Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-31 @ 11:31 AM
Study NCT ID:
NCT06928493
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Pediatric Patients' Dental Anxiety Levels Affected by Covid -19 Clinical Conditions?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003945', 'term': 'Diagnosis, Oral'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test", 'timeFrame': '3 months', 'description': "It is aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety,child'], 'conditions': ['Anxiety, Dental']}, 'referencesModule': {'references': [{'pmid': '33149416', 'type': 'RESULT', 'citation': 'Sharma A, Jain MB. Pediatric Dentistry during Coronavirus Disease-2019 Pandemic: A Paradigm Shift in Treatment Options. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):412-415. doi: 10.5005/jp-journals-10005-1809.'}, {'pmid': '34249814', 'type': 'RESULT', 'citation': "Assathiany R, Salinier C, Bechet S, Dolard C, Kochert F, Bocquet A, Levy C. Face Masks in Young Children During the COVID-19 Pandemic: Parents' and Pediatricians' Point of View. Front Pediatr. 2021 Jun 23;9:676718. doi: 10.3389/fped.2021.676718. eCollection 2021."}, {'pmid': '34434029', 'type': 'RESULT', 'citation': 'Alsaleh MM, Sabbarini JM, Al-Batayneh OB, Khader YS. Changes in Behavior Management and Treatment Modalities in Pediatric Dentistry during COVID-19 Pandemic. Int J Clin Pediatr Dent. 2020;13(Suppl 1):S125-S131. doi: 10.5005/jp-journals-10005-1885.'}, {'pmid': '10063243', 'type': 'RESULT', 'citation': 'Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.'}, {'pmid': '36138354', 'type': 'RESULT', '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."}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov', 'label': 'References identified'}]}, 'descriptionModule': {'briefSummary': "Changes in the dental office environment during the pandemic may affect the children's dental anxiety.\n\nThis double-blind, randomized, controlled clinical study aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test.The results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. The evaluations from the psychiatrist and dentist using CD: H were highly consistent.", 'detailedDescription': "The study involved 120 children aged 5-7 years. All patients and their parents were informed about the purpose and method of the study before the study and signed informed consent forms.\n\nChildren's behaviors and attitudes before the dental exam were assessed using the Frankl behavioral scale. The children were then divided into two groups:The Pandemic Clinical Conditions (PCC) group, who were examined in an isolated dental office with special attire, and the Conventional Clinical Conditions (CCC) group, who were examined in a standard dental office with typical clinical attire. After the exam, the children were asked to draw a picture, which was then evaluated by a pediatric dentist and child psychiatrist using CD: H.\n\nThe results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. The evaluations from the psychiatrist and dentist using CD: H were highly consistent.\n\nIn conclusion, the changes in the dental office and clinical attire during the pandemic did not significantly impact children's anxiety levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '120 healthy patient aged 5-7 years who had no prior dentistry experience and whose parents agree to participate in the study,children willing to draw were included the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy children children between 5-7 years old no prior dentistry experience children willing to draw picture\n\nExclusion Criteria:\n\nChildren who had mental or physical disabilities children \\< 5 years old, previous dentist experience who refused to draw picture'}, 'identificationModule': {'nctId': 'NCT06928493', 'briefTitle': "Are Pediatric Patients' Dental Anxiety Levels Affected by Covid -19 Clinical Conditions?", 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': "Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test", 'orgStudyIdInfo': {'id': 'GU.Ethics Committee 2022.07/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pandemic Clinical Conditions (PCC)', 'description': 'The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor.', 'interventionNames': ['Other: oral examination']}, {'label': 'Conventional Clinical Conditions (CCC)', 'description': 'The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.', 'interventionNames': ['Other: oral examination']}], 'interventions': [{'name': 'oral examination', 'type': 'OTHER', 'description': 'The pre-examination behaviors and attitudes of the children included in the study were measured by an independent dentist (Ş.Y.İ) using the Frankl Behavior Rating Scale (FS). Following this, the children were randomly divided into two groups PCC and CCC . The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor. The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.After that, patients were asked to draw themselves or the pediatric dentist who performed the examination. A child psychiatrist (B.A.S.) and a pediatric dentist (R.D) with an internationally valid "Child Drawing Analysis" training certificate evaluated the children\'s drawings independently.', 'armGroupLabels': ['Conventional Clinical Conditions (CCC)', 'Pandemic Clinical Conditions (PCC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Çankaya', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.9179, 'lon': 32.86268}}], 'overallOfficials': [{'name': 'Haluk Bodur, Prof. Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Pediatric dentistry', 'investigatorFullName': 'Alev Alaçam', 'investigatorAffiliation': 'Gazi University'}}}}