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NCT Number: NCT07309406

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34000, Turkey (Türkiye)

Location contact

öznur AYDENİZ

CONTACT

[email protected]

05075803533

About this study

This semi-experimental study will evaluate a nurse-led Environmental Stressor Reduction Package designed to modify potentially stressful environmental conditions during nighttime care in the intensive care unit (ICU). The intervention is structured around environmental management strategies addressing noise, lighting, thermal comfort, nighttime visitor activity, and the organization of nursing care.

During the intervention period, environmental noise will be monitored and unnecessary alarms and conversations will be minimized. Nighttime lighting will be reduced while maintaining patient safety, and external light exposure will be limited when appropriate. Thermal comfort will be supported according to individual patient needs. Nighttime visitor activity will be restricted, and essential staff communication will be conducted as quietly as possible during rest periods. Routine nursing activities will be organized, whenever clinically feasible, to minimize unnecessary sleep interruptions between 22:00 and 06:00.

Implementation of the intervention will be monitored using a structured Quiet Night Checklist developed by the research team. The checklist will be completed at 22:00, 02:00, and 06:00 to assess adherence to the intervention components. Each item will be rated on a three-point scale (1 = not implemented, 2 = partially implemented, and 3 = fully implemented). Clinical care and patient safety will take priority at all times, and necessary medical and nursing interventions will not be delayed or withheld for study purposes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years and older
  • Admitted to the intensive care unit (ICU)
  • Awake and able to communicate
  • Not receiving sedation or invasive mechanical ventilation
  • Expected to remain in the ICU for at least 2 consecutive nights
  • Willing to participate and provide written informed consent

Exclusion criteria

  • Younger than 18 years of age
  • Diagnosed with delirium or severe cognitive impairment
  • Presence of a psychiatric condition that may substantially affect sleep or perceived environmental stress
  • Receiving continuous sedative or opioid infusion
  • Discharged from the ICU or deceased before completion of the required study assessments

Treatment and study plan

Environmental Stressor Reduction Package

Behavioral

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.

Primary outcomes

  1. Change in environmental stress perception

    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.

Secondary outcomes

  1. Change in sleep quality

    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.

  2. Correlation between environmental stress perception and 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.

Other outcomes

  1. Intervention adherence (implementation fidelity)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ADNAN AYDENİZZ

CONTACT

[email protected]

05379810926

öznur BALKAN, Research Assistant

CONTACT

[email protected]

+905075803533

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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