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Showing 1-20 of 170 trials
NCT07543029
Purpose: This is a randomized controlled trial designed to investigate the effects of Kangaroo Mother Care (KMC) applied in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Methodology and Sample: Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026. Sample Size: Based on G\*Power analysis (alpha=0.05, power=80%, effect size d=0.566), a total of 112 mothers (56 intervention, 56 control) will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org. Intervention: Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported. Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support). Data Collection Tools: Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
NCT07537218
Objective: The study aims to examine the effect of lullabies and white noise on breastfeeding success in newborns. Method: The study was conducted using a randomized controlled experimental design. The sample size, determined based on power analysis, consisted of 160 newborns, and participants were divided into four groups (female voice lullaby=40, male voice lullaby=40, white noise=40, control=40). Infants in the experimental groups were exposed to the relevant auditory stimulus during breastfeeding, while no intervention was made in the control group. Data were collected using the mother and newborn information form and the LATCH Breastfeeding Assessment Scale.
NCT04387552
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).
NCT07474402
This study tests a breastfeeding support program for mothers who give birth by cesarean section. The purpose of the study is to see whether the program helps mothers feel more confident about breastfeeding and improves mother-baby bonding.
NCT07481643
In pregnant women, non-pharmacological methods such as music, massage, yoga, meditation, relaxation breathing exercises, and acupuncture have been tried to reduce anxiety during childbirth, and there are studies on these in the literature. However, researchers have not come across a study in the literature that evaluates the effect of positive affirmations on perioperative maternal anxiety and breastfeeding together. Researchers aim is to evaluate the relationship between anxiety, sedation, and breastfeeding levels in pregnant women who underwent positive affirmations and music therapy during cesarean section.
NCT07354360
Breastfeeding is essential for infant survival and maternal health; however, many primipara women experience breastfeeding difficulties in the early postpartum period, particularly, latching difficulties, ineffective milk transfer, low breastfeeding self-efficacy and breast engorgement, which may compromise successful breastfeeding. Oketani massage is a non-pharmacological, cost-effective breast massage technique developed to enhance milk flow, improve maternal comfort during breastfeeding and reduce breast engorgement. This study aims to evaluate effect of Oketani massage on successful breastfeeding. Successful breastfeeding will be assessed through indicators of maternal latching technique, successful breastfeeding behavior and maternal breastfeeding self-efficacy. The findings of this study may support the use of Oketani massage as a supportive nursing intervention to promote successful breastfeeding outcomes in the early postpartum period
NCT07461428
This randomized controlled trial aimed to evaluate the effectiveness of an education program based on the Information-Motivation-Behavioral Skills (IMB) Model and grounded in the philosophy of hypnobreastfeeding provided to primiparous pregnant women.
NCT07435363
This study is designed as a randomized controlled trial (RCT) focused on improving breastfeeding outcomes among primiparous mothers in the postpartum period. Although the World Health Organization (WHO) recommends exclusive breastfeeding for the first six months as the ideal nutritional source for newborns, the rate in Turkey (41% according to TDHS 2018) lags behind global targets (50-70%). Early cessation of breastfeeding is generally associated with mothers' inability to adapt to physical and psychological challenges. In particular, anxiety and stress experienced during the postpartum period lead to the development of a perceived insufficient milk supply, which negatively affects the acquisition of breastfeeding self-efficacy. In this context, this study investigates the potential of a supportive intervention facilitating stress management and relaxation on breastfeeding sustainability. Participants will be randomized into three groups: Intervention Group I (Online Breastfeeding Education + Breath-Based Yoga), Intervention Group II (Online Breastfeeding Education Only), and the Control Group (Routine Care). The interventions will be delivered remotely via Google Meet over a maximum period of seven weeks (3 weeks of breastfeeding education + 4 weeks of yoga practice). The primary objective of the study is to evaluate whether these structured interventions significantly improve maternal breastfeeding self-efficacy and reduce the perception of insufficient milk. Additionally, secondary outcomes will assess the impact on maternal anxiety levels. To ensure internal validity and isolate the intervention effect, mothers at high risk of postpartum depression (EPDS score \> 13) are excluded from the study. The Hypotheses of the Study Each hypothesis will be tested independently: H₀: The pre- and post-intervention measurement differences do not significantly differ between groups. H₁: The pre- and post-intervention measurement differences significantly differ between groups (p \< 0.05). If a significant difference is detected, H₀ will be rejected and H₁ will be accepted. Multiple comparisons will be evaluated using the Holm-Bonferroni correction to control the Type I error rate. * H1a: Online breastfeeding education provided to primiparous mothers positively affects their anxiety levels. * H1b: Online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy. * H1c: Online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply. * H2a: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their anxiety levels. * H2b: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their breastfeeding self-efficacy. * H2c: Breath-based yoga-supported online breastfeeding education provided to primiparous mothers positively affects their perceived insufficient milk supply.
NCT06736743
This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral feeding.
NCT07404930
The Reuteri17 study is a spontaneous, prospective, randomized intervention study designed to evaluate the effects of maternal supplementation with the probiotic Lactobacillus reuteri SGL 01 on the composition of the breast milk microbiota and subsequent intestinal colonization of the newborn. The protocol involves the enrollment of 20 primiparous mothers of full-term, exclusively breastfed infants. Participants are divided into two groups: the first receives a daily supplement of 5 drops of Reuplus® (equivalent to 1 billion live cultures), while the second serves as a non-supplemented control group. The effectiveness of the intervention is monitored through two sampling moments: at baseline (T0) and after 30 days of treatment (T1). Specifically, 20 ml samples of breast milk and fecal samples from the newborns are collected. Bacterial DNA is extracted from these biological matrices and analyzed using real-time PCR at the University of Bologna, with the aim of quantifying changes in the microbiota and the transfer of the probiotic strain. To complete the investigation, mothers are given a nutritional questionnaire to correlate the results with dietary habits. The study aims to confirm that maternal oral supplementation can be an effective strategy for modulating the bacterial heritage of newborns during the first months of life.
