Clinical trial NCT07017894: Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women
Official title: Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women：A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Engorgement
Keywords: breast engorgement
pain
hardness
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2025-06-12
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group pre-test and repeated post-test study design
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Breast engorgement_self-rating scale
timeFrame: Day1, 2, 3
measure: Breast hardness_Physiological measurements
timeFrame: Day1,2,3.
Secondary outcomes:
measure: Breast mask user experience
timeFrame: Day 3
measure: Continued breastfeeding
timeFrame: Day 30
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou Dist
Study officials:
References: