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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Naile Alankaya, Assosiate Prof. PhD
- Numer telefonu: +905334256510
- E-mail: naile.alankaya@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Sevda Ateş
- E-mail: naile.alankaya@gmail.com
Lokalizacje studiów
-
-
Çanakkale
-
Çanakkale, Çanakkale, Turcja (Türkiye), 17100
- Rekrutacyjny
- Çanakkale Onsekiz Mart University, Faculty of Health Sciences
-
Kontakt:
- Ayten Dinç, PhD
- E-mail: aytendinc@comu.edu.tr
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Usual ICU Care
Participants assigned to this arm receive usual ICU care according to the routine practices of the participating ICU.
No study-specific nighttime care clustering, eye mask, earplugs, or structured reduction of nighttime light and noise is provided as part of the study.
All routine clinical monitoring, nursing care, and medically necessary procedures continue according to standard ICU practice.
|
|
|
Eksperymentalny: Triple Sleep-Promotion Protocol
Participants assigned to this arm receive the Triple Sleep-Promotion Protocol in addition to usual ICU care.
The protocol includes clustering nighttime nursing care, offering an eye mask and earplugs during designated protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible.
The intervention is implemented during the nighttime period, approximately 22:00-08:00.
Urgent or clinically necessary care, monitoring, and patient safety requirements take priority over all sleep-promotion procedures.
|
The Triple Sleep-Promotion Protocol is a multicomponent, non-pharmacological nighttime nursing intervention implemented approximately between 22:00 and 08:00.
Nursing care is clustered within three designated periods (22:00-01:00, 02:30-04:00, and 05:30-07:00) to support two protected sleep periods (01:00-02:30 and 04:00-05:30).
During the protected sleep periods, participants are offered an eye mask and earplugs, and avoidable environmental light and noise are reduced whenever clinically feasible.
Urgent or clinically necessary nursing care, medical procedures, monitoring, and patient safety requirements take priority over the protocol.
If the evening RASS score is -4 or -5, the sleep-promotion intervention is withheld for that night and the participant is reassessed subsequently.
The intervention is discontinued after the first positive CAM-ICU assessment.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of New-Onset Delirium
Ramy czasowe: Up to 5 days after randomization
|
New-onset delirium is defined as at least one positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment during ICU follow-up.
Only participants who are CAM-ICU negative at baseline are randomized.
Richmond Agitation-Sedation Scale (RASS) is assessed before each CAM-ICU assessment; CAM-ICU is performed when RASS is -3 or higher, while RASS -4 or -5 is recorded as not assessable.
|
Up to 5 days after randomization
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire
Ramy czasowe: Daily during ICU follow-up, up to 5 days after randomization
|
Subjective sleep quality is assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a five-item instrument evaluating the preceding night's sleep.
Each item is scored from 0 to 100, and the mean of the five items is calculated as the overall RCSQ score (range: 0-100).
Higher scores indicate better perceived sleep quality.
The RCSQ is administered each morning between 07:00 and 08:00 during ICU follow-up.
Assessments are discontinued after the first positive CAM-ICU assessment.
|
Daily during ICU follow-up, up to 5 days after randomization
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Naile Alankaya, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- COMU-SBF-NA-05
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .