (during 3 minutes at 0 minutes)
|
|
Heart rate variability
Time Frame: during the scenario before the laryngospasm (during 3 minutes at 3 minutes)
|
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)
|
|
Heart rate variability
Time Frame: during the debriefing (3 minutes at 9 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
during the debriefing (3 minutes at 9 minutes)
|
|
Heart rate variability
Time Frame: after the debriefing (3 minutes at 30 minutes)
|
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
|
after the debriefing (3 minutes at 30 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien Picard, M.D, Ph.D., University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 02021 - 097
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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