Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II

Qingdao Municipal Hospital Group

Status: Completed

Conditions: Lactation Induced

Treatments: Other: routine care; Other: Press Needle Acupoint Stimulation Combined with Breast Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06498882

Grant No.(2023LinShenZi No.122

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups

press needle acupoint stimulation combined with breast massage group

Experimental group

Description:

On the basis of the routine care, press needle acupoint stimulation and breast massage were administered to the intervention group

Treatment:

Other: Press Needle Acupoint Stimulation Combined with Breast Massage

Other: routine care

control group

Other group

Description:

Control group received routine care

Treatment:

Other: routine care