- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06200792
Stress and Anxiety Affect Residents' Performance
The Impact of Stress in Residents' Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During a working day, trainees will have their physiological and psychological data recorded before starting their clinical activity and after them. Electrodermal activity with the eSense device, Executive functions through the TOL-R and all the questionnaires and scales will be sampled at the beginning of the day and at the end of the day the same procedure will be applied again (exclusion for PSS-10 scale, STAY-Y trait anxiety and GAD-7) eSense and TOL-R, are useful tools to understand sympathetic activity and executive functions. The galvanometer it is the gold standard to measure EDA; i.e. electrodermal activity, which is a pure sympathetic index, while Tower of London it is the gold standard to assess planning, monitoring and programming skills, both data are supposed to be heavily involved in an anesthesiologist trainee during the all day.
The aims of the study are to evaluate executive functions at the start and at the end of a working day and to understand theirs relationship with anxiety, perceived stress levels and physiological changes in sympathetic activity.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Padova, Italy, 35126
- Recruiting
- Clinica Odontoiatrica
-
Contact:
- Gastone Zanette, Prof.
- Phone Number: 0498212044
- Email: gastone.zanette@unip.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being an anesthesiologist residents
- Written informed consent obtained
Exclusion Criteria:
- Psychiatric disorders
- Neurological disorders
- Suffering from high blood pressure
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in executive functions overtime
Time Frame: baseline and immediately after intervention
|
Evaluating executive functions at the start and at the end of a working day using the Tower of London test (TOL-R) (scoring 0 (worst score)-30 (better score))
|
baseline and immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in dermal activity during working day
Time Frame: baseline and immediately after intervention
|
Evaluating potential differences in electrodermal activity overtime using microsiemens, counting number of stress response
|
baseline and immediately after intervention
|
Assess the general level of anxiety
Time Frame: baseline and immediately after intervention
|
Measuring levels of anxiety using the generalized anxiety disorder-7 item (GAD-7) (minimum 0, maximum score 21)
|
baseline and immediately after intervention
|
General level of anxiety
Time Frame: baseline and immediately after intervention
|
Measuring the general levels of anxiety with the Stait-trait anxiety inventory (STAI-Y1-2) (1 point=not at all/almost never anxiety; 2=somewhat/sometimes; 3=moderately so/often) and 4= very much so/almost always)
|
baseline and immediately after intervention
|
Evaluating the general levels of perceived stress levels
Time Frame: baseline and immediately after intervention
|
Evaluation of the general levels of perceived stress levels using the perceived stress score (PSS)-10 scale (0 (minimum level of anxiety)-10 (maximum level of anxiety))
|
baseline and immediately after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Stress study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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