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

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 randomized controlled trial to evaluate the effectiveness of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery. The sample size was calculated based on the primary outcome of pain intensity measured using the Numeric Rating Scale (NRS). A between-group difference of 1.8 NRS points was considered clinically meaningful. Using a two-sided significance level of 0.05, a power of 80%, and an estimated standard deviation of 2.56, the minimum required sample size was 32 participants per group. After allowing for an anticipated attrition rate of 10%, a total of 72 participants were recruited and randomized equally to the intervention group (n = 36) and the control group (n = 36).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

72

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Altri nomi:
  • ACUPREPRESSURA AIRO
  • Auricular Therapy
  • Auricular Pellets
Comportamentale: 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.
Altri nomi:
  • Cura standard
  • Breast Care
Comparatore fittizio: 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.
Comportamentale: 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.
Altri nomi:
  • Cura standard
  • Breast Care
Procedura: 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.
Altri nomi:
  • ACUPREPRESSURA AEAR FAME
  • Placebo Auricular Acupressure

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in breast pain score (Numeric Rating Scale, NRS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severity of blocked milk ducts
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2026

Completamento primario (Effettivo)

30 maggio 2026

Completamento dello studio (Effettivo)

1 giugno 2026

Date di iscrizione allo studio

Primo inviato

26 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2026

Primo Inserito (Effettivo)

1 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 607/DHYD-HDDD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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