[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648834":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":28,"centralContacts":43,"locations":53,"responsibleParty":68,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":28,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":102,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Kirsehir Ahi Evran Universitesi","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group 1: Kangaroo Care","EXPERIMENTAL","Participants assigned to this group will receive kangaroo care provided by their mothers for 60 minutes following routine midday care and feeding. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.",[13],"Behavioral: Kangaroo Care",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention Group 2: Maternal Lullaby","Participants assigned to this group will receive maternal lullaby intervention for 15 minutes following routine midday care and feeding. Mothers will sing a lullaby of their choice while the infant remains in the crib. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.",[18],"Behavioral: Maternal Lullaby",{"label":20,"type":10,"description":21,"interventionNames":22},"Intervention Group 3: Maternal Tactile-Auditory Soothing","Participants assigned to this group will receive maternal tactile-auditory soothing for 15 minutes following routine midday care and feeding. Mothers will provide gentle rhythmic tactile stimulation to the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds (\"pış pış\"). Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.",[23],"Behavioral: Maternal Tactile-Auditory Soothing",{"label":25,"type":26,"description":27,"interventionNames":28},"Routine Care (Control)","NO_INTERVENTION","Participants assigned to this group will receive routine neonatal intensive care without any additional sensory intervention. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes following routine care.",null,[30,35,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"BEHAVIORAL","Kangaroo Care","Kangaroo care will be provided by the mother for 60 minutes following routine midday care and feeding. The newborn, wearing only a diaper, will be placed in an upright skin-to-skin position on the mother's bare chest. The infant's head will be positioned to maintain airway patency, and a light blanket will be used to maintain thermal stability. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored throughout the 60-minute observation period.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":28},"Maternal Lullaby","Following routine midday care and feeding, mothers will sing a lullaby of their choice to their newborn for 15 minutes while the infant remains in the crib. The lullaby will be performed in a soft, soothing voice at a sound level not exceeding 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.",[15],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"Maternal Tactile-Auditory Soothing","Following routine midday care and feeding, mothers will provide gentle rhythmic tactile stimulation by softly stroking the infant's back and shoulders while simultaneously producing soft rhythmic soothing vocal sounds (\"pış pış\") for 15 minutes. The sound level will not exceed 45-50 dB. Sleep-wake states, sleep onset latency, and physiological parameters will be monitored for a total of 60 minutes.",[20],[44,49],{"name":45,"role":46,"phone":47,"phoneExt":28,"email":48},"Edanur Tar Bolacali, PhD","CONTACT","+908504412483","edanurtar.1107@gmail.com",{"name":50,"role":46,"phone":51,"phoneExt":28,"email":52},"Sibel Kucukoglu, PhD","+903322231623","s_nadaroglu@hotmail.com",[54],{"facility":55,"status":28,"city":56,"state":56,"zip":57,"country":58,"countryCode":28,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Kirsehir Ahi Evran Universty","Kırşehir","40100","Turkey (Türkiye)",{"type":60,"coordinates":61},"Point",[62,63],34.16389,39.14583,{"lat":63,"lon":62},[66],{"name":67,"role":46,"phone":47,"phoneExt":28,"email":48},"Edanur Tar Bolacalı, PhD",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Edanur Tar Bolacali","Asst. Prof.","100648834","maternal-sensory-interventions-in-newborns-100648834",false,"NCT07725094","Maternal Sensory Interventions in Newborns","The Effect of Maternal Sensory Stimulation (Kangaroo Care, Lullabies, Tactile-Auditory Soothing) on Newborns' Sleep-Wake State and Physiological Parameters: A Randomized Controlled Trial","MSI","Inclusion Criteria:\n\n* Gestational age between 35 and 42 completed weeks.\n* Birth weight between 2,000 and 4,200 grams.\n* Clinically stable newborn admitted to the neonatal intensive care unit.\n* Spontaneous breathing without the need for mechanical ventilation.\n* Not receiving sedative medications.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Five-minute Apgar score \\\u003C4.\n* Requirement for advanced resuscitation after birth.\n* Presence of a major congenital anomaly.\n* Requirement for invasive intervention involving the head region.\n* Diagnosed central nervous system dysfunction or neurological disorder.\n* Presence of severe postnatal medical complications that may affect study outcomes.\n\nExclusion Criteria (during the research):\n\n* The newborn develops an unexpected need for resuscitation during the study, as this may adversely affect the central nervous system and consequently influence sleep-wake patterns and study outcomes.\n* A parent or legal guardian withdraws consent for the newborn's participation in the study.",true,"ALL","35 Weeks","42 Weeks",{"count":85,"type":86},80,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in newborns admitted to the neonatal intensive care unit.",[92,93],"Neonatal Intensive Care Unit","Hospitalized Newborn",[95,32,96,97,98,92,99,100,101],"Bispectral Index","Lullaby","Maternal Sensory Intervention","Newborn","Physiological Parameters","Randomized Controlled Trial","Sleep-Wake States","NOT_YET_RECRUITING","2026-07-24",{"date":105,"type":106},"2026-07-27","ACTUAL",{"date":108,"type":86},"2026-08-15",{"date":110,"type":86},"2026-12-30",{"name":5,"class":6},1]