Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-02 @ 7:59 PM
Study NCT ID:
NCT04604769
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perceived Stress Among ICU Medical Staff During COVID-19 Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stress at work', 'timeFrame': 'change from baseline at one year', 'description': 'Job Content Questionnaire (Karasek, 1979)'}, {'measure': 'stress in a medical unit', 'timeFrame': 'change from baseline at one year', 'description': 'Nursing Stress Questionnaire (Gray-Toft, 1981)'}], 'secondaryOutcomes': [{'measure': 'hobby activities', 'timeFrame': 'change from baseline at one year', 'description': 'We will ask if they are used to do activities like hypnosis, yoga, mediation, sport, etc. This factor could help us to know if these activities can help and if we have to promote them in the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronavirus', 'covid-19', 'pandemia', 'professional stress', 'burnout', 'nursing', 'intensive care units (ICU)', 'infection', 'work organization'], 'conditions': ['Coronavirus', "Nurse's Role", 'Professional Stress']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.', 'detailedDescription': 'Well-being of caregivers and stress management in intensive care units are essential keys to an adequate quality of care, especially during the anxious context of coronavirus pandemic. Taking care of numerous patients, the increasing work and mental charges, facing death, the need of material and changes in work organization are all elements that can influence stress among medical workers. Considering real causes of stress and what are the needs of the medical team is fundamental for developing concrete actions to ease the workloads. A few studies were conducted in China on psychological distress of medical staff during COVID-19. According to these few studies about psychological distress in ICU, investigators think that stress scores during COVID-19 could be increased among nurses during pandemic. The second hypothesis is that causes of stress would be not so different from normal care but could be amplified by the actual situation. One point to take into consideration is that most of the studies were conducted in China and medical policy and hospital organization are different in Belgium. The objective of the study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nurses and doctors working in intensive care units before and during the COVID pandemic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years old\n* working in ICU for at least November 2019\n* working in ICU regularly since March 2020\n* Medical and paramedical professionals\n* Working in direct contact with COVID patients\n\nExclusion Criteria:\n\n* Medical professionals from others departments\n* Internship students\n* External volunteers for COVID\n* Non front-line nurses'}, 'identificationModule': {'nctId': 'NCT04604769', 'acronym': 'ICUcovid', 'briefTitle': 'Perceived Stress Among ICU Medical Staff During COVID-19 Crisis', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Perceived Stress and Needs Among Medical Staff in ICU During COVID-19 Crisis', 'orgStudyIdInfo': {'id': 'stressICUcovid'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Daily routine, control group', 'description': 'ICU medical staff were asked about their stress and causes of stress during their daily professional life.'}, {'label': 'During Covid-19', 'description': 'ICU medical staff were asked about their stress and causes of stress in their daily professional life during COVID-19 crisis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Province De Liège', 'country': 'Belgium', 'facility': 'University of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Anne-Sophie Nyssen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Liège'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Head of the Sensation and Perception Research Group, GIGA Consciouness', 'investigatorFullName': 'Audrey Vanhaudenhuyse', 'investigatorAffiliation': 'University of Liege'}}}}