Effect of Prenatal Shared Decision-Making Counseling on Decisional Conflict and Breastfeeding Performance Among Primiparous Women: A Quasi-Experimental Embedded Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Breastfeeding Performance Index (BPI) score
研究概览
简要总结
This quasi-experimental embedded mixed-methods study evaluated the effect of a prenatal shared decision-making (SDM) counseling session on decisional conflict and breastfeeding performance among primiparous women in Zahedan, Iran. A total of 112 pregnant women at 35-37 weeks' gestation were allocated to either an intervention group receiving one 90-minute SDM counseling session or a control group receiving routine prenatal care. Decisional conflict was assessed at baseline, one week post-intervention, and three days postpartum. Breastfeeding performance was evaluated on days 3 and 60 postpartum.
详细描述
This interventional quasi-experimental study with an embedded qualitative component was conducted among primiparous pregnant women in Zahedan, Iran. The quantitative phase included 112 participants recruited at 35-37 weeks of gestation and assigned to either a shared decision-making (SDM) counseling group or a routine care control group.
The intervention consisted of a single 90-minute individualized prenatal SDM counseling session conducted according to the three-step SDM model (choice talk, option talk, and decision talk). The session addressed infant feeding options, benefits and risks of exclusive breastfeeding, clarification of maternal values and preferences, and available support systems.
The primary outcome was decisional conflict measured using the 16-item Decisional Conflict Scale (score range 0-100). Secondary outcomes included breastfeeding performance measured using the 7-item Breastfeeding Performance Index at 3 and 60 days postpartum.
An embedded qualitative grounded theory component explored sociocultural and personal processes influencing infant feeding decisions among participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous pregnant women
- •Gestational age between 35 and 37 weeks at enrollment
- •Singleton pregnancy
- •First breastfeeding experience
- •Planned delivery in Zahedan hospitals
- •Maternal age between 15 and 40 years
- •Receiving care at comprehensive health centers in Zahedan, Iran
- •Willingness to participate and provide informed consent
排除标准
- •Contraindications to breastfeeding (e.g., chemotherapy, ergotamines, breast lesions, HIV infection, prenatal depression)
- •Preterm birth (<37 weeks)
- •Neonatal intensive care unit (NICU) admission
- •Absence from counseling sessions
- •Congenital anomalies in the infant (e.g., cleft lip or palate)
- •Maternal intensive care unit (ICU) admission
- •High-risk pregnancy (e.g., pre-eclampsia/eclampsia, insulin-dependent diabetes, cardiac disease)
研究组 & 干预措施
Routine Prenatal Care
Pregnant women received routine prenatal care without shared decision-making counseling.
干预措施: Shared Decision-Making Counseling (Behavioral)
Experimental: Shared Decision-Making Counseling
Pregnant women received shared decision-making counseling sessions regarding breastfeeding during prenatal care.
干预措施: Shared Decision-Making Counseling (Behavioral)
结局指标
主要结局
Breastfeeding Performance Index (BPI) score
时间窗: 3 days postpartum and 60 days postpartum
Breastfeeding performance will be assessed using the Breastfeeding Performance Index (BPI). The total score ranges from 0 to 7, with higher scores indicating better breastfeeding performance and greater adherence to exclusive breastfeeding practices.
次要结局
- Decisional Conflict Scale (DCS) score(Baseline (35-37 weeks' gestation), immediately after the counselling session (same day), and 3 days postpartum)
研究者
Zahra Moudi
Professor of Reproductive Health
Zahedan University of Medical Sciences