Umraniye Education and Research Hospital
Istanbul, Umraniye, 34000, Turkey (Türkiye)
NCT Number: NCT07309406
This study aims to evaluate the effectiveness of a nurse-led "Environmental Stressor Reduction Package" on critically ill patients' perception of environmental stress and their sleep quality in the intensive care unit (ICU).
The package includes multi-component interventions such as reducing noise levels, adjusting lighting according to circadian rhythm, maintaining thermal comfort, limiting visitor traffic at night, and organizing nursing care to minimize sleep disruption. A structured "Quiet Night Checklist" will be used to monitor the implementation of these interventions during night shifts.
The study will be conducted in the 10-bed anesthesia and reanimation intensive care unit of Ümraniye Training and Research Hospital, İstanbul. Eligible adult patients who are awake, not under sedation, and able to communicate will be recruited. Participants in the intervention group will receive the Environmental Stressor Reduction Package for at least two and up to five consecutive nights, while the control group will continue to receive standard ICU care.
Outcomes will be measured using two validated tools:
The Intensive Care Unit Environmental Stressor Scale (ICUESS) to assess perceived environmental stress.
The Richards-Campbell Sleep Questionnaire (RCSQ) to evaluate self-reported sleep quality.
The findings of this study are expected to contribute to evidence-based nursing interventions in the ICU setting, by improving patients' sleep quality and reducing stressors associated with the intensive care environment.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Istanbul, Umraniye, 34000, Turkey (Türkiye)
This semi-experimental study is designed to investigate the effect of a nurse-led "Environmental Stressor Reduction Package" on patients' perception of environmental stress and their sleep quality in the intensive care unit (ICU).
The intervention package includes five core components:
Noise control: Environmental sound levels will be maintained at ≤45 dB during night hours using a portable sound level meter (Benetech GM1351). Non-critical alarms will be silenced or reduced by 50%, and staff will be reminded to minimize unnecessary conversations at the bedside.
Lighting adjustment: Circadian rhythm-oriented lighting will be supported by turning off unnecessary bedside lights during sleep periods, using curtains to block external light, and providing patients with eye masks when needed.
Thermal comfort: As central air conditioning cannot be individually adjusted, tympanic temperature will be monitored and blankets or portable warmers will be used to ensure comfort.
Visitor regulation: No visitors will be allowed after 22:00, and physicians' or staff communications will be conducted as quietly as possible during patients' rest periods.
Nursing care organization: Routine nursing interventions such as hygiene care or repositioning will be scheduled before 22:00 whenever feasible, to minimize sleep interruption between 22:00 and 06:00.
The structured "Quiet Night Checklist" developed by the research team will be used to monitor the fidelity of the intervention. The checklist will be completed at 22:00, 02:00, and 06:00, covering all intervention domains. Each item is scored on a 3-point Likert scale (1 = not implemented, 2 = partially implemented, 3 = fully implemented).
Data collection will be carried out over a minimum of two and up to five consecutive nights of ICU stay, depending on patients' clinical course. The intervention group will receive the package, while the control group will continue to receive standard ICU care.
The primary outcome will be the change in patients' perceived environmental stress, measured by the Intensive Care Unit Environmental Stressor Scale (ICUESS), a validated 42-item instrument. The secondary outcome will be self-reported sleep quality, measured by the Richards-Campbell Sleep Questionnaire (RCSQ), a validated 5-item visual analogue scale. Both instruments have validated Turkish versions (Toptas et al., 2018; Demir et al., 2021).
It is anticipated that the intervention will reduce patients' stress perception and improve sleep quality compared to standard care. The findings will contribute to evidence-based nursing practices in ICU environments, highlighting the role of structured, nurse-led environmental modifications in improving patient outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients admitted to the intensive care unit (ICU)
Awake and able to communicate (not under sedation or mechanical ventilation)
Expected to remain in the ICU for at least 2 consecutive nights
Voluntary participation with written informed consent
Exclusion criteria
Patients diagnosed with delirium or severe cognitive impairment
Patients with a history of psychiatric illness affecting sleep or stress perception
Patients under continuous sedative or opioid infusion
Patients discharged from the ICU or deceased before completing the intervention period (2-5 nights)
A structured, nurse-led protocol implemented in the ICU to reduce environmental stressors that negatively affect patients' sleep quality. It combines noise reduction, circadian lighting adjustment, thermal comfort, visitor traffic regulation, and adjustment of care activities. Nurses use a standardized checklist ("Quiet Night Checklist") at three time points (22:00, 02:00, and 06:00) to ensure consistency and adherence.
Time frame: Baseline and Day 5
Environmental stress perception will be assessed using the Intensive Care Unit Environmental Stressor Scale (ICUESS), Turkish validated version (Toptaş, Yıldız, & Khorshid, 2018). The ICUESS consists of 42 items rated on a 4-point Likert scale ranging from 0 (not stressful) to 3 (very stressful), yielding a total score range of 0 to 126. Higher total scores indicate greater perceived environmental stress.
Time frame: Baseline and Day 5
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), Turkish validated version (Demir, Zaybak, & Erdoğan, 2021). The RCSQ consists of 5 items rated on a visual analog scale ranging from 0 to 100 mm. The total score is calculated as the mean of the five items, yielding a score range of 0 to 100. Higher scores indicate better subjective sleep quality.
Time frame: Day 5 (end of intervention)
The association between ICUESS total scores and RCSQ mean scores will be analyzed to determine the relationship between perceived environmental stressors and subjective sleep quality.
Time frame: Nightly, at 22:00, 02:00, and 06:00 during intervention nights (2-5 nights).
Adherence to the Quiet Night Protocol will be evaluated using the Sessiz Gece Kontrol Listesi (Quiet Night Control Checklist), developed by the research team. Items are scored with a 3-point Likert scale (1 = not applied, 2 = partially applied, 3 = fully applied). Higher total scores indicate higher fidelity of protocol implementation.
Contact information is provided by the study sponsor or research team.
ADNAN AYDENİZZ
CONTACT
öznur BALKAN, Research Assistant
CONTACT
Fenerbahce University
Other
Evaluating the Effects of a Nurse-Led Multicomponent Environmental Intervention on Stress Perception and Sleep Quality in ICU Patients: A Quasi-Experimental Study
Acronym: ICU-SLEEP
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