Cotton Dampener for Patient Comfort

Overseen ByKymberlyn Warner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Peripheral neuropathy, allergies, others

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

Trial Summary

Will I have to stop taking my current medications?

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

Is the Cotton Dampener generally safe for human use?

Some studies suggest that cotton used in medical treatments can cause irritation, allergy, and inflammation if it contains non-cotton fibers. Additionally, exposure to cotton dust has been linked to respiratory issues and inflammation in the lungs.¹ ² ³ ⁴ ⁵

How does the Cotton Dampener treatment differ from other treatments for patient comfort?

The Cotton Dampener treatment is unique because it focuses on using cotton as a physical comfort aid, which is different from traditional drug-based treatments that target specific medical conditions. This approach is novel as it emphasizes comfort through a non-pharmacological method, potentially reducing the need for medication and its associated side effects.⁶ ⁷ ⁸ ⁹ ¹⁰

What is the purpose of this trial?

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

Research Team

Bryan Carroll, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Cotton as a dampener for a standard vibratory anesthetic deviceExperimental Treatment1 Intervention

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.

Group II: Standard vibratory anesthetic deviceActive Control1 Intervention