Pragmatic Randomised Controlled Trial Assessing the Use of a Simple Distraction Technique to Reduce Discomfort When Performing Transnasal Fiberoptic Laryngoscopy in the ENT Outpatient Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Discomfort during procedure
研究概览
简要总结
To compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.
详细描述
In this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. The distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. All flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. The procedure will be carried out in standard outpatient clinic room setting. Post procedural discomfort assessments will be undertaken using a visual analogue scale (VAS). Power calculations shows that >24 patients would result in an adequately powered study (>80%). Data analysis will be undertaken by SPSS and independent T-tests will be performed to assess for statistical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female participants aged 18+
- •Patient requires flexible fiberoptic transnasal laryngoscopy.
- •Patient has no preferences in relation to which arm of the study they would like to be in.
排除标准
- •Flexible nasal endoscopy not indicated
- •Local anaesthetic required for other reasons - e.g. vasoconstrictor effects
- •Patient has a clear preference to which group they are randomised to
- •Significant sino-nasal disease
- •Patient under the age of 18
研究组 & 干预措施
Local Anaesthetic, no distraction
Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) as an active comparator without distraction during the procedure.
干预措施: Local Anesthetics,Topical (Drug)
Local Anaesthetic, with distraction
Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.
干预措施: Simple distraction technique (Other)
Local Anaesthetic, with distraction
Will receive local (co-phenylcaine) anesthetic spray (Local Anesthetics,Topical) with distraction during the procedure. The simple distraction technique is the experimental intervention.
干预措施: Local Anesthetics,Topical (Drug)
No Local Anaesthetic, with distraction
Will receive no local (co-phenylcaine) anesthetic spray with distraction during the procedure. The simple distraction technique is the experimental intervention.
干预措施: Simple distraction technique (Other)
结局指标
主要结局
Discomfort during procedure
时间窗: 5 minutes
Visual analogue discomfort scale
次要结局
未报告次要终点
