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| ID | Type | Description | Link |
|---|---|---|---|
| ACIC-114-005 | Other Identifier | Taipei Veterans General Hospital |
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| Name | Class |
|---|---|
| National Yang Ming Chiao Tung University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | Day 3 |
| Continued breastfeeding |
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Inclusion Criteria:
Exclusion Criteria:
yes
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu Chen Liao | Contact | +886228712121 | 82003 | scliao@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Beitou Dist | 112304 | Taiwan |
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two-group pre-test and repeated post-test study design
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Double-blind
| 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. |
|
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.
| Day 30 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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