Patient CareNCT06916468
Efficacy of Cotton as a Dampener for Vibration Anesthetic Device
A study testing VAD with Cotton Dampener and Vibratory Anesthetic Device (VAD) in people with Patient Care, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Care
- What is being tested?
- VAD with Cotton Dampener and Vibratory Anesthetic Device (VAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 14 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Broken skin or known peripheral neuropathy on anatomical site of vibration.
- Allergies: Known allergy or sensitivity to nitrile gloves or cotton
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener
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
- Being tested
- VAD with Cotton Dampener, Vibratory Anesthetic Device (VAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAD with Cotton DampenerDevice
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VAD with Cotton Dampener; Device: Vibratory Anesthetic Device (VAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.
Measured: Up to 45 mins
Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.
Measured: Up to 45 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Apr 2025
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient CareStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Carroll, University Hospitals Cleveland Medical Center
- Investigators
- Bryan Carroll, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916468
- Sponsor's protocol ID
- STUDY20250017
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38197978Sharma 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.
PubMed 22001341Gresham 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.
PubMed 27176866Govas 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.
PubMed 31513234
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener
- ClinicalTrials.gov ID
- NCT06916468
- Acronym / sponsor ID
- STUDY20250017
- Conditions
- Patient Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Posted 4 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cotton as a dampener for a standard vibratory anesthetic device | Experimental | Device: VAD with Cotton Dampener, Device: Vibratory Anesthetic Device (VAD)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Broken skin or known peripheral neuropathy on anatomical site of vibration.
- Allergies: Known allergy or sensitivity to nitrile gloves or cotton
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAD with Cotton DampenerA 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. | Device | Cotton as a dampener for a standard vibratory anesthetic device |
| 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. | Device | Cotton as a dampener for a standard vibratory anesthetic device |
Primary outcome
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report.
Time frame: Up to 45 mins
Number of Participants Who Preferred the VAD Without Cotton as Measured Patient Report.
Time frame: Up to 45 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38197978Wilkowski 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.
- Background: PubMed 22001341Sharma 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.
- Background: PubMed 27176866Gresham 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.
- Background: PubMed 31513234Govas 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.
- Individual participant dataSharing planned: No
Related trials for Patient Care
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruiting
Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
Cancer
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Carroll, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAD with Cotton Dampener and Vibratory Anesthetic Device (VAD) in people with Patient Care, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Preferred the VAD With Cotton as Measured by Patient Report. (time frame: Up to 45 mins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06916468, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.