[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650826":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":18,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Maternal Voice Intervention Group","EXPERIMENTAL","Children received a single \\~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback.",[13],"Behavioral: Recorded Maternal Voice",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Children received standard PICU care with no additional intervention. Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Recorded Maternal Voice","A single \\~10-minute audio recording of the child's own mother reading a children's storybook (\"The Invisible String,\" Turkish edition) will be played once through wireless over-ear headphones at a safe listening level (50-55 dB), during a single morning session (10:00-12:00), with no other procedural interventions during playback. The recording will be made in a quiet room by an independent researcher using a digital audio recorder.\n\nWant to be notified when Claude responds?",[9],[26],{"name":27,"affiliation":5,"role":28},"MERAL BAYAT, PhD","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"GAMZE NUR GÜZEL, RN","CONTACT","+905535664246","gmznrgzl446@gmail.com",[36],{"facility":37,"status":18,"city":38,"state":38,"zip":18,"country":39,"countryCode":18,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Kayseri City Hospital","Kayseri","Turkey (Türkiye)",{"type":41,"coordinates":42},"Point",[43,44],35.48528,38.73222,{"lat":44,"lon":43},[47,48],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":27,"role":32,"phone":49,"phoneExt":18,"email":50},"+905336504292","mbayat@erciyes.edu.tr",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Gamze Nur Güzel","nurse","100650826","effect-of-maternal-voice-on-pain-sedation-and-physiological-parameters-in-mechanically-ventilated-children-100650826",false,"NCT07753486","Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children","The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 1-3 years, intubated and mechanically ventilated under sedation\n* No change in sedation dose within the last 24 hours\n* No hearing impairment in the child\n* Parent has no visual, hearing, or speech impairment\n* Parent is a Turkish speaker\u002Freader with at least a primary school education\n* Parent provides written and verbal informed consent\n\nExclusion Criteria:\n\n* Children receiving care\u002Ftreatment due to surgical operation or trauma\n* Children who experience cardiac arrest during the study\n* Children whose parent withdraws consent during the study\n* Children who are extubated during the study","ALL","1 Year","3 Years",{"count":66,"type":67},28,"ESTIMATED","INTERVENTIONAL",[70],"NA","Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine (mechanical ventilator). Children will be randomly placed into one of two groups: one group will listen to a 10-minute recording of their mother's voice through headphones, while the other group will receive usual care with no recording. Researchers will measure pain and comfort levels, heart rate, oxygen levels, blood pressure, and breathing rate before, during, and after the session to see if listening to the mother's voice makes a difference.",[73,74,75],"Pain","Sedation","Mechanical Ventilation",[77,78,79,80,81],"Maternal Voice","Pediatric Intensive Care Unite","Physiological Parameters","COMFORT Scale","Non-pharmacological Intervention","NOT_YET_RECRUITING","2026-08-06",{"date":85,"type":86},"2026-08-10","ACTUAL",{"date":88,"type":67},"2026-08-15",{"date":90,"type":67},"2026-12-15",{"name":5,"class":6},1]