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

Study Overview
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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.

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

Conditions
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Cracked Nipple During Lactation

Intervention / Treatment
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* Other: olive oil


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olive oil<br>use one drop olive oil on each nipple after each feeding | Other: olive oil<br>* 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.<br>* Other names: human milk;|
| No Intervention: breast milk<br>use breast milk on each nipple after each feeding | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal satisfaction | use Maternal Satisfaction Questionnaire 0-40 point | baseline from Baseline nipple sore at 10 days |