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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03467685
Other study ID # Perception
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2018
Est. completion date September 30, 2018

Study information

Verified date August 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients

Exclusion Criteria:

- Patients less than 18 years of age

Study Design


Intervention

Device:
Vibratory Anesthetic Device (VAD)
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz

Locations

Country Name City State
United States Falk Medical Clinic Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Within 5 seconds of injection
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