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Variable Perception of Cutaneous Stimulation

Primary Purpose

Pain, Acute, Anesthesia, Local, Dermatology/Skin - Other

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibratory Anesthetic Device (VAD)

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All patients

Exclusion Criteria:

Patients less than 18 years of age

Sites / Locations

Falk Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

VAD Off arm

VAD On arm

Arm Description

This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration

This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03467685

First Posted

March 9, 2018

Last Updated

August 29, 2020

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT03467685

Brief Title

Variable Perception of Cutaneous Stimulation

Official Title

Determining the Variable Factors in Cutaneous Perception of Vibratory Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

June 19, 2018 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Acute, Anesthesia, Local, Dermatology/Skin - Other

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VAD Off arm

Arm Type

Placebo Comparator

Arm Description

This will be the group that has the VAD placed on their skin in the off mode, i.e. no vibration

Arm Title

VAD On arm

Arm Type

Experimental

Arm Description

This will be the group that has the VAD placed on their skin in the on mode, i.e. vibration

Intervention Type

Device

Intervention Name(s)

Vibratory Anesthetic Device (VAD)

Intervention Description

This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz

Primary Outcome Measure Information:

Title

Numeric Rating Score

Description

Time Frame

Within 5 seconds of injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients Exclusion Criteria: Patients less than 18 years of age

Facility Information:

Facility Name

Falk Medical Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

31895257

Citation

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.

Results Reference

derived

PubMed Identifier

31513234

Citation

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.

Results Reference

derived

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Variable Perception of Cutaneous Stimulation

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