Objectives: This clinical trial has been designed to evaluate the effect of family-centered empowerment program on breast feeding mothers. The study population will be mothers who refer to selected Isfahan health centers. Mothers randomly will be divided into two groups, one group is control (without training) and another be intervention (with training and consultation). Sample size according to the sample size formula and expected effectiveness, is thirty six families in each group. This study is a single blind clinical trial for participants in the intervention and control groups.
Inclusion criteria: mothers with age over eighteen years old, gestational age thirty two to thirty six weeks, singleton pregnancy, low-risk pregnancy with a desire to participate in the research, be able to understand and complete the questionnaire and absence of spiritual and mental disorders.
Exclusion criteria: lack of desire to continue cooperation at any stage of research.
Design: With available sampling, gradually selected pregnant women eligible inclusion criteria and randomly placed in the intervention and control groups. Intervention: in intervention group, two educational sessions (breastfeeding importance and techniques, the prevention and treatment of breast feeding problems and…) will be held during pregnancy and one breastfeeding consultation session after birth for mothers and key members of her family. The control group will not receive any training.
Two weeks and two months after birth, main outcome will be measured include mother’s empowerment in breastfeeding and breastfeeding sufficiency through mothers point of views will be evaluated by the questionnaire in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723657N1
Registration date:2015-11-16, 1394/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-16, 1394/08/25
Registrant information
Name
Zeinab Heidari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 101 5058
Email address
zeinab_heidari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the effect of receiving and not receiving a family-centered empowerment program on breast feeding mothers
Public title
The Effectiveness of family-centered empowerment program on breast feeding mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: mothers over eighteen years, gestational age thirty two to thirty six weeks, singleton pregnancy, low-risk pregnancy with a desire to participate in the research, be able to understand and complete the questionnaire and lack of spiritual and mental disorders.
Exclusion criteria include lack of desire to continue cooperation at every stage of research
Age
From 18 years old to 45 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
Postal code
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
393472
Health conditions studied
1
Description of health condition studied
breastfeeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Mother’s empower in breastfeeding
Timepoint
Two weeks & two months after birth
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Breastfeeding sufficiency in mothers point of views
Timepoint
Two weeks & two months after birth
Method of measurement
Questionnaire
Intervention groups
1
Description
Two sessions (breastfeeding importance and techniques, the prevention and treatment of breast feeding problems and…) in pregnancy period and one breastfeeding consultation session after birth for mothers and key members of her family. Training methods are lecture, question and answer, playing movie, book introduction and support
Category
Behavior
2
Description
Control group will not receive training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Health and Treatment Center
Full name of responsible person
Zeinab Heidari
Street address
Shohada Sq.
City
Isfahan
2
Recruitment center
Name of recruitment center
Navab Health and Treatment Center
Full name of responsible person
Zeinab Heidari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Mahdi Neamatbakhsh
Street address
Isfahan University of Medical Sciences, Hezarjerib St.
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zeinab Heidari
Position
Phd candidate of Reproductive Health
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Isfahan University of Medical Sciences, Hezarjerib St.