CompletedNot Applicable

Noise in the Intensive Care Unit

Netherlands75 participantsStarted 2013-04

Plain-language summary

Rationale: Sound levels in the Intensive Care Unit are frequently reported to exceed the recommended levels. It is plausible to assume that this causes sleep disturbance in the patients on the ICU. Goals/endpoints: to assess sound pressure levels in 6 different Dutch ICU´s and evaluate the effect of higher levels on sleep as perceived by the patient. Study design: observational multicenter study Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Study parameters/endpoints: Primary 1. To gather information on how Dutch ICUs perform on sound levels 1. Average sound pressure level 2. Number of sound peaks 2. To question patients about their perception of sleep quality (measured by RCSQ) 3. Causes of elevated sound pressure levels 4. Identification of the most annoying sounds experienced by the patient Secondary 1\) Incidence of delirium measured by CAM-ICU

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult ICU patient * RASS -2 - +1 * 48 hours after admission on ICU * Expected ICU stay \>24 hours Exclusion Criteria: * Unfavourable prognosis (life expectancy \< 48 hours) * Inability to understand Dutch, including total deafness * Inability to complete visual analog scale due to visual impairment blindness, and/or severe psychomotor retardation * Delirium (defined as positive CAM-ICU) * Participation of the patient in other studies

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Noise Level

Timeframe: 6 months

Trial details

NCT IDNCT01826799

SponsorJeroen Bosch Ziekenhuis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Noise in the ICU trials