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临床试验/NCT06527105
NCT06527105招募中不适用

The Effects of Non-pharmacological Interventions on the Quality of Sleep in Cardiac Surgical Patients

Amrita Institute of Medical Sciences & Research Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月22日最近更新:
适应症

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

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

发起方
Amrita Institute of Medical Sciences & Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nagarjuna P

Assistant Professor, Department of Cardiac Anesthesia

Amrita Institute of Medical Sciences & Research Center

研究点 (2)

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