Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- time to stage II lactogenesis
研究概览
简要总结
This RCT aimed to rigorously evaluate the combined effects of press needle acupuncture and breast massage on accelerating the onset of lactogenesis II, thereby optimizing breastfeeding outcomes and maternal health post-cesarean delivery. It involved 136 mothers who had cesarean sections at this facility along with their healthy single-born infants.
Control group received routine care. On the basis of the control group, press needle acupoint stimulation and breast massage were administered to the intervention group. The main outcome indicators included the sensation of milk coming in, defined as the time to stage II lactogenesis. Additionally, milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water. Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours, the milliliters of formula provided to the infant during this period, and the percentage of mothers exclusively breastfeeding after 72 hours.
详细描述
This RCT aimed to rigorously evaluate the combined effects of press needle acupuncture and breast massage on accelerating the onset of lactogenesis II, thereby optimizing breastfeeding outcomes and maternal health post-cesarean delivery. It involved 136 mothers who had cesarean sections at this facility along with their healthy single-born infants.
Control group: Very early skin-to-skin contact was initiated by researchers within 30 to 40 minutes after birth, with newborns, optionally wearing caps, being placed on the mothers'chests. Mothers were encouraged to breastfeed 8 to 10 times per day to ensure steady milk production. Additionally, mothers were guided by researchers on maintaining a well-balanced diet, achieving emotional stability, and securing adequate sleep to facilitate effective breastfeeding.
Intervention group: On the basis of the control group, press needle acupoint stimulation and breast massage were administered to the intervention group.
Primary Outcome Measurement: The main outcome indicators included the sensation of milk coming in, defined as the time to stage II lactogenesis. Participants were asked to report the approximate time they noticed their breasts feeling "noticeably fuller" using a numeric scale: 1 indicated "no change since giving birth", 3 denoted "noticeably fuller", and 5 represented "uncomfortably full" (Lian et al., 2022). Additionally, milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water.
Secondary Outcome Measurements: Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours (breastfeeds, first 24 h, 24-48 h, 48-72 h), the milliliters of formula provided to the infant during this period (formula fed to infant, first 24 h, 24-48 h, 48-72 h), and the percentage of mothers exclusively breastfeeding after 72 hours.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers ≥18 years old
- •Expecting their first live-born child via cesarean delivery
- •Having a singleton pregnancy
- •Intending to breastfeed with no major contraindications like hepatitis B, HIV, or other infectious diseases
- •Having newborns with Apgar scores above 8 at 1 and 5 minutes, robust sucking reflex, and no neonatal transfer required
- •Able to understand and respond to questions
- •Accessible for follow-up via telephone or WeChat
排除标准
- •Mothers having previous breast surgeries like biopsies or augmentations
- •Having nipple inversions that complicate breastfeeding; (c) taking medications affecting lactation
- •Experiencing severe perinatal complications, such as serious pre-eclampsia or grade 3 or higher cardiac issues per NYHA standards
- •Having severe local skin damage at the acupoint and massage sites
- •Having newborns with critical conditions like cardiopulmonary insufficiency, galactosemia, or phenylketonuria
结局指标
主要结局
time to stage II lactogenesis
时间窗: 0-96 hours after delivery
The main outcome indicators included the sensation of milk coming in, defined as the time to stage II lactogenesis. Participants were asked to report the approximate time they noticed their breasts feeling 'noticeably fuller' using a numeric scale: 1 indicated 'no change since giving birth, '3 denoted 'noticeably fuller,' and 5 represented 'uncomfortably full' (Lian et al., 2022).
milk quality
时间窗: 72 hours after delivery
Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water.
次要结局
- milliliters of formula provided to the infant(0-24 hours, 24-48 hours, 48-72 hours after delivery)
- number of breastfeeding sessions(a) 0-24 hours, 24-48 hours, 48-72 hours after delivery)
- percentage of mothers exclusively breastfeeding(72 hours after delivery)
研究者
Jia Qiao
RN
Qingdao Municipal Hospital