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Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

U

University of Manitoba

Status

Completed

Conditions

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

Treatments

Other: Tapping
Device: Vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT06355817
HS25941

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion criteria

  • previous eyelid surgery
  • inability to give consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

80 participants in 2 patient groups

Group A: Tap then Vibrate
Active Comparator group
Description:
Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
Treatment:
Other: Tapping
Device: Vibration
Group B: Vibrate then Tap
Experimental group
Description:
Vibration first, then tapping
Treatment:
Other: Tapping
Device: Vibration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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