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

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Not yet enrolling

Conditions: Lactation Disorders; Breast Engorgement

Treatments: Behavioral: Basic Breast Care; Procedure: Auricular Acupressure; Procedure: Sham Auricular Acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07561099

607/DHYD-HDDD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Auricular Acupressure + Basic Care

Experimental group

Description:

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.

Treatment:

Procedure: Auricular Acupressure

Behavioral: Basic Breast Care

Sham Auricular Acupressure + Basic Care

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham Auricular Acupressure

Behavioral: Basic Breast Care