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

N/ANot Yet RecruitingNCT07561099

University of Medicine and Pharmacy at Ho Chi Minh City66 enrolled

Overview

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.

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.

Interventions

Auricular AcupressurePROCEDURE

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.

Sham Auricular AcupressurePROCEDURE

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.

Basic Breast CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM

Secondary Outcomes

Severity of blocked milk ducts

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.

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

Amount of rescue analgesic use (paracetamol)

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.

Time frame: From baseline (T0) to Day 3 after intervention (T3)

Incidence of adverse events related to the intervention

All adverse events (e.g., allergic reactions, ear infection, syncope) will be recorded throughout the study period.

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