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

Not Applicable

• Conditions: Cracked Nipple During Lactation
• Interventions: Other: olive oil

• Registration Number: NCT03568370
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-10-11
• Study Start: 2017-10-13
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
olive oil	olive oil	use one drop olive oil on each nipple after each feeding

Primary Outcome Measures

Name	Time	Method
Nipple trauma change	Change from baseline nipple trauma at 10 days	use Nipple Trauma Score 0-5 point
Nipple sore change	Change from baseline nipple pain at 10 days	use Nipple Soreness Score 0-5 point
Nipple pain change	Change from baseline nipple pain at 10 days	use Numeric Rating Scale 0-10 point
breastfeeding duration	30 days	use Infant Feeding Categories

Secondary Outcome Measures

Name	Time	Method
Maternal satisfaction	baseline from Baseline nipple sore at 10 days	use Maternal Satisfaction Questionnaire 0-40 point

Trial Locations

Locations (1)

Lin; 🇨🇳 Taipei, Neihu, Taiwan