The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep quality .
研究概览
简要总结
Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.
详细描述
50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old.
- •Mechanically ventilated patient.
- •Conscious patient.
- •No hearing problems.
- •No eye disease.
- •Not receiving narcotic drugs five to six hours before sleep time at night.
- •No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.
排除标准
- •Head injury.
- •Psychiatric disease.
- •Shocked patients
研究组 & 干预措施
ear plug and eye mask
- The patients will not receive the intervention in the first night (N1) from 9 pm to 6 am
- The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
- The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
- The patients will receive the intervention (eye mask and ear plug) in the fourth night (N4) from 9 pm to 6 am.
干预措施: ear plug (Other)
ear plug and eye mask
- The patients will not receive the intervention in the first night (N1) from 9 pm to 6 am
- The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
- The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
- The patients will receive the intervention (eye mask and ear plug) in the fourth night (N4) from 9 pm to 6 am.
干预措施: eye mask (Other)
control
The researcher will assess and observe the patients who are receiving the routine hospital nursing care during the four nights.
结局指标
主要结局
Sleep quality .
时间窗: four days
to assess sleep quality by using quality of sleep questionnaire or the Richards-Campbell Sleep Questionnaire (RCSQ) (measured by Units on a Scale)
次要结局
- Urine Melatonin(four days)
- Cortisol level(four days)
- Delirium assessment(four days)
研究者
Sayed Kaoud Abd-Elshafy
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University
Assiut University