Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration
NCT ID: NCT06355817
Last Updated: 2024-04-22
Study Results
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2023-09-21
2024-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
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.
Vibration
Vibration Assist Device, held to the forehead
Tapping
Tapping on the forehead
Group B: Vibrate then Tap
Vibration first, then tapping
Vibration
Vibration Assist Device, held to the forehead
Tapping
Tapping on the forehead
Interventions
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Vibration
Vibration Assist Device, held to the forehead
Tapping
Tapping on the forehead
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* inability to give consent
18 Years
ALL
No
Sponsors
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Winnipeg Regional Health Authority
OTHER
University of Manitoba
OTHER
Responsible Party
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Yen Minh Cung
MD, Principle 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
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Specific vibration assist device used in the study
Other Identifiers
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HS25941
Identifier Type: -
Identifier Source: org_study_id
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