Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
1 other identifier
interventional
80
1 country
1
Brief Summary
The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
1 active site
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
First Submitted
Initial submission to the registry
October 11, 2017
CompletedStudy Start
First participant enrolled
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedJune 26, 2018
June 1, 2018
11 months
October 11, 2017
June 13, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Nipple pain change
use Numeric Rating Scale 0-10 point
Change from baseline nipple pain at 10 days
Nipple sore change
use Nipple Soreness Score 0-5 point
Change from baseline nipple pain at 10 days
Nipple trauma change
use Nipple Trauma Score 0-5 point
Change from baseline nipple trauma at 10 days
breastfeeding duration
use Infant Feeding Categories
30 days
Secondary Outcomes (1)
Maternal satisfaction
baseline from Baseline nipple sore at 10 days
Study Arms (2)
olive oil
EXPERIMENTALuse one drop olive oil on each nipple after each feeding
breast milk
NO INTERVENTIONuse breast milk on each nipple after each feeding
Interventions
Evaluate the effectiveness of olive oil and human milk in the prevention of nipple cracking, nipple pain and maternal satisfaction in lactating women during the first 3 days of treatment and the 7th and 10th day after delivery.
Eligibility Criteria
You may qualify if:
- Normal spontaneous delivery.
- Pregnancy weeks between 37-42.
- Single birth.
- Initiated breastfeeding.
You may not qualify if:
- Presence of crack in the nipple.
- Medication applied to the nipple
- The maternal health condition that may interfere with breastfeeding.
- The infant with congenital abnormalities that would impair breastfeeding.
- The infant attained low birth weight or other criteria to intensive care unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lin
Taipei, Neihu, 114, Taiwan
Related Publications (1)
Lin CX, Lu YY. Comparative Effectiveness of Olive Oil and Breast Milk on Nipple Soreness in Breastfeeding Mothers. Breastfeed Med. 2023 Oct;18(10):779-784. doi: 10.1089/bfm.2023.0081. Epub 2023 Oct 5.
PMID: 37797219DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chen-Xi Lin
lin050027@hotmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 11, 2017
First Posted
June 26, 2018
Study Start
October 13, 2017
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
June 26, 2018
Record last verified: 2018-06