BreastfeedingBEEWAX NIP RCTNCT07912216
Effect of Beeswax-Based Nipple Protector and Breast Milk on Nipple Problems
A study testing Beeswax-based nipple shield and Breastmilk in people with Breastfeeding and Nipple Pain During Lactation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Nipple Pain During Lactation, Cracked Nipple
- What is being tested?
- Beeswax-based nipple shield and Breastmilk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 18 and 45 years of age
- Being included in the study within the first 24 hours after birth
- Having given birth to a single live birth
- Having a baby with a gestational age ≥37 weeks
- Being directly breastfeeding the baby
- Planning to breastfeed
Show all 10Show fewer
- No severe trauma to the nipple (initially only intact or mild erythema/tenderness is acceptable)
- Being able to read and write in Turkish
- Agreeing to participate in the research voluntarily. Providing written informed consent
- Being available for follow-up via telephone or video call
Who cannot join
- Allergy to bee products
- Mastitis, breast abscess, Candida, or serious breast disease
- History of breast surgery
- Premature infant or infant in NICU
- Neonatal anomalies that prevent suckling
- Regular use of other topical breast products
- Cessation of breastfeeding or feeding only with expressed milk/formula
- Inability to complete follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Beeswax-Based Nipple Protector and Breast Milk on the Prevention of Nipple Problems Among Postpartum Mothers: A Randomized Controlled Trial
Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a safe and natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited.
This study aims to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study will be conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who meet the inclusion criteria will be randomly assigned to either the intervention group, which will use a beeswax-based nipple protector, or the control group, which will receive routine breast milk application. Participants will be followed during the first 20 postpartum days.
Read more
Data will be collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments will be performed at baseline and on postpartum days 10 and 20. Statistical analyses will be conducted using appropriate descriptive and comparative methods according to data distribution, and repeated measurements will be analyzed using longitudinal statistical models.
This study is expected to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy.
Read the detailed description
Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited.
This study aimed to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study was conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who met the inclusion criteria were randomly assigned to either the intervention group, which used a beeswax-based nipple protector, or the control group, which received routine breast milk application. Participants were followed during the first 20 postpartum days.
Data were collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments were performed at baseline and on postpartum days 10 and 20. The statistical analysis plan included descriptive and comparative methods according to data distribution and longitudinal statistical models for repeated measurements.
The study was designed to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy. The findings may contribute to evidence-based postpartum nursing care and support successful breastfeeding during the early postpartum period.
- Conditions
- Breastfeeding, Nipple Pain During Lactation, Cracked Nipple, Cracked Nipple During Lactation
- Being tested
- Beeswax-based nipple shield, Breastmilk
- Keywords
- Beeswax-based nipple shield, Nipple Crack, Beeswax, Breastfeeding Self-Efficacy, Breast Care, Lactation, Breastfeeding Support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beeswax-based nipple shieldOther
The beeswax-based nipple protector to be used in this study (MEMELYN®, Türkiye) is a commercially available product manufactured from 100% natural beeswax. Each participant allocated to the intervention group will be provided with two sterile nipple protectors. Standardized verbal instructions, practical training, and written educational materials regarding the proper use of the product will be provided. Mothers will be instructed to wash their hands after each breastfeeding session, gently dry the nipple area, and apply the nipple protector so that it completely covers the nipple and areola. The nipple protector will be recommended for continuous use between breastfeeding sessions and may be removed only during breastfeeding and bathing. The product will be reusable and participants will be instructed to clean it with warm water after each use.
BreastmilkOther
Breastfeeding mothers in the control group were instructed to apply their own breast milk to their nipple areolas.Breastfeeding mothers in the control group will apply their own breast milk to their areolas. Breast assessments will be performed on days 10 and 20 using data collection tools.
| Study group | Role | What they receive |
|---|---|---|
| Beeswax-based nipple shield arm | Experimental | Participants in experimental group will use beeswax-based nipple shields. Receives: Other: Beeswax-based nipple shield |
| Breast Milk Arm | Active comparator | Participants in control group group will use breast milk as a preventative measure against breast problems. Receives: Other: Breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Nipple Problems
The occurrence of nipple problems, including nipple pain, fissures, redness, and tenderness, was assessed using the Breast Assessment Form. The presence of nipple problems was evaluated in both intervention groups on postpartum days 10 and 20.
