Improving Patient Comfort of Vibratory Anesthetic Devices With a Cotton Dampener
Phase: NA
Conditions: Patient Care
Sponsor: University Hospitals Cleveland Medical Center

 
 
Improving Patient Comfort of Vibratory Anesthetic Devices with a Cotton Dampener 
 
01/29/2025 
 
NCT06916468 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objectives  
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. 
 
Background  
Vibratory anesthetic devices (VADs) decrease pain associated with anesthetic, steroid, or 
botulinum toxin injection in dermatology patients through the application of vibratory 
stimulation on targeted anatomical site [1,2,3]. While VADs are effective at reducing injection 
pain, a number of factors influence their adoption by injectors. One factor is patient comfort [4]. 
Anecdotally, some patients have reported discomfort with VADs used before dermatologic 
procedures. As this may be influencing the utilization of VADs in dermatological procedures, 
further investigation into patient comfort with VAD is necessary. This study will determine 
whether utilizing cotton balls as a dampener is effective in improving patient comfort with VAD 
use. 
 
Inclusion and Exclusion Criteria 
The study will include potential participants based on their ability to provide informed consent 
and complete the study, while excluding those with skin conditions, sensitivities at testing sites, 
or allergies to nitrile gloves or cotton. 

 
 
Study Design  
The overall study design is a single-site, one-visit, participant-blinded, pilot study for up to 60 
patients in the Westlake dermatology clinic.  
 
Study Procedures  
The study is a single-site, participant-blinded, pilot study for up to 60 patients in the Westlake 
dermatology clinic. Using the pen-like VAD, vibration will be applied with cotton on an 
anatomical site of one side (right or left) and without cotton on the same anatomical site on the 
other side. To fix cotton to the VAD, a cotton ball will be positioned at the tip of the VAD with 
placement into a nitrile glove (5). The VAD we are using for this procedure is the current 
standard of care and is not a novel device. 
The anatomical sites were chosen in terms of sites with minimal subcutaneous fat and areas 
where patients have anecdotally reported discomfort with the VAD. The sites will be the lateral 
nasal wall, sub-malar region of the cheek, ear helix, lateral neck, and dorsal side of the forearm. 
The order of the five anatomical sites and the order of conditions (VAD and VAD with cotton) 
will be randomized, and all possible orders will be placed into an envelope. One envelope will 
be randomly selected for each patient to determine the order of anatomical sites and order of 
condition for that particular patient. The patients will be blinded to what treatment is applied. 
For example, patients will be instructed to close their eyes or to look away from the application 
site. 

There will be 10 total applications (VAD and VAD with cotton for five anatomical sites) each 
subject will undergo. Each application of the VAD will last for 20 seconds. Between each VAD 
application, there will be a delay of 10 seconds. After applying vibration to the same anatomical 
sites on the left and right side, patients will be asked which of the two treatments was 
preferred, which should take around one minute. To monitor participants for safety, participants 
will be encouraged to report any discomfort or adverse effects they experience during or after 
each vibration and after each VAD application, participants will be asked if they are ready to 
move on to the next one. 
Before completion of the protocol, but after the informed consent, patients will be asked 
questions regarding their medical history. Additionally, before administering vibrations, patients 
will be trained to distinguish between small and large dowels, applying the minimum amount of 
pressure, while their eyes are closed to ensure accurate perception of the vibration. 
Data will be patient reported and will be collected in a secure RedCap online database. 
 
Study Timeline 
 
 
Data to be Collected for your study 
The study will collect sociodemographic information, including age, gender, and race, to 
understand the generalizability of data. Medical history data will encompass past medical 
conditions, history of prior procedures, and any previous use of vibration before injection. 
Patient chart will be looked at for the purpose of validating patient survey questions. Chronic 
pain history will be recorded, including the participant’s relationship with a chronic pain 
specialist, current use and duration of pain medication, the specific medication used, and the 

type, location, and duration of chronic pain. The presence, history, and location of neuropathy 
will also be documented. Lastly, the primary outcome variable will assess participant preference 
for each anatomical site, comparing the use of cotton versus no cotton. 
 
