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Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAD Off arm | Placebo Comparator | This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration |
|
| VAD On arm | Experimental | This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibratory Anesthetic Device (VAD) | Device | This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Score | This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain. | Within 5 seconds of injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falk Medical Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31895257 | Derived | Kazi R, Govas P, Slaugenhaupt RM, Carroll BT. Differential Analgesia From Vibratory Stimulation During Local Injection of Anesthetic: A Randomized Clinical Trial. Dermatol Surg. 2020 Oct;46(10):1286-1293. doi: 10.1097/DSS.0000000000002314. | |
| 31513234 | Derived | 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. |
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No plan to share data with other researchers. Data from this study may be used in future work.
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| ID | Title | Description |
|---|---|---|
| FG000 | VAD Off Arm | This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
| FG001 | VAD On Arm | This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VAD Off Arm | This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
| BG001 | VAD On Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Numeric Rating Score | This is a tool used to measure the degree of pain perceived by the patient with application of the tool on their skin and following the injection of anesthetic which is part of the routine medical care of the patient. Score ranges from 0 to 10 with higher score indicating more pain. | Posted | Mean | Standard Deviation | score on a scale | Within 5 seconds of injection |
|
3 months
The definition of adverse events does not differ from that of clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAD Off Arm | This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rashek Kazi | UPMC Dermatology | 5167105208 | kazir@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 21, 2018 | Sep 13, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects will be randomly assigned into one of two groups:
Group 1: Vibratory anesthetic device (VAD) is in the OFF mode Group 2: VAD is in the ON mode
We will use a random number generator to place patients into one of the two groups.
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Subjects will be asked to close their eyes prior to the vibration anesthetic device (VAD) being applied to their skin. Only the user will know whether the VAD will be on or off based on the result of a random number generator. This will prevent anticipatory changes on the subjects side. The subject will be aware of the intervention after the device is turned on or left in the off position.
This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Location of treatment on body | Count of Participants | Participants |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | VAD On Arm | This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration Vibratory Anesthetic Device (VAD): This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz | 0 | 49 | 0 | 49 | 0 | 49 |
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