Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT06916468
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Cotton as a Dampener for Vibration Anesthetic Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bryan.Carroll@UHhospitals.org', 'phone': '(216)844-8200', 'title': 'Dr. Bryan Carroll', 'organization': 'University Hospitals Cleveland Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '5 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.\n\nVAD with Cotton Dampener: A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.\n\nVibratory Anesthetic Device (VAD): A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.\n\nVAD with Cotton Dampener: A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.\n\nVibratory Anesthetic Device (VAD): A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '86.79', 'statisticalMethod': 'Binomial test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Comparing preference to 50/50 baseline'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 45 mins', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.\n\nVAD with Cotton Dampener: A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.\n\nVibratory Anesthetic Device (VAD): A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '13.20', 'statisticalMethod': 'Proportion', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Out of the 53 participants , what proportion preferred the device without the cotton dampener on majority of anatomical sites'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 45 mins', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.\n\nVAD with Cotton Dampener: A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.\n\nVibratory Anesthetic Device (VAD): A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.\n\nVAD with Cotton Dampener: A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.\n\nVibratory Anesthetic Device (VAD): A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.28', 'spread': '15.81', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Neuropathy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Neuropathy, Currently Absent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Chronic Pain', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Chronic Pain, Currently Absent', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-29', 'size': 250910, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-03T10:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2025-03-31', 'resultsFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-13', 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.', 'timeFrame': 'Up to 45 mins'}, {'measure': 'Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.', 'timeFrame': 'Up to 45 mins'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Patient Care']}, 'referencesModule': {'references': [{'pmid': '38197978', 'type': 'BACKGROUND', 'citation': 'Wilkowski CM, Maytin AK, Klatzky RL, Carroll BT. A pilot study comparing the user preference of different forms of mechanical vibration. Arch Dermatol Res. 2024 Jan 10;316(2):69. doi: 10.1007/s00403-023-02797-x. No abstract available.'}, {'pmid': '22001341', 'type': 'BACKGROUND', 'citation': 'Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.'}, {'pmid': '27176866', 'type': 'BACKGROUND', 'citation': "Gresham KA, Carroll BT. A Simple Elastomer-Pad Vibratory Dampener to Maximize Pain Control of Injections in Patient's Undergoing Dermatological Surgery. Dermatol Surg. 2016 Jun;42(6):788-90. doi: 10.1097/DSS.0000000000000718. No abstract available."}, {'pmid': '31513234', 'type': 'BACKGROUND', 'citation': 'Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients. It will compare patient preferences for VAD use with and without cotton across different anatomical sites and identify factors, such as chronic pain or neuropathy status, that may influence these preferences. Finally, the study seeks to generate preliminary data to inform potential modifications to VAD use, optimizing patient comfort in dermatologic procedures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range: from 18+\n2. Dermatologic patients at Westlake Clinic\n3. Consent: Must provide informed consent to participate in the study.\n4. Availability: Able to complete the entire study session, which includes testing all sites in a single session\n\nExclusion Criteria:\n\n1. Broken skin or known peripheral neuropathy on anatomical site of vibration.\n2. Allergies: Known allergy or sensitivity to nitrile gloves or cotton'}, 'identificationModule': {'nctId': 'NCT06916468', 'briefTitle': 'Efficacy of Cotton as a Dampener for Vibration Anesthetic Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener', 'orgStudyIdInfo': {'id': 'STUDY20250017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cotton as a dampener for a standard vibratory anesthetic device', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with and without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order. The study will be blinded to participants, who will be instructed to close their eyes or look away during the vibration application. After the pairs of VAD applications, patients will report their preference for each treatment condition.', 'interventionNames': ['Device: VAD with Cotton Dampener', 'Device: Vibratory Anesthetic Device (VAD)']}], 'interventions': [{'name': 'VAD with Cotton Dampener', 'type': 'DEVICE', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) with cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants. For each anatomical site, one side (either right or left) will receive vibration with cotton, and the opposite side will receive vibration without cotton in a randomized order.', 'armGroupLabels': ['Cotton as a dampener for a standard vibratory anesthetic device']}, {'name': 'Vibratory Anesthetic Device (VAD)', 'type': 'DEVICE', 'description': 'A standard pen-like Vibratory Anesthetic Device (VAD) without cotton will be applied across five anatomical sites (lateral nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm) of participants.', 'armGroupLabels': ['Cotton as a dampener for a standard vibratory anesthetic device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Bryan Carroll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Bryan Carroll', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}