The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Richards-Campbell Sleep Scale
研究概览
简要总结
Coronary artery bypass grafting is the most commonly performed surgical procedure among cardiovascular diseases. Nursing care for patients undergoing cardiac surgery involves a process that includes preoperative preparation and subsequent close monitoring of neurological, cardiac, respiratory, vascular status, kidney function, and pain. Sleep disturbances are observed after cardiac surgery. Sleep plays a critical role in the body's maintenance, repair, and renewal processes. Improved sleep can reduce patient agitation and decrease the risk of delirium. The presence of delirium leads to increased care requirements and prolonged hospital stays, which in turn raises hospital costs. Enhancing sleep quality and preventing delirium after surgery have positive effects on clinical patient outcomes. This study is designed to determine the effects of using eye masks and/or earplugs on sleep quality and delirium in patients undergoing coronary artery bypass grafting during nighttime sleep. This research is a randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily agree to participate in the study
- •Those who have undergone coronary artery bypass graft surgery
- •Those between the ages of 18-79
- •Those who are cooperative and oriented
- •Those who are literate
- •Those who speak Turkish
- •Those whose initial delirium scale score (Nu-DECS) is less than 2
- •Those whose Glasgow coma scale score is >13 will be included in the study.
排除标准
- •• Patients diagnosed with sleep disorders,
- •Those using sleeping pills,
- •Those who have a habit of using an eye patch while sleeping,
- •Those who were not transferred to the clinic on the first day after surgery and whose treatment continues in the intensive care unit,
- •Those who develop complications and/or need to be re-operated,
- •Those who need treatment other than routine treatment,
- •Patients with hearing or vision problems will be excluded.
研究组 & 干预措施
no mask no earblugs
No intervention will be performed on the 1st, 2nd and 3rd postoperative day.
Repeated monitoring will be performed on the 2nd, 3rd and 4th postoperative day using RCUÖ and Nu-DESC.
Patients who wish to leave the study at any stage, who do not perform the intervention, or who die during follow-up will be excluded from the study.
Earplugs
The reserved intervention will be applied during the night sleep with earplugs on the 1st, 2nd and 3rd day group after the surgery.
Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery.
Patients who want to leave at any stage of the study, do not receive the reserved intervention or die during the monitoring will be excluded from the study.
Eye Mask and Earplugs
On the 1st, 2nd and 3rd postoperative day, the experimental group will be given the intervention reserved during their night sleep, using eye patches and earplugs.
On the 2nd, 3rd and 4th postoperative day, repeated monitoring will be performed using RCUÖ and Nu-DESC.
Patients who wish to leave the study at any stage, do not receive the reserved intervention or die during the monitoring will be excluded from the study.
Eye Mask
The intervention allocated during night sleeps with Eye Mask applied on the 1st, 2nd and 3rd days after the surgery will be applied.
Repeated monitoring will be done using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after the surgery.
Patients who want to leave at any stage of the study, do not perform the allocated intervention or die during the follow-up will be excluded from the study.
干预措施: Eye mask (Other)
结局指标
主要结局
Richards-Campbell Sleep Scale
时间窗: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
The RCUS was developed by Richards and colleagues (1987) to assess sleep. The RCUS includes six items (sleep depth, time to fall asleep, frequency of awakenings, time to remain awake when awakened, quality of sleep, and ambient noise level). Each item is rated using a 0-100 visual analog scale. The total score is obtained by dividing the individual items by their numbers: 0 represents the worst sleep, 100 the best sleep. As the score obtained from the scale increases, the sleep quality of the patients also increases. The RCUS provides a short, applicable, comprehensive, and simple tool for assessing sleep quality in the intensive care unit and is the most common. The Cronbach α value of the scale was found to be 0.82. The validity and reliability study of the scale in our country was conducted by Karaman Özlü and Özer (2015). The Cronbach Alpha internal consistency coefficient of the scale was found to be 0.91.
Nursing Delirium Screening Scale- Nu-DESC
时间窗: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.
The scale consists of five items. These are; disorientation, inappropriate behavior, inappropriate communication, illusion-hallucination and slowness in psychomotor behavior. It is critical that all subtypes can be detected in an effective delirium diagnosis. Among the items in Nu-DESC, it is thought that hypoactive delirium is detected more successfully with the item that evaluates psychomotor slowness. Each item in the scale takes a value between 0 and 2 points and the total score varies between 0 and 10. Two points and above indicate delirium. The evaluation time is approximately one minute.
次要结局
未报告次要终点
研究者
Zeliha Birer
Nurse
Necmettin Erbakan University