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临床试验/NCT02637882
NCT02637882Unknown2 期

The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
50
试验地点
1
主要终点
decrease delirium incidence

研究概览

简要总结

The patients will exposed to different intervention through three nights (ear plug, eye mask). 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).

详细描述

The multicomponent bundle of interventions is designed to be multidisciplinary, and included measures taken to reduce noise, light and iatrogenic sleep disturbance, as well as attempts to modify risk factors for delirium. The patients will exposed to different intervention through three nights (ear plug, eye mask) grouping of nursing activity to be delivered before the 23:00 or delay their completion until after 08:00 where possible. Orientate patients regarding time, place and date every eight hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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
否

入选标准

  • •Age >18 years old.
  • •No hearing problems.
  • •No eye disease.

排除标准

  • •Head injury.
  • •Psychiatric disease.
  • •Shocked patients

研究组 & 干预措施

First intervention (ear plug)

Experimental

Other: ear plug

Other Name: eastnova ear plug

干预措施: Ear plug (Other)

Second intervention (eye mask)

Other

Other: eye mask

The patients will receive the second intervention (eye mask) in the second night (N2) from 9 pm to 6 am.

Other Name: Sleeping mask

干预措施: Eye mask (Other)

Ear plug and eye mask

Other

The patients will receive the mixed intervention (eye mask) and (ear plug ) in the first night (N1) from 9 pm to 6 am.

干预措施: Mixed intervention (ear plug and eye mask) (Other)

结局指标

主要结局

decrease delirium incidence

时间窗: 8 month

the patients will exposed to multi-component bundle

次要结局

未报告次要终点

研究者

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

Ghada Shalaby

principal investigator

Assiut University

研究点 (1)

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