Auricular Therapy and Basic Care for Blocked Milk Ducts After Cesarean Delivery

NCT07561099 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-05-01

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether auricular acupressure combined with basic care can improve symptoms in postpartum women with blocked milk ducts after cesarean delivery. The main questions it aims to answer are:

* Does auricular acupressure combined with basic care reduce breast pain more effectively than basic care alone?
* Does the combined approach improve the severity of milk duct blockage compared with basic care alone?
* What adverse effects may occur in participants receiving auricular acupressure? Researchers will compare auricular acupressure combined with basic care to sham auricular acupressure plus basic care to determine whether the intervention provides additional benefits.

Participants will:

* Receive auricular acupressure (or sham auricular acupressure at non-therapeutic ear points) for 3 days.
* Be instructed to perform basic breast care under the supervision of midwives three times daily for 3 days.
* Record daily activities in monitoring forms, including breastfeeding times, and whether they performed warm compresses and breast massage.

Conditions

  • Breast Engorgement
  • Lactation Disorders

Interventions

PROCEDURE

Auricular Acupressure

Auricular acupressure involves stimulation of specific ear acupoints corresponding to body organs. In this study, semi-permanent auricular needles (auricular pellets) will be applied to 4 therapeutic acupoints: Breast AH11, Shenmen TF4, Endocrine CO18, Central Rim AT2-4 on the ear ipsilateral to the affected breast. Needles will be retained for 3 days to provide continuous stimulation. Participants will be prompted to gently press the points 3 times daily. All procedures will be performed by a licensed traditional medicine physician following standardized protocols.

PROCEDURE

Sham Auricular Acupressure

Sham auricular acupressure will be performed using semi-permanent auricular needles applied to 4 non-therapeutic ear points: Wrist SF2, Jaw LO3, Urethra HX3, Outer Nose TF1-2) unrelated to the pathophysiology of blocked milk ducts. The procedure, duration (3 days), and participant instructions will be identical to the active intervention to maintain blinding. All procedures will be performed by a licensed traditional medicine physician.

BEHAVIORAL

Basic Breast Care

Standardized basic breast care includes frequent breastfeeding (at least 8 times per day or milk expression if needed), gentle breast massage during feeding, and warm compresses (40-42°C for 10 minutes before feeding). Participants will be instructed and supervised by trained midwives three times daily and perform self-care at other times. Adherence will be recorded using monitoring forms.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561099 on ClinicalTrials.gov