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

Effect of a Triple Sleep-promotion Protocol on Delirium Incidence in Intensive Care Units: A Multicenter Stratified Randomized Controlled Trial

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 take priority over all sleep-promotion procedures.

Participants will be followed during their ICU stay for up to five days. Delirium will be assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Nighttime sleep quality will also be assessed each morning using the Richards-Campbell Sleep Questionnaire. The primary aim is to determine whether the Triple Sleep-Promotion Protocol reduces the incidence of new-onset delirium compared with usual ICU care.

Sleep disruption is common among critically ill patients and may contribute to the development of delirium. Nighttime sleep in the ICU can be disrupted by environmental light and noise, frequent nursing activities, monitoring, and other clinically necessary procedures. Non-pharmacological strategies that reduce avoidable nighttime disturbances may therefore represent a feasible approach to supporting sleep and preventing delirium without adding medication-related risks.

The Triple Sleep-Promotion Protocol was developed as a multicomponent nursing intervention integrating clustered nighttime nursing care, protected sleep periods, eye mask and earplug use, and pragmatic reduction of avoidable nighttime light and noise. The protocol is designed to reduce modifiable sleep disturbances while maintaining routine clinical monitoring and prioritizing patient safety and necessary care at all times.

This multicenter randomized controlled trial will examine whether implementation of the Triple Sleep-Promotion Protocol reduces new-onset delirium compared with usual ICU care. The study will also evaluate subjective nighttime sleep quality and document intervention adherence and clinically necessary protocol interruptions.

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.