Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT03159793
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Different Modelling Techniques on Child Anxiety (RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-12-09', 'releaseDate': '2019-11-22'}], 'estimatedResultsFirstSubmitDate': '2019-11-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental Anxiety [using Facial Image Scale]', 'timeFrame': 'after finishing the procedures in the 2nd dental visit [ after two weeks of allocation]'}], 'secondaryOutcomes': [{'measure': 'Oxygen Saturation [using Pulse oximetry]', 'timeFrame': 'Readings are taken in the 2nd dental visit [after two weeks from allocation]'}, {'measure': 'Heart Rate [using Pulse oximetry]', 'timeFrame': 'Readings are taken in the 2nd dental visit [after two weeks from allocation]'}, {'measure': 'Patient Cooperation [usind Frankl rating scale]', 'timeFrame': 'This is perfomred in the allocation visit , in the 1st dental visit [ after a week from allocation], in the 2nd visit [ after two weeks from allocation]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'A huge number of children suffer from anxiety during their dental treatment especially those who did not receive any type of behavior management during their first dental visit. This will result in a more complicated treatment sessions for the children, dentist and the parents. Fear and anxiety control is the key to change the resistant nature of the anxious patients and also allow them to receive the proper treatment they require. From the point of view that there is no difference between the techniques effectiveness, evaluation of two modelling techniques (live modelling and filmed modelling versus no modelling) for children anxious behavior management during the dental treatment will be performed.', 'detailedDescription': "i. Diagnosis:\n\n1. History taking \\[personal, medical and dental\\].\n2. Clinical examination using mirror and probe.\n3. Radiographic examination to make sure that the caries is simple.\n4. Preoperative photograph is taken.\n\nii. Interventions to each group\n\n1. Group A: Live modelling technique\n\n 1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.\n 2. A cooperative patient will be the model for the child.\n 3. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.\n 4. The treatment is performed as follows:\n\n i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. e. The child will be asked to complete a facial image scale\n2. Group B: video modelling technique (1) In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.\n\n 1. A recorded film will be shown to the child.\n 2. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form of Frankl behavior rating scale is filled.\n 3. The treatment is performed as follows:\n\n i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material placement. v. Finishing of the filling. d. The child will be asked to complete a facial image scale.\n3. Group C: No modelling\n\n 1. In the 1st dental visit the operator will start by measuring the behavior of the child by Frankl behavior rating scale.\n 2. In the 2nd dental visit the pulse oximetry device will be installed on the child's finger and another form to Frankl behavior rating scale.\n 3. The treatment is performed as follows:\n\n i. Place topical anesthesia. ii. Place anesthetic injection. iii. Cavity preparation. iv. Filling material places. v. Finishing of the filling. d. The child will be asked to complete a facial image scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English articles\n2. In vivo study (RCT)\n3. Medically free children\n4. Age group 5-6 years old\n\nExclusion Criteria:\n\n1. Medically compromised children\n2. Adult patients'}, 'identificationModule': {'nctId': 'NCT03159793', 'briefTitle': 'Evaluation of Different Modelling Techniques on Child Anxiety (RCT)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Live Modelling and Filmed Modelling Techniques Versus no Modelling on Child Anxiety During Dental Treatment: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Protocol Paper'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Live Modelling', 'interventionNames': ['Behavioral: Live Modelling Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Filmed Modelling', 'interventionNames': ['Behavioral: Filmed Modelling technique']}, {'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'No Modelling'}], 'interventions': [{'name': 'Live Modelling Technique', 'type': 'BEHAVIORAL', 'description': 'Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.', 'armGroupLabels': ['Group A']}, {'name': 'Filmed Modelling technique', 'type': 'BEHAVIORAL', 'description': 'Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mariam S. Yassin, Master', 'role': 'CONTACT', 'email': 'dr.mariamsala7@gmail.com', 'phone': '01112622228'}], 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mariam S Yassin, B.D.S.', 'role': 'CONTACT', 'email': 'dr.mariamsala7@gmail.com', 'phone': '+2001112622228'}], 'overallOfficials': [{'name': 'Fatma A El Shehaby, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Soad Abd El Moniem, Ass. prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mariam Salah Mohammad Yassin', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-11-22', 'type': 'RELEASE'}, {'date': '2019-12-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mariam Salah Mohammad Yassin, Principal investigator, Cairo University'}}}}