NCT04536597

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.6 years

First QC Date

August 25, 2020

Last Update Submit

August 28, 2020

Conditions

Keywords

breast milkearly postpartum periodnipple fissuresmidwiferyquince seed jelly

Outcome Measures

Primary Outcomes (1)

  • Nipple pains and fissures

    the Breast Care Monitoring Form

    between the 1st and 10th days of the postpartum period

Study Arms (3)

Quince seed jelly group

EXPERIMENTAL
Other: Quince seed jelly group

Breast milk group

EXPERIMENTAL
Other: Breast milk group

Control group

OTHER

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

Other: Control group

Interventions

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.

Quince seed jelly 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.

Breast milk 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

Control group

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparity,
  • those having no nipple problems and allergy history
  • volunteered to participate in the study

You may not qualify if:

  • nipple problems and allergy history
  • multiparity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Sciences

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 2, 2020

Study Start

October 15, 2015

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share