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OpenTrials
Completed

NCT Number: NCT06355817

Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.

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Key information

Conditions

Anesthetics, Local Adult Age-Related Ptosis Blepharoplasty Humans Lidocaine Ophthalmologic Surgical Procedure Surgery Vibration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Misericordia Health Centre

Winnipeg, Manitoba, R3C 1A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion criteria

  • previous eyelid surgery
  • inability to give consent

Treatment and study plan

Vibration

Device

Vibration Assist Device, held to the forehead

Other names: Facial Massager

Tapping

Other

Tapping on the forehead

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Winnipeg Regional Health Authority

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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