Comparing the effect of Lanolin, Peppermint and Dxpanthenol on treatment of traumatic nipple in lactating mothers: a randomized double-blind controlled trial
The aim of this randomized controlled trial (double blind) is comparing the effect of Lanolin, Peppermint and Dexpanthenol on treatment of traumatic nipples in lactating mothers. In this study, 126 lactating women aged 18 to 40 years affected by traumatic nipples will be recruited. This study will be conducted at selected health care centers in Sanandaj city. Eligible women will be selected through convenience sampling and will be randomly assigned into 3 groups of 42 persons using permuted block randomization with allocation ratio of 1:1:1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 126, which contains one tube (tubes containing a cream Lanolin, Peppermint and Dexpanthenol , which is similar in shape, color and size) will be used for allocation concealment. Medication immediately after breastfeeding 3 times a day for 2 weeks, some of the drug so that a thin layer of cover around the nipple and areola is applied. Main outcome include nipple trauma injury with Champion scale and secondary outcome include nipple pain with Pain Sttor scale will be assessed by researcher before the intervention and two weeks after the intervention. The researcher and the participants will be blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403116709N16
Registration date:2014-10-06, 1393/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-06, 1393/07/14
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences.
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Lanolin, Peppermint and Dxpanthenol on treatment of traumatic nipple in lactating mothers: a randomized double-blind controlled trial
Public title
The effect of Lanolin, Peppermint and Dexpanthenol on traumatic nipple in lactating mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single birth; exclusive breastfeeding; term infant; infants less than 2 months of age; earn a minimum score 1 on a scale of NTS and NSRS; mother's lack of sensitivity to Lanolin, Peppermint and Dexpanthenol; 2500-4000 grams birth weight; the absence of abnormal nipple (flat, depressed).
Exclusion criteria: infant with tongue and teeth abnormalities; baby use pacifier, glass and plastic nipple; mother with history of mental illness
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:
126
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Postal code
51665-118
Approval date
2014-06-23, 1393/04/02
Ethics committee reference number
9342
Health conditions studied
1
Description of health condition studied
Cracked nipple
ICD-10 code
N64.0
ICD-10 code description
Other disorder of breast
Primary outcomes
1
Description
Nipple trauma injury
Timepoint
Before the intervention and two weeks after intervention
Method of measurement
Champion scale
Secondary outcomes
1
Description
Nipple pain
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
pain Sttor scale
Intervention groups
1
Description
Control group: Lanolin cream with trade name of Lanolin made by Iran Nazhoo Company, containing purest Lanolin and no preservative and any other additives that for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
Category
Treatment - Drugs
2
Description
Intervention group 1: Peppermint cream, made by pharmacy faculty in Tabriz, containing Carbopol, Methyl paraben, Tritanolamin and Glycerin with 0.2% Peppermint oil added to it that for 2 weeks, 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
Category
Treatment - Drugs
3
Description
Intervention group 2: Dexpanthonel cream with trade name of Panthoderm made by Caspian Company, containing Pantothenic acid for 2 weeks 3 times a day immediately after milking, the amount of the drug so that a thin layer of it covers the nipple and areola will be applied.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health centers of Sanandaj city
Full name of responsible person
Dr Ronak Hemati
Street address
Abbas Abad street, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research dupty of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research dupty of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
kazhal Masoudin
Position
Masters of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street,Tabriz
City
Tabriz
Postal code
5177854616
Phone
+98 41 1447 4467
Fax
Email
K_masoudin@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Master of sciences of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Postal code
51745347
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kazhal Masoudin
Position
Master of science student midwifery
Other areas of specialty/work
Street address
Facultyof Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Postal code
5177854616
Phone
+98 41 1447 4467
Fax
Email
k_masoudin@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)