Effectiveness of Auricular Acupressure Combined With Basic Care for Blocked Milk Ducts After Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in breast pain score (Numeric Rating Scale, NRS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Gestational age ≥ 37 weeks, with a healthy newborn without abnormalities.
- •Willing and able to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Auricular Acupressure (Procedure)
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.
干预措施: Basic Breast Care (Behavioral)
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.
干预措施: Sham Auricular Acupressure (Procedure)
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.
干预措施: Basic Breast Care (Behavioral)
结局指标
主要结局
Change in breast pain score (Numeric Rating Scale, NRS)
时间窗: 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.
次要结局
- Severity of blocked milk ducts(From baseline (T0) to Day 3 after intervention (T3), assessed daily)
- Amount of rescue analgesic use (paracetamol)(From baseline (T0) to Day 3 after intervention (T3))
- Incidence of adverse events related to the intervention(From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.)
研究者
Le Lam My Duyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City