NCT05903846
The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. The universe of the study consisted of mothers who were hospitalized in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023 and gave birth by cesarean section. The Open Epi calculation tool was used to determine the sample of the study. The sample calculation was made on the average score differences in the Open Epi info program. Accordingly, it was planned to include 106 mothers, 53 of whom were in the control group and 53 in the massage group. Considering the sample loss to be experienced during data collection, a total of 116 mothers, 58 in the control group and 58 in the massage group, were included in the study. Randomization of the groups participating in the study was made as simple randomization using the www.random.org site. Introductory Characteristics Questionnaire, oketany massage follow-up form, breast engorgement assessment scale and LATCH breastfeeding diagnostic measurement tool were used to collect the research data.
NCT05377372
This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.
NCT06417385
Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.
NCT06993103
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.
NCT07369947
As of 2024, nearly half (48%) of infants under six months worldwide are exclusively breastfed, approaching the global target of 50%. Building on this progress, the World Health Organization has extended the target to 60% by 2030, emphasizing the need for innovative, scalable, and supportive interventions to strengthen breastfeeding practices. Breastfeeding has well-established benefits for infant growth, immunity, and long-term health, while also reducing maternal postpartum complications and chronic disease risks. Early postpartum support, particularly within the first hours after birth, is critical for successful and sustained breastfeeding. However, in busy clinical settings, providing continuous and individualized support can be challenging, especially for primiparous women who may experience low confidence, pain, and insufficient guidance. This randomized controlled trial aims to evaluate the effect of an artificial intelligence (AI)-supported relaxing breastfeeding video on breastfeeding self-efficacy, breastfeeding motivation, and LATCH scores among primiparous women. Unlike instructional videos, the AI-based video is designed to promote emotional relaxation, instinctive breastfeeding perception, and maternal confidence during the early postpartum period. The study adopts a two-arm randomized controlled experimental design. The population consists of primiparous women who deliver vaginally at Ağrı Training and Research Hospital postpartum unit between February and June 2026. A priori power analysis (α=0.05, power=0.95) indicated a minimum sample size of 38 participants; considering a 20% attrition rate, a total of 46 women (23 per group) will be recruited. Eligible participants include primiparous, Turkish-speaking women without postpartum or neonatal complications. Women who undergo cesarean delivery, have medical or psychiatric conditions preventing breastfeeding, or whose newborns require intensive care will be excluded. Participants will be randomized into intervention and control groups using an online randomization tool. All participants will receive a standardized 5-minute breastfeeding education based on the Turkish Ministry of Health breastfeeding counseling guidelines. In addition to standard care, the intervention group will watch a 10-minute AI-supported relaxing video at the 2nd and 6th postpartum hours during breastfeeding. The video will be displayed via tablet while the mother is in a comfortable breastfeeding position. The control group will receive standard care only. The AI-generated video will be produced using Kling AI, a generative video platform that enables controlled text-to-video workflows. To ensure ethical and cultural sensitivity, the video will not include real human or animal breastfeeding images. Instead, it will feature abstract, metaphorical visuals (e.g., pastel silhouettes, minimalist line art, or flat illustrations) that convey calmness, bonding, rhythm, and instinctive closeness. The final version will be selected following expert review and pilot testing with three postpartum women. Low-level white noise (\<60 dB) will accompany the video to enhance maternal relaxation and infant comfort. Data collection tools include a demographic information form, the Breastfeeding Self-Efficacy Scale-Short Form, the Primipara Breastfeeding Motivation Scale, and the LATCH Breastfeeding Assessment Tool. Breastfeeding observations and LATCH scoring will be conducted by an independent midwife blinded to group allocation. Statistical analyses will include descriptive statistics, paired and between-group comparisons, and repeated-measures analyses where appropriate. Ethical approval will be obtained from the relevant institutional ethics committee, and written informed consent will be secured from all participants. The findings are expected to contribute novel evidence on the role of AI-supported emotional and relaxing digital interventions in enhancing early postpartum breastfeeding outcomes and maternal confidence.
NCT05262920
Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal and infant health, development, and well-being. The highest rate of BF cessation occurs within 3 weeks after birth, with 30% of women ceasing BF due to acute breast and nipple pain (BNP). BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signaling that stimulates multiple pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy, a key predictor of BF at 6 months and increased maternal distress symptoms contributing to differences in early BF cessation rates. The investigators developed and tested their 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory. Aligned with the needs and preferences elicited from BF participants, the investigators used a cloud-based platform to deliver BF knowledge and skills and provided support through nurse-led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits, and increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56NR020041 Randomized Control Trial (RCT), Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. Study results will advance knowledge on the BSM intervention, with direct implications for nurse-designed and lead self-management interventions in clinical settings or health care systems.
NCT06583174
The importance of breast milk, whose physiological nutritional properties for an infant are not equal to any other food, has been the subject of many studies. In this study, it is aimed to evaluate the relationship between breastfeeding attitude and nutritional knowledge levels of mothers who have 0-6 months infants.
NCT06781190
This research aimed to identify sustainable breastfeeding practices and green mothers' initiatives to develop a strong mother-child bond.
NCT07336186
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. The study compares their milk volume and self-efficacy scores to a control group receiving standard care.
NCT05767658
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.