NCT05456438

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 5, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (3)

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

Other: İntervention 1Other: 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.

Other: İntervention 1Other: İntervention 2

Interventions

Group 1 applied coconut oil to the nipple

Also known as: application of coconut oil and tea tree oil to the nipple.
COCONUT OİLTEA TREE OİL

Group 2 applied tea tree oil to the nipple

COCONUT OİLTEA TREE OİL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Mothers who could not breastfeed,
  • had stillbirth,
  • who had infants with congenital anomalies preventing breastfeeding were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Yıldırım

Çorum, 19600, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 13, 2022

Study Start

February 14, 2021

Primary Completion

June 14, 2021

Study Completion

January 16, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations