An interventional study of Environmental Stressor Reduction Package in Sleep Disturbance, sponsored by Fenerbahce University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Supportive care
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).
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 68 is close to the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: Baseline and Day 5
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.
Time frame: 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.
Time frame: Day 5 (end of intervention)
Intervention adherence (implementation fidelity)
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.
Time frame: Nightly, at 22:00, 02:00, and 06:00 during intervention nights (2-5 nights).
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
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