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临床试验/NCT02612636
NCT02612636已完成不适用

The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Sleep quality .

研究概览

简要总结

Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.

详细描述

50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old.
  • Mechanically ventilated patient.
  • Conscious patient.
  • No hearing problems.
  • No eye disease.
  • Not receiving narcotic drugs five to six hours before sleep time at night.
  • No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.
  • Exclusion Criteria
  • Head injury.
  • Psychiatric disease.
  • Shocked patients

排除标准

  • 未提供

结局指标

主要结局

Sleep quality .

时间窗: four days

to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)

次要结局

  • Cortisol level(four days)
  • Urine Melatonin(four days)
  • Delirium assessment(four days)

研究者

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

Sayed Kaoud Abd-Elshafy

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Assiut University

研究点 (2)

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