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临床试验/IRCT2014061717237N2
IRCT2014061717237N2已完成3 期

The Effects of Ear Plug and Eye Mask on Nocturnal Sleep Quality in Patients of Cardiac Intensive Care Unit

Deputy of Research and Technology0 个研究点目标入组 68 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
68

研究概览

简要总结

Background: Sleep is a basic human need and factors related to the physical environment are one of the major causes of sleep disorder in patients of cardiac intensive care units. In this study the effect of using eye mask and earplugs on the quality of nocturnal sleep, melatonin and cortisol in cardiac intensive care unit patients were studied.
Materials and Methods: This randomized clinical trial was done in 68 patients of cardiac intensive care unit at a Kordkoy Hospital in 2014. At first, the lighting and the sound of the cardiac intensive care unit was measured for 24 hours in two days. The quality of nocturnal sleep for all participants with VSH-scale was investigated at the second night of admission, as well as urine melatonin and cortisol levels was measured between the hours of 22 pm to 7 am. Participants at the third night of admission were randomly divided into four groups (three experimental groups and one control group). For patients in the intervention groups, respectively eye mask, earplugs and both eye mask and earplugs was used in addition of usual care and there was no intervention for control group. Sleep quality, urine melatonin and cortisol levels in experimental and control group was measured. The data was analyzed in SPSS-16 using ANOVA, ANCOVA and Shapiro-Wilk test.
Results: The mean score of sleep quality showed a significant difference before and after the intervention in all intervention groups (P

研究设计

研究类型
Interventional

入排标准

年龄范围
17 years 至 65 years(—)
性别
All

入选标准

  • Age between 18 and 65 years old, consciousness, orientation to time and place, have no sleep disorders, have no visual and hearing problem, the absence of psychiatric disorders, have no history of night-shift work at least in past 3 years, no use of coffee, alcohol and hypnotic medication at least 12 hours before the study time.
  • Exclusion criteria: Occurrence of sleep disorders during study period (such as sleep apnea, narcolepsy, restless leg syndrome), use of hypnotic medication during study period, the onset of menstruation in female patients during the study, patients who will be discharged or died during the study, sleeping confounding medications (e.g., opiates, amphetamines), receive tranquilizers and anesthetics, cardiopulmonary resuscitation during the study.

排除标准

  • 未提供

研究者

发起方
Deputy of Research and Technology

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