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Triple Sleep-promotion Protocol for Delirium Prevention in Intensive Care Patients

RecruitingNAAges 18 Years - anyAllNaile ALANKAYA
NCT07801092 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Delirium is a common complication in intensive care units (ICUs) and may be associated with sleep disruption and frequent nighttime disturbances. This randomized controlled trial will evaluate whether a multicomponent nighttime sleep-promotion intervention, called the Triple Sleep-Promotion Protocol, can reduce the occurrence of new-onset delirium in adult ICU patients. The study is being conducted in four ICUs in Türkiye. Eligible patients who do not have delirium at the beginning of the study will be randomly assigned to either the intervention group or the control group. The intervention includes clustering nighttime nursing care, offering an eye mask and earplugs during protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. Patients in the control group will receive usual ICU care. Patient safety and clinically necessary care will tak

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older. * Admitted to one of the participating intensive care units. * Expected ICU stay of at least 24 hours. * Richmond Agitation-Sedation Scale (RASS) score between -3 and +4 at baseline. * Negative Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment at baseline. * Able to communicate in Turkish when communication is required for study assessments. * Written informed consent provided by the patient or, when the patient is unable to provide consent because of their clinical condition, by a first-degree relative. Exclusion Criteria: * Positive CAM-ICU assessment at baseline. * Dementia or a severe neurological disorder that may interfere with delirium assessment, including stroke or severe head trauma. * Delirium related to alcohol or substance withdrawal. * Visual or hearing impairment that prevents implementation of the sleep-promotion intervention. * Ear infection or tympanic membrane perforation that precludes the use of earplugs. * Terminal clinical condition.
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What it tests

  • Triple Sleep-Promotion Protocol
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Where

1 site
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Çanakkale, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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