Efficacy of Cotton as a Dampener for Vibration Anesthetic Device

University Hospitals (UH)

Status: Enrolling

Conditions: Patient Care

Treatments: Device: Vibratory Anesthetic Device (VAD); Device: VAD with Cotton Dampener

Study type: Interventional

Funder types: Other

Identifiers

NCT06916468

STUDY20250017

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cotton as a dampener for a standard vibratory anesthetic device

Experimental group

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.

Treatment:

Device: VAD with Cotton Dampener

Standard vibratory anesthetic device

Active Comparator group

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.

Treatment:

Device: Vibratory Anesthetic Device (VAD)