Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:14 PM
Study NCT ID:
NCT07341295
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception of Stress and Safety Culture: Analysis of Critical Factors in Healthcare (SICURES)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-14', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relationship betweemn levels of risk management perceived and perceived stress levels', 'timeFrame': 'July 2025 - October 2025', 'description': 'This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Work Stress', 'Patient Safety']}, 'descriptionModule': {'briefSummary': 'The study adopts an observational design, based on a sample of 143 healthcare professionals, using two validated anonymous questionnaires: the Perceived Stress Scale (PSS-10) to measure perceived stress levels and the Hospital Survey on Patient Safety Culture 2.0 (SOPS AHRQ) to assess perceptions of patient safety culture.\n\nData collection will take place at a single point in time and without external intervention, on a sample of healthcare professionals belonging to the various hospital operating units of the CCM.\n\nObjectives (primary and secondary):\n\n* Primary: This study aims to analyze whether the levels of risk management perceived by healthcare professionals are predictive of perceived stress levels in the same clinical context.\n* Secondary:\n\n * Assess the level of stress perceived by healthcare professionals\n * Explore the perception of patient safety culture\n * Analyze the correlation between perceived stress and safety culture in hospital settings\n * Identify possible critical areas or organizational factors that contribute to the onset of stress and influence the perception of safety in care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "healthcare professionals of CCM DAPS'", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthcare professionals of CCM DAPS'\n\nExclusion Criteria:\n\n* none"}, 'identificationModule': {'nctId': 'NCT07341295', 'acronym': 'SICURES', 'briefTitle': 'Perception of Stress and Safety Culture: Analysis of Critical Factors in Healthcare (SICURES)', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Percezione Dello Stress e Cultura Della Sicurezza: Analisi Dei Fattori Critici in Ambito Sanitario (SICURES)', 'orgStudyIdInfo': {'id': 'L2-376'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthcare professionals', 'description': 'healthcare professionals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Irrcs Centro Cardiologico Monzino', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}