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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Experimental: breast mask containing cabbage leaves extract group
Combination productapply breast mask to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days
Sham Comparator
Combination productApply 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
Trial outcomes
Primary outcomes
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.
Breast hardness_Physiological measurements
NEUTONE TDM-Z2 durometer pressure gauge
Secondary outcomes
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?
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.
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: