[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659757":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":28,"studyPopulation":19,"armGroups":29,"interventions":50,"overallOfficials":19,"centralContacts":64,"locations":19,"responsibleParty":70,"collaborators":19,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":19,"maxAge":19,"enrollmentInfo":83,"targetDuration":19,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":19,"overallStatus":94,"whyStopped":19,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":19},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Breastfeeding Quality","Breastfeeding quality will be assessed using the Bristol Breastfeeding Assessment Tool. Changes in breastfeeding quality from baseline to post-test will be evaluated.","Before hospital discharge (pre-test) and at 4 weeks postpartum (post-test)",{"measure":14,"description":15,"timeFrame":12},"Mother-infant bonding","Mother-infant bonding will be assessed using the Mother-Infant Bonding Scale. Changes in mother-infant bonding from baseline to post-test will be evaluated.",{"measure":17,"description":18,"timeFrame":12},"Breastfeeding self-efficacy","Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale. Changes in breastfeeding self-efficacy from baseline to post-test will be evaluated.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":23,"primaryPurpose":24,"observationalModel":19,"timePerspective":19,"maskingInfo":25},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of four parallel groups: (1) standard postpartum care (control group), (2) infant massage applied by the mother, (3) oxytocin back massage applied to the mother by the father, or (4) a combination of infant massage applied by the mother and oxytocin back massage applied to the mother by the father. Participants will remain in their assigned group throughout the study.","TREATMENT",{"masking":26,"maskingDescription":27,"whoMasked":19},"NONE","This is an open-label study. Participants and individuals delivering the massage interventions will be aware of group assignment because the nature of the interventions does not allow masking. Data analysis will be performed by an independent statistician using groups coded as A, B, C, and D. The group codes will be revealed only after completion of the statistical analyses, and the results will then be interpreted.","The postpartum period is a critical period during which mothers and newborns adapt to important physiological, psychological, and social changes . During this period, maternal postpartum recovery, neonatal adaptation to life, successful initiation of breastfeeding, and the development of the mother-infant relationship are interrelated processes. In particular, the first hours and days after birth are critical for establishing breastfeeding behaviors, regulating milk production, and strengthening mother-infant interaction. Initiation of breastfeeding during the first hours after birth is one of the key practices supporting the newborn's access to colostrum, early immune protection, and the continuation of breastfeeding.\n\nLactation is a complex physiological process involving preparation of the breast for breastfeeding, milk synthesis and secretion, milk ejection (let-down) reflex, and maintenance of lactation. Effective infant suckling and regular breast emptying are important for successful continuation of this process. Inadequate breastfeeding may lead to decreased prolactin levels and adversely affect milk production. However, breastfeeding success cannot be explained solely by physiological mechanisms; it is influenced by multiple factors, including maternal knowledge, breastfeeding beliefs, sources of social support, childbirth experience, and breastfeeding self-efficacy.\n\nBreastfeeding self-efficacy is defined as a mother's confidence in her ability to breastfeed her infant successfully and is considered an important determinant of breastfeeding initiation and continuation. Maternal education level, mode of delivery, postpartum care experiences, social support, and breastfeeding-related concerns may influence breastfeeding self-efficacy. In addition, hormonal changes, physical fatigue, sleep deprivation, adjustment to the maternal role, and concerns related to infant care may increase maternal stress during the postpartum period. Increased stress and anxiety may adversely affect oxytocin release and the milk ejection reflex, potentially resulting in reduced milk flow, shorter breastfeeding duration, and decreased maternal confidence in breastfeeding.\n\nTherefore, there is a need for safe, feasible, and low-cost postpartum care interventions that address mothers' physiological and psychological needs. Oxytocin massage is a non-pharmacological complementary intervention used to support breast milk production and milk ejection. Oxytocin massage consists of circular massage movements applied along the neck, scapular, and spinal areas for approximately 15-20 minutes. It has been suggested that this intervention may stimulate the central nervous system through cutaneous and neural pathways, thereby increasing oxytocin release through the hypothalamic-pituitary pathway and supporting the milk ejection reflex. Previous studies have reported that oxytocin massage may have beneficial effects on milk volume, milk flow, and breastfeeding outcomes.\n\nAnother non-pharmacological intervention that may support mother-infant interaction is infant massage. Infant massage is an easily applicable caregiving approach that increases tactile communication between the mother and infant and may support the infant's physiological and behavioral regulation. Infant massage has been reported to increase vagal activity and potentially improve gastrointestinal function, nutrient absorption, and growth. Increased vagal activity may influence gastrin and insulin levels, potentially facilitating more efficient utilization of nutrients and supporting infant weight gain. In addition, by promoting infant relaxation and supporting sucking behaviors, infant massage may increase breastfeeding frequency, which may in turn stimulate prolactin secretion and contribute to milk production.\n\nInfant massage may have beneficial effects not only on infant physical development but also on the mother-infant relationship. According to attachment theory, the mother-infant relationship begins at birth and develops through the mother's sensitive responsiveness to the infant's needs and reciprocal communication. Positive tactile contact during infant massage has been reported to support secure attachment, increase maternal sensitivity toward the infant, and strengthen mother-infant interaction.\n\nThe literature indicates that the effects of oxytocin massage and infant massage on breastfeeding, milk production, infant development, and mother-infant interaction have generally been evaluated separately. However, randomized controlled studies examining the effects of combining maternal oxytocin massage with infant massage performed by mothers on breastfeeding parameters, breastfeeding self-efficacy, and mother-infant bonding are limited. Since breastfeeding is a dynamic process shaped not only by maternal physiological factors but also by reciprocal mother-infant interaction, evaluating the effects of integrated tactile approaches targeting both the mother and infant is important.\n\nThis study is designed to evaluate the effects of maternal oxytocin massage and infant massage performed by mothers, when applied separately and in combination, on breastfeeding scores, time to breastfeeding initiation, breastfeeding duration and frequency, breastfeeding status at hospital discharge, breastfeeding problems, infant feeding method, breastfeeding self-efficacy, and mother-infant bonding during the postpartum period.\n\nThe originality of this study lies in its four-arm randomized controlled design, which comparatively evaluates two different non-pharmacological interventions targeting the mother and infant, both individually and in combination. This approach aims to provide evidence for a holistic model of postpartum care that considers the mother and infant together and to contribute new evidence to postpartum care practices.\n\nThe findings of this study are expected to contribute to the development of evidence-based interventions that can be implemented by midwives and nurses in postpartum care, support breastfeeding, strengthen mother-infant bonding, and promote family-centered care.",[30,34,40,45],{"label":31,"type":32,"description":33,"interventionNames":19},"Control Group","NO_INTERVENTION","Mothers and their infants in the control group will not receive any experimental intervention, including oxytocin massage or infant massage, from the researcher. They will continue to receive the hospital's standard routine postpartum care and breastfeeding counseling according to the institutional protocol. Assessments will be conducted before hospital discharge (pre-test) and at 4 weeks postpartum (post-test).",{"label":35,"type":36,"description":37,"interventionNames":38},"Infant Massage Group","EXPERIMENTAL","Mothers in this group will administer infant massage to their own infants once daily for four weeks, for approximately 15 minutes per session, in accordance with the standardized infant massage protocol described above.",[39],"Behavioral: Infant Massage",{"label":41,"type":36,"description":42,"interventionNames":43},"Oxytocin Massage Group","Mothers in this group will receive oxytocin massage from their partners\u002Ftheir infants' fathers once daily for four weeks, in accordance with the standardized oxytocin massage protocol described above.",[44],"Behavioral: Oxytocin Massage",{"label":46,"type":36,"description":47,"interventionNames":48},"Infant Massage and Oxytocin Massage Group","Both interventions will be administered in this group. Oxytocin massage will be administered by the father to the mother, while infant massage will be administered by the mother to the infant. Both interventions will be performed once daily for four weeks in accordance with the standardized intervention protocols described above.",[49],"Behavioral: Infant Massage and Oxytocin Massage",[51,56,60],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":19},"BEHAVIORAL","Infant Massage","Mothers will be trained by the researcher to administer standardized infant massage to their own infants. After supervised practice before hospital discharge, mothers will administer infant massage once daily for 4 weeks, for approximately 15 minutes per session. Massage will be performed according to the standardized protocol.",[35],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":19},"Oxytocin Massage","Fathers will be trained by the researcher to administer standardized oxytocin massage to the mothers. After supervised practice before hospital discharge, fathers will administer oxytocin massage once daily for 4 weeks according to the standardized protocol. Each session will last approximately 15-20 minutes.",[41],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":19},"Infant Massage and Oxytocin Massage","Mothers will administer standardized infant massage to their own infants, while fathers will administer standardized oxytocin massage to the mothers. Both interventions will be performed once daily for 4 weeks according to the standardized intervention protocols. Infant massage will last approximately 15 minutes, and oxytocin massage will last approximately 15-20 minutes per session.",[46],[65],{"name":66,"role":67,"phone":68,"phoneExt":19,"email":69},"Özge Şen, PhD","CONTACT","05393644201","ozgeylmz53@gmail.com",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","OZGE SEN","PhD Candidate","100659757","effects-of-maternal-and-infant-massage-on-breastfeeding-and-mother-infant-bonding-100659757",false,"NCT07867054","Effects of Maternal and Infant Massage on Breastfeeding and Mother-Infant Bonding","The Effect of Different Massage Techniques Applied to Mother and Baby on Breastfeeding Parameters and Mother-Baby Bonding","MIM-BOND","Inclusion Criteria:\n\nMother:\n\n* Being primiparous.\n* Being within the first 24 hours postpartum.\n* Having a singleton birth.\n* Rooming-in with her infant during the postpartum period.\n* Having no physical or mental health condition that would prevent breastfeeding or participation in the study.\n* Being willing to regularly administer infant massage to her infant for 4 weeks postpartum.\n* Having no health condition that would prevent the mother or infant from receiving massage.\n* Being able to speak Turkish and having no condition that would interfere with communication.\n\nFather:\n\n* Being present with the mother during the postpartum period.\n* Being able to speak Turkish and having no condition that would interfere with communication.\n* Being able to regularly administer oxytocin massage to the mother for 4 weeks postpartum.\n\nInfant:\n\n* Being born at term (37-42 weeks of gestation).\n* Having a birth weight between 2,500 and 4,000 g.\n\nExclusion Criteria:\n\n* The mother cannot be reached at 4 weeks postpartum.\n* Infant massage is performed fewer than twice per week.\n* Oxytocin massage is performed fewer than twice per week.\n* The infant is admitted to the neonatal intensive care unit.\n* The mother develops a postpartum complication (e.g., postpartum hemorrhage or suspected infection).\n* Participants assigned to the oxytocin massage group administer infant massage.\n* Participants assigned to the infant massage group administer oxytocin massage.\n* Participants assigned to the control group administer either oxytocin massage or infant massage.","FEMALE",{"count":84,"type":85},136,"ESTIMATED","INTERVENTIONAL",[88],"NA","This study aims to evaluate the effects of different massage techniques applied to mothers and infants on breastfeeding parameters and mother-infant bonding during the postpartum period. The study will investigate whether infant massage applied by mothers, oxytocin massage applied to mothers by fathers, or the combination of both interventions improves breastfeeding outcomes and mother-infant bonding compared with standard postpartum care.",[91,92,93],"Breastfeeding","Mother-Infant Bonding","Lactation","NOT_YET_RECRUITING","2026-10-06",{"date":97,"type":98},"2026-10-09","ACTUAL",{"date":100,"type":85},"2026-11-01",{"date":102,"type":85},"2027-08-01",{"name":5,"class":6}]