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

NCT07017894 | Not Yet Recruiting

• 2 other identifiers: 2025-04-009AACIC-114-005
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Engorgement

Keywords

breast engorgement; pain; hardness

Outcome Measures

Primary Outcomes (2)

• Breast engorgement_self-rating scale

  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.

  Day1, 2, 3

• Breast hardness_Physiological measurements

  NEUTONE TDM-Z2 durometer pressure gauge

  Day1,2,3.

Secondary Outcomes (2)

• Breast mask user experience

  Day 3

• Continued breastfeeding

  Day 30

Study Arms (2)

breast mask containing cabbage leaves extract group

EXPERIMENTAL

Apply the breast mask containing cabbage leaf extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.

Combination Product: Experimental: breast mask containing cabbage leaves extract group

breast mask without cabbage leaves extract group

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.

Combination Product: Sham Comparator

Interventions

Experimental: breast mask containing cabbage leaves extract group COMBINATION_PRODUCT

apply breast mask to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days

breast mask containing cabbage leaves extract group

Sham Comparator COMBINATION_PRODUCT

Apply a breast mask without cabbage leaves extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.

breast mask without cabbage leaves extract group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: yes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old.
• Breastfeeding.
• Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.
• Able to read and understand Chinese.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou Dist, 112304, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shu Chen Liao

CONTACT

+886228712121; scliao@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: two-group pre-test and repeated post-test study design

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: April 13, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

TW (1)