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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:
Participants will:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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;
| From baseline (T0) to Day 3 after intervention (T3), assessed daily |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics, Le Van Thinh Hospital | Ho Chi Minh City | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24465097 | Background | 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. | |
| 22619640 | 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. |
| Label | URL |
|---|---|
| Treatment of disorders of breastfeeding by auriculotherapy: Case report | View source |
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| ID | Term |
|---|---|
| D007775 | Lactation Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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| 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. |
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| 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. |
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| 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. | 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. | From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period. |
| 33000573 | 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. |
| 38379313 | 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. |
| 7619260 | Background | Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212. |
| 23301475 | Background | Yu J, Zhou J. [Effect of auricular point sticking on lactation of puerperant]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1087-9. Chinese. |
| 18819238 | Background | Spencer JP. Management of mastitis in breastfeeding women. Am Fam Physician. 2008 Sep 15;78(6):727-31. |
| 32944940 | 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. |
| 29122257 | 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. |
| 38524574 | 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. |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |