Stress, ProfessionalResiStressNCT05073445
Stress and Resilience in Anesthesia Professionals
An observational study of Stress, Professional and Resilience, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Professional, Resilience, Anaesthesiology
- What is being tested?
- SDNN measurement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2021to 15 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- volunteer in anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.
Read the 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.
- Being tested
- SDNN measurement
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDNN measurementBehavioural
SDNN measurement during pediatric simulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: during the laryngospasm (during 3 minutes at 6 minutes)
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.
Measured: 5 days before scenario
Secondary outcomes (16)
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%).
Measured: 5 days before scenario
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%).
Measured: just Before the scenario (at 0 minute )
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%).
Measured: just after briefing (at 3 minutes)
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%).
Measured: just after the end of scenario (at 9 minutes)
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%).
Measured: just after the debriefing (at 30 minutes)
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.
Measured: 5 days before scenario
Age of anesthesia professionals
Age of anesthesia professionals: (quantitative variable)
Measured: 5 days before scenario
Experience in anesthesia:
Experience in anesthesia: number of years since the beginning of specialized training training (quantitative variable)
Measured: 5 days before scenario
Pediatric experience:
Pediatric experience: qualitative variable (yes, no)
Measured: 5 days before scenario
Pediatric laryngospasm experience
Pediatric laryngospasm experience: qualitative variable: (yes, no)
Measured: 5 days before scenario
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: 5 days before scenario (during 3 minutes)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: Before the scenario (during 3 minutes)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: during briefing (during 3 minutes at 0 minutes)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: during the scenario before the laryngospasm (during 3 minutes at 3 minutes)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: during the debriefing (3 minutes at 9 minutes)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: after the debriefing (3 minutes at 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start18 Jun 2021
- Primary completion13 Oct 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoann Zafiriou, Principal investigator, University Hospital, GrenobleJulien Picard, M.D, Ph.D., Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073445
- Sponsor's protocol ID
- IRB 02021 - 097
- Acronym
- ResiStress
- Status last verified
- Mar 2022
- First submitted
- 29 Jul 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Resilience in Anesthesia Professionals
- ClinicalTrials.gov ID
- NCT05073445
- Acronym / sponsor ID
- ResiStress / IRB 02021 - 097
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- volunteer in anesthesia
Key exclusion criteria (6 listed)
- Rhythm disorders
- Endocrine pathology
- High blood pressure
- Pregnancy or breastfeeding in progress
- Taking anti-inflammatory or psychotropic drugs that interfere with the heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDNN measurementSDNN measurement during pediatric simulation | Behavioural | – |
Primary outcome
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
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.
16 secondary outcomes
Self-reported stress
Time frame: 5 days before scenario
Self-reported stress
Time frame: just Before the scenario (at 0 minute )
Self-reported stress
Time frame: just after briefing (at 3 minutes)
Self-reported stress
Time frame: just after the end of scenario (at 9 minutes)
Self-reported stress
Time frame: just after the debriefing (at 30 minutes)
Perceived Stress Scale
Time frame: 5 days before scenario
Age of anesthesia professionals
Time frame: 5 days before scenario
Experience in anesthesia:
Time frame: 5 days before scenario
Pediatric experience:
Time frame: 5 days before scenario
Pediatric laryngospasm experience
Time frame: 5 days before scenario
Heart rate variability
Time frame: 5 days before scenario (during 3 minutes)
Heart rate variability
Time frame: Before the scenario (during 3 minutes)
Heart rate variability
Time frame: 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)
Heart rate variability
Time frame: during the debriefing (3 minutes at 9 minutes)
Heart rate variability
Time frame: after the debriefing (3 minutes at 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoann Zafiriou principal investigator
University Hospital, Grenoble
Julien Picard, M.D, Ph.D. principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Professional and Resilience, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: during the laryngospasm (during 3 minutes at 6 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.