[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616730":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":34,"studyPopulation":29,"armGroups":35,"interventions":46,"overallOfficials":29,"centralContacts":52,"locations":62,"responsibleParty":79,"collaborators":29,"id":83,"slug":29,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":29,"enrollmentInfo":92,"targetDuration":29,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":107,"whyStopped":29,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fenerbahce University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"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.","Day 5 (end of intervention)",[22],{"measure":23,"description":24,"timeFrame":25},"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.","Nightly, at 22:00, 02:00, and 06:00 during intervention nights (2-5 nights).",{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":29,"timePerspective":29,"maskingInfo":31},"NON_RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":32,"maskingDescription":33,"whoMasked":29},"NONE","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.","This semi-experimental study is designed to investigate the effect of a nurse-led \"Environmental Stressor Reduction Package\" on patients' perception of environmental stress and their sleep quality in the intensive care unit (ICU).\n\nThe intervention package includes five core components:\n\nNoise control: Environmental sound levels will be maintained at ≤45 dB during night hours using a portable sound level meter (Benetech GM1351). Non-critical alarms will be silenced or reduced by 50%, and staff will be reminded to minimize unnecessary conversations at the bedside.\n\nLighting adjustment: Circadian rhythm-oriented lighting will be supported by turning off unnecessary bedside lights during sleep periods, using curtains to block external light, and providing patients with eye masks when needed.\n\nThermal comfort: As central air conditioning cannot be individually adjusted, tympanic temperature will be monitored and blankets or portable warmers will be used to ensure comfort.\n\nVisitor regulation: No visitors will be allowed after 22:00, and physicians' or staff communications will be conducted as quietly as possible during patients' rest periods.\n\nNursing care organization: Routine nursing interventions such as hygiene care or repositioning will be scheduled before 22:00 whenever feasible, to minimize sleep interruption between 22:00 and 06:00.\n\nThe structured \"Quiet Night Checklist\" developed by the research team will be used to monitor the fidelity of the intervention. The checklist will be completed at 22:00, 02:00, and 06:00, covering all intervention domains. Each item is scored on a 3-point Likert scale (1 = not implemented, 2 = partially implemented, 3 = fully implemented).\n\nData collection will be carried out over a minimum of two and up to five consecutive nights of ICU stay, depending on patients' clinical course. The intervention group will receive the package, while the control group will continue to receive standard ICU care.\n\nThe primary outcome will be the change in patients' perceived environmental stress, measured by the Intensive Care Unit Environmental Stressor Scale (ICUESS), a validated 42-item instrument. The secondary outcome will be self-reported sleep quality, measured by the Richards-Campbell Sleep Questionnaire (RCSQ), a validated 5-item visual analogue scale. Both instruments have validated Turkish versions (Toptas et al., 2018; Demir et al., 2021).\n\nIt is anticipated that the intervention will reduce patients' stress perception and improve sleep quality compared to standard care. The findings will contribute to evidence-based nursing practices in ICU environments, highlighting the role of structured, nurse-led environmental modifications in improving patient outcomes.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"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:\n\nNoise control (≤45 dB, alarms adjusted, staff reminders)\n\nCircadian lighting adjustments (bedside lights off during sleep hours, local lighting for procedures, use of eye masks when appropriate)\n\nThermal comfort monitoring (timpanically measured, blankets or controlled bedside warmers if needed)\n\nRestricted visitor traffic (no visitors after 22:00, quiet medical rounds at night)\n\nAdjustment of care activities (minimizing unnecessary night interventions, clustering nursing care before 22:00)\n\nUse of the \"Quiet Night Checklist\" by nurses at 22:00, 02:00, and 06:00 to standardize monitoring.",[41],"Behavioral: Environmental Stressor Reduction Package",{"label":43,"type":44,"description":45,"interventionNames":29},"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.",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":29},"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.",[37],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},"öznur BALKAN, Research Assistant","CONTACT","+905075803533","oznur.balkan34@gmail.com",{"name":59,"role":55,"phone":60,"phoneExt":29,"email":61},"ADNAN AYDENİZZ","05379810926","adnan.aydeniz@hotmail.com",[63],{"facility":64,"status":29,"city":65,"state":66,"zip":67,"country":68,"countryCode":29,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Umraniye Education and Research Hospital","Istanbul","Umraniye","34000","Turkey (Türkiye)",{"type":70,"coordinates":71},"Point",[72,73],28.94966,41.01384,{"lat":73,"lon":72},[76],{"name":77,"role":55,"phone":78,"phoneExt":29,"email":61},"öznur AYDENİZ","05075803533",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","öznur balkan","Research Assistant","100616730",false,"NCT07309406","Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients","Evaluating the Effects of a Nurse-Led Multicomponent Environmental Intervention on Stress Perception and Sleep Quality in ICU Patients: A Quasi-Experimental Study","ICU-SLEEP","Inclusion Criteria:\n\n* Adults aged 18 years and older\n\nPatients admitted to the intensive care unit (ICU)\n\nAwake and able to communicate (not under sedation or mechanical ventilation)\n\nExpected to remain in the ICU for at least 2 consecutive nights\n\nVoluntary participation with written informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years old\n\nPatients diagnosed with delirium or severe cognitive impairment\n\nPatients with a history of psychiatric illness affecting sleep or stress perception\n\nPatients under continuous sedative or opioid infusion\n\nPatients discharged from the ICU or deceased before completing the intervention period (2-5 nights)","ALL","18 Years",{"count":93,"type":94},68,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study aims to evaluate the effectiveness of a nurse-led \"Environmental Stressor Reduction Package\" on critically ill patients' perception of environmental stress and their sleep quality in the intensive care unit (ICU).\n\nThe package includes multi-component interventions such as reducing noise levels, adjusting lighting according to circadian rhythm, maintaining thermal comfort, limiting visitor traffic at night, and organizing nursing care to minimize sleep disruption. A structured \"Quiet Night Checklist\" will be used to monitor the implementation of these interventions during night shifts.\n\nThe study will be conducted in the 10-bed anesthesia and reanimation intensive care unit of Ümraniye Training and Research Hospital, İstanbul. Eligible adult patients who are awake, not under sedation, and able to communicate will be recruited. Participants in the intervention group will receive the Environmental Stressor Reduction Package for at least two and up to five consecutive nights, while the control group will continue to receive standard ICU care.\n\nOutcomes will be measured using two validated tools:\n\nThe Intensive Care Unit Environmental Stressor Scale (ICUESS) to assess perceived environmental stress.\n\nThe Richards-Campbell Sleep Questionnaire (RCSQ) to evaluate self-reported sleep quality.\n\nThe findings of this study are expected to contribute to evidence-based nursing interventions in the ICU setting, by improving patients' sleep quality and reducing stressors associated with the intensive care environment.",[100],"Sleep Disturbance",[102,103,104,105,106],"Critical Care Nursing","Environmental Stressors","Intensive Care Unit","Sleep Quality","Quiet Night Protocol","NOT_YET_RECRUITING","2025-12-15",{"date":110,"type":111},"2025-12-30","ACTUAL",{"date":113,"type":94},"2025-12-29",{"date":115,"type":94},"2026-02-01",{"name":5,"class":6},1]