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The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients
DOI 10.1186/ISRCTN36198138
ClinicalTrials.gov identifier
EudraCT number
Public title The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients
Scientific title The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients: an observational study
Acronym N/A
Serial number at source N/A
Study hypothesis Sleeping with earplugs during the night lowers the prevalece of delirium and confusion in intensive care patients. Also, sleep perception will improve.
Lay summary Lay summary under review 3
Ethics approval The study was approved by the ethical board of the Antwerp University hospital in November 2008, reference number 8/40/223
Study design Single center observational randomized clinical trial
Countries of recruitment Belgium
Disease/condition/study domain Delirium in intensive care patients
Participants - inclusion criteria 1. Adult (18 year or older)
2. The expected length of stay in the intensive care unit (ICU) was over 24 hours
3. Dutch or English speaking
4. Scoring a minimum Glasgow Coma Scale of 10
Participants - exclusion criteria 1. Patients with known hearing impairment
2. Dementia
3. Confusion or delirium at admittance
4. Also, sedation was used as a exclusion criterion to optimize the assessment of delirium and sleep perception
Anticipated start date 21/11/2008
Anticipated end date 01/04/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants When the use of earplugs could lower the incidence of ‘delirium or confusion’ with 20%, a power of 0.80 and á=0.05 showed that 46 patients in each group had to be included
Interventions The researchers screened all intensive care patients on a daily basis to invite eligible patients to the study. After giving informed consent, an independent nurse researcher assigned the patients to the study group or the control group. Next, a nontransparent canister holding earplugs or a dummy was positioned at the bedside of the patient. Tthe critical care nurse opened the cannister at 22.00 hr and positioned the earplugs when present. A second assignment at 06.00 hr asked the critical care nurse to remove the earplugs from the patient and to keep them in the closed canister again. When the canister contained a dummy instead of earplugs, no action was undertaken. Patients and staff were instructed not to report on wearing earplugs or not during the night to the researchers. One of the blinded researchers visited the patients during the morning to assess them for delirium and sleep perception.
Primary outcome measure(s) 1. Delirium was assessed using the Neelon and Champagne Confusion Scale (NEECHAM)
1.1. The NEECHAM is based on the nurses’ twenty-four hour assessment of the level of processing information, the level of behavior and the physiological condition rating the patient on a 30-0 scale. Next, the results can be classified in one of four categories. The cut-off values, 30-27 ‘normal’, 26-25 ‘at risk’, 24-20 ‘early to mild confusion’ (mild confusion) were standardized. The scores 19-0 ‘moderate to severe confusion’ show delirium in the studied patient.
2. Sleep perception was assessed using five dichotomous questions on the self reported sleep quality of the patient:
2.1. Did you sleep well? 2.2. Did you sleep better as expected?
2.3. Did you sleep better than at home?
2.4. Were you awake for a long time before falling asleep?
2.5. Do you feel sufficiently rested? The score on question four was reversed. A higher total sum score on the five questions showed a better sleep perception.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding University of Antwerp (Belgium)
Trial website
Contact name Prof  Bart  Van Rompaey
  Address Universiteitsplein 1
Gebouw R 3.30
  City/town Antwerp
  Zip/Postcode 2610
  Country Belgium
  Email bart.vanrompaey@ua.ac.be
Sponsor University of Antwerp (Belgium)
  Address Faculty of Medicine and Healthcare
Division of Nursing Science and Midwifery
Universiteitsplein 1
  City/town Antwerp
  Zip/Postcode 2610
  Country Belgium
  Sponsor website: http://www.ua.ac.be/
Date applied 11/11/2011
Last edited 17/07/2013
Date ISRCTN assigned 09/12/2011
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