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

Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women:A Double-blind Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07017894
Acronym
BMCCLE
Enrollment
154
Registered
2025-06-12
Start date
2025-06-01
Completion date
2026-04-13
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Engorgement

Keywords

breast engorgement, pain, hardness

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.

Interventions

COMBINATION_PRODUCTExperimental: 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_PRODUCTSham 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.

Sponsors

National Yang Ming Chiao Tung University
CollaboratorOTHER
Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Double-blind

Intervention model description

two-group pre-test and repeated post-test study design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Breast engorgement_self-rating scaleDay1, 2, 3Total 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 measurementsDay1,2,3.NEUTONE TDM-Z2 durometer pressure gauge

Secondary

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

Countries

Taiwan

Contacts

Primary ContactShu Chen Liao
scliao@vghtpe.gov.tw+886228712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026