Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients
NCT ID: NCT07309406
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
68 participants
INTERVENTIONAL
2025-12-29
2026-02-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Quiet Night Protocol (Environmental Stressor Reduction Package)
This arm will receive the Environmental Stressor Reduction Package, a multi-component nursing intervention designed to reduce environmental stressors in the ICU. The package includes:
Noise control (≤45 dB, alarms adjusted, staff reminders)
Circadian lighting adjustments (bedside lights off during sleep hours, local lighting for procedures, use of eye masks when appropriate)
Thermal comfort monitoring (timpanically measured, blankets or controlled bedside warmers if needed)
Restricted visitor traffic (no visitors after 22:00, quiet medical rounds at night)
Adjustment of care activities (minimizing unnecessary night interventions, clustering nursing care before 22:00)
Use of the "Quiet Night Checklist" by nurses at 22:00, 02:00, and 06:00 to standardize monitoring.
Environmental Stressor Reduction Package
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.
Standard ICU Care
This arm will receive routine ICU care without the structured Environmental Stressor Reduction Package. Standard care includes typical ICU monitoring, treatments, and nursing interventions according to hospital policies, without specific modifications for noise, light, thermal comfort, or visitor regulation beyond institutional standards.
No interventions assigned to this group
Interventions
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Environmental Stressor Reduction Package
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.
Eligibility Criteria
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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)
18 Years
ALL
No
Sponsors
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Fenerbahce University
OTHER
Responsible Party
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öznur balkan
Research Assistant
Locations
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Umraniye Education and Research Hospital
Istanbul, Umraniye, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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öznur AYDENİZ
Role: primary
Other Identifiers
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FenerbahceU-ICUREST-2025
Identifier Type: -
Identifier Source: org_study_id