[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626902":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":77,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ankara Yildirim Beyazıt University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group - Family-Centered Comfort","EXPERIMENTAL","Children receive a multifaceted, family-centered comfort intervention including storytelling using the mother's voice, dimmed lighting, and weighted blanket. Outcomes measured include child comfort, anxiety, fear, sleep, and parent anxiety and satisfaction.",[13],"Behavioral: Intervention Family-Centered Comfort",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group - Standard Care","Children receive standard care in the PICU without the additional comfort interventions. Outcomes measured are the same as the intervention group for comparison purposes.",[18],"Other: Standard Care (in control arm)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Intervention Family-Centered Comfort","Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Care (in control arm)","Routine care provided to children in the control group without additional comfort interventions.",[15],[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":25,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ordu Universitesi Egitim ve Arastirma Hastanesi","RECRUITING","Ordu","Altınordu","52200","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],37.89047,40.97782,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Mine Nur Temucin, PhD","CONTACT","90452 226 52 00","minenurtemucin@odu.edu.tr",{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100626902","comfort-intervention-in-picu-children-100626902",false,"NCT07441668","Comfort Intervention in PICU Children","The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial","CCI-PICU","Inclusion Criteria:\n\n* Child aged 5-10 years\n* Has not received intravenous sedation or anesthetic medication in the past 12 hours\n* Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours\n* Conscious and able to communicate\n* Glasgow Coma Scale score of 15\n* No pain as assessed by the Wong-Baker FACES Pain Rating Scale\n* Written informed consent obtained from parent\u002Flegal guardian\n* Child and parent able to communicate in Turkish\n* No medical contraindications to non-pharmacological, non-interactive interventions\n\nExclusion Criteria:\n\n* Mechanically ventilated or intubated\n* Hearing impairment\n* Visual impairment\n* Hand motor limitations\n* Severe or profound intellectual disability\n* Epilepsy or history of seizures\n* Severe underweight\n* Chronic respiratory disease\n* Chronic cardiovascular disease\n* Surgical implants\n* Osteoporosis\n* Diagnosis of sleep disorder\n* Use of sleep medication\n* Any physical or mental health condition that prevents communication",true,"ALL","5 Years","10 Years",{"count":65,"type":66},86,"ESTIMATED","INTERVENTIONAL",[69],"NA","This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.",[72,73,74,75,76],"Pediatric Intensive Care Unit","Comfort","Anxiety in Children","Fear","Sleep",[78,79,80,81,75,76],"Pediatric intensive care","Child comfort","Kolcaba Comfort Theory","Anxiety","2026-05-09",{"date":84,"type":85},"2026-05-12","ACTUAL",{"date":87,"type":85},"2026-02-20",{"date":89,"type":66},"2027-07-01",{"name":5,"class":6},1]