The aim of this randomized clinical trial is to investigating Assessing the Compare the effect of purslane cream and lanolin to sore nipples in referring to health centers affiliated to Mashhad University of Medical Sciences in2016. In this study, women suffering from nipple fissure and nipple pain who exclusively breast fed ; have healthy term infants; normal infant weight and without any mouth or palate or jaw or face anomaly; mother without any nipple malformation are entered to this study. Excluding criteria include the infant usage of a pacifier or feeding bottle; the infant gets infected to a disease; the mother makes use of milking machine or plastic nipple; the mother gets infected to mastitis, breast abscesses or fungal infection of the breast and use of the proposed treatment less thanThree times a day. 80 sample will be assigned randomly into two groups:applying purslane cream or control group (lanolin). In the intervention group mothers apply an amount of purslane cream on nipple and Areola after feeding Three times a day for 7 days. Mothers in control group apply lanolin on nipple and areola after each feeding for 7 days . At the begining two groups will receive correct feeding technique. Store and Numerical Rating Scale is completed before the study, on day 3 and on day8 after the study by the investigator to evaluate nipple fissure intensity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042421915N1
Registration date:2017-01-28, 1395/11/09
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-01-28, 1395/11/09
Registrant information
Name
Azin Niazi
Name of organization / entity
Mashhad Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 9914
Email address
azin_niazi65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Mashhad University of Mdical Sciences
Expected recruitment start date
2016-10-08, 1395/07/17
Expected recruitment end date
2016-12-26, 1395/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Purslane Cream and Lanolin to Sore Nipple Feeding women
Public title
Comparing the effect of Purslane Cream and Lanolin to Sore Nipple
تعریفهای crack
صفت
damaged and showing lines on the surface from having split without coming apart.
the old pipes were cracked and leaking
مترادفها: chipped, broken, crazed, fractured, splintered, shattered, split, damaged, defective, flawed, imperfect
crazy; insane.
you must think my family is cracked
فعل
break or cause to break without a complete separation of the parts.
the ice all over the lake had cracked
مترادفها: break
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: Mothers suffering from nipple pain and nipple fissure who; Iranian; literate; singleton birth; term and healthy infant and exclusively breast fed; infant weight 2500 to 4000 grams; infant without any mouth or palate or jaw or face anomaly; mother without any identified mental disease; mother without any nipple malformation (flat or inverted nipples or any nipple malformation which is followed by burning or any history of nipple and areola operation in childhood); mothers don't suffer from known background diseases such as diabetes or any kind of internal_surgical diseases; mothers who do not have any allergy to purslane and lanolin cream . Excluding Criteria: During the study, the infant uses a pacifier or feeding bottle;The mother makes use of milking machine or plastic nipple; During the study, the infant gets infected to a disease; During the study, allergy to purslane and lanolin cream occurs; During the study the mother uses antibiotic;The mother gets infected to mastitis, breast abscesses or fungal infection of the breast; The mother does not desire to continue cooperation; Use of the proposed treatment less than five times a day; Use of the other treatments by the mother.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research of Mashhad University of medical sciences
Street address
Mashhad ، Ghoreshi Building ، Daneshgah street
City
Mashhad
Postal code
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.MUMS.REC.1395.300
Health conditions studied
1
Description of health condition studied
Nipple fissure
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Reduction of nipple pain
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Using Numerical Rating Scale for measuring pain intensity
Secondary outcomes
1
Description
The improvement of nipple fissures
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Measure the severity of damage, by store
Intervention groups
1
Description
In the intervention group after breastfeeding 1gr purslane cream will be rubbed to the nipple and areola 3 times a day for8 days.control group after breastfeeding 1grlanolin cream will be rubbed to the nipple and areola 3 times a day for8 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In Mashhad
Full name of responsible person
Azin Niazi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
Mashhad، Ghoreshi Building , Daneshgah street
City
Mashhad
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 and Technology Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Azin Niazi
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing And Midwifery
City
mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
niazia931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Univercity of Medical Sciences
Full name of responsible person
Sedighe Yousefzade
Position
Academic Faculty Member
Other areas of specialty/work
Street address
Fourway Doctoral Faculty، of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sedighe yousefzade@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Univercity of Medical Sciences
Full name of responsible person
Azin Niazi
Position
Master of Science University Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
niazia931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)