Comparing the add-on Effectiveness of Electro-acupuncture or Transcutaneous Electrical Nerve Stimulation in Early Postpartum Breast Engorgement: A Pilot Randomized Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Severity Index (0-19)
研究概览
简要总结
A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.
详细描述
Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 37 wk
- •Delivery of singleton, healthy newborn baby
- •Within 7 days postpartum
- •Within 24 hours from initial painful breast engorgement
- •Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)
排除标准
- •Fever>37.5∘C
- •Mastitis or breast abscess
- •Signs of sepsis or other infection
- •Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
- •Psychological diseases
- •Bleeding tendency
- •Artificial valves
- •Pacemaker
- •Consciousness disturbance
- •Skin infections
- •Hepatitis B carrier
- •Acquired Immune Deficiency Syndrome
- •Breast tumors
- •Breast Surgeries
结局指标
主要结局
Severity Index (0-19)
时间窗: Changes from Baselines of Severity Index, at each treatment and 1 month later
Sum of the degree of Erythema, Tension and Pain scores over breasts
次要结局
- EPDS(Changes from Baseline of EPDS, after each treatment and 1 month later)
- BSES-SF(Changes from Baseline of BEES-SF, after each treatment and 1 month later)