Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT05067218
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding of the operator and the patients will not be applicable due to the difference between the used techniques, however, the statistician will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split mouth'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-03', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-03', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Child's behavior during local anesthesia injection.", 'timeFrame': 'one hour', 'description': 'FLACC scale'}], 'primaryOutcomes': [{'measure': 'Pain perception during LA injection', 'timeFrame': 'one hour', 'description': 'by wong baker scale'}], 'secondaryOutcomes': [{'measure': 'Heart rate during injection of local anesthesia.', 'timeFrame': 'one hour', 'description': 'pulse oximeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Anesthesia, Local', 'Vibration']}, 'descriptionModule': {'briefSummary': 'This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).', 'detailedDescription': 'The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.\n* Medically fit children (ASA I, II).\n* Children mentally capable of communication.\n* Children aged 6-11 years.\n* First dental visit.\n* Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.\n\nExclusion Criteria:\n\n* Children with a behavioral management problem.\n* Children with known allergy to local anesthetic agents.\n* Parental refusal for participation"}, 'identificationModule': {'nctId': 'NCT05067218', 'briefTitle': 'Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.', 'orgStudyIdInfo': {'id': 'Buzzy device in Children.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'buzzy device (intervention)', 'description': 'The wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered.', 'interventionNames': ['Device: buzzy device']}, {'type': 'EXPERIMENTAL', 'label': 'Conventinal anasthesia ( control )', 'description': '* The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute.\n* Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles.', 'interventionNames': ['Other: Conventinal anasthesia']}], 'interventions': [{'name': 'buzzy device', 'type': 'DEVICE', 'description': 'bee shaped with wings could be frozen.', 'armGroupLabels': ['buzzy device (intervention)']}, {'name': 'Conventinal anasthesia', 'type': 'OTHER', 'description': 'normal technique of injection', 'armGroupLabels': ['Conventinal anasthesia ( control )']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mai Gamal Eldeen Hassan Sabra', 'investigatorAffiliation': 'Cairo University'}}}}