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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04536597
Other study ID # TRSIVAS01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2015
Est. completion date May 10, 2017

Study information

Verified date August 2020
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood circulation) and has no side effects or contraindications.

Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.

Methods: Randomised controlled experimental study.


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date May 10, 2017
Est. primary completion date May 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 49 Years
Eligibility Inclusion Criteria:

- primiparity,

- those having no nipple problems and allergy history

- volunteered to participate in the study

Exclusion Criteria:

- nipple problems and allergy history

- multiparity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quince seed jelly group
Quince seed jelly, prepared by the researcher, was given to the mothers belonging to this group. Briefly, 3 g (2-3 pieces) of quince seeds are placed in 100 mL water and heated to boiling for 10 min. The prepared quince kernel was used for 3 days, immediately after cooling.14,15 On the 1st day postpartum, the researcher provided the mothers with practical training at the hospital, regarding the application of quince seed jelly to the nipple and areola and leaving it to dry. This training was repeated on the 3rd, 7th and 10th days, to ensure that the mothers followed it precisely. The training process was completed in 5-10 min, including questions and answers. Every 3-4 days (days 1, 3, 7 and 10), quince seed jelly prepared by the researcher was given to the mothers to continue applying, according to the procedure. The mothers were asked to apply it after every breastfeeding.
Breast milk group
Mothers in this group received practical training, conducted by the researcher on the 1st day postpartum at the hospital, on applying a few drops of their breast milk to the nipples and areola after each breastfeeding and leaving it to dry. This training lasted 5-10 min. Breast milk application of mothers in this group was recorded on the 1st, 3rd, 7th and 10th days, by the researcher.
Control group
Any kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Outcome

Type Measure Description Time frame Safety issue
Primary Nipple pains and fissures the Breast Care Monitoring Form between the 1st and 10th days of the postpartum period
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