title: Effects of earplugs and eye masks combined with relaxing music on sleep, melatonin and cortisol levels in ICU patients: a randomized controlled trial.
abstract: BACKGROUND
  Intensive care unit (ICU) environmental factors such as noise and light have been cited as important causes of sleep deprivation in critically ill patients. Previous studies indicated that using earplugs and 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 earplugs and eye masks with relaxing background music on sleep, melatonin and cortisol levels in ICU patients.
  
  
  METHODS
  Fifty patients who underwent a scheduled cardiac surgery and were expected to stay at least 2 nights in Cardiac Surgical ICU (CSICU) were included. They were randomized to sleep with or without earplugs and eye masks combined with 30-minute relaxing music during the postoperative nights in CSICU. Urine was analyzed for nocturnal melatonin and cortisol levels. Subjective sleep quality was evaluated using the Chinese version of Richards-Campbell Sleep Questionnaire (a visual analog scale, ranging 0-100).
  
  
  RESULTS
  Data from 45 patients (20 in intervention group, 25 in control group) were analyzed. Significant differences were found between groups in depth of sleep, falling asleep, awakenings, falling asleep again after awakening and overall sleep quality (P < 0.05). Perceived sleep quality was better in the intervention group. No group differences were found in urinary melatonin levels and cortisol levels for the night before surgery, and the first and second nights post-surgery (P > 0.05). The urinary melatonin levels of the first and second postoperative nights were significantly lower than those of the night before surgery (P = 0.01). The opposite pattern was seen with urinary cortisol levels (P = 0.00).
  
  
  CONCLUSIONS
  This combination of non-pharmacological interventions is useful for promoting sleep in ICU adult patients; however, any influence on nocturnal melatonin levels and cortisol level may have been masked by several factors such as the timing of surgery, medication use and individual differences. Larger scale studies would be needed to examine the potential influences of these factors on biological markers and intervention efficacy on sleep.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-IOR-14005511 . Registered 21 November 2014.
authors.affiliation: School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350108, China. hulu2886@sina.com.
authors.forename: Rong-Fang
authors.initials: RF
authors.lastname: Hu
authors.affiliation: School of Nursing, Fujian Medical University, 1 Xue Yuan Road, University Town, Fuzhou, 350108, China. xiaoyj320@163.com.
authors.forename: Xiao-Ying
authors.initials: XY
authors.lastname: Jiang
authors.affiliation: Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada. kathy.hegadoren@ualberta.ca.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Hegadoren
authors.affiliation: Department of Nuclear Medicine, Fujian Province Hospital, East Street 134, Fuzhou, 350001, China. xinhuining@gmail.com.
authors.forename: You-Hua
authors.initials: YH
authors.lastname: Zhang
mesh_terms: D000328:Adult; D004430:Ear Protective Devices; D004781:Environmental Exposure / Q000009:adverse effects; D005135:Eye Protective Devices; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D007362:Intensive Care Units; D008027:Light / Q000009:adverse effects; D008297:Male; D008550:Melatonin / Q000652:urine; D008875:Middle Aged; D009146:Music; D009622:Noise / Q000009:adverse effects; D017286:Polysomnography; D012890:Sleep / Q000502:physiology*
chemical_list: D008550:Melatonin; D006854:Hydrocortisone