Auricular Therapy and Basic Care for Blocked Milk Ducts After Cesarean Delivery
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ho Chi Minh City
-
Ho Chi Minh City, Ho Chi Minh City, Vietnam
- Department of Obstetrics, Le Van Thinh Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
Otros nombres:
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.
Otros nombres:
|
|
Comparador falso: 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.
|
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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in breast pain score (Numeric Rating Scale, NRS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Severity of blocked milk ducts
Periodo de tiempo: 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;
|
From baseline (T0) to Day 3 after intervention (T3), assessed daily
|
|
Amount of rescue analgesic use (paracetamol)
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.
- 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.
- 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.
- 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.
- 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.
- 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.
- Yu J, Zhou J. [Effect of auricular point sticking on lactation of puerperant]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1087-9. Chinese.
- Spencer JP. Management of mastitis in breastfeeding women. Am Fam Physician. 2008 Sep 15;78(6):727-31.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Enfermedades de la piel
- Enfermedades de los senos
- Trastornos Puerperales
- Enfermedades de la piel y del tejido conectivo
- Trastornos de la lactancia
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 607/DHYD-HDDD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .