StressNCT06200792
Stress and Anxiety Affect Residents' Performance
An observational study of Stress and Stress Disorder, run by University of Padova at 1 site in Italy.
Trial summary
Being an anesthesiologist implies huge dedication and both physical and psychological efforts. None has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Stress Disorder, Work Related Stress
- What is being tested?
- eSense device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 1 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Anesthesiologists residents
Who may be able to join
- Being an anesthesiologist residents
- Written informed consent obtained
Who cannot join
- Psychiatric disorders
- Neurological disorders
- Suffering from high blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Stress in Residents' Performance
Being an anesthesiologist implies huge dedication and both physical and psychological efforts. None has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions.
Read the 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.
- Conditions
- Stress, Stress Disorder, Work Related Stress
- Being tested
- eSense device
- Medical subject headings
- Stress Disorders, Traumatic, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSense deviceDevice
Also called Questionnaires and scales for evaluating esecutive function.
eSense device for monitoring electrodermal activity. Visual analogic scale (VAS) for pain and discomfort; TOL-R tests for investigating working performances.
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in executive functions overtime
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))
Measured: baseline and immediately after intervention
Secondary outcomes (4)
Differences in dermal activity during working day
Evaluating potential differences in electrodermal activity overtime using microsiemens, counting number of stress response
Measured: baseline and immediately after intervention
Assess the general level of anxiety
Measuring levels of anxiety using the generalized anxiety disorder-7 item (GAD-7) (minimum 0, maximum score 21)
Measured: baseline and immediately after intervention
General level of anxiety
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)
Measured: baseline and immediately after intervention
Evaluating the general levels of perceived stress levels
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))
Measured: baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Dec 2024
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Boscolo, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200792
- Sponsor's protocol ID
- Stress study
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Nope
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Stress in Residents' Performance
- ClinicalTrials.gov ID
- NCT06200792
- Acronym / sponsor ID
- Stress study
- Conditions
- Stress, Stress Disorder, Work Related Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 11 Jan 2024 (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.
Being an anesthesiologist implies huge dedication and both physical and psychological efforts. None has ever studied the impact of a working day on anxiety, perceived stress levels, physiological data, and executive functions.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Anesthesiologists residents
Key inclusion criteria (2 listed)
- Being an anesthesiologist residents
- Written informed consent obtained
Key exclusion criteria (3 listed)
- Psychiatric disorders
- Neurological disorders
- Suffering from high blood pressure
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 |
|---|---|---|
| eSense deviceAlso: Questionnaires and scales for evaluating esecutive function.eSense device for monitoring electrodermal activity. Visual analogic scale (VAS) for pain and discomfort; TOL-R tests for investigating working performances. | Device | – |
Primary outcome
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))
4 secondary outcomes
Differences in dermal activity during working day
Time frame: baseline and immediately after intervention
Assess the general level of anxiety
Time frame: baseline and immediately after intervention
General level of anxiety
Time frame: baseline and immediately after intervention
Evaluating the general levels of perceived stress levels
Time frame: baseline and immediately after intervention
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 31 Dec 2024.
- Individual participant dataSharing planned: No. Nope
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Stress Disorder, run by University of Padova at 1 site in Italy.
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 2 inclusion and 3 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 31 Dec 2024. 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 Italy. 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?
Differences in executive functions overtime (time frame: baseline and immediately after intervention). 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 31 Dec 2024.