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

NCT07309406 | Not Yet Recruiting

• 1 other identifier: FenerbahceU-ICUREST-2025
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sleep Disturbance

Keywords

Critical Care Nursing; Environmental Stressors; Intensive Care Unit; Sleep Quality; Quiet Night Protocol

Outcome Measures

Primary Outcomes (1)

• Change in environmental stress perception

  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.

  Baseline and Day 5

Secondary Outcomes (2)

• Change in sleep quality

  Baseline and Day 5

• Correlation between environmental stress perception and sleep quality

  Day 5 (end of intervention)

Other Outcomes (1)

• Intervention adherence (implementation fidelity)

  Nightly, at 22:00, 02:00, and 06:00 during intervention nights (2-5 nights).

Study Arms (2)

Quiet Night Protocol (Environmental Stressor Reduction Package)

EXPERIMENTAL

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.

Behavioral: Environmental Stressor Reduction Package

Standard ICU Care

NO INTERVENTION

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.

Interventions

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.

Quiet Night Protocol (Environmental Stressor Reduction Package)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

öznur BALKAN, Research Assistant

CONTACT

+905075803533; oznur.balkan34@gmail.com

ADNAN AYDENİZZ

CONTACT

05379810926; adnan.aydeniz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No parties are masked in this trial. The intervention (environmental stressor reduction package, including noise and light adjustment, eye mask use, and night-time care regulation) is directly observable by patients and healthcare providers. Therefore, participants, care providers, and outcome assessors are aware of group assignments. Data entry and statistical analyses will be performed independently to reduce potential bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 30, 2025
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the primary results and will remain accessible for a period of 2 years.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form, and analytic code) will be made available to qualified researchers. Access will be granted only to investigators affiliated with academic or health research institutions who provide a methodologically sound research proposal and obtain local ethics approval. Researchers must sign a data use agreement to ensure data security and confidentiality. Access will be provided through secure, password-protected electronic transfer upon request to the study sponsor.

Locations

TU (1)