[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651797":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":23,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":45,"conditions":56,"keywords":60,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Selcuk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Intervention","EXPERIMENTAL","Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable system is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period.",[13],"Device: AI-Based Oxytocin-Stimulated Smart Lactation Support Vest",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - Control","ACTIVE_COMPARATOR","Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.",[13,19],"Behavioral: Standard Lactation Care and Counseling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","AI-Based Oxytocin-Stimulated Smart Lactation Support Vest","Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable vest is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period. The system includes temperature and bioelectrical impedance sensors and an AI-based decision-support module intended to provide individualized recommendations regarding stimulation parameters.",[9,15],null,{"type":28,"name":29,"description":17,"armGroupLabels":30,"otherNames":26},"BEHAVIORAL","Standard Lactation Care and Counseling",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Seyhan Çankaya, PhD","CONTACT","+903322233577","seyhane32@gmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Seyhan Çankaya","Assoc.Prof.","100651797","ai-based-oxytocin-stimulated-smart-lactation-support-vest-100651797",false,"NCT07765992","AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation","Inclusion Criteria:\n\nFor Mothers:\n\n* Aged 18 years or older;\n* Primiparous;\n* Delivered by cesarean section;\n* Singleton pregnancy;\n* Delivered at 32-37 weeks of gestation;\n* Newborn admitted to the Neonatal Intensive Care Unit (NICU);\n* No medical condition that would prevent breast milk expression or use of the smart lactation support vest;\n* Owns or has access to a smartphone;\n* Willing to participate voluntarily and able to provide written informed consent;\n* Able to read, understand, and communicate in Turkish.\n\nFor Newborns:\n\n* Born at 32-37 weeks of gestation;\n* No condition that would prevent the intake of breast milk.\n\nExclusion Criteria:\n\nFor Mothers:\n\n* Body mass index (BMI) \\>30 kg\u002Fm²;\n* History of a psychiatric diagnosis or currently receiving psychiatric treatment (e.g., depression, schizophrenia, obsessive-compulsive disorder);\n* Any medical condition that may interfere with breast milk expression (e.g., mastitis);\n* Stillbirth;\n* History of thyroid dysfunction;\n* Any physical condition or disability that prevents wearing the smart lactation support vest;\n* Previous breast surgery (e.g., breast implant surgery, mastectomy);\n* Insufficient Turkish language proficiency preventing the participant from understanding and completing the study instruments.\n\nFor Newborns:\n\n* Cleft palate or cleft lip;\n* Congenital anomaly;\n* Requirement for mechanical ventilation.","FEMALE","18 Years","50 Years",{"count":51,"type":52},76,"ESTIMATED","INTERVENTIONAL",[55],"NA",[57,58,59],"Lactation","Lactation Disorder - Postpartum Condition or Complication","Breast Feeding",[57,61,62,63,64,65,66,67,68],"Breast Milk Production","Wearable Technology","Thermo-Massage","Vibration Therapy","Artificial Intelligence","Smart Wearable Device","Cesarean Section","Neonatal Intensive Care Unit","NOT_YET_RECRUITING","2026-08-10",{"date":72,"type":73},"2026-08-14","ACTUAL",{"date":75,"type":52},"2026-12-01",{"date":77,"type":52},"2028-05-01",{"name":5,"class":6}]