Press Needle Acupoint Stimulation Combined With Breast Massage on the Initiation of Lactogenesis II
NCT06498882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2024-07-12
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
Interventions
- 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.
Sponsors & Collaborators
-
Qingdao Municipal Hospital
lead OTHER
Principal Investigators
-
Shan-Shan Huan, Bachelor · Qingdao Municipal Hospital
-
Jia Qiao, Master · Qingdao Municipal Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-12-28
- Primary Completion
- 2024-06-15
- Completion
- 2024-06-21
Countries
- China
Study Locations
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