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临床试验/NCT05564351
NCT05564351已完成不适用

Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study

Mersin University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月10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
120
试验地点
1
主要终点
Richards Campbell Sleep Scale

研究概览

简要总结

This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the "Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask". As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night's sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years or older
  • Being literate
  • No hearing impairment
  • Ability to communicate verbally
  • Receiving inpatient treatment in the GICU for at least 3 days
  • Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response)
  • Agreeing to participate in the research

排除标准

  • Having a Visual Analog Scale (VAS) score above 7
  • Using sleeping pills or sedative drugs
  • Being treated with a diagnosis of sleep disorder
  • Being on mechanical ventilation
  • Having an active ear or eye infection
  • Having a diagnosed psychiatric illness

结局指标

主要结局

Richards Campbell Sleep Scale

时间窗: Three day

RCSS is a six-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of waking, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment.

次要结局

  • Visual Analog Scale(Three day)

研究者

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

AYSUN KAZAK

Lecturer

Mersin University

研究点 (1)

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