跳至主要内容
临床试验/NCT04959968
NCT04959968已完成不适用

The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery

Taksim Egitim ve Arastirma Hastanesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The Richards-Campbell Sleep Questionnaire

研究概览

简要总结

This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

详细描述

This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

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

  • Patients scheduled for elective craniotomy and intensive care for at least 48 hours
  • Glasgow Coma Scale score = 15
  • Turkish literate

排除标准

  • Diagnosis of sleep disorder
  • Hearing and/or vision loss
  • Hearing aid use
  • Pregnant women
  • Communication and/or cooperation problem
  • Chronic pain medication

结局指标

主要结局

The Richards-Campbell Sleep Questionnaire

时间窗: Post-operative second day of craniotomy

Sleep quality levels of the craniotomy cases

次要结局

  • The General Comfort Questionnaire(Post-operative second day of craniotomy)
  • The Hospital Anxiety and Depression Scale(Post-operative second day of craniotomy)

研究者

发起方
Taksim Egitim ve Arastirma Hastanesi
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验