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The effect of topical use of ostrich oil on the severity of nipple cracks in nursing mothers

Protocol summary

Study aim
Determining the effect of topical use of ostrich oil on the severity of cracked nipples in nursing mothers, Gonabad city, year 1403
Design
A clinical trial with a control group, with parallel groups, randomization of 4 permutation blocks on 48 patients, G.Power 3.1.9.2 software will be used based on the average comparison formula in two independent groups.
Settings and conduct
Lactating mothers suffering from nipple fissure during the first 6 weeks after giving birth, referring to public and private healthcare centers in Gonabad city in Year1403
Participants/Inclusion and exclusion criteria
Obtaining at least a score of 3 from the Storr scale, exclusive breastfeeding, birth weight of 2500-4000 grams, full-term delivery of singletons, the time of cleft within the first 6 weeks of delivery, willingness to participate in the study
Intervention groups
In this study, 100% pure ostrich oil is used in the intervention group and breast milk in the control group. The intervention is that each of the research units is given a jar containing 25 ml of ostrich oil and they are asked to put 5 drops of ostrich oil on the nipple and the areola around it 5 times a day after breastfeeding. Continue this work for 7 days. In the control group, lactating women put 5 drops of their milk on the nipple and the areola around it 5 times a day after breastfeeding.
Main outcome variables
The time of occurrence of clefts after childbirth, the type of delivery, the number of nipples affected by clefts, previous breastfeeding problems, the time of the first breastfeeding after childbirth, the number of times of breastfeeding during the day and night, breastfeeding methods, the weight of the baby at birth, the age of the infant and the time of the onset of clefts.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240317061315N1
Registration date: 2024-03-27, 1403/01/08
Registration timing: prospective

Last update: 2024-03-27, 1403/01/08
Update count: 0
Registration date
2024-03-27, 1403/01/08
Registrant information
Name
Zohreh Pourgheisar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 8701
Email address
m_amoozeshi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical use of ostrich oil on the severity of nipple cracks in nursing mothers
Public title
Year1403, Gonabad city, the effect of topical use of ostrich oil on the severity of nipple cracks in nursing mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The time of rupture is in the first 6 weeks of childbirth Existence of exclusive breastfeeding The birth weight of a newborn is 2500-4000 grams Obtaining at least 3 points from the store scale Single term delivery Willingness to participate in the study
Exclusion criteria:
The mother has breast abnormalities, including sunken or too long nipples or previous breast surgery. Mother's disease and breast skin sensitivities based on the mother's self-report The mother's mental illness based on the mother's self-report History of mother's allergy to ostrich oil based on the mother's self-report Using a breast pump or a breast connector Infants suffering from oral candidiasis based on the infant's oral examination Infant suffering from congenital malformation of mouth and jaw and face and short frenulum based on observation of the infant Feeding the infant with a bottle, powdered milk, beer and sugar water based on the mother's self-report Use of drugs to stop breastfeeding such as cabergoline tablets, bromocriptine tablets, Dastinx tablets based on the mother's self-report. The use of other topical wound healing creams based on the mother's self-report
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to each of the 2 intervention and control groups, permutation blocks of 4 are used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.GMU.REC.1402.175

Health conditions studied

1

Description of health condition studied
Cleft nipple
ICD-10 code
XII
ICD-10 code description
complications of pregnancy, childbirth and the puerperium (O00-O99)

Primary outcomes

1

Description
Severity of breast fissure
Timepoint
At the beginning of the study (before the start of the intervention) and day 3 and day 7 after the intervention
Method of measurement
Store scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: To determine the effect of topical use of breast milk on the severity of nipple cracks in nursing mothers who are advised to put 5 drops of their milk on the nipple and the areola around it for 5 times a day after breastfeeding.
Category
Treatment - Other

2

Description
Intervention group: To determine the effect of topical use of ostrich oil on the severity of nipple cracks in nursing mothers, hygienic ostrich oil with 100% purity will be used in the intervention group, and the intervention is to give each research unit a bottle containing 25 ml of oil. Ostrich is given and they are asked to put 5 drops of ostrich oil on the nipple and the areola around it 5 times a day after breastfeeding and continue this work for 7 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Public and private healthcare centers of Gonabad city
Full name of responsible person
Zohreh Pourgheisar
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Phone
+98 51 5725 8701
Email
pourgheisarz5@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Vice President of University Research and Technology
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Phone
+98 915 300 0383
Email
pourgheisarz5@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Pourgheisar Zohreh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Phone
009857258701
Email
pourgheisarz5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Pourgheisar Zohreh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Phone
009857258701
Email
pourgheisarz5@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Pourgheisar Zohreh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, sub-10, Imam Khomeini St. 19
City
Gonabad
Province
Razavi Khorasan
Postal code
9691654467
Phone
009857258701
Email
pourgheisarz5@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Will be available if needed for further research
From where data/document is obtainable
I will respond by e-mail and phone numbers along with the names and addresses of the people
What processes are involved for a request to access data/document
The reason for the request should be clear to be used in the advancement of science
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