跳至主要内容
临床试验/NCT05000476
NCT05000476Unknown不适用

Effect of Eye Mask and Earplugs on Prevention of Delirium in Intensive Care Patients

Baskent University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2020年2月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
delirium

研究概览

简要总结

This research is planned as a randomized controlled experimental study to examine the effect of using eye mask and earplugs in preventing delirium with evidence-based nonpharmacological nursing interventions in intensive care units.

详细描述

In the prevention of delirium, the necessity of using a multicomponent, nonpharmacological interventions is emphasized and focused on nursing interventions. In this regard, it is believed that the use of eye mask and ear plugs, which have recently started to take place in the guides, as well as known evidence-based nursing interventions, will provide nurses with power to improve delirium-related outcomes.

The research is expected to consist of intervention and control groups older than 18, volunteering to participate in the research, which the expected length of stay in the ICU more than 24 hours at Başkent University Ankara Hospital. Data will be collected through Patient Information Form, APACHE II, Glasgow Coma Scale, Richmond Sedation Agitation Scale, Nursing-Delirium Screening Scale, Richard-Campbell Sleep Scale and Daily Monitoring Form. In preparation step of the research, nurses will be trained, guidelines are required for nurses, necessary interventions will be planned. At the application stage , after determining the experimental and control groups, eye mask and ear plugs will be given before going to sleep in addition to the patients in the experimental group, before going to sleep, and followed for three days. Also, it will be examined through a semi-structured interview technique for the examination of patients in the experimental group.It is believed that the early diagnosis of delirium, nonpharmacological interventions to be implemented will affect the diagnosis-treatment costs positively by reducing morbidity and mortality rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, 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

  • The expected duration of stay in the intensive care unit is more than 24 hours.
  • In the first 24 hours of hospitalization,
  • On mechanical ventilation, conscious patients
  • Patients who volunteered to participate in the study
  • Not using sleeping pills* * Prescription drugs (benzodiazepines, nonbenzodiazepines), quetiapine, antihistamines, antidepressants used for their sedative effects

排除标准

  • Suspected or approved drug or alcohol poisoning
  • Contraindication to the use of earplugs or eye masks (eg facial trauma or other safety concerns)
  • Patients using hearing aids
  • Severe neurological deficits defined as coma (Richmond Agitation Sedation Score <-4 or -5 (deeply sedated and coma) due to cranial trauma, malignancy, anoxic brain injury, or cerebral edema)
  • Having a known cognitive disorder (such as dementia, Alzheimer's, psychosis.)
  • Patients with a Glasgow coma scale (GCS) of 8 and below

结局指标

主要结局

delirium

时间窗: three days

The effect of non-pharmacological interventions on the prevalence of delirium

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

Gülşen Kılıç

Nurse

Baskent University

研究点 (2)

Loading locations...

相似试验