Comparison of the effect of mint herbal tea and peppermint cream versus expressed breast milk on treatment of cracked nipple in women during breastfeeding: a randomized controlled trial
Objectives: To compare the effect of mint herbal tea and peppermint cream versus expressed breast milk on treatment of cracked nipple in women during breastfeeding.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible women with cracked nipple who will refer to Hamadan Heath Centers during the study period will be enrolled into the trial.
Inclusion criteria: breastfeeding; cracked nipple; age of 15 to 40 years; Hamadan resident; literate; having a phone line for communication; having a term, singleton, healthy newborn weighting between 2500 to 4000 gr; exclusive breast feeding.
Exclusion criteria: oral, palate, jaw or facial abnormalities; addiction and psychiatric problems; breast infection or inflammation; using antibiotic.
Intervention group: (a) compresses of mint tea bag on nipple for 15 min 4 times a day for 2 weeks; (b) mint cream 1 ml on nipple for 15 min 4 times a day for 2 weeks.
Control group: mother's breast milk 1 ml on nipple for 15 min 4 times a day for 2 weeks
Primary outcome: improvement of cracked nipple on 4, 8, and 14 days from beginning of the treatment through physical examination.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611039014N131
Registration date:2016-11-18, 1395/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-18, 1395/08/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-12-03, 1395/09/13
Expected recruitment end date
2017-05-03, 1396/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of mint herbal tea and peppermint cream versus expressed breast milk on treatment of cracked nipple in women during breastfeeding: a randomized controlled trial
Public title
Comparison of the effect of mint herbal tea and peppermint cream versus expressed breast milk on treatment of cracked nipple in women during breastfeeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: breastfeeding; cracked nipple; age of 15 to 40 years; Hamadan resident; literate; having a phone line for communication; having a term, singleton, healthy newborn weighting between 2500 to 4000 gr; exclusive breast feeding.
Exclusion criteria: oral, palate, jaw or facial abnormalities; addiction and psychiatric problems; breast infection or inflammation; using antibiotic.
Age
From 15 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
216
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.332
Health conditions studied
1
Description of health condition studied
cracked nipple
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
improvement of cracked nipple
Timepoint
on 4, 8, and 14 days from beginning of the treatment
Method of measurement
through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: compresses of mint tea bag on nipple for 15 min 4 times a day for 2 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: mint cream 1 ml on nipple for 15 min 4 times a day for 2 weeks
Category
Treatment - Drugs
3
Description
Control group: mother's breast milk 1 ml on nipple for 15 min 4 times a day for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Heath Centers
Full name of responsible person
Tayebeh Gharaknani
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Tayebeh Gharaknani
Position
Midwife
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
tabahar67@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Zahra Massomi
Position
Health Fertility Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
zahramid2001@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)