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

August 14, 2026 updated by: öznur balkan, Fenerbahce University

Evaluating the Effects of a Nurse-Led Multicomponent Environmental Intervention on Stress Perception and Sleep Quality in ICU Patients: A Quasi-Experimental Study

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 5
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.
Day 5 (end of intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Nightly, at 22:00, 02:00, and 06:00 during intervention nights (2-5 nights).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenerbahce University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FenerbahceU-ICUREST-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

What data will be shared? Anonymized individual participant data (IPD) including demographic information (age, sex, diagnosis, length of ICU stay) and primary outcome measures (ICUESS scores and RCSQ scores). No identifying information (e.g., names, contact details, medical record numbers) will be shared.

When will data be available? De-identified data will be available beginning 6 months after publication of the main study results and will remain accessible for 2 years.

With whom and under what conditions? Data will be shared with academic researchers upon submission of a methodologically sound proposal and approval from an institutional review board (IRB) or ethics committee. Interested researchers must sign a data-sharing agreement to ensure confidentiality and appropriate use of data.

How will data be shared? Data will be provided through secure, password-protected institutional servers. Requests can be directed to the principal investigator via email.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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