Clinical Research Directory

Ankyloglossia and Its Effects on Breastfeeding, Feeding and Speech Disorders. A Prospective Study From Birth to 4 Years of Age.

The diagnosis of ankyloglossia (restrictive lingual frenulum) and the number of frenotomies in infants have sharply increased, raising concerns among the medical community and the ONE. While some studies suggest benefits of frenotomy on breastfeeding, all emphasize the lack of consensus regarding the definition, diagnosis, and classification of ankyloglossia, as well as the scarcity of prospective data on its impact on breastfeeding, feeding, occlusion, and speech. This prospective study aims to determine whether lingual frenulum characteristics influence early breastfeeding difficulties and duration, as well as later feeding, occlusion, and speech outcomes. Breastfed newborns are followed from the first days of life (T1) to age 4 years (T7). During the first 3 months, tongue mobility, frenulum characteristics, breastfeeding, maternal pain, and complications are assessed. Several clinical tools are compared to identify the most reliable ones. Frenulum length is measured using calibrated photographs. Phone follow-ups at 6 months, 1 and 2 years assess feeding outcomes; speech and occlusion are evaluated at 4 years. This project could provide objective data to guide clinicians in evaluating ankyloglossia and making informed frenotomy decisions, improve breastfeeding support, and help parents make evidence-based choices.

The Effect of a Multi-Component Breastfeeding Support Program on Breastfeeding Self-Efficacy and Mother-Infant Bonding in Mothers Following Cesarean Section

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.

Effect of Oketani Breast Massage on Promoting Breastfeeding

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

EVALUATİON OF THE EFFECTİVENESS OF A MODEL-BASED HYPNOBREASTFEEDİNG EDUCATİON PROGRAM GİVEN TO PRİMİPAROUS PREGNANT WOMEN

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.

Breastfeeding Education

This study was designed to determine the effect of breastfeeding education given to primiparous pregnant women using the pecha kucha technique on breastfeeding self-efficacy and maternal bonding. The research is a randomized controlled experimental study.

THE EFFECT OF REIKI ON BREASTFEEDING, PAIN AND COMFORT AFTER CESAREAN SECTION

EFFECT OF REİKİ APPLİED DURİNG THE POSTPARTUM PERİOD ON BREASTFEEDİNG, PAİN, AND COMFORT IN WOMEN WHO DELİVERED BY CESAREAN SECTİON The aim of this randomized controlled trial is to determine the effect of Reiki applied to volunteer women after cesarean section on breastfeeding, pain, and comfort in the postpartum period. The main questions it aims to answer are: Is there a difference in postpartum breastfeeding, pain, and comfort between the group receiving Reiki and the group receiving standard care? Is there a difference in postpartum breastfeeding, pain, and comfort between the group receiving Reiki and the group receiving Sham Reiki? Participants will receive Reiki six times postpartum: three times one-on-one during their hospital stay, and remotely in the second, third, and fourth weeks. The control group will receive standard care. The Sham Reiki group will receive Reiki points applied by a person without Reiki knowledge.

Telehealth-Supported Breastfeeding Counseling in Primiparous Mothers

Breastfeeding is critical for infant and maternal health; however, many first-time mothers experience difficulties that may lead to early discontinuation of breastfeeding. Telehealth-supported breastfeeding counseling has the potential to provide timely, accessible, and continuous support to mothers during the postpartum period. This randomized controlled trial aims to evaluate the effect of telehealth-supported breastfeeding counseling on breastfeeding duration, breastfeeding self-efficacy, and postpartum depressive symptoms in primiparous mothers. Participants will be randomly assigned to either a telehealth-supported breastfeeding counseling group or a routine postpartum care group. The intervention group will receive structured breastfeeding counseling sessions delivered via telecommunication tools in addition to standard care, while the control group will receive routine postpartum care only. Outcomes will be assessed using validated questionnaires and follow-up evaluations during the postpartum period. The findings of this study may contribute to improving breastfeeding support strategies and maternal mental health outcomes.

Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence

This study tests whether a nurse-led "4-step narrative nursing" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section. What is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common. What will we do? We will randomly assign 160 mothers (1:1) to either: Usual care - standard education and ward care, or Usual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse: Before surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to "name" pain or worries and separate them from herself. Before discharge - guide her to find positive moments and build a "strong-mom" story. Two weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months. Possible benefits: Lower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking. Risks: Minimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.

Breastfeeding Intervention to Prevent Obesity Among Children

The goal of this clinical trial is to learn how to improve exclusive breastfeeding rates. The main questions it aims to answer are: Do Hispanic mothers benefit from peer counseling support from peer counselors who can speak Spanish? Are mothers more likely to continue exclusive breastfeeding if additional funds are given so that the WIC exclusive breastfeeding package has the same cash value as the WIC formula feeding package? Researchers will compare participants in the intervention group (who receive peer counseling and additional funds) to a control group (who do not receive peer counseling or additional funds) to see if the intervention package improves breastfeeding rates. All participants (intervention and control) will complete weekly surveys about their feeding experiences ($8 per week). Members of the research team will also take infant weight/length measurements at home (twice during the first month and then at 2, 4, and 6 months). Participants will be recruited during pregnancy and the study will last for the first 6 months after their babies are born. Mothers and their infants are both participants in the study. Participants in the intervention condition will also be matched with Spanish-speaking peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study). In Month 1, mothers can choose to receive a $150 gift card or an electric breast pump. In Months 2-5, if infants are signed up for the WIC exclusive breastfeeding package, infants will receive $100 and mothers will receive $50. If infants are signed up for the WIC partial breastfeeding package, infants will receive $50 and mothers will receive $30.

Text-based Motivational Interviewing Intervention to Promote Exclusive Breastfeeding Rates

The goal of this clinical trial is to evaluate whether a text-based motivational interviewing (MI) intervention can increase exclusive breastfeeding rates and breastfeeding self-efficacy in mothers of healthy full-term infants. This study focuses on addressing breastfeeding barriers, particularly among mothers in underserved and rural populations. The main questions it aims to answer are: * Does a text-based MI intervention improve exclusive breastfeeding rates at two, four, and six weeks postpartum? * Does the intervention increase maternal breastfeeding self-efficacy during the same period? Researchers will compare the outcomes of mothers receiving the text-based MI intervention to standard breastfeeding support to assess its feasibility, acceptability, and initial effectiveness. Participants will: * Receive weekly personalized motivational text messages for six weeks postpartum. * Engage in interactive exchanges with MI-trained interviewers addressing breastfeeding challenges. * Complete surveys at baseline, mid-intervention, and post-intervention to assess breastfeeding behaviors and self-efficacy.

Essential Coaching for Every Mother in Tanzania

The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.