[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658774":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":64,"armGroups":73,"interventions":92,"overallOfficials":64,"centralContacts":110,"locations":116,"responsibleParty":132,"collaborators":64,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":64,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":64,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":64,"overallStatus":156,"whyStopped":64,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":64},[9],{"measure":10,"description":11,"timeFrame":12},"Sleep Efficiency","Sleep efficiency is defined as the percentage of total sleep time (TST) relative to time in bed (TIB) during the sleep-related nocturnal interval. TIB refers to the interval from the start of an attempt to sleep until the end of the nocturnal sleep opportunity and includes sleep onset latency and intervening wakefulness. Sleep efficiency will be assessed using a contactless ballistocardiography (BCG)-based sleep monitoring mat during postoperative nights 0-2. The mean sleep efficiency across the three postoperative nights will be used as the primary outcome measure. Higher values indicate better sleep efficiency.","Postoperative nights 0, 1, and 2",[14,17,20,23,26,29,33,36,39,43,46,49,52,56,60],{"measure":15,"description":16,"timeFrame":12},"Total Sleep Time","Total sleep time during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.",{"measure":18,"description":19,"timeFrame":12},"Sleep-Onset Latency","Time from the beginning of the nocturnal sleep monitoring period to sleep onset, measured using a contactless sleep monitoring mat.",{"measure":21,"description":22,"timeFrame":12},"Wake After Sleep Onset","Total duration of wakefulness occurring after sleep onset during the nocturnal monitoring period, measured using a contactless sleep monitoring mat.",{"measure":24,"description":25,"timeFrame":12},"Sleep Fragmentation Index","Sleep fragmentation index derived from the contactless sleep monitoring mat, reflecting the degree of sleep disruption during the nocturnal monitoring period.",{"measure":27,"description":28,"timeFrame":12},"Sleep-Stage Distribution","Estimated distribution of sleep stages during the nocturnal monitoring period, expressed as the proportion of total sleep time and measured using a contactless sleep monitoring mat.",{"measure":30,"description":31,"timeFrame":32},"Incidence of Postoperative Delirium","Postoperative delirium will be assessed using the Cornell Assessment of Pediatric Delirium (CAPD). A total CAPD score ≥9 will indicate a positive delirium screen. Assessments will be performed every 12 hours.","Postoperative night 0 through postoperative day 2",{"measure":34,"description":35,"timeFrame":32},"Richmond Agitation-Sedation Scale Score","Sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS). Scores range from -5 to +4, with lower scores indicating deeper sedation and higher scores indicating greater agitation. Assessments will be performed every 4 hours.",{"measure":37,"description":38,"timeFrame":32},"Pain Score","Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Scores range from 0 to 10, with higher scores indicating greater pain severity. Assessments will be performed every 4 hours.",{"measure":40,"description":41,"timeFrame":42},"Postoperative Sedative Exposure","Administration of dexmedetomidine and other sedative medications will be recorded to characterize postoperative sedative exposure.","Postoperative day 0 through postoperative day 2",{"measure":44,"description":45,"timeFrame":42},"Postoperative Analgesic Exposure","Administration of sufentanil and other analgesic medications will be recorded to characterize postoperative analgesic exposure.",{"measure":47,"description":48,"timeFrame":42},"Postoperative Vasoactive Medication Exposure","Administration of dopamine and other vasoactive medications will be recorded to characterize postoperative vasoactive medication exposure.",{"measure":50,"description":51,"timeFrame":12},"Heart Rate Variability","Heart rate variability will be continuously measured using the 5S Sleep Tracking Mat as an objective indicator of autonomic regulation.",{"measure":53,"description":54,"timeFrame":55},"CICU Length of Stay","Cardiac intensive care unit (CICU) length of stay will be calculated from postoperative CICU admission to CICU discharge.","Measured in days admitted to the CICU, an average of 2 days",{"measure":57,"description":58,"timeFrame":59},"Total Hospital Length of Stay","Total hospital length of stay will be calculated as the number of days from hospital admission to hospital discharge.","Measured in days admitted to the hospital, an average of 10 days.",{"measure":61,"description":62,"timeFrame":63},"Parental satisfaction","Parental satisfaction with the child's overall hospital care will be assessed using a 100-mm visual analogue scale (VAS), ranging from 0 mm (\"very dissatisfied\") to 100 mm (\"very satisfied\"). Higher scores indicate greater satisfaction.","On the day of discharge, an average of 10 days",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","FACTORIAL","SUPPORTIVE_CARE",{"masking":70,"maskingDescription":64,"whoMasked":71},"SINGLE",[72],"OUTCOMES_ASSESSOR",[74,80,84,89],{"label":75,"type":76,"description":64,"interventionNames":77},"Starry-Sky Projection + Maternal Voice","EXPERIMENTAL",[78,79],"Behavioral: Starry-Sky Projection","Behavioral: Maternal Voice",{"label":81,"type":76,"description":64,"interventionNames":82},"Starry-Sky Projection + Unfamiliar Female Voice",[78,83],"Behavioral: Unfamiliar Female Voice",{"label":85,"type":86,"description":64,"interventionNames":87},"Conventional Lighting + Maternal Voice","ACTIVE_COMPARATOR",[88,79],"Other: Conventional Lighting",{"label":90,"type":86,"description":64,"interventionNames":91},"Conventional Lighting + Unfamiliar Female Voice",[88,83],[93,98,102,106],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":64},"BEHAVIORAL","Starry-Sky Projection","A starry-sky projector will display gently moving, diffuse star-like points on the ceiling, avoiding direct light exposure to the child's eyes. Settings will remain constant, without rapid movement, frequent colour changes, or visible flicker. Built-in audio will be disabled. Sessions will last 20 minutes before anticipated sleep onset on postoperative nights 0-2.",[75,81],{"type":6,"name":99,"description":100,"armGroupLabels":101,"otherNames":64},"Conventional Lighting","Participants will remain under routine nocturnal lighting in the CICU or general ward without additional projection.",[85,90],{"type":94,"name":103,"description":104,"armGroupLabels":105,"otherNames":64},"Maternal Voice","A personalised recording from the child's mother containing the child's name, reassuring and sleep-related phrases, and a familiar lullaby or gentle melody will be played for 20 minutes before anticipated sleep onset. The recording will be played using a speaker positioned approximately 20 cm from the child's ear, with sound intensity maintained at 45-50 dB.",[85,75],{"type":94,"name":107,"description":108,"armGroupLabels":109,"otherNames":64},"Unfamiliar Female Voice","A standardized recording by an unfamiliar adult woman who is not involved in the child's clinical care will be played for 20 minutes before anticipated sleep onset. The recording will contain generic reassuring and sleep-related phrases and a gentle lullaby or nursery rhyme. Playback duration, speaker placement, and sound intensity will be identical to the maternal voice condition.",[90,81],[111],{"name":112,"role":113,"phone":114,"phoneExt":64,"email":115},"Biyu Shen, PhD","CONTACT","+86 13862937317","shenbiyu@126.com",[117],{"facility":118,"status":64,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200127","China","CN",{"type":125,"coordinates":126},"Point",[127,128],121.45806,31.22222,{"lat":128,"lon":127},[131],{"name":112,"role":113,"phone":114,"phoneExt":64,"email":115},{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"PRINCIPAL_INVESTIGATOR","Biyu Shen","Chief Nurse","100658774","starry-sky-projection-and-maternal-voice-for-sleep-after-pediatric-cardiac-surgery-100658774",false,"NCT07854145","Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery","Effects of Starry-Sky Projection and Maternal Voice on Postoperative Sleep in Children Undergoing Cardiac Surgery: A 2 × 2 Factorial Randomized Controlled Trial","Inclusion Criteria:\n\n* A confirmed diagnosis of congenital heart disease.\n* Age between 6 months and 6 years.\n* Scheduled to undergo their first elective open-heart surgery.\n* An anticipated postoperative stay in the cardiac intensive care unit (CICU) of at least 48 hours.\n* Written informed consent provided by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Epilepsy or another severe neurological disorder.\n* A severe psychiatric disorder.\n* Hearing impairment that interferes with the perception of auditory stimuli.\n* Visual impairment that interferes with the perception of visual stimuli.\n* Malformations of other organs or pre-existing severe comorbidities.\n* A history of chronic pain.\n* A previously diagnosed sleep disorder.\n* Endotracheal tube could not be successfully removed before 7 p.m. on the day of surgery.","ALL","6 Months","6 Years",{"count":147,"type":148},172,"ESTIMATED","INTERVENTIONAL",[151],"NA","The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children. The main question it aims to answer is:\n\n• Does a starry-sky projection improve how well children sleep during the first three nights after surgery compared with routine nighttime lighting? The study will also explore whether sleep outcomes differ between children who listen to their mother's recorded voice and those who listen to an unfamiliar woman's recorded voice, and whether the effect of the starry-sky projection differs depending on the type of voice.\n\nChildren aged 6 months to 6 years will be randomly assigned to one of four combinations of visual and sound conditions. They will:\n\n* Receive either a starry-sky projection or routine nighttime lighting\n* Listen to either their mother's recorded voice or an unfamiliar woman's recorded voice\n* Have their sleep monitored during the first three nights after surgery using a contactless device placed under the pillow that does not require sensors attached to the child.",[154,155],"Congenital Heart Disease (CHD)","Postoperative Sleep","NOT_YET_RECRUITING","2026-09-26",{"date":159,"type":160},"2026-10-02","ACTUAL",{"date":162,"type":148},"2026-10-08",{"date":164,"type":148},"2026-12-31",{"name":5,"class":6},1]