Comparison of the effect of thyme tea bag and chamomile tea bag versus milked milk on nipple crack’s repair during breastfeeding period: a randomized controlled trial
To assess the effect of tea bag (thyme) and tea bag (chamomile) versus milked milk on nipple crack’s repair during breastfeeding period
Design
This is a randomized clinical trial with control group, in which 108 eligible patients will be randomly assigned through block randomization to three intervention groups (receiving thyme tea bag or chamomile tea bag) and control group (receiving milked milk).
Settings and conduct
This stud will be performed in the Comprehensive Health Centers in Hamadan city. The patients will be randomly assigned to the intervention and control groups through block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 45 years,
Lactating women with nipple crack;
A full-term, singleton, healthy baby with a minimum weight of 2,500 to 4,000 grams;
Exclusive breastfeeding;
Exclusion criteria:
A baby with any abnormality in the mouth, palate, jaw and face;
Nipple abnormality or history of previous nipple surgery;
Mastitis, abscess or fungal infection of the breast;
Intervention groups
Intervention group 1: Thyme tea bag on the nipple for 15 minutes 4 times a day for 14 days. Intervention group 2: Chamomile tea bag on the nipple for 15 minutes 4 times a day for 14 days. Control group: Rubbing maternal milk on the nipple for 15 minutes 4 times a day for 14 days
Main outcome variables
Intensity of nipple crack
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N413
Registration date:2021-12-18, 1400/09/27
Registration timing:registered_while_recruiting
Last update:2021-12-18, 1400/09/27
Update count:0
Registration date
2021-12-18, 1400/09/27
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
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2023-09-04, 1402/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of thyme tea bag and chamomile tea bag versus milked milk on nipple crack’s repair during breastfeeding period: a randomized controlled trial
Public title
Comparison of the effect of thyme tea bag and chamomile tea bag versus milked milk on nipple crack’s repair during breastfeeding period
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 45 years
Lactating women with nipple crack
A full-term, singleton, healthy baby with a minimum weight of 2,500 to 4,000 grams
Exclusive breastfeeding
Exclusion criteria:
A baby with any abnormality in the mouth, palate, jaw and face
Nipple abnormality or history of previous nipple surgery
Mastitis, abscess or fungal infection of the breast
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.UMSHA.REC.1400.606
Health conditions studied
1
Description of health condition studied
Nipple crack
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Intensity of nipple crack
Timepoint
Before the intervention and on days 4, 8 and 14 after the intervention
Method of measurement
Using Storr questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Thyme tea bag on the nipple for 15 minutes 4 times a day for 14 days
Category
Treatment - Other
2
Description
Intervention group 2: Chamomile tea bag on the nipple for 15 minutes 4 times a day for 14 days
Category
Treatment - Other
3
Description
Control group: Rubbing milked milk on the nipple for 15 minutes 4 times a day for 14 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Arezoo Shayan
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahtab Satari
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahtabsattari212@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available