- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05456438
Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation
July 12, 2022 updated by: Fatma Yildirim, Hitit University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Çorum, Turkey, 19600
- Fatma Yıldırım
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Mothers who could not breastfeed,
- had stillbirth,
- who had infants with congenital anomalies preventing breastfeeding were not included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COCONUT OİL
|
Group 1 applied coconut oil to the nipple
Other Names:
Group 2 applied tea tree oil to the nipple
|
|
No Intervention: Control group
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.
|
|
|
Experimental: TEA TREE OİL
|
Group 1 applied coconut oil to the nipple
Other Names:
Group 2 applied tea tree oil to the nipple
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2021
Primary Completion (Actual)
June 14, 2021
Study Completion (Actual)
January 16, 2022
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-27
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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