Stress and Anxiety Affect Residents' Performance

Stress Clinical Trial

Official title:

The Impact of Stress in Residents' Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200792
• Other study ID #: Stress study
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being an anesthesiologist residents

• Written informed consent obtained

Exclusion Criteria:

• Psychiatric disorders

• Neurological disorders

• Suffering from high blood pressure

Related Conditions & MeSH terms

• Occupational Stress
• Stress
• Stress Disorder
• Work Related Stress

Intervention

Device:
• eSense device
eSense device for monitoring electrodermal activity. Visual analogic scale (VAS) for pain and discomfort; TOL-R tests for investigating working performances.

Locations

Country	Name	City	State
Italy	Clinica Odontoiatrica	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	baseline and immediately after intervention
Secondary	Differences in dermal activity during working day	Evaluating potential differences in electrodermal activity overtime using microsiemens, counting number of stress response	baseline and immediately after intervention
Secondary	Assess the general level of anxiety	Measuring levels of anxiety using the generalized anxiety disorder-7 item (GAD-7) (minimum 0, maximum score 21)	baseline and immediately after intervention
Secondary	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)	baseline and immediately after intervention
Secondary	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))	baseline and immediately after intervention