Cotton Dampener for Patient Comfort

Overseen By Kymberlyn Warner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Peripheral neuropathy, allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding cotton to a vibratory anesthetic device (VAD) increases comfort during dermatologic procedures. It compares patient preferences when using the device with and without cotton on different skin sites, such as the cheek and forearm. The aim is to determine if cotton can reduce discomfort, particularly for those with chronic pain. Participants must be dermatologic patients at Westlake Clinic without broken skin or neuropathy at the test sites. As an unphased trial, this study allows patients to contribute to innovative research that could enhance comfort during dermatologic procedures.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that using cotton as a dampener for vibratory anesthetic devices is safe?

Research has shown that using cotton with a vibratory anesthetic device (VAD) is likely safe. Cotton, a common material in medical settings, has no known serious side effects.

The vibratory anesthetic device reduces pain during skin procedures. Studies have demonstrated that these devices can make procedures more comfortable by minimizing pain. No major side effects have been reported from using these devices.

This study is in a phase that does not require safety testing, indicating the treatment is generally considered safe. Participants in this type of study typically try treatments already expected to be safe. Any issues with using cotton with the VAD would likely have been identified in earlier tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cotton as a dampener for vibratory anesthetic devices because it offers a simple, non-invasive way to potentially enhance patient comfort during procedures. Unlike traditional anesthetic methods that may involve injections or topical creams, this approach uses cotton to modify the sensation of the standard vibratory anesthetic device. The use of cotton is straightforward and cost-effective, which could make it an appealing option in various medical settings. By testing this method, researchers hope to determine if such a simple addition can significantly improve the patient experience without compromising the effectiveness of the anesthetic device.

What evidence suggests that using cotton as a dampener is effective for improving patient comfort with vibratory anesthetic devices?

Research shows that adding cotton to devices using vibrations to numb the skin can enhance comfort during dermatology procedures. In this trial, participants will use a standard vibratory anesthetic device with and without cotton across various anatomical sites. Studies have found that many people prefer these devices with cotton, suggesting it might help reduce discomfort. These vibrating devices already lessen pain during procedures like injections. Adding cotton could further improve the experience, especially in sensitive areas like the face and neck. Early results suggest this simple change could make a noticeable difference. ^{1 3 4 5 6}

Who Is on the Research Team?

Bryan Carroll, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for dermatologic patients who may need anesthetic devices. It's open to those interested in comparing the comfort of using a Vibratory Anesthetic Device (VAD) with and without cotton as a dampener. Specific factors like chronic pain or neuropathy will be considered.

Inclusion Criteria

Dermatologic patients at Westlake Clinic

Must provide informed consent to participate in the study

I can complete all tests in one session.

Exclusion Criteria

Broken skin or known peripheral neuropathy on anatomical site of vibration

Known allergy or sensitivity to nitrile gloves or cotton

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vibratory anesthetic device applications with and without cotton across five anatomical sites

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cotton as a Dampener

Trial Overview The study tests the effectiveness of using cotton to dampen vibrations from anesthetic devices during skin procedures. Patients' preferences for VAD use with or without cotton across different body areas are compared, aiming to improve patient comfort.

How Is the Trial Designed?

Group I: Cotton as a dampener for a standard vibratory anesthetic device Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06916468

Efficacy of Cotton as a Dampener for Vibration Anesthetic ... Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener ... Percentage of participants who preferred the VAD with Cotton as measured ...

2. trialx.com trialx.com/clinical-trials/listings/310667/efficacy-of-cotton-as-a-dampener-for-vibration-anesthetic-device/?&radius=10&place=A&user_country=Almada%20N

Efficacy of Cotton as a Dampener for Vibration Anesthetic ... Overview. The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic ...

3. withpower.com withpower.com/trial/phase-patient-care-3-2025-f2099

Cotton Dampener for Patient Comfort The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients.

4. meddatax.com meddatax.com/clinical-trials/NCT06916468

Efficacy of Cotton as a Dampener for Vibration Anesthetic Device The study aims to determine the effectiveness of cotton as a dampener for vibratory anesthetic devices (VADs) for dermatologic patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8388110/

Differential Analgesia From Vibratory Stimulation During ... Vibratory anesthetic device reduces pain during anesthetic injection, primarily for HN treatments and older male subjects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6743061/

Effect of a Vibratory Anesthetic Device on Pain Anticipation ... This randomized clinical trial assesses the effect of a vibratory anesthetic device during dermatologic surgery on patients who catastrophize ...