Objectives: To assess the effect of counseling about the breast-feeding techniques versus no counselling on breast fissure in primiparous women.
Design: A randomized clinical trial.
Setting and conduct: The eligible primiparous women who will refer to health centers of Hamadan city during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 35 years; monogamous delivery; exclusive breast-feeding; possibility of telecommunication or presence during study period.
Exclusion criteria: Abnormality in neonate's mouth; feeding neonate with bottle; abnormality in nipple; using topical drugs for breast fissure, presence of infection in breast or mastitis.
Intervention group: Routine cares plus face-to-face counseling about the breast-feeding techniques one hours a day for 3 days.
Control group: Just routine cares.
Primary outcome: Assessing breast fissure before counseling, 5, and 10 days after that through physical examination.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709059014N183
Registration date:2017-09-10, 1396/06/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
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 and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling about the breast-feeding techniques versus no counselling on breast fissure in primiparous women: a randomized clinical trial
Public title
The effect of counseling about the breast-feeding techniques versus no counselling on breast fissure in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 35 years; monogamous delivery; exclusive breast-feeding; possibility of telecommunication or presence during study period.
Exclusion criteria: Abnormality in neonate's mouth; feeding neonate with bottle; abnormality in nipple; using topical drugs for breast fissure, presence of infection in breast or mastitis.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
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
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.314
Health conditions studied
1
Description of health condition studied
Breast fissure
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Assessing breast fissure
Timepoint
before counseling, 5, and 10 days after that
Method of measurement
through physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine cares plus face-to-face counseling about the breast-feeding techniques one hours a day for 3 days.
Category
Other
2
Description
Control group: Just routine cares.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Atefeh Vafadar
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 and 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 and 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
Atefeh Vafadar
Position
Midwifery Student
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
atefeh.vafa66@yahoo.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 Seyyedh Zahra Masoomi
Position
Specialist in fertility hygiene
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
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)