Determination of the effect of chamomile ointment on treatment of Nipple fissure in breastfeeding mothers
Design
Clinical trials with controlled, randomized, and single blind
Settings and conduct
Sampling is done in health centers. In the absence of sensitivity , the ointment of chamomile & lanolin is used 3 times a day after lactation; the treatment is conducted for 7 days. On the 3rd and 7th days, the mother refer to be examined after the intervention, and the effect of the intervention is measured by
using Storr scale and the pain scale ruler
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years; nipple fissure with a 1-4 Storr score; Singleton birth; The term baby; The natural weight of the baby (2500-4000);Infant without any congenital malformation of palate, jaw and face and short frenulum ; Exclusive breastfeeding; Moms with average and good breastfeeding scores;lack of nipple abnormalities such as indented nipple and breast or nipple surgery; very small or large breast ; Lack of maternal immunodeficiency diseases; diabetes and hypertension ; Lack of mother's neurological diseases and depression ; Insensitivity to chamomile and lanolin ointments ; Non-compliance criteria:Sickness and bedridden baby;Mastitis; abscess or puerperal fever؛ Infant’s being infected to oral infections ;Taking antibiotics, other topical ointment; or analgesics
Intervention groups
Intervention 1: Using chamomile ointment as a fingernail on the nipple fissure and areola 3 times a day for one week during the study + Training the correct lactation technique
Intervention 2: Interventions 1: Using lanolin ointment as a fingernail on the nipple fissure and areola 3 times a day for one week during the study + Training the correct lactation technique
Main outcome variables
The severity of breast fissure and the amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180127038528N1
Registration date:2018-07-09, 1397/04/18
Registration timing:retrospective
Last update:2018-07-09, 1397/04/18
Update count:0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
shaghayegh Dehghan nayeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3610 8022
Email address
dehghannayeri.sh@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Chamomile Ointment on Treatment of Nipple Fissure in Breast FeedingMothers
Public title
"Effect of Chamomile Ointment in Treatment of Nipple Fissure"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Nippel fissure with 1-4 score for Store
Single delivery
The term baby
The natural weight of the baby (2500-4000 gr)
Infant without congenital malformation; plate, jaw and face and short fernoloma
Exclusive breastfeeding
Absence of nipple abnormalities such as nipple and breast or nipple surgery; very small or large breast
Lack of maternal immunodeficiency diseases; diabetes and hypertension
Lack of mother's neurological diseases and depression
Insensitivity to chamomile and lanolin ointments
Mothers with a lactation position grade score; medium and good
Exclusion criteria:
Sickness and bedridden baby
Mastitis; abscess or puerperal fever
Infant’s being infected to oral infections
Taking antibiotics, other topical ointment; or analgesics
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified patients will be randomly assigned to one of the two groups of lanolin ointment and chamomile. To randomize the block method
Randomized block permuted with 4 blocks. According to volume
The sample of which 106 is set, the 4th block using the site (www.sealedenvelope.com)will be. In order to apply the concealment in the randomization process, the unique codes on the ointment line
The code will be used by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher (midwife) is not informed of the type of drug used in the studied groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-03, 1396/07/11
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9413373002
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
Nipple pain
Timepoint
Before intervention ,3 and 7 days after intervention
Method of measurement
Visual Analogue scale
2
Description
Nipple fissure
Timepoint
Before intervention ,3 and 7 days after intervention
Method of measurement
Storr scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group,after breatfeeding, chamomile cream will be rubbed 3 times a day for 7 days on the nipple and the areola around it.
Category
Treatment - Drugs
2
Description
In the control group:after breasfeeding Lanolin will be rubbed 3 times a day for 7 days on the nipple and the areola around it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Health Care Centers in Alborz
Full name of responsible person
Dehghan nayeri shaghayegh
Street address
Amirabad street.,Health Center
City
Karaj
Province
Alborz
Postal code
3164838441
Phone
+98 26 3610 8022
Email
Sh.midwife31680@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malakuti Kazem
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dehggan nayeri shaghayegh
Position
collegian
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.4, dehghan nayeri., amir abad Blvd., Garmdare town
City
Karaj
Province
Alborz
Postal code
3164838441
Phone
+98 26 3610 8022
Email
Sh.midwife31680@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kheirkhah masume
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
Shivakheirkhah1345@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dehghan nayeri shaghayegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Rashid Yasemi Ave., Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8670 5503
Email
Sh.midwife31680@gmail.com
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