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

April 26, 2026 updated by: Le Lam My Duyen, University of Medicine and Pharmacy at Ho Chi Minh City

Effectiveness of Auricular Acupressure Combined With Basic Care for Blocked Milk Ducts After Cesarean Delivery: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, single-blind, controlled clinical trial aims to evaluate the effectiveness and safety of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery.

Participants who meet the eligibility criteria will be randomly assigned to either the intervention group (auricular acupressure plus basic breast care) or the control group (sham auricular acupressure plus basic breast care). Auricular acupressure will be applied using semi-permanent auricular pellets at therapeutic ear acupoints on the ear ipsilateral to the affected breast, while the control group will receive sham intervention at non-therapeutic points. Both groups will receive standardized basic breast care, including frequent breastfeeding or milk expression, breast massage during feeding, and warm compresses before feeding.

The intervention will be administered over 3 consecutive days. Participants will be instructed and supervised by trained midwives and will perform self-care during the study period. Outcomes will be assessed at baseline and daily during the intervention period.

The primary outcome is the change in breast pain score measured by the Numeric Rating Scale (NRS). Secondary outcomes include changes in the severity of blocked milk ducts, use of rescue analgesic medication, and incidence of adverse events.

This study is designed as a pilot randomized controlled trial to preliminarily evaluate the effectiveness and feasibility of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery. Due to the lack of prior studies for accurate sample size estimation, the sample size was determined based on recommendations for pilot studies, with a minimum of 30 participants per group. Allowing for a 10% dropout rate, the total sample size is set at 66 participants (33 per group). The results of this pilot study will inform the design and sample size calculation of a future definitive randomized controlled trial.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam
        • Department of Obstetrics, Le Van Thinh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following criteria:

  • Postpartum women aged 18-40 years who have undergone cesarean delivery and are hospitalized in the obstetrics department.
  • At least 24 hours after cesarean delivery.
  • Diagnosed with uncomplicated blocked milk ducts based on clinical signs, including localized breast pain and engorgement, a palpable localized firm mass, and reduced or interrupted milk flow.
  • Absence of systemic signs of infection (e.g., fever ≥38.5°C, chills, or severe fatigue) and no evidence of breast abscess.
  • Numeric Rating Scale (NRS) pain score ≥ 4.
  • Gestational age ≥ 37 weeks, with a healthy newborn without abnormalities.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

  • Clinical signs of mastitis, breast abscess, or breast infection.
  • Underlying medical conditions that may affect lactation, such as diabetes mellitus, thyroid disorders, or chronic liver or kidney disease.
  • Known allergy or hypersensitivity to materials used in auricular acupressure or components of basic breast care.
  • Severe psychiatric or cognitive conditions that may impair the ability to follow study procedures.
  • Inability or unwillingness to comply with the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular Acupressure + Basic Care
In addition to standard basic breast care, participants will receive ear acupressure treatment using ear acupressure beads applied to therapeutic points on the ear corresponding to the affected breast, for three consecutive days.
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.
Other Names:
  • Ear Acupressure
  • Auricular Therapy
  • Auricular Pellets
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.
Other Names:
  • Standard Care
  • Breast Care
Sham Comparator: Sham Auricular Acupressure + Basic Care
Participants will receive sham auricular acupressure using auricular pellets applied to non-therapeutic ear points, along with the same standardized basic breast care, for 3 consecutive days.
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.
Other Names:
  • Standard Care
  • Breast Care
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.
Other Names:
  • Sham Ear Acupressure
  • Placebo Auricular Acupressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in breast pain score (Numeric Rating Scale, NRS)
Time Frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM
Breast pain will be assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Participants will be interviewed by investigators at each assessment point.
From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of blocked milk ducts
Time Frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily

Severity will be assessed based on the number and size of palpable breast lumps. The largest diameter (cm) will be measured, and severity will be classified into 5 levels:

0 = no lump;

  1. = one lump <3 cm;
  2. = one lump 3-<5 cm;
  3. = one lump ≥5 cm;
  4. = multiple lumps.
From baseline (T0) to Day 3 after intervention (T3), assessed daily
Amount of rescue analgesic use (paracetamol)
Time Frame: From baseline (T0) to Day 3 after intervention (T3)
Participants may use paracetamol 500 mg when NRS ≥7, with a maximum dose of 3 tablets per day. The number of tablets used will be recorded.
From baseline (T0) to Day 3 after intervention (T3)
Incidence of adverse events related to the intervention
Time Frame: From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.
All adverse events (e.g., allergic reactions, ear infection, syncope) will be recorded throughout the study period.
From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 607/DHYD-HDDD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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