Efficacy of Cotton as a Dampener for Vibration Anesthetic Device

Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener

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

Study Overview

• Status: Completed
• Conditions: Patient Care
• Intervention / Treatment: Device: VAD with Cotton Dampener; Device: Vibratory Anesthetic Device (VAD)

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age range: from 18+
2. Dermatologic patients at Westlake Clinic
3. Consent: Must provide informed consent to participate in the study.
4. Availability: Able to complete the entire study session, which includes testing all sites in a single session

Exclusion Criteria:

1. Broken skin or known peripheral neuropathy on anatomical site of vibration.
2. Allergies: Known allergy or sensitivity to nitrile gloves or cotton

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.	Up to 45 mins
Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.	Up to 45 mins

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Bryan Carroll, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Actual): May 14, 2025
• Study Completion (Actual): May 14, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: STUDY20250017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No