title: The effect of earplugs during the night on the onset of delirium and sleep perception: a randomized controlled trial in intensive care patients.
abstract: BACKGROUND
  This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium. Two research questions were formulated. First, does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU? Second, does the use of earplugs during the night improve the quality of sleep in the ICU?
  
  
  METHODS
  A randomized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night. The researchers were blinded during data collection. Assignment was performed by an independent nurse researcher using a computer program. Eligible patients had an expected length of stay in the ICU of more than 24 hours, were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10. Delirium was assessed using the validated NEECHAM scale, sleep perception was reported by the patient in response to five questions.
  
  
  RESULTS
  The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients. A vast improvement was shown by a Hazard Ratio of 0.47 (95% confidence interval (CI) 0.27 to 0.82). Also, patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs. After the first night in the ICU, patients sleeping with earplugs reported a better sleep perception.
  
  
  CONCLUSIONS
  Earplugs may be a useful instrument in the prevention of confusion or delirium. The beneficial effects seem to be strongest within 48 hours after admission. The relation between sleep, sound and delirium, however, needs further research.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN36198138.
authors.forename: Bart
authors.initials: B
authors.lastname: Van Rompaey
authors.forename: Monique M
authors.initials: MM
authors.lastname: Elseviers
authors.forename: Wim
authors.initials: W
authors.lastname: Van Drom
authors.forename: Veronique
authors.initials: V
authors.lastname: Fromont
authors.forename: Philippe G
authors.initials: PG
authors.lastname: Jorens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003422:Critical Care / Q000379:methods*; D003693:Delirium / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology*; D004430:Ear Protective Devices / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010465:Perception / Q000502:physiology; D016037:Single-Blind Method; D012890:Sleep / Q000502:physiology; D055815:Young Adult