Data Analysis Plan 
As this is a pilot study, we are not able to conduct a power analysis. However, similar studies at 
UH using this same VAD have a similar target of up to 60 patients. A binomial test will be used 
to determine whether the proportion of participants preferring cotton differs significantly from 
the expected 50/50 baseline for each anatomical site. Additionally, Chi-Square Tests of 
Independence will be conducted to assess whether preferences for cotton versus no cotton vary 
based on participant characteristics, including chronic pain status, neuropathy status, or 
anatomical site. Qualitative data on the reason behind preference will be asked and 
independently categorized by at least two raters. 
 
Risks to Research Participants 
Minor discomfort may be experienced by patients from vibration for a few seconds per site. 
Additionally, there might be an anxiety due to potential discomfort. There will also be a risk of 
breach of confidentiality. Participants will be informed that they can withdraw from the study at 
any time without penalty. 
 
Provisions to Protect the Privacy Interests of Research Participants 
Vibration tests will occur in private rooms. All collected data will be de-identified in RedCap, 
ensuring that no personally identifiable information is linked to study responses. Data will be 
securely stored in a password-protected, restricted-access database of REDCap, with access 
limited to authorized research personnel only. A coding system will be used, where a unique 
participant code is linked to each subject's data. Only authorized research personnel will have 
access to this code, and it will be securely stored separately from the study data in a linking log. 
 
Potential Benefit to Research Participants 
There is no direct benefit to research participants. Indirectly, if the use of cotton with vibration 
proves to be more comfortable for patients, it could provide a simple, cost-effective, and widely 
implementable solution for VAD use which optimizes patient comfort. This could be especially 

beneficial for individuals with heightened pain sensitivity, such as those with chronic pain or 
neuropathy. 
 
Withdrawal of Research Participants 
Participants will be withdrawn from the study if they experience unexpected or intolerable 
discomfort that prevents them from completing the procedure. Additionally, participants may 
be withdrawn if they do not follow study instructions properly, which could compromise the 
integrity of the data collection process. If a participant withdraws before completing the 
procedure, their data will not be included in the study analysis. If a participant is withdrawn due 
to noncompliance or intolerable discomfort, their collected data will be discarded. Participants 
will be informed of their right to withdraw at any time without penalty. 
 
Alternatives to Participation 
The alternative to participation is not to participate. 
 
Drugs or Devices 
The pen-like vibratory anesthetic device which is the current standard of care in UH 
dermatology clinics and is not a novel device will be the main device used for this study on 5 
anatomical sites each on the left and right side. 
 
Additional Information 
This VAD used is a current standard of care for dermatologic procedures, and this is not a novel 
device. 
 
Community-Based Participatory Research 
This is not community-based participatory research. 
 
References 

1. Govas 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. PMID: 31513234; PMCID: 
PMC6743061. 
2. Gresham KA, Carroll BT (2016) A simple elastomer-pad vibratory dampener to maximize 
pain control of injections in patients undergoing dermatological surgery. Dermatol Surg 
42(6):788–790.https://doi.org/10.1097/DSS.0000000000000718 
3. Sharma P, Czyz CN, Wulc AE (2011) Investigating the efficacy of vibration anesthesia to 
reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J 31(8):966–971. 
https://doi.org/10.1177/1090820X11422809 
4. Wilkowski, C. M., Maytin, A. K., Klatzky, R. L., & Carroll, B. T. (2024). A pilot study 
comparing the user preference of different forms of mechanical vibration. Archives of 
dermatological research, 316(2), 69. https://doi.org/10.1007/s00403-023-02797-x 
5. Gresham KA, Carroll BT. A simple elastomer-pad vibratory dampener to maximize pain 
control of injections in patient’s undergoing dermatological surgery. Dermatol Surg. 
2016;42(6):788-790. doi: 10.1097/DSS.0000000000000718