This research is a clinical trial at the at the breastfeed women referring to Shahid beheshti university of medical science healthcara centers with research unit criteria. Women after interance in research will divide in three groups. In one group will use pepperment water, anotherwill use Aloevra jelly and third group will use breast milk after breasfeeding on the breast nipple and areol. Then will be camper three groups as pain, discharge and damage of breast nipple in 5 times.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206166807N5
Registration date:2012-06-30, 1391/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-30, 1391/04/10
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Science
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peppermint water, Aloevra jelly and breast milk on the breast fissure at breastfeed women
Public title
Effect of pepperment water, Aloevra jelly and breast milk on the breast fissure at the breastfeed women referring toShahid beheshti university of medical science healthcare centers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single pregnancy; no breast abnormality; first pregnancy and term pregnancy.
Exclusion criteria: post partum fever; neonatal mouth infection; breast infection and neonate short fernolom.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
shahid beheshti university of medical science
Street address
research manager,shahid beheshti university of medical science, near the Taleghani hospital,Tabnak St,Evin, Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2012-03-17, 1390/12/27
Ethics committee reference number
8212-8141-86-1-90
Health conditions studied
1
Description of health condition studied
Breast fissure
ICD-10 code
N61.0
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
Pain
Timepoint
3, 5, 7, 10, 12 and 14 days after delivery
Method of measurement
Mack gil roller
2
Description
Discharge
Timepoint
3, 5, 7, 10, 12 and 14 days after delivery
Method of measurement
Observation
3
Description
Breast nipple damage
Timepoint
3, 5, 7, 10, 12 and 14 days after delivery
Method of measurement
Observation
Secondary outcomes
1
Description
Allergy
Timepoint
3, 5, 7, 10, 12 and 14 days after delivery
Method of measurement
Pirorrtus and irritation assessment
Intervention groups
1
Description
second group: breastfeed women with breast fussier will use 0.5 CC Aloevra jelly after every times breastfeeding on the breast nipple and areola at third day after delivery.Then will be evaluate level of pain , damage and discharge in 5 times(5,7,10,12,14 days after delivery)
Category
Treatment - Drugs
2
Description
third group: breastfeed women with breast fussier will use1 drip breast milk after every times breastfeeding on the breast nipple and areola at third day after delivery.Then will be evaluate level of pain , damage and discharge in 5 times(5,7,10,12,14 days after delivery)
Category
Treatment - Drugs
3
Description
First group: breastfeed women with breast fussier will use4 drip peppermint water after every times breastfeeding on the breast nipple and areola at third day after delivery.Then will be evaluate level of pain , damage and discharge in 5 times(5,7,10,12,14 days after delivery)