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

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ClinicalTrials.gov Identifier: NCT03568370
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Lin, Chen-xi, 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.

Condition or disease Intervention/treatment Phase
Cracked Nipple During Lactation Other: olive oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

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 Name: human milk

No Intervention: breast milk
use breast milk on each nipple after each feeding



Primary Outcome Measures :
  1. Nipple pain change [ Time Frame: Change from baseline nipple pain at 10 days ]
    use Numeric Rating Scale 0-10 point

  2. Nipple sore change [ Time Frame: Change from baseline nipple pain at 10 days ]
    use Nipple Soreness Score 0-5 point

  3. Nipple trauma change [ Time Frame: Change from baseline nipple trauma at 10 days ]
    use Nipple Trauma Score 0-5 point

  4. breastfeeding duration [ Time Frame: 30 days ]
    use Infant Feeding Categories


Secondary Outcome Measures :
  1. Maternal satisfaction [ Time Frame: baseline from Baseline nipple sore at 10 days ]
    use Maternal Satisfaction Questionnaire 0-40 point



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568370


Contacts
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Contact: Chen-Xi Lin 917112589 lin050027@hotmail.com

Locations
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Taiwan
Lin Recruiting
Taipei, Neihu, Taiwan, 114
Contact: Chen-Xi Lin    917112589    lin050027@hotmail.com   
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Investigators
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Study Chair: Chen-Xi Lin lin050027@hotmail.com

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Responsible Party: Lin, Chen-xi, PI, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03568370     History of Changes
Other Study ID Numbers: 1-106-05-131
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No