Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03902158
Status:
UNKNOWN
Last Update Posted:
2019-04-03
First Post:
2019-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of pain', 'timeFrame': '5 minutes after anesthesia, i.e., after anesthesia, VAS will be performed in a maximum of 5 minutes after anesthesia', 'description': 'Visual analogue scale (VAS) will be used to measure pain immediately after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).\n\nThe treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman\'s terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98\') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.', 'detailedDescription': "One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Anxiety is often manifested by children during dental appointments, and may represent a challenge in the dental surgeon's clinical practice. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. In view of the basic techniques used to manage children's behavior, distraction has been widely used to provide a more relaxed and effective experience during dental treatment for children. Thus, this study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized through the draw of envelopes at the time of the service, being 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).\n\nThe treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman\\'s terms using the basic techniques of behavior management, such as the \\"tell-show-do\\" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98) will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health;\n* no prior dental experience involving anesthesia in the last 2 years;\n* need for restorative treatment or exodontia under local anesthesia.\n\nExclusion Criteria:\n\n* physical or mental disabilities;\n* report of poor behavior during dental treatment.'}, 'identificationModule': {'nctId': 'NCT03902158', 'briefTitle': 'Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Pelotas'}, 'officialTitle': 'Use of Virtual Reality Glasses as an Audiovisual Distraction Technique During Anesthesia in Behavior, Anxiety and Pain Perception in Children', 'orgStudyIdInfo': {'id': 'PPGO 0028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glasses', 'interventionNames': ['Device: Glasses', 'Behavioral: Distraction techniques']}, {'type': 'NO_INTERVENTION', 'label': 'Distraction techniques', 'description': 'No glasses will be used'}], 'interventions': [{'name': 'Glasses', 'type': 'DEVICE', 'description': 'The patient will wear virtual reality glasses during anesthesia', 'armGroupLabels': ['Glasses']}, {'name': 'Distraction techniques', 'type': 'BEHAVIORAL', 'description': 'The patient will undergo distraction techniques', 'armGroupLabels': ['Glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96015080', 'city': 'Pelotas', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Marília L Goettems, PhD', 'role': 'CONTACT', 'email': 'mariliagoettems@hotmail.com', 'phone': '555332606741'}], 'facility': 'School of Dentistry', 'geoPoint': {'lat': -31.76997, 'lon': -52.34101}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Pelotas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Maximiliano Sergio Cenci', 'investigatorAffiliation': 'Federal University of Pelotas'}}}}