Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06711367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child anxiety', 'timeFrame': 'through study completion, an average of four months', 'description': 'Venham anxiety scale (score from 1-8)'}], 'secondaryOutcomes': [{'measure': 'Pulse rate', 'timeFrame': 'through study completion, an average of four months', 'description': 'Pulse oximeter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental storybook', 'tell show do', 'dental anxiety'], 'conditions': ['Child Behavior', 'Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'Conventional behavior management techniques, namely: verbal communication and tell-show-do were used in the operatory for the participating children (Group A). The children allocated in intervention group (Group B) received a costume-designed storybook explaining the diagnosis and procedures of occlusal composite restoration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Healthy children and children/parents can read and understand Arabic.\n\n * The child needs an occlusal composite restoration.\n\nExclusion Criteria:\n\n* Children with special needs; children with a complete audiovisual impairment; children with\n* Learning difficulties or mental retardation.\n* Children who are not Arabic speakers.'}, 'identificationModule': {'nctId': 'NCT06711367', 'briefTitle': 'Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': 'Comparative Evaluation of the Effectiveness of Custom-designed Dental Storybook Vs Tell Show Do on the Dental Anxiety and Behavior of Children: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REC-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tell show do behavior management technique', 'interventionNames': ['Behavioral: tell show do behavior management technique']}, {'type': 'EXPERIMENTAL', 'label': 'a costume-designed dental storybook', 'interventionNames': ['Behavioral: a costume-designed storybook']}], 'interventions': [{'name': 'tell show do behavior management technique', 'type': 'BEHAVIORAL', 'description': 'tell show do behavior management technique about the the diagnosis and procedures of dental restoration', 'armGroupLabels': ['tell show do behavior management technique']}, {'name': 'a costume-designed storybook', 'type': 'BEHAVIORAL', 'description': 'a costume-designed storybook explaining the diagnosis and procedures of dental restoration', 'armGroupLabels': ['a costume-designed dental storybook']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Naglaa I Ezzeldin, Associate professor', 'role': 'CONTACT', 'email': 'niezz@msa.edu.eg', 'phone': '+20 1001984184'}, {'name': 'Radwa Y Khater, Lecturer', 'role': 'CONTACT', 'email': 'rkhater@msa.eg', 'phone': '+20 122 743 2614'}, {'name': 'Naglaa I Ezzeldin, Associate professor', 'role': 'CONTACT'}], 'facility': 'October University of Modern Sciences and Arts', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Naglaa I Ezzeldin, Associate professor', 'role': 'CONTACT', 'email': 'niezz@msa.edu.eg', 'phone': '+201001984184'}, {'name': 'Radwa Y Khater, Lecturer', 'role': 'CONTACT', 'email': 'rkhater@msa.edu.eg', 'phone': '+20 122 743 2614'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Naglaa Ibrahim Ezz', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}