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临床试验/NCT03191370
NCT03191370已完成不适用

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

United Lincolnshire Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月8日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Experimental

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

Experimental

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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