Measured: Postpartum Day 10, Postpartum Day 20
Secondary outcomes (1)
Breastfeeding Self-Efficacy
Breastfeeding self-efficacy was assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy
Measured: Postpartum day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start23 Jun 2026
- Primary completion30 Sep 2026
- Study completion30 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a two-arm, parallel-group randomized controlled design. Ninety postpartum breastfeeding mothers were randomly allocated to either the beeswax nipple shield group (n=45) or the breast milk application group (n=45) using the URN randomization method. Both groups were assessed at baseline and on postpartum days 10 and 20.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912216
- Sponsor's protocol ID
- 07.12.2018/866
- Acronym
- BEEWAX NIP RCT
- Status last verified
- Nov 2026
- First submitted
- 23 Jun 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to participant confidentiality and ethical considerations. Data collected during the study will be used in accordance with the approved research protocol and informed consent.
Publications
Niazi A, Rahimi VB, Soheili-Far S, Askari N, Rahmanian-Devin P, Sanei-Far Z, Sahebkar A, Rakhshandeh H, Askari VR. A Systematic Review on Prevention and Treatment of Nipple Pain and Fissure: Are They Curable? J Pharmacopuncture. 2018 Sep;21(3):139-150. doi: 10.3831/KPI.2018.21.017. Epub 2018 Sep 30.
PubMed 30283701Nakamura M, Asaka Y, Ogawara T, Yorozu Y. Nipple Skin Trauma in Breastfeeding Women During Postpartum Week One. Breastfeed Med. 2018 Sep;13(7):479-484. doi: 10.1089/bfm.2017.0217. Epub 2018 Aug 3.
PubMed 30074830Serhatlioglu 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.
PubMed 37236877Modarresy SZ, Sattarpour R, Sadeghimoghadam P, Maleki FM, Belar S, Saniani AM, Hashemi BS, Noori M. Efficacy of a Topical Lanolin-Beeswax-Olive Oil Blend (RepoGen Cream) in Preventing Nipple Fissures in Breastfeeding Women: A Randomized Controlled Trial. J Cosmet Dermatol. 2025 Sep;24(9):e70409. doi: 10.1111/jocd.70409.
PubMed 40874389Fratini F, Cilia G, Turchi B, Felicioli A. Beeswax: A minireview of its antimicrobial activity and its application in medicine. Asian Pac J Trop Med. 2016 Sep;9(9):839-843. doi: 10.1016/j.apjtm.2016.07.003. Epub 2016 Jul 26.
PubMed 27633295Dennis 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.
PubMed 25506813
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beeswax-Based Nipple Protector and Breast Milk on the Prevention of Nipple Problems Among Postpartum Mothers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07912216
- Acronym / sponsor ID
- BEEWAX NIP RCT / 07.12.2018/866
- Conditions
- Breastfeeding, Nipple Pain During Lactation, Cracked Nipple, Cracked Nipple During Lactation
- Keywords
- Beeswax-based nipple shield, Nipple Crack, Beeswax, Breastfeeding Self-Efficacy, Breast Care, Lactation, Breastfeeding Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a safe and natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited.
This study aims to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study will be conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who meet the inclusion criteria will be randomly assigned to either the intervention group, which will use a beeswax-based nipple protector, or the control group, which will receive routine breast milk application. Participants will be followed during the first 20 postpartum days.
Data will be collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments will be performed at baseline and on postpartum days 10 and 20. Statistical analyses will be conducted using appropriate descriptive and comparative methods according to data distribution, and repeated measurements will be analyzed using longitudinal statistical models.
This study is expected to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy.
Detailed description
Breastfeeding is the optimal method of infant feeding and provides significant health benefits for both mothers and infants. However, nipple pain, tenderness, fissures, and other nipple-related problems are common during the early postpartum period and frequently lead to breastfeeding difficulties or early discontinuation. Although various interventions, including breast milk, lanolin, and hydrogel dressings, have been used to prevent nipple trauma, there is still no consensus regarding the most effective approach. Beeswax possesses moisturizing, antimicrobial, anti-inflammatory, and wound-healing properties and may represent a natural alternative for preventing nipple damage. However, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited.
This study aimed to evaluate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application in preventing nipple problems among postpartum breastfeeding mothers. The study was conducted as a prospective, randomized controlled trial in a university hospital. Postpartum mothers who met the inclusion criteria were randomly assigned to either the intervention group, which used a beeswax-based nipple protector, or the control group, which received routine breast milk application. Participants were followed during the first 20 postpartum days.
Data were collected using a descriptive information form, a breast assessment form, the Visual Analogue Scale for pain, and the Breastfeeding Self-Efficacy Scale-Short Form. Assessments were performed at baseline and on postpartum days 10 and 20. The statistical analysis plan included descriptive and comparative methods according to data distribution and longitudinal statistical models for repeated measurements.
