Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

April 18, 2024 updated by: Yen Minh Cung, University of Manitoba
To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be selected from 3 local oculoplastics surgeons' procedural slates during the study period. Eligible participants are those who will be undergoing bilateral eye procedures. They will be randomized into one of two groups: Group A will receive tapping on their forehead for their first eye injection of local anesthesia, and then vibration to their forehead for the second eye. Group B will receive the reverse. Pain scores will be aggregated and an average taken to help determine which method is superior. The vibration assist device (variety of facial massagers are available on Amazon for roughly $16-20CDN) is being considered in addition to the current standard of tapping or no tactile distraction at all during the injection of local anesthetic. The 11-point pain Visual Analog Scale will be used to help grade pain experience after each eye is frozen. To help qualify, if there is a difference, the patient will be asked if they felt one technique was better than the other by a little, quite a bit, or a lot.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1A2
        • Misericordia Health Centre

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion Criteria:

  • previous eyelid surgery
  • inability to give consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Tap then Vibrate
Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
Device: Vibration
Vibration Assist Device, held to the forehead
Other Names:
  • Facial Massager
Other: Tapping
Tapping on the forehead
Experimental: Group B: Vibrate then Tap
Vibration first, then tapping
Device: Vibration
Vibration Assist Device, held to the forehead
Other Names:
  • Facial Massager
Other: Tapping
Tapping on the forehead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia
Time Frame: Immediately after both eyes receive local anesthetic
How effective each intervention was in reducing the pain of peri-ocular local anesthesia, as graded on an 11-point Visual Analog Pain Scale (from 0-10 where 10/10 pain is the worst and 0/10 pain is no pain at all)
Immediately after both eyes receive local anesthetic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Pain Reduction
Time Frame: Immediately after both eye receive local anesthetic
If there was a difference, subjective qualitative grading of how much difference: a little bit, quite a bit, or a lot
Immediately after both eye receive local anesthetic

Collaborators and Investigators

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

Sponsor

University of Manitoba

Collaborators

Winnipeg Regional Health Authority

Investigators

  • Principal Investigator: Yen Minh Cung, MD, University of Manitoba, Dept of Ophthalmology

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

Helpful Links

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)

September 21, 2023

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

March 19, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS25941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After 5 years the hard copies of data collection sheets and master list will be shredded.

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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