[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616730":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Fenerbahce University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Environmental Stressor Reduction Package",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"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.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"öznur BALKAN, Research Assistant","CONTACT","+905075803533","oznur.balkan34@gmail.com",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"ADNAN AYDENİZZ","05379810926","adnan.aydeniz@hotmail.com",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":18,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Umraniye Education and Research Hospital","Istanbul","Umraniye","34000","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],28.94966,41.01384,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":51,"phoneExt":18,"email":34},"öznur AYDENİZ","05075803533",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","öznur balkan","Research Assistant","100616730","effect-of-a-nurse-led-environmental-stressor-reduction-package-on-perceived-stress-and-sleep-quality-in-intensive-care-unit-patients-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":67,"type":68},68,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Sleep Disturbance",[76,77,78,79,80],"Critical Care Nursing","Environmental Stressors","Intensive Care Unit","Sleep Quality","Quiet Night Protocol","NOT_YET_RECRUITING","2025-12-15",{"date":84,"type":85},"2025-12-30","ACTUAL",{"date":87,"type":68},"2025-12-29",{"date":89,"type":68},"2026-02-01",{"name":5,"class":6},1]