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Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients

Study acronym: ICU-SLEEP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 1, 2026 → Dec 31, 2026
See other at-risk trials from Fenerbahce University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jan 1, 2026 to Dec 31, 2026v2 Show 4 more changesShow less
    • Start date: Dec 29, 2025 to Sep 1, 2026
    • Study completion pushed from Feb 1, 2026 to Jan 31, 2027
    • Study description shortened, about 177 words
    • Eligibility criteria expanded, about 2 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to evaluate the effect of a nurse-led Environmental Stressor Reduction Package on perceived environmental stress and sleep quality among adult patients in the intensive care unit (ICU). The Environmental Stressor Reduction Package is a structured, multicomponent nursing intervention designed to reduce potentially disturbing environmental stimuli during nighttime care. The package focuses on reducing unnecessary noise, optimizing nighttime lighting, supporting thermal comfort, limiting nighttime visitor activity, and organizing nursing care to minimize avoidable sleep interruptions while maintaining patient safety and essential clinical care. Participants in the intervention group will receive the Environmental Stressor Reduction Package during their ICU stay, while participants in the control group will receive standard ICU care. The study will assess whether the nurse-led intervention reduces perceived environmental stress and improves self-reported sleep quality compared with standard care. Perceived environmental stress will be assessed using the Intensive Care Unit Environmental Stressor Scale (ICUESS), and sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).
Trial Details
NCT Number NCT07309406
Lead Sponsor Fenerbahce University
Conditions
(from sponsor)
Sleep Disturbance
Related terms Parasomnias, Sleep Initiation and Maintenance Disorders
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov