[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617533":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":82,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","Group A (26 babies) :\n\n1. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)\n2. Monitoring in an open incubator for the next 3 hours (control)",[13],"Other: Multifunctional Baby Carrier",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B","Group B (26 babies) :\n\n1. Monitoring in an open incubator for the next 3 hours (control)\n2. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Multifunctional Baby Carrier","The study will be conducted using a randomized controlled crossover design. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs. Since the study is cross-over in design, infants in both groups (Group A and Group B) will be included in both the experimental group and the control group. Each baby will be monitored for a total of 6 hours.\n\nGroup A (26 babies):\n\n1. Monitoring in a multifunctional main cradle during the first 3 hours (experiment)\n2. Monitoring in an open incubator wrapped for the second 3 hours (control)\n\nGroup B (26 babies):\n\n1. Monitoring in an open incubator wrapped for the second 3 hours (control)\n2. Monitoring in a multifunctional main cradle during the first 3 hours (experiment)",[9,15],null,[25],{"name":26,"affiliation":5,"role":27},"Birsen Mutlu, Assc prof","STUDY_DIRECTOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Aynur Baykal, Phd Student","CONTACT","+90 538 471 39 71","aynur.baykal10@ogr.iuc.edu.tr",{"name":26,"role":31,"phone":35,"phoneExt":23,"email":36},"+90 532 682 68 62","bdonmez@iuc.edu.tr",[38],{"facility":39,"status":23,"city":40,"state":41,"zip":42,"country":43,"countryCode":23,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Health Sciences University Dr. Siyami Ersek Chest, Heart, and Vascular Surgery Education and Research Hospital","Istanbul","Üsküdar","34668","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],28.94966,41.01384,{"lat":48,"lon":47},[51,52],{"name":30,"role":31,"phone":23,"phoneExt":23,"email":33},{"name":26,"role":31,"phone":35,"phoneExt":23,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Aynur Baykal","PHD STUDENT","100617533","the-effect-of-using-multifunctional-baby-carrier-with-heart-surgery-100617533",false,"NCT07319858","The Effect of Using Multifunctional Baby Carrier With Heart Surgery","The Effect of Using Multifunctional Baby Carrier on Physiological Parameters, Pain and Sleep Status in Babies With Heart Surgery","Inclusion Criteria:\n\n* Babies born at 38 weeks or later\n* Babies aged 0 to 3 months after birth\n* No illness other than congenital heart disease\n* Who has undergone surgery for the first time due to congenital heart disease\n* Whose clinical condition is stable (PSOFA score below 8 points)\n* Infants with stable thermoregulation\n\nExclusion Criteria:\n\n* Babies born before 38 weeks of pregnancy\n* Babies older than 3 months\n* The presence of other chromosomal or neurological disorders and syndromes in the infant\n* Those who have undergone two or more surgeries due to congenital heart disease\n* pSOFA score above 8 points","ALL","1 Day","3 Months",{"count":68,"type":69},52,"ESTIMATED","INTERVENTIONAL",[72],"NA","The study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. It is planned to be conducted in a randomized controlled crossover design. Following congenital heart surgery, the use of sedative interventions in the high-stress environment of the intensive care unit has a significant effect on preserving the energy reserves necessary for the infant's growth and development. Using a sensitive and soothing mobile crib to assist in the postoperative care of infants who have undergone congenital heart surgery is a potential opportunity for the infant, nurse, and parent. The combined application of swaddling, sound, and movement reduces the baby's fussiness and has a calming effect on their physiological activation.\n\nInfants who underwent heart surgery between 0-3 months and were followed up in a multi-purpose baby carrier (swaddling, white noise, and rocking) compared to infants in the follow-up experimental group, compared to infants in the control group who were only swaddled;\n\nHypothesis 1: The heart rate is lower. Hypothesis 2: Blood pressure is lower. Hypothesis 3: Oxygen saturation levels are higher. Hypothesis 4: Sleep durations are longer. Hypothesis 5: Pain scores are lower.",[75],"Congenital Heart Surgery",[77,78,79,80,81],"nursing","pain","sleep","congenital heart defect","surgery","NOT_YET_RECRUITING","2026-04-18",{"date":85,"type":86},"2026-04-21","ACTUAL",{"date":88,"type":69},"2026-06",{"date":90,"type":69},"2028-08",{"name":5,"class":6},1]