The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
NCT ID: NCT04259320
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2020-02-17
2020-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Beeswax containing barrier
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.
Beeswax containing barrier
Use beeswax containing barrier on each nipple after each breastfeeding.
Breast milk
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.
Breast milk
Apply breast milk on each nipple and areola after each breastfeeding.
No treatment- control
It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done.
No interventions assigned to this group
Interventions
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Beeswax containing barrier
Use beeswax containing barrier on each nipple after each breastfeeding.
Breast milk
Apply breast milk on each nipple and areola after each breastfeeding.
Eligibility Criteria
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Inclusion Criteria
* Normal spontaneous delivery.
* Pregnancy weeks between 37-42.
* Single birth.
* Initiated breastfeeding.
* Having given birth to a healthy, full-term child.
* Newborn with no oral, palatal or maxillofacial abnormalities.
* Not taking any medication, considering that drug use may cause nipple problems.
* Being able to read and write.
* Volunteering to participate in the study.
* Not having contraindications for breastfeeding.
Exclusion Criteria
* Being a multipara.
* Not breastfeeding within the first 24 hours.
* Development of any breast problem: Mastitis, engorgement etc.
* Taking newborn into intensive care.
* Not sticking to the application.
* Using another nipple crack preventing method during application.
* Being allergic to beeswax.
18 Years
49 Years
FEMALE
Yes
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Karabuk Training and Research Hospital
UNKNOWN
Karabuk University
OTHER
Responsible Party
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Seda Serhatlioglu
Principal Investigator
Principal Investigators
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Sibel Mutlu, OB/GYN
Role: STUDY_DIRECTOR
Karabuk University Research and Training Hospital
Locations
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Karabuk University Training and Research Hospital
Karabük, Merkez, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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E-01
Identifier Type: -
Identifier Source: org_study_id