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

ISRCTN	ISRCTN36198138
DOI	https://doi.org/10.1186/ISRCTN36198138
Secondary identifying numbers	N/A

Submission date: 11/11/2011
Registration date: 09/12/2011
Last edited: 11/12/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Delirium is a state of mental confusion that can happen if you become medically unwell. It is a common complication in the intensive care unit (ICU). The aim of this study is to find out whether delirium can be prevented in ICU patients by using earplugs at night.

Who can participate?
Adult patients staying for at least one night in the intensive care department of the Antwerp University Hospital.

What does the study involve?
Participants are randomly allocated either to wear earplugs overnight or to not wear earplugs overnight. Delirium and sleep quality are assessed on the following morning.

What are the possible benefits and risks of participating?
The intervention did not interfere with the treatment or standard ICU care. No risks were expected.

Where is the study run from?
University of Antwerp (Belgium).

When is the study starting and how long is it expected to run for?
November 2008 to April 2010.

Who is funding the study?
University of Antwerp (Belgium).

Who is the main contact?
1. Prof dr P Jorens
2. Prof dr B Van Rompaey (bart.vanrompaey@ua.ac.be)

Contact information

Prof Bart Van Rompaey
Scientific

Universiteitsplein 1
Gebouw R 3.30
Antwerp
2610
Belgium

Email	bart.vanrompaey@ua.ac.be

Study information

Study design	Single-center observational randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of earplugs during the night on the onset of delirium and sleep perception in intensive care patients: an observational study
Study objectives	Sleeping with earplugs during the night lowers the prevalence of delirium and confusion in intensive care patients. Also, sleep perception will improve.
Ethics approval(s)	Ethical board of the Antwerp University hospital, November 2008, ref: 8/40/223
Health condition(s) or problem(s) studied	Delirium in intensive care patients
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	21/11/2008
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
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
Key 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
Key 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
Date of first enrolment	21/11/2008
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

Belgium

Study participating centre

University of Antwerp

Antwerp
2610
Belgium

Sponsor information

University of Antwerp (Belgium)
University/education

Faculty of Medicine and Healthcare
Division of Nursing Science and Midwifery
Universiteitsplein 1
Antwerp
2610
Belgium

Website	http://www.ua.ac.be/
"ROR"	https://ror.org/008x57b05

Funders

Funder type

University/education

University of Antwerp (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/05/2012		Yes	No