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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
| Karabuk Training and Research Hospital | OTHER |
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In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing barrier and breast milk used in the first ten days of breastfeeding to prevent the formation of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women. Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no treatment-control).
Current evidence-based guidelines report that the incidence of nipple cracks ranges between 34-96%. Nipple cracks generally occur in the first week after the birth and may continue in the following periods of breastfeeding. Nipple crack is the second most common reason to stop breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies has been expressed as extremely painful and terrible. It is known that breast milk, olive oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks, will successfully allow to continue breastfeeding. In this way, breastfeeding will not be interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months. Using non-pharmacological, effective and therapeutic methods will also have a positive effect to increase the rate of breastfeeding.
Studies in the literature cover the evaluation of the effectiveness of beeswax or beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an effective and sufficient material in preventing and healing nipple cracks.
In this study, it is planned to include 90 lactating women (30 women in each group) to meet the parametric test assumptions in the experimental and control groups (beeswax-containing barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the experimental and control groups will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beeswax containing barrier | Experimental | Beeswax containing barrier will be given to the breastfeeding mother within the first 24 hours. After breastfeeding, it can be placed on the breast after it is expected to dry a little.Outside of breastfeeding and bathing, it will be constantly attached to the breasts. |
|
| Breast milk | Experimental | After breastfeeding, 2-3 drops of breast milk are applied to the nipple and areola. After the milk has dried, the breasts are closed. This application should be done at least 5 times a day. |
|
| No treatment- control | No Intervention | It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beeswax containing barrier | Device | Use beeswax containing barrier on each nipple after each breastfeeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nipple crack change | Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases) | Change from baseline nipple crack at 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of nipple pain change | Use Numeric Rating Scale 0-10 point (The severity of pain increases as the score increases) | Change from baseline severity of nipple pain at 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of nipple pain change | Questionary (Yes/No) | Change from baseline presence of nipple pain at 10 days. |
| Maternal satisfaction | Questionary (Use the satisfaction categories-likert) |
Inclusion Criteria:
Exclusion Criteria:
primipara lactating women who is in the first ten days of breastfeeding
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| Name | Affiliation | Role |
|---|---|---|
| Sibel Mutlu, OB/GYN | Karabuk University Research and Training Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karabuk University Training and Research Hospital | Karabük | Merkez | 07780 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24380583 | Background | Buck ML, Amir LH, Cullinane M, Donath SM; CASTLE Study Team. Nipple pain, damage, and vasospasm in the first 8 weeks postpartum. Breastfeed Med. 2014 Mar;9(2):56-62. doi: 10.1089/bfm.2013.0106. Epub 2013 Dec 31. | |
| 28278382 | Background | Puapornpong P, Paritakul P, Suksamarnwong M, Srisuwan S, Ketsuwan S. Nipple Pain Incidence, the Predisposing Factors, the Recovery Period After Care Management, and the Exclusive Breastfeeding Outcome. Breastfeed Med. 2017 Apr;12:169-173. doi: 10.1089/bfm.2016.0194. Epub 2017 Mar 9. |
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After begin to study
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized clinical trial
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| Breast milk | Biological | Apply breast milk on each nipple and areola after each breastfeeding. |
|
| Baseline from baseline nipple crack at 10 days |
| 25506813 | Background | Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2. |
| 37236877 | Derived | Serhatlioglu S, Gencturk N, Mutlu S. Determination of the effectiveness of beeswax in preventing nipple pain and cracks in primiparous breastfeeding mothers: A randomized controlled trial. Explore (NY). 2023 Nov-Dec;19(6):851-858. doi: 10.1016/j.explore.2023.05.002. Epub 2023 May 13. |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |