Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-01 @ 1:46 AM
Study NCT ID:
NCT07034833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Ventriloquist Puppet for Reducing Dental Anxiety in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental anxiety', 'timeFrame': 'From immediately before to immediately after the dental procedure', 'description': 'Change in Anxiety Score using MCDAS scale'}, {'measure': 'Heart rate', 'timeFrame': 'From immediately before to immediately after the dental procedure', 'description': 'change in heart rate during the visit to investigate the anxiety effect using pulse oximeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental anxiety', 'behavior management'], 'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'thhe goal of this clinical trial is to assess the effect of ventriloquist puppets to reduce the strees accompined by the dental visit in cgilren . The main questions it aims to answer are:\n\n* Does the ventriloquist puppet can reduce the stress accompanied by the dental visit for the children ?\n* What medical problems do participants have when taking drug ABC? Researchers will compare ventriloquist puppet to a control group (conventional behavior management techniques ) to see if ventriloquist puppet can lower the anxiety or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* healthy children with no systemic diseases.\n* children require dental intervention\n\nExclusion Criteria:\n\n* children with bad dental experience\n* children require invasive surgical intervention'}, 'identificationModule': {'nctId': 'NCT07034833', 'acronym': 'Puppets', 'briefTitle': 'Assessment of a Ventriloquist Puppet for Reducing Dental Anxiety in Children', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Assessment of a Ventriloquist Puppet for Reducing Dental Anxiety in Children', 'orgStudyIdInfo': {'id': '1200/384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group: 25 child managed by basic behavior management tecniques', 'description': 'this group managed normaly with the basic behavior managment techniques like tell , show , do and others'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'puppet therapy group: Children allocated to the Ventriloquist Puppet group', 'description': 'Children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play , talk and interact with the puppet for five to 10 min', 'interventionNames': ['Behavioral: Ventriloquist Puppet Interaction']}], 'interventions': [{'name': 'Ventriloquist Puppet Interaction', 'type': 'BEHAVIORAL', 'description': 'children allocated to the Ventriloquist Puppet group were introduced to a Ventriloquist Puppet inside the clinic and were allowed to play, talk, and interact with the puppet for 5-10 minutes.', 'armGroupLabels': ['puppet therapy group: Children allocated to the Ventriloquist Puppet group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pediatric dentistry and oral health', 'investigatorFullName': 'Hamdy Badreldin', 'investigatorAffiliation': 'Al-Azhar University'}}}}