- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392972
Stress of Anesthesia Professionals in the Operating Room (StressBloc)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial will be conducted at the Grenoble Alpes University Hospital (CHUGA). Volunteer anesthesiologists, anesthesia interns, nurse anesthetists and nurse anesthetist students will answer questionnaires evaluating resilience, perceived stress in the last month, sleep quality, number of hours worked in the month, number of night hours and will evaluate each working day the perceived stress with the visual analogical scale of stress over 3 periods of the working day
The main objective is to determine if there is an association between the resilience (questionnaire: Connord davidson resielience scale: CDRISC10) of the anesthesia professionals in the block of the CHUGA and the perceived stress at work (Perceived stress sacle 10: PSS10).
The secondary objectives are to study the association between:
- The mean of the two stress VAS (at the beginning and end of the shift) collected and the PSS10 over the same period.
- The median of the peaks of stress VAS collected and the PSS10 over the same period.
- The PSS10 and the PSQI (Pittsburgh Sleep Quality Index)
- The PSS10 and the number of hours worked in the month.
- The PSS10 and the number of night hours worked in the month.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Grenoble, France
- University Hospital Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- resident in anaesthesiology, Anesthesiologist,anaesthetic nursing student, anaesthetic nurse graduated
Criteria for non-inclusion:
- Professionals objecting to the use of their data in the the research
- Professionals working part-time
- Professionals who had a number of CA > 3 during the month of the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: at day 0
|
Measurement of resilience by Connor-Davidson Resilience Scale 10 (CD RISC 10 from 0 to 40) in participants.
A high score indicates better resilience.
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at day 0
|
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Perceived Stress Scale
Time Frame: at day 30
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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.
|
at day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported stress at the beginning of the workday.
Time Frame: Each work day at the start of the shift. From day 0 to day 30.
|
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%).
|
Each work day at the start of the shift. From day 0 to day 30.
|
|
Self-reported stress at the end of the workday.
Time Frame: Every working day at the end of the shift. From day 0 to day 30.
|
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%).
|
Every working day at the end of the shift. From day 0 to day 30.
|
|
Maximum self-reported stress of the workday.
Time Frame: Every working day at the end of the shift. From day 0 to day 30.
|
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%).
|
Every working day at the end of the shift. From day 0 to day 30.
|
|
The score of the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at day 30
|
The PSQI contains 19 self-assessed questions.
These 19 questions combine to yield 7 components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) use of sleeping medication, and (7) daytime dysfunction.
Each component gives a score from 0 to 3 points (0 indicates no difficulty, while 3 indicates major difficulty).
The scores of the seven components are then added together to give an overall score of 0 to 21 points (0 indicating no difficulty, and 21 indicating major difficulty).
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at day 30
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number of hours worked
Time Frame: Each work day at the end of the service. From day 0 to day 30.
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number of hours worked during the working day
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Each work day at the end of the service. From day 0 to day 30.
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number of hours worked at night
Time Frame: Each night of work at the end of the service. From day 0 to day 30.
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the number of hours worked during the work night
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Each night of work at the end of the service. From day 0 to day 30.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julien Picard, 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 (Estimate)
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 00010254 - 2022 - 055
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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