Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05114967
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2021-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Anxiety During COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety level', 'timeFrame': 'Before surgery', 'description': 'The anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic will be measured'}], 'secondaryOutcomes': [{'measure': 'Factors accentuating the anxiety levels', 'timeFrame': 'Before surgery', 'description': 'Factors accentuating the anxiety levels in patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'SARS CoV-2', 'Pandemic', 'Perioperative'], 'conditions': ['Anxiety', 'Pandemic, COVID-19']}, 'descriptionModule': {'briefSummary': 'The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al, will be used after permission from the authors, to investigate the preoperative anxiety of patients undergoing surgery during the 4th wave of the pandemic', 'detailedDescription': 'Studies have been conducted on the stress and anxiety induced by the COVID-19 pandemic in both the general population as well as specific groups, such as health care workers, pregnant women and adolescents. Given that anxiety has a strong bearing on the physical, mental and emotional well-being of the patients and their subsequent recovery from surgery and other procedures, we were interested in assessing anxiety among the patients presenting for elective procedures in the post-lockdown phase of the pandemic. The primary objective of the present study was to assess the anxiety levels among the preoperative patients scheduled for surgeries in the 4th wave of the COVID-19 pandemic, and the secondary objective was to assess the factors accentuating the same. The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult consecutive patients, \\>18 years old who will undergo surgery for one month in the University Hospital of Larissa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult consecutive patients, \\>18 years old\n* Undergoing surgery in the UHL\n\nExclusion Criteria:\n\n* Patients aged\\<18 years\n* Patients that will refuse to participate\n* Patients unable/not fit to consent'}, 'identificationModule': {'nctId': 'NCT05114967', 'briefTitle': 'Preoperative Anxiety During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'Preoperative Anxiety Levels in Patients Undergoing Surgery During the 4th Wave of the SARS-CoV-2 Pandemic. A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'COVID-19_Anxiety_UHL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing surgery', 'description': 'Patients undergoing surgery during the 4th wave of the pandemic for 1 month duration in the University Hospital of Larissa', 'interventionNames': ['Other: mPAS questionnaire']}], 'interventions': [{'name': 'mPAS questionnaire', 'type': 'OTHER', 'description': 'The modified Preoperative Anxiety Scale (mPAS) questionnaire as given in the article by Viola et al will be used after permission from the authors', 'armGroupLabels': ['Patients undergoing surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'Univeristy of Thessaly', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Eleni Arnaoutoglou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Thessaly'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Elena Arnaoutoglou', 'investigatorAffiliation': 'University of Thessaly'}}}}