The study was designed to provide evidence regarding the effectiveness of a beeswax-based nipple protector in reducing nipple pain and trauma and improving breastfeeding self-efficacy. The findings may contribute to evidence-based postpartum nursing care and support successful breastfeeding during the early postpartum period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a two-arm, parallel-group randomized controlled design. Ninety postpartum breastfeeding mothers were randomly allocated to either the beeswax nipple shield group (n=45) or the breast milk application group (n=45) using the URN randomization method. Both groups were assessed at baseline and on postpartum days 10 and 20.
| Arm | Type | Receives |
|---|---|---|
| Beeswax-based nipple shield arm | Experimental | Other: Beeswax-based nipple shieldParticipants in experimental group will use beeswax-based nipple shields. |
| Breast Milk Arm | Active comparator | Other: BreastmilkParticipants in control group group will use breast milk as a preventative measure against breast problems. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Being between 18 and 45 years of age
- Being included in the study within the first 24 hours after birth
- Having given birth to a single live birth
- Having a baby with a gestational age ≥37 weeks
- Being directly breastfeeding the baby
Key exclusion criteria (8 listed)
- Allergy to bee products
- Mastitis, breast abscess, Candida, or serious breast disease
- History of breast surgery
- Premature infant or infant in NICU
- Neonatal anomalies that prevent suckling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beeswax-based nipple shieldThe beeswax-based nipple protector to be used in this study (MEMELYN®, Türkiye) is a commercially available product manufactured from 100% natural beeswax. Each participant allocated to the intervention group will be provided with two sterile nipple protectors. Standardized verbal instructions, practical training, and written educational materials regarding the proper use of the product will be provided. Mothers will be instructed to wash their hands after each breastfeeding session, gently dry the nipple area, and apply the nipple protector so that it completely covers the nipple and areola. The nipple protector will be recommended for continuous use between breastfeeding sessions and may be removed only during breastfeeding and bathing. The product will be reusable and participants will be instructed to clean it with warm water after each use. | Other | Beeswax-based nipple shield arm |
| BreastmilkBreastfeeding mothers in the control group were instructed to apply their own breast milk to their nipple areolas.Breastfeeding mothers in the control group will apply their own breast milk to their areolas. Breast assessments will be performed on days 10 and 20 using data collection tools. | Other | Breast Milk Arm |
Primary outcome
Incidence of Nipple Problems
Time frame: Postpartum Day 10, Postpartum Day 20
The occurrence of nipple problems, including nipple pain, fissures, redness, and tenderness, was assessed using the Breast Assessment Form. The presence of nipple problems was evaluated in both intervention groups on postpartum days 10 and 20.
1 secondary outcome
Breastfeeding Self-Efficacy
Time frame: Postpartum day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 30283701Niazi A, Rahimi VB, Soheili-Far S, Askari N, Rahmanian-Devin P, Sanei-Far Z, Sahebkar A, Rakhshandeh H, Askari VR. A Systematic Review on Prevention and Treatment of Nipple Pain and Fissure: Are They Curable? J Pharmacopuncture. 2018 Sep;21(3):139-150. doi: 10.3831/KPI.2018.21.017. Epub 2018 Sep 30.
- Background: PubMed 30074830Nakamura M, Asaka Y, Ogawara T, Yorozu Y. Nipple Skin Trauma in Breastfeeding Women During Postpartum Week One. Breastfeed Med. 2018 Sep;13(7):479-484. doi: 10.1089/bfm.2017.0217. Epub 2018 Aug 3.
- Background: PubMed 37236877Serhatlioglu 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.
- Background: PubMed 40874389Modarresy SZ, Sattarpour R, Sadeghimoghadam P, Maleki FM, Belar S, Saniani AM, Hashemi BS, Noori M. Efficacy of a Topical Lanolin-Beeswax-Olive Oil Blend (RepoGen Cream) in Preventing Nipple Fissures in Breastfeeding Women: A Randomized Controlled Trial. J Cosmet Dermatol. 2025 Sep;24(9):e70409. doi: 10.1111/jocd.70409.
- Background: PubMed 27633295Fratini F, Cilia G, Turchi B, Felicioli A. Beeswax: A minireview of its antimicrobial activity and its application in medicine. Asian Pac J Trop Med. 2016 Sep;9(9):839-843. doi: 10.1016/j.apjtm.2016.07.003. Epub 2016 Jul 26.
- Background: PubMed 25506813Dennis 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to participant confidentiality and ethical considerations. Data collected during the study will be used in accordance with the approved research protocol and informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beeswax-based nipple shield and Breastmilk in people with Breastfeeding and Nipple Pain During Lactation, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Nipple Problems (time frame: Postpartum Day 10, Postpartum Day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07912216, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.