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Showing 1-20 of 219 trials
NCT07660965
The aim of this study is to examine the effect of breastfeeding education provided via podcast to mothers of preterm infants admitted to the neonatal intensive care unit on the mothers' breastfeeding success, awareness, motivation, self-efficacy, and perception of insufficient milk supply. The research aims to help mothers overcome challenges in the breastfeeding process by increasing their knowledge levels and to strengthen their confidence in this process. Thus, the goal is to better meet the nutritional needs of preterm infants and to improve mothers' breastfeeding experiences in a positive direction.
NCT07647211
This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding outcomes among mothers who are not exclusively breastfeeding. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive a mindfulness-based breastfeeding education program in addition to routine care. Breastfeeding outcomes, maternal breastfeeding self-efficacy, and related variables will be assessed following the intervention.
NCT06650254
The World Health Organization and the United Nations Children\'s Fund report that exclusive breastfeeding for six months and continuing breastfeeding for two years or longer with appropriate complementary foods is one of the most powerful practices to increase the survival and well-being of the child. Some difficulties experienced during the breastfeeding process negatively affect the continuation of breastfeeding and prevent the baby from receiving breast milk. It has been determined in the studies in the literature that various interventions have been made and recommendations have been made to increase breastfeeding rates. However, it has been seen that there is a need for studies that address the needs of mothers regarding breastfeeding problems in a holistic manner and provide support in line with their needs. In order to increase breastfeeding success and ensure the continuity of effective breastfeeding, it is obvious that a holistic assessment of mothers; breastfeeding problems is needed, physical, psychospiritual, sociocultural and environmental factors that may cause deterioration in comfort are determined and comfort-focused nursing support is provided. In this context, the aim of the study is to determine the effect of the breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period on the breastfeeding comfort of mothers, and the second aim is to develop the \"Postpartum Breastfeeding Comfort Scale\" and test its validity and reliability. Hypotheses of the study: H0: The breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period is not an effective method in increasing the breastfeeding comfort of mothers. H1: The breastfeeding support structured according to Kolcaba\'s comfort theory given to mothers in the postpartum period increases the breastfeeding comfort of mothers. H2: "Postpartum Breastfeeding Comfort Scale" is a valid and reliable tool for measuring mothers\' breastfeeding comfort.
NCT07540923
This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.
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).
NCT07525830
The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of "co-dodo" cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib. This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.
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.
NCT06673160
The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is: \- What effect does pumping frequency have on breast milk supply. Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce. Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.
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.
NCT07410754
This randomized controlled study aims to evaluate the effect of consecutive skin-to-skin contact applied by the mother and father on breastfeeding parameters and parent-infant bonding in babies born by cesarean section. The study includes two groups: an intervention group receiving consecutive skin-to-skin contact by the father followed by the mother, and a control group receiving routine postnatal care. Breastfeeding success and parental bonding will be assessed using validated measurement tools during the early postnatal period and follow-up.
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.
NCT07069582
This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms: * Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10). * Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20). * Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5). * Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15). * Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10). * Arm F: Single-dose bedaquiline at 400 mg (BDQ400).
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.