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临床试验/NCT06268158
NCT06268158已完成不适用

The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit Following Abdominal Surgery

TC Erciyes University2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2023年4月1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
45
试验地点
2
主要终点
Richard-Campbell Sleep Scale

研究概览

简要总结

After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.Considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, 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
Prevention
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

  • Those who have had abdominal surgery
  • Those who volunteer to participate in the research
  • Those who are over 18 years old
  • Richmond Agitation-Sedation Scale -1, 0, +1
  • Those who have been in intensive care for at least 3 days
  • No communication problems (language, hearing impairment, etc.)
  • No mental problems
  • Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.

排除标准

  • Those who experience blood loss and fluid electrolyte imbalance after surgery
  • There are contraindications to the use of eye masks (for example, head trauma),
  • Patients with delirium before or after surgery will not be included in the study.

结局指标

主要结局

Richard-Campbell Sleep Scale

时间窗: day 1 and 4 of the study

It is a scale consisting of 6 items that evaluate the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. The 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.

Nursing Delirium Screening Scale

时间窗: day 1 and 4 of the study

The scale consists of 5 items, including disorientation, inappropriate behavior, inappropriate communication, illusion-hallucination and slowing down of psychomotor behaviors. Each item in the scale receives a value between 0 and 2 points, and the total score varies between 0 and 10. A score of two and above indicates delirium.

次要结局

  • Richmond Agitation-Sedation Scale(day 1)

研究者

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

Yeliz Sürme

Assoc.Prof. Dr.

TC Erciyes University

研究点 (2)

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