Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women

Not Applicable

Not yet recruiting

• Conditions: Breast Engorgement

• Registration Number: NCT07017894
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-07-01
• Study Completion: 2026-04-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 154

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Breast engorgement_self-rating scale	Day1, 2, 3	Total four items of breast engorgement, pain, hardness, and heat. There are eleven grades, a score of 0 represents no problem at all, and a score of 10 represents the most severe degree.
Breast hardness_Physiological measurements	Day1,2,3.	NEUTONE TDM-Z2 durometer pressure gauge

Secondary Outcome Measures

Name	Time	Method
Breast mask user experience	Day 3	Does Pleura fit your needs? Pleural comfort level? Purchase intention? Recommend others to buy? How much would you consider buying it at?
Continued breastfeeding	Day 30	Total five items. There are five items of Exclusive breastfeeding/breastfeeding, Exclusive breastfeeding/bottle feeding, Exclusive breastfeeding/breastfeeding and bottle feeding, Mixed feeding, Feeding formula.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Beitou Dist, Taiwan