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

24. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: 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.
Andere Namen:
  • Ohr -Akupressur
  • Auricular Therapy
  • Auricular Pellets
Verhalten: 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.
Andere Namen:
  • Standardpflege
  • Breast Care
Schein-Komparator: 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.
Verhalten: 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.
Andere Namen:
  • Standardpflege
  • Breast Care
Verfahren: 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.
Andere Namen:
  • Schein -Ohr -Akupressur
  • Placebo Auricular Acupressure

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in breast pain score (Numeric Rating Scale, NRS)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Severity of blocked milk ducts
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2026

Primärer Abschluss (Tatsächlich)

30. Mai 2026

Studienabschluss (Tatsächlich)

1. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

26. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. April 2026

Zuerst gepostet (Tatsächlich)

1. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 607/DHYD-HDDD

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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