The Effect of Telehealth-Supported Breastfeeding Counseling on Breastfeeding Duration, Self-Efficacy, and Postpartum Depressive Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Breastfeeding Self-Efficacy
研究概览
简要总结
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.
详细描述
This study is a single-center, parallel-group, randomized controlled trial designed to investigate the effectiveness of telehealth-supported breastfeeding counseling in primiparous mothers.
Eligible participants will be primiparous women who have delivered a healthy, term, singleton infant and meet the inclusion criteria. After providing informed consent, participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
The intervention group will receive structured breastfeeding counseling delivered through telehealth methods, including scheduled video or telephone-based counseling sessions conducted by trained healthcare professionals, in addition to routine postpartum care. The control group will receive routine postpartum care alone.
Primary outcomes include breastfeeding self-efficacy and postpartum depressive symptoms, assessed using validated measurement tools. Secondary outcomes include breastfeeding duration and exclusive breastfeeding status during follow-up. Data will be collected at predefined time points during the postpartum period.
The study will be conducted in accordance with ethical principles and has received approval from the Marmara University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee. The results of this study are expected to provide evidence regarding the role of telehealth-based breastfeeding support in improving maternal and infant health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous women aged 18-45 years.
- •Mothers who have delivered a healthy, term (≥37 weeks), singleton infant.
- •Ability to communicate in Turkish.
- •Willingness to participate in the study and provide informed consent.
- •Access to a telephone or internet-enabled device for telehealth communication.
排除标准
- •Mothers with severe maternal medical or psychiatric conditions that may interfere with breastfeeding.
- •Infants with congenital anomalies or conditions affecting feeding.
- •Mothers who require neonatal intensive care admission for their infants.
- •Mothers who are unable to participate in telehealth follow-up.
研究组 & 干预措施
Telehealth-Supported Breastfeeding Counseling
Participants assigned to this arm will receive structured breastfeeding counseling delivered via telehealth methods, including scheduled video or telephone-based counseling sessions provided by trained healthcare professionals, in addition to routine postpartum care.
干预措施: Telehealth-Supported Breastfeeding Counseling (Behavioral)
Routine Postpartum Care
Participants assigned to this arm will receive routine postpartum care according to standard clinical practice, without additional telehealth-supported breastfeeding counseling.
干预措施: Routine Postpartum Care (Other)
结局指标
主要结局
Breastfeeding Self-Efficacy
时间窗: From baseline (early postpartum period) to 1 month postpartum
Change in breastfeeding self-efficacy measured using a validated breastfeeding self-efficacy scale.
Postpartum Depressive Symptoms
时间窗: From baseline (early postpartum period) to 1 month postpartum
Change in postpartum depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS).
次要结局
- Exclusive Breastfeeding Status(Up to 6 months postpartum)
- Breastfeeding Duration(Up to 6 months postpartum)