Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: breast mask containing cabbage leaves extract group, Sham Comparator.
- Who it may be relevant to
- Registry conditions: Breast Engorgement. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women：A Double-blind Randomized Controlled Trial
Overview
In this article, women were randomly assigned to the Breast Mask Containing Cabbage Leaves Extract group and Breast Mask without Cabbage Leaves Extract group, and the breast engorgement, pain, hardness, before and after each treatment were measured. At the end of the study breast mask user experience and continued breastfeeding were measured.
Detailed description
Breast engorgement as the swelling and distention of breast, which is one of the most common problems often occurs 2-4 days after delivery, resulting in pain and fever, which reduces the intention of mothers to continue breastfeeding and causes to stop breastfeeding in the early postpartum period.
There are many conservative treatments for relieving breast engorgement. At present, there have been published studies on the application of medications, cold compresses, warm compresses, massages, gua sha and cabbage leaves compression to breast problems during lactation. Previous studies have shown that cabbage leaves compression can relieve the breast engorgement, pain, and hardness of postpartum women. However, safety concerns related to freshness, preservation, and residual pesticides must be considered when using cabbage leaves in a clinical setting. The purpose of this study was to examine whether breast mask containing cabbage leaves extract can improve breast engorgement, pain, and hardness.
Interventions
- Combination product Experimental: breast mask containing cabbage leaves extract group
apply breast mask to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days - Combination product Sham Comparator
Apply a breast mask without cabbage leaves extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.
Primary outcome measures
- Breast engorgement_self-rating scale [Time frame: Day1, 2, 3]
- Breast hardness_Physiological measurements [Time frame: Day1,2,3.]
Secondary outcome measures (2)
- Breast mask user experience [Time frame: Day 3]
- Continued breastfeeding [Time frame: Day 30]
Eligibility criteria
Inclusion criteria
- Over 18 years old.
- Breastfeeding.
- Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.
- Able to read and understand Chinese.
Exclusion criteria
- Stillbirth
- Allergy to cabbage or sulfa.
- lactation inhibitors agents used.
- Fever symptoms (> 38 degrees Celsius), including: wound infection, upper respiratory tract infection, urinary tract infection.
- Breast symptoms, including: nipple cracks, skin damage, breast abscesses, mastitis, Malignant tumors.
- Postpartum complications, including: postpartum hemorrhage, amniotic fluid embolism or other diseases requiring close care.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07017894 · 2025-04-009A · ACIC-114-005