AzTrials
AzTrials

Anesthetics, LocalNCT06355817

Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration

A study testing Vibration and Tapping in people with Anesthetics, Local and Blepharoplasty, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vibration and Tapping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
21 Sep 2023to 19 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients undergoing elective bilateral eye procedures such as blepharoplasty

Who cannot join

  • previous eyelid surgery
  • inability to give consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Misericordia Health Centre

    Winnipeg, Manitoba, R3C 1A2

Other trials in Canada

About this study

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

Read the 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.

Being tested
Vibration, Tapping
Keywords
Study, Crossover, Pain Measurement, Prospective Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VibrationDevice

    Also called Facial Massager

    Vibration Assist Device, held to the forehead

  • TappingOther

    Tapping on the forehead

Study groups in NCT06355817
Study groupRoleWhat they receive
Group A: Tap then VibrateActive comparatorTapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
Receives: Device: Vibration; Other: Tapping
Group B: Vibrate then TapExperimentalVibration first, then tapping
Receives: Device: Vibration; Other: Tapping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia

    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)

    Measured: Immediately after both eyes receive local anesthetic

Secondary outcomes (1)

  1. Difference in Pain Reduction

    If there was a difference, subjective qualitative grading of how much difference: a little bit, quite a bit, or a lot

    Measured: Immediately after both eye receive local anesthetic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study start21 Sep 2023
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Each patient will receive both interventions and serve as their own comparator.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355817
Sponsor's protocol ID
HS25941
Status last verified
Apr 2024
First submitted
28 Mar 2024
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After 5 years the hard copies of data collection sheets and master list will be shredded.

Publications

  • 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.

    PubMed 30664129

  • 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.

    PubMed 18784857

  • 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.

    PubMed 23985640

  • 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.

    PubMed 20883298

  • 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.

    PubMed 31513234

  • 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.

    PubMed 30666086

  • 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.

    PubMed 5320816

  • 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.

    PubMed 11849262

  • 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.

    PubMed 15530291

  • 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.

    PubMed 10411170

  • 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.

    PubMed 11260545

  • 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.

    PubMed 10352653

  • 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.

    PubMed 11690728

  • 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.

    PubMed 20303597

  • 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.

    PubMed 22001341

Questions about this trial

What is this clinical trial studying?

A study testing Vibration and Tapping in people with Anesthetics, Local and Blepharoplasty, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia (time frame: Immediately after both eyes receive local anesthetic). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06355817, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in