The Effect of Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs in Intensive Care Patients: A Randomized Controlled Study
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
- 2
- 主要终点
- Visual Analog Scale (Fear)
研究概览
简要总结
This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.
详细描述
In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.
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
- Single (Participant)
盲法说明
Experimental group and control group
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years or older,
- •New York Heart Association (NYHA) functional class II and III,
- •Not having received any general anaesthesia for the previous 24 hours,
- •Not having received any sedative medications or opioids for the past 24 hours,
- •Not having a verbal communication disability (hearing and speaking),
- •Absence of pain,
- •Not having a previously diagnosed sleep disorder,
- •Not having psychiatric problems,
- •Not having a cognitive problem,
- •Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.
排除标准
- •Diagnosed with delirium (Intensive care delirium screening checklist >=5),
- •Unconscious (Glasgow coma scale<13),
- •Presence of additional chronic diseases,
- •Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study,
- •Patients whose condition suddenly worsened,
- •Those who cannot use earplugs and eye masks effectively at night,
- •Those who voluntarily withdrew from the study and were transferred from the intensive care unit.
结局指标
主要结局
Visual Analog Scale (Fear)
时间窗: the first day after receiving randomisation
Patients are asked to show the severity of their fear on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Visual Analog Scale (Anxiety)
时间窗: the first day after receiving randomisation
Patients are asked to show the severity of their anxiety on a 10 cm long vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm.
Vital Signs Follow-up Form
时间窗: the first day after receiving randomisation
This form was created by the researcher in order to record the systolic-diastolic blood pressure, and heart rate (pulse), values of the patient who was applied an eye patch or earphone at night.
The Richards-Campbell Sleep Questionnaire
时间窗: the first day after receiving randomisation
This brief five-item questionnaire was used to evaluate perceived sleep depth, sleep latency (time to fall asleep), number of awakenings, efficiency (percentage of time awake), and sleep quality. It also includes a sixth item evaluating perceived night-time noise. Each item is evaluated on a scale of 0-100 with a visual analogue scale technique. A score of 0-25 indicates very poor quality sleep, whereas a score of 76-100 indicates very good sleep quality.
次要结局
- Visual Analog Scale (Fear)(4. days)
- Visual Analog Scale (Anxiety)(4. days)
- Vital Signs Follow-up Form(4. days)
- The Richards-Campbell Sleep Questionnaire(4. days)
研究者
Zülfünaz ÖZER
Investigator
Istanbul Sabahattin Zaim University