Patient Care
Conditions
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
Interventions
DEVICEVAD 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.
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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Cotton as a dampener for a standard vibratory anesthetic device |
|---|---|
| Age, Continuous | 66.28 years STANDARD_DEVIATION 15.81 |
| Current Chronic Pain No | 36 Participants |
| Current Chronic Pain Yes | 17 Participants |
| Current Neuropathy No | 40 Participants |
| Current Neuropathy Yes | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 53 Participants |
| Past Chronic Pain, Currently Absent No | 46 Participants |
| Past Chronic Pain, Currently Absent Yes | 7 Participants |
| Past Neuropathy, Currently Absent No | 50 Participants |
| Past Neuropathy, Currently Absent Yes | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.
Time frame: Up to 45 mins
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cotton as a dampener for a standard vibratory anesthetic device | Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report. | 47 Participants |
p-value: <0.001Binomial test
Primary
Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.
Time frame: Up to 45 mins
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cotton as a dampener for a standard vibratory anesthetic device | Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report. | 6 Participants |
p-value: <0.001Proportion