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

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.

Study Overview

• Status: Unknown
• Conditions: Cracked Nipple During Lactation
• Intervention / Treatment: Other: olive oil

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen-Xi Lin; Phone Number: 917112589; Email: lin050027@hotmail.com

Study Locations

• Taiwan
  • Neihu
    • Taipei, Neihu, Taiwan, 114
      • Recruiting
      • Lin
      • Contact: Chen-Xi Lin; Phone Number: 917112589; Email: lin050027@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: olive oil; use one drop olive oil on each nipple after each feeding	Other: 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.; Other Names: human milk
No Intervention: breast milk; use breast milk on each nipple after each feeding

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Study Chair: Chen-Xi Lin, lin050027@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1-106-05-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No