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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Over 18 years old.

Breastfeeding.

Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.

Able to read and understand Chinese.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: breast mask containing cabbage leaves extract groupExperimental treatment 1 intervention
Group B: breast mask without cabbage leaves extract groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day1, 2, 3
2

Breast hardness_Physiological measurements

NEUTONE TDM-Z2 durometer pressure gauge

Time frame
Day1,2,3.

Secondary outcomes

1

Breast mask user experience

Does Pleura fit your needs? Pleural comfort level? Purchase intention? Recommend others to buy? How much would you consider buying it at?

Time frame
Day 3
2

Continued breastfeeding

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.

Time frame
Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

National Yang Ming Chiao Tung University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: