Effect of Postpartum Acupressure Education on Breastfeeding Outcomes: A 12-Month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Exclusive breastfeeding rate at 6 months postpartum
研究概览
简要总结
This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.
详细描述
Exclusive breastfeeding for the first 6 months and continued breastfeeding up to 12 months are strongly associated with improved maternal and infant health outcomes. Despite widespread implementation of Baby-Friendly Hospital Initiative practices, early postpartum challenges often compromise breastfeeding continuation. Scalable, low-cost, self-care-based interventions that enhance maternal confidence and perceived control may support sustained breastfeeding.
This study is a two-arm, parallel-group, randomized controlled trial designed to assess the effectiveness of postpartum acupressure education as an adjunct to standard breastfeeding care. Eligible mothers will be randomized in a 1:1 ratio to either an acupressure education plus standard care group or a standard care-only group. Acupressure education will include face-to-face instruction, printed visual materials, and a short instructional video, focusing on the acupoints CV17 (Shanzhong), ST18 (Rugen), SI1 (Shaoze), ST36 (Zusanli), and SP6 (Sanyinjiao).
The primary outcome is the rate of exclusive breastfeeding at 6 months postpartum, defined according to World Health Organization criteria. Secondary outcomes include any breastfeeding at 12 months, breastfeeding self-efficacy, breastfeeding quality, timing of complementary feeding introduction, breastfeeding-related adverse events, and maternal satisfaction. Analyses will be conducted using an intention-to-treat approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and the statistician will be blinded to group allocation.
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
- •Age 18 to 45 years
- •Term singleton birth (≥37 weeks of gestation)
- •≤48 hours postpartum at the time of enrollment
- •Intention to breastfeed
- •Ability to communicate in Turkish
- •Access to a smartphone for educational materials and follow-up reminders
- •Willingness to provide written informed consent
排除标准
- •Contraindications to breastfeeding (e.g., infant galactosemia)
- •Severe neonatal condition preventing breastfeeding
- •Severe maternal medical or psychiatric condition interfering with breastfeeding
- •Current opioid, alcohol, or substance dependence
- •Multiple gestation pregnancy
- •Severe breast injury or condition within the first 72 hours postpartum preventing breastfeeding
研究组 & 干预措施
Standard Care Alone
Participants receive routine postpartum breastfeeding care and counseling according to institutional Baby-Friendly Hospital Initiative practices. No acupressure education, materials, or reminders are provided.
Acupressure Education Plus Standard Care
Participants receive standard postpartum breastfeeding care in addition to structured education on self-administered acupressure. Acupressure education is provided within 48 hours postpartum and includes face-to-face instruction, printed visual materials, and a short instructional video. Participants are instructed to apply acupressure at the specified points twice daily at home throughout the postpartum period, according to the study protocol.
干预措施: Postpartum Acupressure Education Program (Other)
结局指标
主要结局
Exclusive breastfeeding rate at 6 months postpartum
时间窗: At 6 months postpartum
Proportion of participants exclusively breastfeeding at 6 months postpartum, assessed by maternal self-report using 24-hour recall with additional validation questions, consistent with World Health Organization definitions.
次要结局
- Time to introduction of complementary feeding(From birth up to 12 months postpartum)
- Any breastfeeding rate at 12 months postpartum(At 12 months postpartum)
- Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) score(Baseline (≤48 hours postpartum), 1, 3, 6, and 12 months postpartum)
- Breastfeeding quality score (LATCH)(Baseline (≤48 hours postpartum) and 1 month postpartum)
- Maternal breastfeeding satisfaction score(1 month, 3 months, 6 months, and 12 months postpartum)
- Bottle or pacifier use(1 week, 1 month, 3 months, 6 months, 9 months, and 12 months postpartum)
- Breastfeeding-related adverse events(From baseline through 12 months postpartum)
研究者
Pınar Erdoğan
Associated Professor
Nigde Omer Halisdemir University