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

Impact of Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Lactation Induced
• Intervention / Treatment: Other: Press Needle Acupoint Stimulation Combined with Breast Massage; Other: routine care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Qingdao Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: press needle acupoint stimulation combined with breast massage group; 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; 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.; Other: routine care; 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.
Other: control group; Control group received routine care	Other: routine care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of breastfeeding sessions	Secondary outcomes tracked include the number of breastfeeding sessions within the first 72 hours (breastfeeds, 0-24 hours, 24-48 hours, 48-72 hours)	a) 0-24 hours, 24-48 hours, 48-72 hours after delivery
milliliters of formula provided to the infant	Secondary outcomes tracked include the milliliters of formula provided to the infant during this period (formula fed to infant, 0-24 hours, 24-48 hours, 48-72 hours)	0-24 hours, 24-48 hours, 48-72 hours after delivery
percentage of mothers exclusively breastfeeding	Secondary outcomes tracked include the percentage of mothers exclusively breastfeeding after 72 hours.	72 hours after delivery

Collaborators and Investigators

• Sponsor: Qingdao Municipal Hospital
• Investigators: Study Director: Shan-Shan Huan, Bachelor, Qingdao Municipal Hospital; Principal Investigator: Jia Qiao, Master, Qingdao Municipal Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: press needle; breast milk composition; breast massage; acupoint stimulation; lactogenesis II; breastfeeding sessions
• Other Study ID Numbers: Grant No.(2023LinShenZi No.122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing study protocol.
• IPD Sharing Time Frame: 31/08/2025 to 31/08/2018
• IPD Sharing Access Criteria: On reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Study Data/Documents

1. Individual Participant Data Set
   Information comments: The authors have full control of all primary data and that they agree to allow other researchers to review their data if requested.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No