Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-26 @ 12:08 AM
Study NCT ID:
NCT06200792
Status:
COMPLETED
Last Update Posted:
2024-12-31
First Post:
2023-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress and Anxiety Affect Residents' Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-29', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in executive functions overtime', 'timeFrame': 'baseline and immediately after intervention', 'description': '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))'}], 'secondaryOutcomes': [{'measure': 'Differences in dermal activity during working day', 'timeFrame': 'baseline and immediately after intervention', 'description': 'Evaluating potential differences in electrodermal activity overtime using microsiemens, counting number of stress response'}, {'measure': 'Assess the general level of anxiety', 'timeFrame': 'baseline and immediately after intervention', 'description': 'Measuring levels of anxiety using the generalized anxiety disorder-7 item (GAD-7) (minimum 0, maximum score 21)'}, {'measure': 'General level of anxiety', 'timeFrame': 'baseline and immediately after intervention', 'description': '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)'}, {'measure': 'Evaluating the general levels of perceived stress levels', 'timeFrame': 'baseline and immediately after intervention', 'description': '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))'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Stress Disorder', 'Work Related Stress']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anesthesiologists residents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being an anesthesiologist residents\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Psychiatric disorders\n* Neurological disorders\n* Suffering from high blood pressure'}, 'identificationModule': {'nctId': 'NCT06200792', 'briefTitle': "Stress and Anxiety Affect Residents' Performance", 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': "The Impact of Stress in Residents' Performance", 'orgStudyIdInfo': {'id': 'Stress study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'eSense device', 'type': 'DEVICE', 'otherNames': ['Questionnaires and scales for evaluating esecutive function.'], 'description': 'eSense device for monitoring electrodermal activity. Visual analogic scale (VAS) for pain and discomfort; TOL-R tests for investigating working performances.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35126', 'city': 'Padua', 'country': 'Italy', 'facility': 'Clinica Odontoiatrica', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Nope'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Annalisa Boscolo', 'investigatorAffiliation': 'University of Padova'}}}}