Clinical trial with control group, with parallel groups, randomized, single-blind
Settings and conduct
In this clinical trial, 120 primiparous mothers with postpartum nipple fissure (they have referred to the health centers of Zarand city in the first six weeks after delivery) will be participated in the study and will be allocated to quaternary blocks by random blocking method. They will be divided in two groups of intervention (coconut oil) and control (breast milk).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willingness to participate in the study , No mother getting mental illness , No mother getting skin diseases and insensitivity to coconut oil; Exclusion criteria:
Mother getting abscess or fungal infection of the breast after entering the study, mother use of other treatments except recommended treatment, reluctance to continue collaborating in the study, nonconformity the time interval of the intervention.
Intervention groups
In the intervention group, mothers will be requested use of 0.5 mL coconut oil 3 times a day (after breastfeeding) on the nipple and around it. Coconut oil, stay in place for at least one hour. To the mothers in the control group will be trained in order to pour 3-4 drops of their breast milk on the nipple and the area around it after each breastfeeding and allow it to dry.
Main outcome variables
Nipple fissure and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190724044318N1
Registration date:2020-08-19, 1399/05/29
Registration timing:prospective
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
maryam alikamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3342 3494
Email address
m_kamali1984@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of coconut oil and breast milk on treatment of nipple fissure and pain in primiparous mothers: single blind clinical trial
Public title
Comparison the effect of coconut oil and breast milk on improvement of nipple fissure and breast pain primiparous mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Getting nipple fissure in the first six weeks after delivery and earn a minimum score of 3 on the store scale.
Age : 18 to 40 years
Having a telephone line to follow up the intervention
Exclusive breastfeeding
Single-term delivery with normal weight (2500-4000 gr)
Willingness to participate in the study
No infant getting the mouth, palate, jaw and face abnormalities.
No mother getting nipple abnormalities or previous nipple and areola surgeries.
No mother getting mental illness
No mother getting skin diseases and insensitivity to coconut oil.
Exclusion criteria:
Infant starts feeding with a bottle milk
Use a breast pump or breast interface
Mother uses of other treatments except recommended treatment
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be selected based on referral to the health center and having all the inclusion criteria in research. Random allocation will be done by block method with quaternary blocks, then eligible individuals are placed in the intervention and control group based on the allocated block by the computer. By identifying all members of the intervention group in two weeks, the intervention will be done individually.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blind study, sampling will be done by individuals that do not know the characteristics of groups. It is also possible to make a random selection by someone who does not have information about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Medical University Campus, Haft-Bagh Highway, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.KMU.REC.1399.204
Health conditions studied
1
Description of health condition studied
Nipple fissure and pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nipple fissure
Timepoint
Before the intervention and 7th and 14th days of the intervention
Method of measurement
Store scale questionnaire
2
Description
Nipple pain
Timepoint
Before the intervention and 7th and 14th days of the intervention
Method of measurement
Visual Analoge scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the main group, mothers who earned a score higher than 3 from the Store scale and have all the inclusion criteria will enter the study. In the intervention group, mothers will be requested use of 0.5 mL coconut oil 3 times a day (after breastfeeding) on the nipple and around it (100% pure in 30 mg bottles from Barij Essential Pharmaceutical Company). Coconut oil, stay in place for at least one hour and if the baby demands breastfeeding before one hour, should be eliminated that turn and intervene to be performed again after breastfeeding.Mothers will be requested refer to health centers with the coordination of the researcher assistance on the 7th and 14th days of the intervention in order to evaluate the severity of nipple fissure and pain.
Category
Treatment - Drugs
2
Description
In the intervention group, mothers who earned a score higher than 3 from the Store scale will enter the study. To the mothers in the control group will be trained in order to pour 3-4 drops of their breast milk on the nipple and the area around it after each breastfeeding and allow it to dry.Mothers will be requested refer to health centers with the coordination of the researcher assistance on the 7th and 14th days of the intervention in order to evaluate the severity of nipple fissure and pain.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zarand city health centers
Full name of responsible person
Maryam Alikamali
Street address
Imam Khomeini Ave.,Zarand School of Medical Sciences.,Zarand city
City
Zarand
Province
Kerman
Postal code
7761713115
Phone
+98 34 3342 5400
Email
m_kamali1984@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhty
Street address
Ebn-e-Sina St.,Jahad Blvd.,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Alikamali
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Ave.,Zarand School of Medical Sciences., Zarand city
City
Zarand
Province
Kerman
Postal code
7761713115
Phone
+98 34 3342 5400
Email
m_kamali1984@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Alikamali
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Ave.,Zarand School of Medical Sciences.,Zarand city
City
Zarand
Province
Kerman
Postal code
7761713115
Phone
+98 34 3342 5400
Email
m_kamali1984@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Alikamali
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Ave.,Zarand School of Medical Sciences.,Zarand city
City
Zarand
Province
Kerman
Postal code
7761713115
Phone
+98 34 3342 5400
Email
m_kamali1984@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available