Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia
研究概览
简要总结
To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients undergoing elective bilateral eye procedures such as blepharoplasty
排除标准
- •previous eyelid surgery
- •inability to give consent
研究组 & 干预措施
Group B: Vibrate then Tap
Vibration first, then tapping
干预措施: Tapping (Other)
Group A: Tap then Vibrate
Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
干预措施: Vibration (Device)
Group A: Tap then Vibrate
Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye.
干预措施: Tapping (Other)
Group B: Vibrate then Tap
Vibration first, then tapping
干预措施: Vibration (Device)
结局指标
主要结局
Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia
时间窗: 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)
次要结局
- Difference in Pain Reduction(Immediately after both eye receive local anesthetic)
研究者
Yen Minh Cung
MD, Principle Investigator
University of Manitoba