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

NCT06498882 | Completed

• 1 other identifier: Grant No.(2023LinShenZi No.122
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lactation Induced

Keywords

press needle; acupoint stimulation; breast massage; lactogenesis II; breastfeeding sessions; breast milk composition

Outcome Measures

Primary Outcomes (2)

• time to stage II lactogenesis

  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).

  0-96 hours after delivery

• milk quality

  Milk quality was assessed 72 hours after birth, focusing on the content of protein, fat, lactose, minerals, and water.

  72 hours after delivery

Secondary Outcomes (3)

• number of breastfeeding sessions

  a) 0-24 hours, 24-48 hours, 48-72 hours after delivery

• milliliters of formula provided to the infant

  0-24 hours, 24-48 hours, 48-72 hours after delivery

• percentage of mothers exclusively breastfeeding

  72 hours after delivery

Study Arms (2)

press needle acupoint stimulation combined with breast massage group

EXPERIMENTAL

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

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

control group

OTHER

Control group received routine care

Other: routine care

Interventions

Press Needle Acupoint Stimulation Combined with Breast Massage OTHER

Press needle acupoint stimulation and breast massage were administered. Key press needle acupoints were identified for selection: Dan zhong (RN17), bilateral Ru gen (ST18), bilateral Shao ze (SI1), bilateral Zu san li (ST36) and bilateral San yin jiao (SP6). The areas were sterilized with 75% alcohol before installing 0.22\*1.55mm press needles. Within 4-6 hours post-surgery, mothers received acupoint stimulation through needle pressing. This procedure was administered by nurses who had undergone six-month standardized training in traditional Chinese medicine techniques. Instructions were then given to mothers and their family members to stimulate the acupoints pulsatively every 3-4 hours for 20-30 minutes per session, removing the press needles after 24 hours. Additionally, a specialized nurse massaged the back, both breast areas, and armpits for 10-15 minutes, three times daily over three days, using a circular and oscillating breast massage device.

press needle acupoint stimulation combined with breast massage group

routine care OTHER

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. It was ensured by researchers that mothers completely emptied one breast before switching to the other to maintain cleanliness. Additionally, mothers were guided by researchers on maintaining a well-balanced diet, achieving emotional stability, and securing adequate sleep to facilitate effective breastfeeding.

control group; press needle acupoint stimulation combined with breast massage group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qingdao Municipal Hospital: lead

Study Sites (1)

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

Location

Related Publications (2)

• Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.

  PMID: 34130991 BACKGROUND

• Becker GE, Smith HA, Cooney F. Methods of milk expression for lactating women. Cochrane Database Syst Rev. 2016 Sep 29;9(9):CD006170. doi: 10.1002/14651858.CD006170.pub5.

  PMID: 27684560 BACKGROUND

Related Links

• view only

Study Officials

• Shan-Shan Huan, Bachelor

  Qingdao Municipal Hospital

  STUDY DIRECTOR

• Jia Qiao, Master

  Qingdao Municipal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 12, 2024
• Study Start: December 28, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 21, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 31/08/2025 to 31/08/2018
• Access Criteria: On reasonable request

Locations

CN (1)