[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650439":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":61,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nesting Group","EXPERIMENTAL","Term newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection. Pain, stress level, and breastfeeding success will be assessed using validated outcome measures.",[13],"Behavioral: Nesting",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","NO_INTERVENTION","Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention. Pain, stress level, and breastfeeding success will be assessed using the same outcome measures.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Nesting","Nesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection. The intervention aims to reduce procedural pain and stress and improve breastfeeding success.",[9],[26],{"name":27,"affiliation":28,"role":29},"Sevil İnal, Prof. Dr.","Istanbul University-Cerrahpasa, Department of Midwifery","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Emine Nur Çalımlı Celep, MSc","CONTACT","+90 506 126 48 03","enurcalimli@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Yasemin Dinçel, MSc","+90 545 939 49 26","yasemindincel96@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":18,"country":46,"countryCode":18,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Kocaeli Darıca Farabi Training and Research Hospital","RECRUITING","Darıca","Kocaeli","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],29.39454,40.77973,{"lat":51,"lon":50},[54,56,57,59],{"name":55,"role":33,"phone":34,"phoneExt":18,"email":35},"Emine Nur Çalımlı Celep, Msc",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"name":55,"role":58,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":18,"phoneExt":18,"email":18},"Yasemin Dinçel, Msc",{"type":29,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Emine Nur Çalımlı Celep","PhD Student","100650439","effect-of-nesting-during-intramuscular-injection-on-pain-stress-and-breastfeeding-success-in-cesarean-born-term-newborns-100650439",false,"NCT07748520","Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns","The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section","NESTING","Inclusion Criteria:\n\n* Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.\n* Born by cesarean section.\n* Term newborn (gestational age between 37+0 and 41+6 weeks).\n* Birth weight between 2,500 g and 4,000 g.\n* Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).\n* No acute or chronic medical conditions.\n* No congenital anomalies.\n* No requirement for endotracheal intubation, resuscitation, or admission to the neonatal intensive care unit (NICU).\n* Scheduled to receive the first intramuscular injection after birth.\n\nExclusion Criteria:\n\n* Multiple birth (e.g., twins or higher-order multiples).\n* Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.\n* Withdrawal of parental consent at any time during the study.\n* Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.\n* Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.\n* Delayed mother-newborn reunion due to maternal general anesthesia or prolonged sedation following spinal or epidural anesthesia.\n* Delayed transfer of the newborn to the mother because of prolonged surgery, intraoperative complications, or delayed postoperative stabilization.",true,"ALL","30 Minutes",{"count":76,"type":77},112,"ESTIMATED","INTERVENTIONAL",[80],"NA","This randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section. A total of 112 newborns will be randomly assigned in a 1:1 ratio to either a nesting intervention group or a routine care control group. Newborns in the intervention group will receive nesting until the first intramuscular injection, whereas those in the control group will receive routine neonatal care. Pain, stress level, physiological parameters, settling time, and breastfeeding success will be evaluated using validated assessment tools. The findings are expected to provide evidence regarding the effectiveness of nesting as a simple, safe, and non-pharmacological intervention for reducing procedural pain and stress in newborns while supporting breastfeeding success.",[83,84,85],"Newborn Pain","Newborn Stress","Breastfeeding Success in Newborns",[22,87,88,89,83,84,90],"Term Newborn","Cesarean Section","Intramuscular Injection","Breastfeeding Success","2026-08-02",{"date":93,"type":94},"2026-08-05","ACTUAL",{"date":96,"type":94},"2025-10-15",{"date":98,"type":77},"2026-10-15",{"name":5,"class":6},1]