Nipple InfectionNCT05456438
Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation
A study testing İntervention 1 and İntervention 2 in people with Nipple Infection, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine the effect of tea tree oil and coconut oil applied to the nipples during the early postpartum period on nipple crack formation. 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
- Nipple Infection
- What is being tested?
- İntervention 1 and İntervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2021to 16 Jan 2022
- 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
- Mothers who volunteered for participation, h
- aged from 18-45 years,
- with new and live birth after 37 weeks,
- without flat or small nipple problems,
- without previous breast operations,
- able to apply correct breastfeeding methods and with infants with birth weight of 2500 g and above were included in the study.
Who cannot join
- Mothers who could not breastfeed,
- had stillbirth,
- who had infants with congenital anomalies preventing breastfeeding were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation in the Early Postpartum Period
The aim of the study was to determine the effect of tea tree oil and coconut oil applied to the nipples during the early postpartum period on nipple crack formation.
Read the detailed description
This randomized controlled experimental research included a total of 90 women in the research sample abiding by the research criteria, with 30 each in the intervention groups (coconut oil or tea tree oil application) and 30 in the control group. Women in the intervention groups applied coconut oil or tea tree oil to the nipples on the 3rd, 7th and 10th days postpartum, while the control group did not have any intervention
- Conditions
- Nipple Infection
- Being tested
- İntervention 1, İntervention 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntervention 1Other
Also called application of coconut oil and tea tree oil to the nipple.
Group 1 applied coconut oil to the nipple
İntervention 2Other
Group 2 applied tea tree oil to the nipple
| Study group | Role | What they receive |
|---|---|---|
| COCONUT OİL | Experimental | * After feeding, wash hands and apply 2 drops of oil, COCONUT OİL in the 1st intervention group to the index finger and spread on the areola and nipple,
* Continue this application for 10 days Receives: Other: İntervention 1; Other: İntervention 2 |
| Control group | No intervention | They were told that no intervention would be performed, and that they should not use any application like herbal or chemical oils, creams, medications, etc. on the nipples during the first 10 days postpartum. |
| TEA TREE OİL | Experimental | * After feeding, wash hands and apply 2 drops of oil, TEA TREE OİL in the 2nd intervention group, to the index finger and spread on the areola and nipple,
* Continue this application for 10 days. Receives: Other: İntervention 1; Other: İntervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain score
It is assessed on a line with 10 cm length marked at 1 cm intervals. On the scale, 0 cm represents no pain, 5 cm is moderate levels of pain and 10 cm is unbearable pain. The scale was used to assess the severity of nipple pain perceived by mothers.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start14 Feb 2021
- Primary completion14 Jun 2021
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nipple InfectionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yildirim, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456438
- Sponsor's protocol ID
- 2020-27
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sahin E, Yildirim F, Buyukkayaci Duman N. Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation in the Early Postpartum Period. Breastfeed Med. 2023 Mar;18(3):226-232. doi: 10.1089/bfm.2022.0260. Epub 2023 Feb 10.
PubMed 36763614
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation in the Early Postpartum Period
- ClinicalTrials.gov ID
- NCT05456438
- Acronym / sponsor ID
- 2020-27
- Conditions
- Nipple Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 13 Jul 2022 (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.
The aim of the study was to determine the effect of tea tree oil and coconut oil applied to the nipples during the early postpartum period on nipple crack formation.
Detailed description
This randomized controlled experimental research included a total of 90 women in the research sample abiding by the research criteria, with 30 each in the intervention groups (coconut oil or tea tree oil application) and 30 in the control group. Women in the intervention groups applied coconut oil or tea tree oil to the nipples on the 3rd, 7th and 10th days postpartum, while the control group did not have any intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COCONUT OİL | Experimental | Other: İntervention 1, Other: İntervention 2* After feeding, wash hands and apply 2 drops of oil, COCONUT OİL in the 1st intervention group to the index finger and spread on the areola and nipple, * Continue this application for 10 days |
| Control group | No intervention | –They were told that no intervention would be performed, and that they should not use any application like herbal or chemical oils, creams, medications, etc. on the nipples during the first 10 days postpartum. |
| TEA TREE OİL | Experimental | Other: İntervention 1, Other: İntervention 2* After feeding, wash hands and apply 2 drops of oil, TEA TREE OİL in the 2nd intervention group, to the index finger and spread on the areola and nipple, * Continue this application for 10 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Mothers who volunteered for participation, h
- aged from 18-45 years,
- with new and live birth after 37 weeks,
- without flat or small nipple problems,
- without previous breast operations,
Key exclusion criteria (3 listed)
- Mothers who could not breastfeed,
- had stillbirth,
- who had infants with congenital anomalies preventing breastfeeding were not included in the study.
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 |
|---|---|---|
| İntervention 1Also: application of coconut oil and tea tree oil to the nipple.Group 1 applied coconut oil to the nipple | Other | COCONUT OİL, TEA TREE OİL |
| İntervention 2Group 2 applied tea tree oil to the nipple | Other | COCONUT OİL, TEA TREE OİL |
Primary outcome
VAS Pain score
Time frame: 12 months
It is assessed on a line with 10 cm length marked at 1 cm intervals. On the scale, 0 cm represents no pain, 5 cm is moderate levels of pain and 10 cm is unbearable pain. The scale was used to assess the severity of nipple pain perceived by mothers.
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 13 Jul 2022.
- Derived from this study: PubMed 36763614Sahin E, Yildirim F, Buyukkayaci Duman N. Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation in the Early Postpartum Period. Breastfeed Med. 2023 Mar;18(3):226-232. doi: 10.1089/bfm.2022.0260. Epub 2023 Feb 10.
Related trials for Nipple Infection
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Breastfeeding Education Through Clinical Demonstration for Primiparous Women to Prevent Sore Nipples and Engorgement
Nipple Infection, Nipple Discharge
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 İntervention 1 and İntervention 2 in people with Nipple Infection, run by Hitit 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 6 inclusion and 3 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 13 Jul 2022. 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?
VAS Pain score (time frame: 12 months). 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 NCT05456438, which also lists 1 linked publication.
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 13 Jul 2022.