Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04579627
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Facial Hair, PPE and COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-05', 'size': 524028, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-25T07:00', 'hasProtocol': False}, {'date': '2020-05-06', 'size': 405475, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-25T07:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in facial hair between January 2020 and during April 2020.', 'timeFrame': 'January 2020 and during April 2020.', 'description': 'Our primary outcome measure was change in facial hair between January 2020 (before guidance was circulated in the UK about facial hair), and during April 2020 (after guidance was circulated relating to PPE appropriate facial hair)'}], 'secondaryOutcomes': [{'measure': 'Does facial hair change adhere to the PPE guidance from PHE', 'timeFrame': 'January 2020 and during April 2020.', 'description': 'Does facial hair change adhere to the PPE guidance from PHE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Facial Hair', 'Beard', 'Personal Protective Equipment'], 'conditions': ['COVID', 'Safety Issues']}, 'descriptionModule': {'briefSummary': 'An observational cross sectional questionnaire study looking into facial hair of hospital doctors during the COVID-19 pandemic, and how personal protective equipment guidance has affected this.', 'detailedDescription': 'COVID-19 is a highly contagious virus which has caused a global pandemic. There have been significant health consequences for healthcare workers, which may be related to the provision of personal protective equipment (PPE). Following PPE guidance is a significant health and safety concern, under which facial hair guidance for tight fitting masks falls.\n\nThis has implications as FFP3 masks are not the only form of PPE for the face, and this study may highlight a need for employers to diversify which PPE they supply to their employees, such as full hoods if staff need to maintain facial hair for cultural or religious reasons.\n\nAs such, facial hair has potential implications for patient safety, but also these have to be balanced with personal or religious reasons for maintaining facial hair. Our study aimed to determine the facial hair styles of hospital doctors, and reasons for maintaining them during the COVID-19 pandemic. We also looked at whether these styles adhered to the PPE guidance set about by Public Health England (PHE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All hospital doctors working at Royal Cornwall Hospital between January 2020 and April 2020.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll hospital doctors working at the main site at Royal Cornwall Hospital between January and April 2020 were included in the study population. This includes all genders and ethnicities.\n\nExclusion Criteria:\n\nThe principle exclusion criteria were those who did not work at the Royal Cornwall Hospital main site. Also, while not forming part of the exclusion criteria, those who are unable to grow facial hair were excluded from the statistical analyses.'}, 'identificationModule': {'nctId': 'NCT04579627', 'acronym': 'FACIAL HAIR', 'briefTitle': 'Facial Hair, PPE and COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Royal Cornwall Hospitals Trust'}, 'officialTitle': "How Has the Increased Use of FFP3 Style Respirators During the COVID-19 Pandemic Affected Hospital Doctor's Facial Hair? Implications for Staff Safety and Welfare.", 'orgStudyIdInfo': {'id': '283609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital Doctors', 'description': 'Hospital doctors working at Royal Cornwall Hospital during the COVID-19 pandemic', 'interventionNames': ['Behavioral: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'BEHAVIORAL', 'description': 'A single survey questionnaire to staff to report their demographics and facial hair styles between January and April 2020', 'armGroupLabels': ['Hospital Doctors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Cornwall Hospitals Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}