The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients

The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients: an observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36198138

Enrollment

Registered

2011-12-09

Start date

2008-11-21

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium in intensive care patients Mental and Behavioural Disorders Delirium, unspecified

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026