StressStressBlocNCT05392972
Stress of Anesthesia Professionals in the Operating Room
An observational study of Stress, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The objective of this study was to determine whether there was an association between the resilience of anesthesia professionals in the operating room of the Grenoble University Hospital and perceived work-related stress. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Assessment of stress, resilience and associated factors in anesthesia professionals
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 12 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: resident in anesthesiology, anesthesiologist, student nurse in anesthesia, volunteer nurse in anesthesia and working at the university hospital center grenoble alpes
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to determine whether there was an association between the resilience of anesthesia professionals in the operating room of the Grenoble University Hospital and perceived work-related stress.
Read the 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.
- Conditions
- Stress
- Being tested
- Assessment of stress, resilience and associated factors in anesthesia professionals
- Keywords
- Stress, Professional Resilience, Anaesthesiology, sleep quality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of stress, resilience and associated factors in anesthesia professionalsBehavioural
Assessment of stress, resilience and associated factors in anesthesia professionals
What is being measured
The primary outcome is the main question the study is designed to answer.
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: at day 0
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: at day 30
Secondary outcomes (6)
Self-reported stress at the beginning of the workday.
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: Each work day at the start of the shift. From day 0 to day 30.
Self-reported stress at the end of the workday.
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: Every working day at the end of the shift. From day 0 to day 30.
Maximum self-reported stress of the workday.
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: Every working day at the end of the shift. From day 0 to day 30.
The score of the Pittsburgh Sleep Quality Index (PSQI)
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).
Measured: at day 30
number of hours worked
number of hours worked during the working day
Measured: Each work day at the end of the service. From day 0 to day 30.
number of hours worked at night
the number of hours worked during the work night
Measured: Each night of work at the end of the service. From day 0 to day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 74 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, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392972
- Sponsor's protocol ID
- IRB 00010254 - 2022 - 055
- Acronym
- StressBloc
- Status last verified
- Dec 2022
- First submitted
- 16 May 2022
- Last updated
- 13 Dec 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 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress of Anesthesia Professionals in the Operating Room
- ClinicalTrials.gov ID
- NCT05392972
- Acronym / sponsor ID
- StressBloc / IRB 00010254 - 2022 - 055
- Conditions
- Stress
- Keywords
- Stress, Professional Resilience, Anaesthesiology, sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 26 May 2022 (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 objective of this study was to determine whether there was an association between the resilience of anesthesia professionals in the operating room of the Grenoble University Hospital and perceived work-related stress.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- resident in anesthesiology, anesthesiologist, student nurse in anesthesia, volunteer nurse in anesthesia and working at the university hospital center grenoble alpes
Key inclusion criteria (5 listed)
- resident in anaesthesiology, Anesthesiologist,anaesthetic nursing student, anaesthetic nurse graduated
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Assessment of stress, resilience and associated factors in anesthesia professionalsAssessment of stress, resilience and associated factors in anesthesia professionals | Behavioural | – |
Primary outcome
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.
Perceived Stress Scale
Time frame: at day 30
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.
6 secondary outcomes
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.
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.
Maximum self-reported stress of the workday.
Time frame: 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
number of hours worked
Time frame: Each work day at the end of the service. From day 0 to day 30.
number of hours worked at night
Time frame: Each night of work at the end of the service. From day 0 to day 30.
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 13 Dec 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 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, 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 5 inclusion and 0 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 13 Dec 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?
Resilience (time frame: at day 0). 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 13 Dec 2022.