Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

NCT ID: NCT06355817

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2024-03-19

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each patient will receive both interventions and serve as their own comparator.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure.

Study Groups

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Group A: Tap then Vibrate

Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.

Group Type ACTIVE_COMPARATOR

Vibration

Intervention Type DEVICE

Vibration Assist Device, held to the forehead

Tapping

Intervention Type OTHER

Tapping on the forehead

Group B: Vibrate then Tap

Vibration first, then tapping

Group Type EXPERIMENTAL

Vibration

Intervention Type DEVICE

Vibration Assist Device, held to the forehead

Tapping

Intervention Type OTHER

Tapping on the forehead

Interventions

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Vibration

Vibration Assist Device, held to the forehead

Intervention Type DEVICE

Tapping

Tapping on the forehead

Intervention Type OTHER

Other Intervention Names

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Facial Massager

Eligibility Criteria

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Inclusion Criteria

* adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Exclusion Criteria

* previous eyelid surgery
* inability to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winnipeg Regional Health Authority

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Yen Minh Cung

MD, Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yen Minh Cung, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Dept of Ophthalmology

Locations

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Misericordia Health Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Gostimir M, Hussain A. A Systematic Review and Meta-analysis of Methods for Reducing Local Anesthetic Injection Pain Among Patients Undergoing Periocular Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):113-125. doi: 10.1097/IOP.0000000000001209.

Reference Type BACKGROUND
PMID: 30664129 (View on PubMed)

Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.

Reference Type BACKGROUND
PMID: 18784857 (View on PubMed)

Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2.

Reference Type BACKGROUND
PMID: 23985640 (View on PubMed)

Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x.

Reference Type BACKGROUND
PMID: 20883298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31513234 (View on PubMed)

Ing EB, Philteos J, Sholohov G, Kim DT, Nijhawan N, Mark PW, Gilbert J. Local anesthesia and anxiolytic techniques for oculoplastic surgery. Clin Ophthalmol. 2019 Jan 10;13:153-160. doi: 10.2147/OPTH.S188790. eCollection 2019.

Reference Type BACKGROUND
PMID: 30666086 (View on PubMed)

Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

Reference Type BACKGROUND
PMID: 5320816 (View on PubMed)

Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. doi: 10.1046/j.1524-4725.2001.01854.x.

Reference Type BACKGROUND
PMID: 11849262 (View on PubMed)

Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.

Reference Type BACKGROUND
PMID: 15530291 (View on PubMed)

McKinlay JR, Hofmeister E, Ross EV, MacAllister W. EMLA cream-induced eye injury. Arch Dermatol. 1999 Jul;135(7):855-6. doi: 10.1001/archderm.135.7.855. No abstract available.

Reference Type BACKGROUND
PMID: 10411170 (View on PubMed)

Reed ML. Surgical pearl: mechanoanesthesia to reduce the pain of local injections. J Am Acad Dermatol. 2001 Apr;44(4):671-2. doi: 10.1067/mjd.2001.110641. No abstract available.

Reference Type BACKGROUND
PMID: 11260545 (View on PubMed)

Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.

Reference Type BACKGROUND
PMID: 10352653 (View on PubMed)

Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

Reference Type BACKGROUND
PMID: 11690728 (View on PubMed)

Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. doi: 10.1016/j.ophtha.2009.11.025. Epub 2010 Mar 19.

Reference Type RESULT
PMID: 20303597 (View on PubMed)

Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.

Reference Type RESULT
PMID: 22001341 (View on PubMed)

Related Links

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Other Identifiers

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HS25941

Identifier Type: -

Identifier Source: org_study_id

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