Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-28 @ 1:32 PM
Study NCT ID:
NCT05371561
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of PPE on Children's Fear in Dental Office
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract 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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, legal guardians, and the dentist who carried out the examination were not blinded as it was inapplicable. The accessor and statistician were blinded'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2022-05-09', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Arabic version of children's fear survey schedule-dental subscale (CFSS-DS)", 'timeFrame': 'just after examination', 'description': "Children's fear survey schedule-dental subscale CFSS-DS is a tool to measure children's anxiety in dental settings. The CFSS-DS consists of 15 items, revolving around dental setting and procedures, child will answer each item by choosing a rate from a 5-point Likert scale that ranges from 1 ('not afraid at all') to 5 ('very afraid'), the total score should range from 15 to 75"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PPE', 'Dentist attire', 'Child behavior', 'dental fear'], 'conditions': ['COVID-19', 'Infections', 'COVID-19 Virus Infection']}, 'referencesModule': {'references': [{'pmid': '36138354', 'type': 'DERIVED', 'citation': "Azab MM. Influence of different personal protective equipment on children's anxiety in dental office: a randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):421. doi: 10.1186/s12903-022-02442-5."}]}, 'descriptionModule': {'briefSummary': "the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face reusable respirators; on preoperative child's fear in the dental office.", 'detailedDescription': "Each patient meeting the inclusion criteria and assigned to a specific study group will enter the clinic for dental examination. The examining dentist, wearing the selected PPE will communicate with patient and parent, taking personal, previous and current history, and carrying out simple examination not involving the use of sharp instruments, provoking pain or investigations as radiographs. The process should take from three to five minutes. Then, the child will be escorted to another room to meet a blinded accessor, where he assesses the child's anxiety using the Arabic version of children's fear survey schedule-dental subscale CFSS-DS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Six to ten-year-old patients\n\nExclusion Criteria:\n\n* emergency patients\n* patients who have systemic, mental or psychological conditions as indicated by their medical history,'}, 'identificationModule': {'nctId': 'NCT05371561', 'briefTitle': "Effect of PPE on Children's Fear in Dental Office", 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': "Influence of Different Personal Protective Equipment on Children's Fear in Dental Office: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'Fayoum U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Goggles + surgical mask', 'description': 'Dentist wearing Goggles + surgical mask will examin the patient', 'interventionNames': ['Device: reusable respirators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Face shield+ surgical mask', 'description': 'Dentist wearing Face shield+ surgical mask will examin the patient', 'interventionNames': ['Device: reusable respirators']}, {'type': 'EXPERIMENTAL', 'label': 'Half face reusable respirator+ Filter', 'description': 'Dentist wearing Half face reusable respirator+ Filter will examin the patient', 'interventionNames': ['Device: reusable respirators']}, {'type': 'EXPERIMENTAL', 'label': 'Full face reusable respirator+ Filter', 'description': 'Dentist wearing Full face reusable respirator+ Filter will examin the patient', 'interventionNames': ['Device: reusable respirators']}], 'interventions': [{'name': 'reusable respirators', 'type': 'DEVICE', 'description': 'Dentist wearing reusable respirator will examin the patient', 'armGroupLabels': ['Face shield+ surgical mask', 'Full face reusable respirator+ Filter', 'Goggles + surgical mask', 'Half face reusable respirator+ Filter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Fayoum university', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Maha Moussa Azab', 'investigatorAffiliation': 'Fayoum University'}}}}