1)Objectives of the study
The study aims to assess the effects of parents' education on their knowledge, attitude and practice pants and the pattern of breastfeeding until four months.
2)Design of the study
This research is a non-blinded randomized clinical trial on two groups of parents intervention and control groups (n=66) who were randomized based on table of random figure.
3)Setting
Parents in two groups of intervention and control who have inclusion criteria and were randomized based on table of random figure. The intervention group will be taught in two 40-minuth sessions a week about benefits of breastfeeding and harms of formula and correct position and how to help the mother in breastfeeding by father. The control group will be managed as routine.
The knowledge, attitude and practice of participants in two groups will be measured by the questionnaires before and after 4 months. The data will be analyzed and compared before and after intervention as well as between two groups.
4) Participants
The participants in the study are fathers and mothers who referred to Rastravesh health center, and have infants aged 3-5 days and have the following inclusion and exclusion criteria. sample size of 66 people will be placed randomly allocated in to two groups
Inclusion Criteria for mothers: Being Iranian; Speaking in Persian; residency in Karaj city; literacy; Being nulliparous; No known medical conditions and mental illness; birth of a singleton and Healthy infant; have no obstacle for infant' breastfeeding.
Inclusion Criteria for Fathers: Being Iranian; Speaking in Persian; residency in Karaj city; literacy.
Exclusion criteria for participation: Unwillingness to continue cooperation with researcher; Hospitalization of the infant or mother for medical condition; Death of relatives in a period of study; Parents' separation from baby; Taking contraindicated medicines for breastfeeding by mothers; Death of infant; not Start feeding baby with breast milk during the first visit; Use of pacifiers; Unwanted pregnancy.
5)Intervention
The intervention group will be taught in two 40-minuth sessions a week about benefits of breastfeeding and harms of formula and correct position and how to help the mother in breastfeeding by father.
Then the knowledge, attitude and practice of participants in two groups will be measured by the questionnaires before and immediately after intervention and after 4 months. The data will be analyzed and compared before and after intervention in two groups.
6)Main outcome measures
The knowledge, attitude and practice of participants in two groups will be measured by the questionnaires before and after 4 months. The data will be analyzed and compared before and after intervention as well as between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508248801N10
Registration date:2016-08-31, 1395/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor of research
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of parents education on knowledge، altitude، practice and patterns of breastfeeding until four month.
Public title
The effect of parents education on knowledge، altitude، practice and patterns of breastfeeding.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria for mothers: Being Iranian; Speaking in Persian; residency in Karaj city; literacy; Being nulliparous; No known medical conditions and mental illness; birth of a singleton and Healthy infant; have no obstacle for infant, breastfeeding.
Inclusion Criteria for Fathers: Being Iranian; Speaking in Persian; residency in Karaj city; literacy.
Exclusion criteria for participation: Unwillingness to continue cooperation with researcher; Hospitalization of the infant or mother for medical condition; Death of relatives in a period of study; Parents' separation from baby; Taking contraindicated medicines for breastfeeding by mothers; Death of infant; not start feeding baby with breast milk during the first visit; Use of pacifiers; Unwanted pregnancy.
Age
From 10 years old to 49 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical commitee of Shahid Beheshti University of Medical Sciences
Street address
Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery
City
Tehran
Postal code
1985717443
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
SBMU2.REC.1394.162
Health conditions studied
1
Description of health condition studied
P92.5 Neonatal difficulty in feeding at breast
ICD-10 code
P92.5 Neon
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Knowledge
Timepoint
Before intervention and Four month after the training intervention
Method of measurement
Assess parents' knowledge about Breastfeeding Questionnaire
2
Description
Atittude
Timepoint
Before intervention and Four month after the training intervention
Method of measurement
Assess parents' Attitude about Breastfeeding Questionnaire
3
Description
Practice
Timepoint
Before intervention and Four month after the training intervention
Method of measurement
Assess parents' Performance -behavior about Breastfeeding Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Two 40-minute sessions Within a week of training That includes an explanation about the benefits of breastfeeding and how to properly breastfeed As well as face to face and direct training to mother and training to fathers on how to help encourage breastfeeding and help mother in planning or participating in other activities to provide time off for breast-feeding mother at night.
Category
Prevention
2
Description
Breast-feeding mothers in the control group is training as usual. Fathers are not in this band.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rastravesh Health center affiliated with Alborz University
Full name of responsible person
Farideh Panahi
Street address
Street martyr Beheshti, after Taleghani intersection, next to pool knowledge, Rastravesh health centers
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences