The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedOctober 25, 2021
October 1, 2021
4 months
February 2, 2020
October 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Nipple crack change
Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases)
Change from baseline nipple crack at 10 days
Secondary Outcomes (1)
Severity of nipple pain change
Change from baseline severity of nipple pain at 10 days.
Other Outcomes (2)
Presence of nipple pain change
Change from baseline presence of nipple pain at 10 days.
Maternal satisfaction
Baseline from baseline nipple crack at 10 days
Study Arms (3)
Beeswax containing barrier
EXPERIMENTALBeeswax 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
EXPERIMENTALAfter 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 INTERVENTIONIt is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done.
Interventions
Use beeswax containing barrier on each nipple after each breastfeeding.
Apply breast milk on each nipple and areola after each breastfeeding.
Eligibility Criteria
You may qualify if:
- Being over 18 years old;
- 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.
You may not qualify if:
- Not approving to participate in the research.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karabuk Universitylead
- Istanbul University - Cerrahpasacollaborator
- Karabuk Training and Research Hospitalcollaborator
Study Sites (1)
Karabuk University Training and Research Hospital
Karabük, Merkez, 07780, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 24380583BACKGROUNDPuapornpong 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.
PMID: 28278382BACKGROUNDDennis 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.
PMID: 25506813BACKGROUNDSerhatlioglu 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.
PMID: 37236877DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sibel Mutlu, OB/GYN
Karabuk University Research and Training Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 2, 2020
First Posted
February 6, 2020
Study Start
February 17, 2020
Primary Completion
June 30, 2020
Study Completion
November 30, 2020
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
After begin to study