Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-25 @ 5:20 AM
Study NCT ID:
NCT03229720
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2017-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The statistician is blinded by naming the groupes into group A and group B\n\n.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-07-24', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart Rate (using Pulse oximetry)', 'timeFrame': 'During the dental visit', 'description': "to asses heart beats per minute and relate it to the patient's anxiety"}], 'primaryOutcomes': [{'measure': 'Facial Image Scale', 'timeFrame': 'Immediately right after the dental visit.', 'description': 'To measure dental Anxiety by using Facial Image Scale'}], 'secondaryOutcomes': [{'measure': 'Oxygen Saturation (using Pulse oximetry)', 'timeFrame': 'During the dental visit', 'description': 'to assess the amount of oxygen saturation and relate to the stress level.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Audio Visual Distraction'], 'conditions': ['Anxiety, Dental', 'Fear, Dental']}, 'descriptionModule': {'briefSummary': 'Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.\n\nThis study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.', 'detailedDescription': '\\[I\\] Recruitment: Children aged 5\\~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.\n\n\\[II\\] Intervention:\n\n-Steps:\n\n1. The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.\n2. The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.\n3. Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.\n4. Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.\n5. Above steps will be done in both visits, with and without the intervention.\n6. If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.\n7. The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.\n8. The operator will apply topical and dental anaesthesia\n9. Pulse rate will be measured every 5 minutes.\n10. The operator will allow extra time if the dental visit ended before the child finishes the tv-show.\n11. Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.\n\nIntervention modifications:\n\nIn case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 5-8 years old.\n* Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)\n* Cooperative children and potentially cooperative\n* Physically and mentally normal children.\n* No previous dental experience involving local anaesthetic administration for the last 2 years\n\nExclusion Criteria:\n\n* Children with visual impairment.\n* Children with hearing disabilities.\n* Children with disability complicating the dental treatment as trismus, or TMJ problems.\n* Children with highly inflamed pulp tissue inducing pain during dental visit.\n* Patients or caregivers who refuse to sign the consent.'}, 'identificationModule': {'nctId': 'NCT03229720', 'briefTitle': "Evaluation of Audio-Visual Distraction Technique on Child's Anxiety", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Protocol CairoU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Audio-Visual Distraction Group', 'description': 'In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group.', 'interventionNames': ['Device: Nibiru 3D Virtual Reality Headset']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Dental Environment Group', 'description': 'Normal Dental Environment without any distractions.'}], 'interventions': [{'name': 'Nibiru 3D Virtual Reality Headset', 'type': 'DEVICE', 'description': 'This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.', 'armGroupLabels': ['Audio-Visual Distraction Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sherif A Zakhary, B.D.S', 'role': 'CONTACT', 'email': 'Sherif_zakhary@hotmail.com', 'phone': '+2001224579366'}], 'overallOfficials': [{'name': 'Mahmoud Hamdy, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Nada Wassef, 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': 'Sherif Adel Khalaf Zakhary', 'investigatorAffiliation': 'Cairo University'}}}}