Stress and Resilience in Anesthesia Professionals (ResiStress)

March 17, 2022 updated by: University Hospital, Grenoble
The purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julien Picard, M.D, Ph.D., University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 02021 - 097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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