An interventional study of Beeswax-based nipple shield and Breastmilk in Breastfeeding, Nipple Pain During Lactation and Cracked Nipple, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Marmara University · Not applicable, Interventional, and Prevention
Among 274 studies in Breast Feeding with a site in Turkey — 68 open to participants now, 77 under way, none of them phase 3. Breast Feeding · Turkey.
Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 94th largest by enrollment of the 252 interventional ones, is one of 33 that started in 2026, is one of 251 with no phase, and was the 255th registered.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 90 is close to the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →68 of the 274 studies in Breast Feeding with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 126 Breast Feeding studies recruiting now, 66 (52%) set no upper age limit and 58 (46%) stop at 75 or younger; 54 take children under 18; 76 take healthy volunteers.
This study: 18 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →274 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 33 started in 2026.
Median enrollment 80 across the 252 interventional studies, 163 across the 22 observational. Of the 178 that completed or were terminated, 0 (0%) have results posted.
None of the 274 has an industry lead sponsor. The 10 most frequent:
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Marmara University has 7 studies filed under Breast Feeding — fewer than ten, so there is no comparison to draw.
19 of the studies in Breast Feeding with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07902271Kutahya Health Sciences UniversityThe Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels | 2026-11-15 |
| NCT07656207Gaziantep Islam Science and Technology UniversityThe Effect of Skin-to-skin Contact at Birth | 2026-12 |
| NCT07800078Özlem Ülkü BULUTEvaluation of a Wearable Technology to Support Breastfeeding Women | 2026-12-01 |
| NCT07864753Balikesir UniversityEVALUATION OF TWO MIDWIFE-SUPPORTED BREASTFEEDING POSITIONS DURING THE FIRST BREASTFEEDING FOLLOWING VAGINAL BIRTH | 2026-12-30 |
| NCT07899593Karadeniz Technical UniversityEffect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers | 2026-12-31 |
Among the 274 studies in Breast Feeding with a site in Turkey, from their registry updates:
Nipple pain, fissures, and other nipple-related problems are common during the early postpartum period and may negatively affect breastfeeding continuation. Although several approaches are used to prevent nipple trauma, evidence regarding the effectiveness of beeswax-based nipple protectors remains limited.
This prospective, randomized controlled trial was conducted at a university hospital to evaluate the effectiveness of a beeswax-based nipple protector compared with breast milk application in preventing nipple problems among postpartum breastfeeding mothers. Participants were randomly assigned to an intervention or control group and followed for 20 days postpartum. Nipple condition, pain intensity, and breastfeeding self-efficacy were assessed at baseline and on postpartum days 10 and 20.
The study was designed to provide evidence on the potential effectiveness of beeswax-based nipple protectors in postpartum nipple care and breastfeeding support.
Nipple pain and trauma are important challenges during the establishment of breastfeeding, particularly in the early postpartum period. These problems may cause maternal discomfort, interfere with effective breastfeeding, and contribute to breastfeeding difficulties or premature discontinuation. Preventive nipple care is therefore an important component of postpartum nursing practice. Various approaches, including the application of expressed breast milk, lanolin-based products, and protective dressings, have been used to maintain nipple integrity and reduce discomfort. However, the comparative effectiveness of these approaches remains uncertain. Beeswax-based products have been proposed as potential alternatives because of their moisturizing and protective characteristics. Nevertheless, clinical evidence supporting the use of beeswax-based nipple protectors during breastfeeding is limited.
This study was designed as a prospective, two-arm, randomized controlled trial to investigate the effectiveness of a beeswax-based nipple protector compared with routine breast milk application during the early postpartum period.
Following enrollment and baseline assessment, eligible postpartum breastfeeding mothers were randomly allocated to one of two parallel groups. Mothers assigned to the intervention group used the beeswax-based nipple protector, whereas those in the control group followed the routine nipple care approach involving breast milk application. The interventions were implemented during the first 20 days postpartum.
The study incorporated repeated assessments to examine changes in nipple condition, pain intensity, and breastfeeding self-efficacy over time. Data were collected at baseline and on postpartum days 10 and 20 using standardized assessment instruments. This longitudinal assessment approach enabled the evaluation of changes within each group and comparisons between the intervention and control groups.
The statistical analysis plan included descriptive and comparative analyses, with longitudinal statistical methods planned to account for repeated measurements within participants.
The study was intended to contribute to the evidence base for preventive nipple care interventions and inform postpartum nursing practices aimed at maintaining nipple integrity, reducing breastfeeding-related discomfort, and supporting breastfeeding self-efficacy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in experimental group will use beeswax-based nipple shields.
Other: Beeswax-based nipple shield
Participants in control group group will use breast milk as a preventative measure against breast problems.
Other: Breastmilk
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.
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.
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.
Time frame: Postpartum Day 10, Postpartum Day 20
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
Time frame: Postpartum day 20
Plan to share: 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.
Ran from Jun 2026 to primary completion in Sep 2026, 3 months.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 3 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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