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临床试验/NCT04178252
NCT04178252已完成不适用

Effectiveness of Eye Mask and Noise Reduction Headset in Emergency Treatment of Primary Headache

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
change in pain

研究概览

简要总结

Primary headache can be triggered by light or noise. Getting rest in a quiet and dark environment for the treatment of acute headache is recommended for relief of pain during an attack. It is hard to provide this kind of environment in a busy emergency department. We aimed to determine if eye masks and noise reduction head sets are effective in reducing pain scores, fastening pain relief when used together with standard care. We also aimed to see if these methods were preferred over standard care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • patients with current headache as a chief complaint presenting to Emergency Department
  • triage category 3,4,
  • preliminary clinical diagnosis of primary headache is made after brief history and physical exam by the attending emergency physician according to International Classification of Headache disorders version 3
  • the attending physician ordered IV treatment

排除标准

  • known or suspected diagnosis of a secondary etiology of headache at presentation or at any point during the Emergency Department visit
  • head trauma within 14 days
  • inability comply with the study due to insufficient knowledge of Turkish language
  • known allergy to standard treatment or rescue treatment
  • history of GI bleeding in the last year
  • taking any analgesic drug in the last four hours or taking the maximum dose of standard treatment before coming to Emergency Department
  • hepatic or renal failure
  • patients with hearing or vision loss

结局指标

主要结局

change in pain

时间窗: 60 min

Change in pain measured by visual analogue scale from baseline measurement achieved at min 0. Investigators will use a 100mm visual analogue scale in which 0 represents no pain and 100 mm represents worse pain ever

次要结局

  • preference of method over standard treatment(60 min)
  • need for rescue analgesic drug(60 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gul Pamukcu Gunaydin

MD, Faculty Member of Ankara Yildirim Beyazıt University, Principal Investigator

Ankara City Hospital Bilkent

研究点 (1)

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