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

NCT07561099 | Not Yet Recruiting

• 1 other identifier: 607/DHYD-HDDD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in breast pain score (Numeric Rating Scale, NRS)

  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 Outcomes (3)

• Severity of blocked milk ducts

  From baseline (T0) to Day 3 after intervention (T3), assessed daily

• Amount of rescue analgesic use (paracetamol)

  From baseline (T0) to Day 3 after intervention (T3)

• Incidence of adverse events related to the intervention

  From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.

Study Arms (2)

Auricular Acupressure + Basic Care

EXPERIMENTAL

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; Behavioral: Basic Breast Care

Sham Auricular Acupressure + Basic Care

SHAM COMPARATOR

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.

Procedure: Sham Auricular Acupressure; Behavioral: Basic Breast Care

Interventions

Auricular Acupressure PROCEDURE

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.

Also known as: Auricular Therapy, Ear Acupressure, Auricular Pellets

Auricular Acupressure + Basic Care

Sham Auricular Acupressure PROCEDURE

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.

Also known as: Placebo Auricular Acupressure, Sham Ear Acupressure

Sham Auricular Acupressure + Basic Care

Basic Breast Care BEHAVIORAL

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.

Also known as: Standard Care, Breast Care

Auricular Acupressure + Basic Care; Sham Auricular Acupressure + Basic Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Department of Obstetrics, Le Van Thinh Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Location

Related Publications (10)

• Kataria K, Srivastava A, Dhar A. Management of lactational mastitis and breast abscesses: review of current knowledge and practice. Indian J Surg. 2013 Dec;75(6):430-5. doi: 10.1007/s12262-012-0776-1. Epub 2012 Dec 12.

  PMID: 24465097 BACKGROUND

• Abou-Dakn M, Richardt A, Schaefer-Graf U, Wockel A. Inflammatory Breast Diseases during Lactation: Milk Stasis, Puerperal Mastitis, Abscesses of the Breast, and Malignant Tumors - Current and Evidence-Based Strategies for Diagnosis and Therapy. Breast Care (Basel). 2010 Mar;5(1):33-37. doi: 10.1159/000272223. Epub 2010 Feb 16.

  PMID: 22619640 BACKGROUND

• Boram L, Chan-Young K, Sun Haeng L. Effectiveness and safety of auriculotherapy for breastfeeding: a systematic review. J Tradit Chin Med. 2020 Oct;40(5):721-737. doi: 10.19852/j.cnki.jtcm.2020.05.002.

  PMID: 33000573 BACKGROUND

• Han S, Kim B, Park H. Auricular Acupressure on Breast Pain Among Breastfeeding Mothers Receiving Gentle Hand Techniques: A Randomized, Single-Blind, Sham-Controlled Trial. J Hum Lact. 2024 May;40(2):248-258. doi: 10.1177/08903344241228545. Epub 2024 Feb 20.

  PMID: 38379313 BACKGROUND

• Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.

  PMID: 7619260 BACKGROUND

• Yu J, Zhou J. [Effect of auricular point sticking on lactation of puerperant]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1087-9. Chinese.

  PMID: 23301475 BACKGROUND

• Spencer JP. Management of mastitis in breastfeeding women. Am Fam Physician. 2008 Sep 15;78(6):727-31.

  PMID: 18819238 BACKGROUND

• Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.

  PMID: 32944940 BACKGROUND

• Chen ML, Tan JY, Suen LK. Auricular therapy for lactation: A systematic review. Complement Ther Clin Pract. 2017 Nov;29:169-184. doi: 10.1016/j.ctcp.2017.09.006. Epub 2017 Sep 18.

  PMID: 29122257 BACKGROUND

• Fang YW, Chen SF, Wang ML, Wang MH. Effects of traditional Chinese medicine-assisted intervention on improving postpartum lactation: A systematic review and meta-analysis. Heliyon. 2024 Mar 1;10(6):e27154. doi: 10.1016/j.heliyon.2024.e27154. eCollection 2024 Mar 30.

  PMID: 38524574 BACKGROUND

Related Links

• Treatment of disorders of breastfeeding by auriculotherapy: Case report

MeSH Terms

Conditions

Lactation Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Duyen Lam My Le, MD

CONTACT

+8464656356; llmduyen.ths.yhct24@ump.edu.vn

Huy Chung Ly, MD, PhD

CONTACT

+84989974868; lychunghuy@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is designed as a single-blind randomized controlled trial. Participants will be randomly assigned to either the intervention group or the control group and will be blinded to group allocation. They will not be informed about the specific therapeutic effects of the auricular acupoints used. Both groups will receive similar procedures, including the use of identical auricular pellets, application techniques, and instructions for self-pressing, to minimize the risk of unblinding. Investigators administering the interventions and collecting outcome data will not be blinded due to the nature of the procedures. However, data analysis will be performed by an independent statistician using coded group allocation (e.g., A/B) to reduce potential bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

VN (1)