Trial Outcomes & Findings for Efficacy of Cotton as a Dampener for Vibration Anesthetic Device (NCT NCT06916468)

NCT ID: NCT06916468

Last Updated: 2025-11-04

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

Up to 45 mins

Results posted on

2025-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cotton as a dampener for a standard vibratory anesthetic device 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. VAD 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. Vibratory 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.
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Cotton as a Dampener for Vibration Anesthetic Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cotton as a dampener for a standard vibratory anesthetic device n=53 Participants 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. VAD 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. Vibratory 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.
Age, Continuous	66.28 years STANDARD_DEVIATION 15.81 • n=15 Participants
Sex: Female, Male Female	27 Participants n=15 Participants
Sex: Female, Male Male	26 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	53 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants
Race (NIH/OMB) White	53 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Current Neuropathy Yes	13 Participants n=15 Participants
Current Neuropathy No	40 Participants n=15 Participants
Past Neuropathy, Currently Absent Yes	3 Participants n=15 Participants
Past Neuropathy, Currently Absent No	50 Participants n=15 Participants
Current Chronic Pain Yes	17 Participants n=15 Participants
Current Chronic Pain No	36 Participants n=15 Participants
Past Chronic Pain, Currently Absent Yes	7 Participants n=15 Participants
Past Chronic Pain, Currently Absent No	46 Participants n=15 Participants

PRIMARY outcome

Timeframe: Up to 45 mins

Outcome measures

Outcome measures
Measure	Cotton as a dampener for a standard vibratory anesthetic device n=53 Participants 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. VAD 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. Vibratory 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.
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.	47 Participants

PRIMARY outcome

Timeframe: Up to 45 mins

Outcome measures

Outcome measures
Measure	Cotton as a dampener for a standard vibratory anesthetic device n=53 Participants 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. VAD 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. Vibratory 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.
Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.	6 Participants

Adverse Events

Cotton as a dampener for a standard vibratory anesthetic device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bryan Carroll

University Hospitals Cleveland Medical Center

Phone: (216)844-8200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place