Variable Perception of Cutaneous Stimulation

August 29, 2020 updated by: Bryan Carroll, University of Pittsburgh

Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Falk Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients

Exclusion Criteria:

  • Patients less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: VAD Off arm
This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration
Device: Vibratory Anesthetic Device (VAD)
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
EXPERIMENTAL: VAD On arm
This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration
Device: Vibratory Anesthetic Device (VAD)
This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Score
Time Frame: 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.
Within 5 seconds of injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2018

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perception

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data with other researchers. Data from this study may be used in future work.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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