Variable Perception of Cutaneous Stimulation

Not Applicable

Completed

• Conditions: Anesthesia, Local; Pain, Acute; Dermatology/Skin - Other
• Interventions: Device: Vibratory Anesthetic Device (VAD)

• Registration Number: NCT03467685
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Study Start: 2018-06-19
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2020-08
• Results First Submitted: 2020-08-29
• Results First Submitted QC: 2020-08-29
• Last Update Submitted: 2020-08-29
• Results First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• All patients

Exclusion Criteria

• Patients less than 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VAD Off arm	Vibratory Anesthetic Device (VAD)	This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration
VAD On arm	Vibratory Anesthetic Device (VAD)	This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration

Primary Outcome Measures

Name	Time	Method
Numeric Rating Score	Within 5 seconds of injection	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.

Trial Locations

Locations (1)

Falk Medical Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States