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临床试验/NCT03213860
NCT03213860已完成不适用

The Effect of Night Eye Mask on Post-operative Pain in Cardiac Surgery Patients

Assiut University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

Environmental factors such as noise and light have been cited as important causes of sleep deprivation in Intensive care unit (ICU) patients. Previous studies demonstrated a hyperalgesic alteration in pain perception following a controlled sleep deprivation protocol. Another studies indicated that using eye masks can improve REM sleep in healthy subjects in simulated ICU environment, and improve sleep quality in ICU patients. This study aimed to determine the effects of using eye masks on sleep and thus on pain quality in postoperative cardiac surgery patients in ICU.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

While it is not possible to blind participants and clinical staff to the assigned interventions, the assessments will be undertaken by a researcher blinded to group allocation.

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

  • (1) age ≧18 years; (2) no history of neurological or psychiatric disorders; (3) ability of patients to communicate verbally and understand the sleep questionnaires administered in the ICU; (3) length of ICU stay ≥48 hours; (4) Glasgow coma score (GCS) >8 in the first to third day. Postoperative Extubation of MV within few hour (before the time of 9 pm for postoperative patients.

排除标准

  • Patients over age 65 were excluded from the study because of potential age-related differences in sleep. Patients reporting frequent nighttime awakenings, snoring, or chronic use of benzodiazepines or opioids were excluded because of potential confounding influences of these factors on postoperative sleep, pain, or opioid requirement.

结局指标

主要结局

postoperative pain

时间窗: 3 postoperative days

visual analogue scale will be used. ranging from 0 mm (no pain) to 100 mm (worst pain imaginable).

次要结局

  • Quality of sleep(3 postoperative days)

研究者

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

Mostafa Samy Abbas

Lecturer

Assiut University

研究点 (2)

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