Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions

NCT ID: NCT03568370

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.

Conditions

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Cracked Nipple During Lactation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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olive oil

use one drop olive oil on each nipple after each feeding

Group Type EXPERIMENTAL

olive oil

Intervention Type OTHER

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.

breast milk

use breast milk on each nipple after each feeding

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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olive oil

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.

Intervention Type OTHER

Other Intervention Names

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human milk

Eligibility Criteria

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Inclusion Criteria

* Normal spontaneous delivery.
* Pregnancy weeks between 37-42.
* Single birth.
* Initiated breastfeeding.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Defense Medical Center, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Lin, Chen-xi

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen-Xi Lin

Role: STUDY_CHAIR

[email protected]

Locations

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Lin

Taipei, Neihu, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chen-Xi Lin

Role: CONTACT

917112589

Facility Contacts

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Chen-Xi Lin

Role: primary

917112589

References

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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.

Reference Type DERIVED
PMID: 37797219 (View on PubMed)

Other Identifiers

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1-106-05-131

Identifier Type: -

Identifier Source: org_study_id

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