Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 3:03 AM
Study NCT ID:
NCT07467395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate (HR) assessment', 'timeFrame': 'Baseline to immediately after the procedure (within the same treatment visit).', 'description': "Heart rate (HR) will be employed as an anxiety indicator, as stress or anxiety can increase it. It will be measured using a pulse oximeter. A brief demonstration using the pulse oximeter will be done, and the patient will be instructed to stay still and not to move his hands a lot in order to obtain accurate readings. The pulse oximeter will be placed on the patient's index finger."}, {'measure': 'Anxiety assessment using the Facial Image Scale (FIS)', 'timeFrame': 'Baseline to immediately after the procedure (within the same treatment visit).', 'description': "The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling."}, {'measure': "Anxiety assessment using Venham's clinical anxiety scale", 'timeFrame': 'Baseline to immediately after the procedure (within the same treatment visit).', 'description': "The Venham's clinical anxiety rating scale will be used to assess the child's dental anxiety at baseline, during and after anesthesia injection and extraction procedure. The assessment will take place by the operator and the independent outcome assessor using the recorded video tapes. This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact."}, {'measure': 'Pain assessment using Wong-Baker FACES pain rating scale', 'timeFrame': 'Baseline to immediately after the procedure (within the same treatment visit).', 'description': 'The Wong-Baker FACES Pain Rating Scale will be used to quantify the child\'s pain experience. This scale ranges from a neutral face, assigned a score of "0," indicating no pain, to a frowning face with a score of "10," representing the highest level of discomfort. The scale will be explained to the child, who will be asked to choose the face that represents how much pain he or she will feel during anesthesia injection and extraction from one of the graphic rating scales by pointing his finger at one of the six faces shown on the chart will be given to him.'}, {'measure': 'Pain assessment using Face, legs, activity, cry, consolability (FLACC) scale', 'timeFrame': 'Baseline to immediately after the procedure (within the same treatment visit).', 'description': "FLACC behavioral pain assessment scale will be used to assess the child's dental pain during the procedure. This objective measure scores the child's level of pain with a correlating behavior description. It consists of 5 categories (F) face, (L) leg, (A) activity, (C) cry, (C) consolability each is scored from 0 to 2, which results in a total score between zero and ten. The assessment will take place by the operator and the independent outcome assessor, the assessors will assign a score to each category based on the child's response during anesthesia injection and extraction by analysis of the recorded videotapes."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the impact of using virtual reality glasses compared to augmented reality glasses as distraction methods to reduce the dental anxiety and pain in children during extraction of primary molars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically free children without visual or auditory impairment (ASA I).\n* Children aged 6-8 years.\n* Children with Frankl behaviour rating score 3 or 4.\n* Children requiring extraction in one of their primary molars.\n* Parents who will accept to give their consent and participate in the study\n\nExclusion Criteria:\n\n* Children require emergency dental treatment.\n* Children with a history of epilepsy and anxiety disorder.\n* Children with previous bad dental experience.\n* Allergy to local anaesthetic drugs.'}, 'identificationModule': {'nctId': 'NCT07467395', 'briefTitle': "Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction", 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': "Evaluation of Augmented Reality on Dental Pain and Anxiety During Primary Molars' Extraction: Randomized Controlled Clinical Trial", 'orgStudyIdInfo': {'id': '1189-11/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Augmented Reality', 'interventionNames': ['Device: Augmented reality glasses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality', 'interventionNames': ['Device: VR glasses']}], 'interventions': [{'name': 'Augmented reality glasses', 'type': 'DEVICE', 'description': 'Augmented reality glasses will be introduced to the child and he will be allowed to choose his favourite cartoon movie from this list: Rapunzel, Stitch, Ratatouille, Frozen, Minions, Zootopia, and The lion king during the first dental visit to get familiar with the AR glasses. The augmented reality is an eye goggle that will be connected to the laptop through a wire, then after playing the cartoon that will be selected by the child on the laptop the child will enjoy watching the cartoon movie through the eye goggle.', 'armGroupLabels': ['Augmented Reality']}, {'name': 'VR glasses', 'type': 'DEVICE', 'description': 'Children allocated to this group will be managed by Virtual reality glasses, which will be introduced to the child and he will be allowed to choose his favourite cartoon from the same list during the first dental visit to get familiar with the VR glasses. The virtual reality is a head-mounted display, the child will be asked to select his favourite cartoon on a mobile, then the mobile will be inserted in that head-mounted display', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara H Rabie, BDS', 'role': 'CONTACT', 'email': 'sararabie96@hotmail.com', 'phone': '+20 10 67200674'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sara Hazem Mohamed Rabie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MSc. researcher of pediatric dentistry', 'investigatorFullName': 'Sara Hazem Mohamed Rabie', 'investigatorAffiliation': 'Alexandria University'}}}}