Efficacy of Cotton as a Dampener for Vibration Anesthetic Device

NCT06916468 | Completed Results FDA Device

• 1 other identifier: STUDY20250017
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Care

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Cotton as a dampener for a standard vibratory anesthetic device

EXPERIMENTAL

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; Device: Vibratory Anesthetic Device (VAD)

Interventions

VAD with Cotton Dampener DEVICE

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.

Cotton as a dampener for a standard vibratory anesthetic device

Vibratory Anesthetic Device (VAD) DEVICE

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.

Cotton as a dampener for a standard vibratory anesthetic device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

• 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: 38197978 BACKGROUND

• 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: 22001341 BACKGROUND

• 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: 27176866 BACKGROUND

• 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.

  PMID: 31513234 BACKGROUND

Results Point of Contact

• Title: Dr. Bryan Carroll
• Organization: University Hospitals Cleveland Medical Center

Bryan.Carroll@UHhospitals.org

(216)844-8200

Study Officials

• Bryan Carroll, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: April 30, 2025
• Primary Completion: May 14, 2025
• Study Completion: May 14, 2025
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)