The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of sleep
研究概览
简要总结
Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.
The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease
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
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery
排除标准
- •Not willing to give consent
- •Preoperative sleep medications use
- •Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident
结局指标
主要结局
Quality of sleep
时间窗: 6 months
On the morning after the intervention, patient's sleep quality will be assessed using Richard-Campbell sleep questionnaire (RCSQ). Each point in RCSQ will be scored using a visual analog score, ranging from 0-100. Total score will be calculated and then will be divided by 5.
次要结局
- Atrial fibrillation(6 months)
- Vasoactive inotropic score(6 months)
- Mechanical ventilation(6 months)
- Delirium(6 months)
- Intensive care unit stay(6 months)
研究者
Nagarjuna P
Assistant Professor, Department of Cardiac Anesthesia
Amrita Institute of Medical Sciences & Research Center
