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临床试验/NCT05408650
NCT05408650Unknown不适用

Effectiveness of Aromatherapy Massage on Sleep Quality and Physiological Parameters of Post-Operative Cardiothoracic Surgery Patients

Mansoura University0 个研究点目标入组 62 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
主要终点
Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire

研究概览

简要总结

Poor sleep is common in the ICU, especially among post-operative CABG and more severely ill patients. Additionally, patients after surgery suffer from changes in physiological parameters related to ICU stressors. Pharmacological interventions for sleep improvement can both disrupt and induce sleep and have many negative side effects on intensive care patients. Therefore, this gives the green light for using complementary therapy.

详细描述

Critically ill patients suffer from decreased sleep quality, especially in patients who fear death and are more severely ill. The critical care experience is stressful for patients and can result in numerous physiological and psychological effects, including physiological instability as an increase in the heart rate (HR), respiration rate (RR), and risk of cardiac dysrhythmias, leading to prolonged length of stay and subsequent complications. Sleep is affected by a variety of factors, including hospitalization and the severity of the disease. Therefore, improving the sleep quality of cardiac patients is one of the most important nursing interventions.

Sleep is a circadian state characterized by the partial or total suspension of consciousness, voluntary muscle inhibition, and relative insensitivity to stimulation. Sleep quality is an individual's general satisfaction with the sleep experience, and its main components are the quantity of sleep, sleep continuity, and a reviving feeling upon awakening. Short sleep duration is defined as less than seven hours of sleep per 24-hour period.

Sleep is a biological need for many physiological processes under primary neurobiological regulation that affects many physiological systems, so sleep is necessary for the body to repair and restore itself. At least when compared to the early morning hours, an increase in parasympathetic cardiac transition during non-rapid eye movement sleep 2 makes the nighttime a period of proportional protection from cardiovascular diseases (CVD) events. Sleep and sleep disturbances affect various components of human homeostasis, including the cardiovascular system.

Cardiovascular diseases are the most common cause of death globally, taking an estimated 17.9 million lives each year. Over three-quarters of CVD deaths take place in low and middle-income countries. In the Eastern Mediterranean Region, more than 1.3 million people died of CVD, which equals one-third of all deaths annually. Sleep disturbance is a common problem in cardiac patients. Cardiac surgery patients' perceptions of their sleep in the intensive care unit (ICU) indicate that it is inadequate.

Sleep disturbance occurs in 60 to 80% of patients in the first few days after heart surgery. One of the most common causes of sleep disturbance after coronary artery bypass graft (CABG) is subsequent alterations in physiological parameters such as systolic and diastolic blood pressure (SBP and DBP), RR, and HR.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Adult conscious patients ≥ 18 years of both gender
  • ICU length of stay > 2 nights
  • Physiologically or hemodynamically stable
  • Free from skin problems and fractures in the area of massage

排除标准

  • Patients who are on sedative drugs or narcotic analgesics
  • Patients with an allergic history to lavender oil
  • Mechanically ventilated patients
  • History of sleep disorders
  • History of mental disorders

结局指标

主要结局

Quality of sleep or Level of sleep as assessed by Richards-Campbell Sleep Questionnaire

时间窗: 2 days

Sleep quality will be assessed by Richards-Campbell Sleep Questionnaire which covers five aspects of sleep: depth, latency, frequency of awakening, percentage of time awake, and sleep quality. A total score is obtained by summing each score out of 100, then dividing the total by five and ranking the total score into three categories as follows: * A score from 0 mm to 33 mm indicates poor sleep * A score of between 33 mm to 66 mm indicates normal sleep * A score of over 66 mm indicates very good sleep

Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.

时间窗: 2 days

Physiological parameters include heart rate, respiratory rate, systolic and diastolic blood pressure, mean arterial blood pressure, and percutaneous oxygen saturation, which will be assessed by a bedside electronic monitor.

次要结局

未报告次要终点

研究者

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

Aya Ali Saad Elhusseini

Principle Investigator (Demonstrator of critical care and emergency nursing)

Mansoura University

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