Sleep DisturbanceICU-SLEEPNCT07309406
Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients
A study testing Environmental Stressor Reduction Package in people with Sleep Disturbance, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Environmental Stressor Reduction Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34000
öznur AYDENİZ, 05075803533, adnan.aydeniz@hotmail.com
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Sleep Disturbance
- Being tested
- Environmental Stressor Reduction Package
- Keywords
- Critical Care Nursing, Environmental Stressors, Intensive Care Unit, Sleep Quality, Quiet Night Protocol
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental Stressor Reduction PackageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 5
Secondary outcomes (2)
Change in sleep quality
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.
Measured: Baseline and Day 5
Correlation between environmental stress perception and sleep quality
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.
Measured: Day 5 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur balkan, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309406
- Sponsor's protocol ID
- FenerbahceU-ICUREST-2025
- Acronym
- ICU-SLEEP
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of a Nurse-Led Multicomponent Environmental Intervention on Stress Perception and Sleep Quality in ICU Patients: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07309406
- Acronym / sponsor ID
- ICU-SLEEP / FenerbahceU-ICUREST-2025
- Conditions
- Sleep Disturbance
- Keywords
- Critical Care Nursing, Environmental Stressors, Intensive Care Unit, Sleep Quality, Quiet Night Protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quiet Night Protocol (Environmental Stressor Reduction Package) | Experimental | Behavioral: Environmental Stressor Reduction PackageThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental Stressor Reduction PackageA 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. | Behavioural | Quiet Night Protocol (Environmental Stressor Reduction Package) |
Primary outcome
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.
2 secondary outcomes
Change in sleep quality
Time frame: Baseline and Day 5
Correlation between environmental stress perception and sleep quality
Time frame: Day 5 (end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Stressor Reduction Package in people with Sleep Disturbance, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact öznur BALKAN, Research Assistant (+905075803533, oznur.balkan34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in environmental stress perception (time frame: Baseline and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.