The objective of this randomized clinical trial is comparing efficacy of olive oil and aloe vera extract on healing of breast fissure in breastfeeding women. The sample size will be determined on the basis of a pilot study. Samples randomly (by permutation blocks) will be divided into intervention and control groups. The inclusion criteria include: having breast fissure and a minimum score of 3 of Store scale; Incidence of breast fissures in first 6 weeks after childbirth; exclusive breastfeeding mothers; Term Single birth pregnancies with normal weight; lack of abnormalities in the mouth, palate, jaw and face of newborn; the absence of infection or previous surgery of nipple; lack of abnormalities of nipple and areola ; not suffering from mental disorders. Exclusion criteria included the bottle-fed infants; use of milking breast or breast shield; oral fungal infection of the newborn; abscess or fungal infection of the breast; The first group of mothers use olive oil and the second group use aloe vera extract three times a day on the nipple and areola of the breast. The third group after each breastfeeding rubbing their milk on the nipple and areola 4-3 drop and allow to dry. the first and second group mothers In addition to the considered intervention rub their milk on the nipple and areola. The main variable are olive oil, aloe vera extract and breast milk that their effect on healing of breast fissure will be measured and compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010320544N1
Registration date:2015-02-08, 1393/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-08, 1393/11/19
Registrant information
Name
Mina Mesbah
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
mesbah.mina@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison efficacy of Olive Oil and Aloe vera extract on healing of breast fissure in breastfeeding women
Public title
Comparison efficacy of Olive Oil and Aloe vera extract on healing of breast fissure
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria include: The incidence of breast fissure and a minimum score of 3 on store scale؛ incidence fissures in the first 6 weeks after childbirth؛ age between 18 and 40 years؛ have a telephone for follow-up؛ exclusive breastfeeding mothers; Term Single birth pregnancies with normal weight; lack of abnormalities in the mouth, palate, jaw and face of newborn؛ lack previous surgery or abnormalities of nipple and areola؛ not suffering from mental disorders. Exclusion criteria include: the bottle-fed infants؛ use of milking breast or breast shield ؛ oral fungal infection of the newborn ؛abscess or fungal infection of the breast؛ Baby feeding bottle؛ use of interface milking breast؛ oral fungal infection of the newborn؛ abscess or fungal infection of the breast؛ The use of other therapies other than the recommended treatment؛ Unwillingness to continue cooperation in the study؛ non-compliance interval intervention
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
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
Gonabad UGonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
GMU.REC.1393.92
Health conditions studied
1
Description of health condition studied
breast fissure
ICD-10 code
O92.1
ICD-10 code description
Cracked nipple associated with childbirth
Primary outcomes
1
Description
The severity of breast fissure
Timepoint
Days of first, third and seventh
Method of measurement
store scale
Secondary outcomes
1
Description
intensity of pain caused by breast fissure
Timepoint
days of first, third and seventh
Method of measurement
Visual Analoge Scale
2
Description
The extent of damage caused by breast fissure
Timepoint
days of first, third and seventh
Method of measurement
Amir criteria
Intervention groups
1
Description
The first group of mothers rub about 3-4 drops of their milk on the nipples and around areola after each feeding and allow it to dry, in addition use 5.0 ml of olive oil on the nipple and areola three times a day.
Category
Treatment - Other
2
Description
The second group of mothers rub 3-4 drops of their milk on the nipples and around areola after each feeding and allow to dry, in addition use 0/5ml of aloe vera extract three times a day on the nipple and areola.
Category
Treatment - Other
3
Description
The third group(control group) rub 4-3 drops of their milk on the nipple and areola after each feeding and allow it to dry
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad University of Medical Sciences, 22 Bahman Hospital
Full name of responsible person
Mina Mesbah
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mina Mesbah
Position
MSC Student in Nursing Education
Other areas of specialty/work
Street address
University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
mesbah.mina@gmu.ac.ir; mina_mesbah62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Eshghizadeh
Position
Master of Science in Nursing Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
m.eshghizadeh@yahoo.cim
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mina Mesbah
Position
MSC Student in Nursing Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 557223028
Fax
Email
mesbah.mina@gmu.ac.ir; mina_mesbah62@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)