Clinical Research Directory

Feasibility and Efficacy of GTEP for Birth Trauma

This clinical study aims to evaluate the feasibility and initial efficacy of Group Traumatic Episode Protocol (GTEP) for reducing trauma symptoms (measured by the PCL-5 and City BiTS) for individuals following a traumatic birthing experience. A secondary aim is to evaluate the efficacy of GTEP in improving parental wellbeing (measured through the CORE-10) and parent-infant bonding (measured through the PBQ) following a traumatic birthing experience. Participants (those who have experienced a traumatic birthing experience) will complete the GTEP intervention, delivered online. They will be asked to complete outcome measures and give feedback on their experience of the group.

The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants

This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance. The study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention. Outcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments. The findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.

Bond Strength Evaluation

This study was evaluated the effect of dimethyl sulfoxide pretreatment on tensile bond strength and nanoleakage of resin composite bonded to aged dentin.

The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.

This is a multicenter, 1:1 parallel-group, randomized controlled trial designed to compare the effect of the Enhanced Recovery After Cesarean (ERAS) protocol versus standard perioperative care on mother-infant and father-infant bonding in women undergoing cesarean delivery. The study will initially be conducted as a single-center trial at Istanbul Okan University Hospital. Once adequate site preparation is completed, additional centers will be added to expand the study to a multicenter setting. Primary Outcome: The primary outcome is the total score on the Postpartum Bonding Questionnaire (PBQ) assessed on postpartum day 7, reflecting mother-infant bonding. Secondary Outcomes: Secondary outcomes include: Maternal/Parental Postnatal Attachment Scale (MIBS) score at 2 hours postpartum (mother) PBQ score at 24 hours postpartum (mother) PBQ score at day 4 postpartum (mother) PBQ score at day 7 postpartum (father-infant bonding) Edinburgh Postnatal Depression Scale (EPDS) scores for mothers at 2 hours and 7 days postpartum Time to initiation of breastfeeding Requirement for neonatal intensive care unit (NICU) admission Sample Size: The total multicenter target sample size is n=300, with 150 participants in the ERAS group and 150 in the standard care group. The initial single-center phase at Okan University Hospital will enroll a target of n=100 participants (50 per group). Randomization: Participants will be randomized using a block and stratified randomization approach based on parity (primiparous vs multiparous) and planned type of anesthesia. Blinding (Masking): Due to the nature of the intervention, care providers cannot be blinded to group assignment. However, outcome assessors and data analysts will remain blinded to treatment allocation to minimize bias. Study Timeline and Visits: Participants will be evaluated at multiple time points following cesarean delivery: 2 hours postpartum, 24 hours postpartum, day 4 postpartum, and day 7 postpartum. All primary and secondary outcomes will be collected at the specified time points. Significance and Rationale: The ERAS protocol for cesarean delivery is designed to optimize perioperative care, enhance recovery, and potentially improve early parent-infant bonding. While previous studies have focused on maternal recovery and clinical outcomes, evidence regarding the impact of ERAS on both mother-infant and father-infant bonding remains limited. This trial aims to provide high-quality evidence on whether ERAS implementation can improve early bonding experiences, maternal mental health, breastfeeding initiation, and neonatal outcomes compared with standard perioperative care. The findings may guide future clinical practice and contribute to optimizing family-centered care in cesarean deliveries. Key Features: Multicenter, randomized controlled design Parallel 1:1 allocation Stratified randomization by parity and anesthesia type Blinded outcome assessment and data analysis Multiple postpartum evaluation points Focus on psychosocial and clinical outcomes Expected Contributions: This study will provide comprehensive data on the feasibility and effectiveness of ERAS protocols in cesarean deliveries and their potential benefits for both maternal and paternal bonding with the newborn. The inclusion of both mother-infant and father-infant outcomes, as well as maternal mental health and breastfeeding indicators, ensures a holistic assessment of early family-centered outcomes.

Effects of Music on Post-Cesarean Pain, Anxiety, Breastfeeding and Mother Infant Attachment Impact

The physiological effects of music therapy include creating a behavioral change and changing the mood by reducing psychophysiological stress, pain, anxiety and isolation. Music has the ability to create deep relaxation. It is known to have relieving effects on insomnia. In addition, it has been reported that music therapy application before and during birth reduces labor pain and reduces postpartum anxiety and depression levels. The postpartum period, which begins with the birth of the newborn, covers the 6-8 week period that it takes for the changes that occur in the woman's body during pregnancy to return to its pre-pregnancy state. This period is an important transition period in which physical, social and emotional changes occur in mothers. In addition to rapid anatomical and physiological changes, mothers experience a difficult process in which the transition to motherhood is experienced, new roles and responsibilities are assumed, and relationships with their spouses and other family members are reorganized. Although a woman begins to feel the changes that having a baby creates in her daily life during pregnancy, she usually experiences the biggest change after the baby is born. The period when the first emotional bond between the newborn and her family is formed and a sense of trust develops is defined as mother-baby bonding. Many factors affect mother-baby bonding in the postpartum period, which is the most important time when the bond established between the expectant mother and the baby during pregnancy, referred to as prenatal bonding, is strengthened after birth. It is particularly affected by the mother's upbringing, as well as her experiences during pregnancy, birth, puerperium, and the baby's first months. Healthy and early interaction between mother and baby initiates a healthy bonding process.

The Effects of Video-Based and Practical Newborn Bathing Education Provided to Primiparous Pregnant Women During the Third Trimester on Knowledge, Anxiety, and Bonding During the First Bath: A Randomized Controlled Trial

This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.

Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS

The PreDECESS trial is a prospective study where that will evaluate a new method taking care of premature infants in gestational weeks 30+0 to 34+6 at birth. The new method includes delayed cord clamping and early skin-to-skin contact with a parent. Two populations of infants with their parents will be compared. Infants taken care of in the traditional way before the new method is introduced, and infants taken care of with the new method when it is being introduced. Primary question: Does delayed cord clamping and early skin-to skin contact (SSC) lead to better bonding between parents and their infants? Secondary questions: Are there any potential adverse effects with delayed cord clamping and early skin-to skin contact (SSC)? Is there a difference in infants level of bilirubin, haemoglobin or proBNP? Is there a difference in infants growth? Is there a difference in infants neurological development? Is there a difference in infants and parents level of stress? Is there a difference in mothers production of breastmilk, frequency of breastfeeding or experience of breastfeeding? Is there a difference in parents mood? How do parents of preterm infants experience giving birth of their preterm baby before and after the introduction of the new method?