Protocol summary

Summary
The Purpose of this study is to determine the effect of education program on awareness, worry and self efficacy in nulliparous women in infant care. Inclusion criteria are: Iranian pregnant ladies that having records in health centers of Sari; ability to understand Persian language; gestational between 31-34week; exclusion criteria: move location; diagnosis of anomalies in the fetus or newborn; preterm labor; non interference in each session; sever marital problems; unwillingness to continue and working. For this study 150 nulliparous pregnant woman will be randomly assigned to intervention and control groups, 75 woman in each group. Awareness, worry and self efficacy will be compared in each group before prevention immediately after prevention and two month after delivery. The measurement tool for this of study is a questionnaire that will be completed in three stages by all units.

General information

Acronym
Education and parental self efficacy
IRCT registration information
IRCT registration number: IRCT201104123037N4
Registration date: 2011-06-19, 1390/03/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Mehrnaz Geranmayeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1669
Email address
geranmay@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-10-30, 1389/08/08
Expected recruitment end date
2011-04-28, 1390/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education program on knowledge worry and self efficacy
Public title
Effect of education on self efficacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian; living in Sari; having records in health centers of Sari; ability to understand Persian language; gestational between 31-34week; lack of infant care experience; no record of infertility; recurrent abortion; stillbirth; no known disease such as hypertension; renal and heart disease; thyroid; non motor disability; no obvious abnormalities in fetal diagnosis. Exclusion criteria: move location; diagnosis of anomalies in the fetus or newborn; preterm labor; non interference in each session; sever marital problems; unwillingness to continue; working.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Ethics Commiitee, Tehran University of Medical Sciences
Street address
6th floor, Central building of Tehran University of Medical Sciences, Ghods st., Keshavarz blv.
City
Tehran
Postal code
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
89/د/130/325

Health conditions studied

1

Description of health condition studied
Worry
ICD-10 code
F59
ICD-10 code description
Psychogenic physiological dysfunction NOS

Primary outcomes

1

Description
Parental self efficacy; believe the mother in child-related tasks successfully
Timepoint
Before and after intervention and 2 months after childbirth
Method of measurement
Questionnair

Secondary outcomes

1

Description
Awarness
Timepoint
Before and after intervention and 2 months after childbirth
Method of measurement
Questionnair

Intervention groups

1

Description
Intervention group: educational program infant care will carry out with adult education methods and workshop that is conducted on two consecutive days. Slides and doll will be used for education. At the end of training sessions pamphlets will be given to the mothers and phone calls 10days after birth will be established by the researcher with mothers and telephone number of the researcher will be given to the subjects if necessary. Questionnaires will be completed in three stages.
Category
Prevention

2

Description
Control group: do not receive the training research
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center number1
Full name of responsible person
Nazfar
Street address
End of shahband avenu
City
Sari

2

Recruitment center
Name of recruitment center
Health center number2
Full name of responsible person
Seyedi
Street address
Emamzade abas alley, Emam reza boulevard
City
Sari

3

Recruitment center
Name of recruitment center
Health center number3
Full name of responsible person
Sedighi
Street address
Ghanbarian alley, Rahband dokhaniat
City
Sari

4

Recruitment center
Name of recruitment center
Health center number4
Full name of responsible person
kholardi
Street address
Haghani alley, Emam reza boulevard
City
Sari

5

Recruitment center
Name of recruitment center
Health center number5
Full name of responsible person
Azimi
Street address
City
Sari

6

Recruitment center
Name of recruitment center
Health center number6
Full name of responsible person
Fazilat
Street address
City
Sari

7

Recruitment center
Name of recruitment center
Health center number7
Full name of responsible person
Hafezian
Street address
City
Sari

8

Recruitment center
Name of recruitment center
Health center number8
Full name of responsible person
Gooran
Street address
City
Sari

9

Recruitment center
Name of recruitment center
Health center number9
Full name of responsible person
Roozbeh
Street address
City
Sari

10

Recruitment center
Name of recruitment center
Health center number10
Full name of responsible person
Elvich
Street address
City
Sari

11

Recruitment center
Name of recruitment center
Health center number11
Full name of responsible person
Vahedi
Street address
City
Sari

12

Recruitment center
Name of recruitment center
Health center number12
Full name of responsible person
Firoozian
Street address
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Scinces
Full name of responsible person
Abbas Hoshmand Behabadi
Street address
Faculty of Nursing and Midwiferyو Nosrat st., Tohid sq.
City
Tehran
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, Tehran University of Medical Scinces
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
Tehran University of Medical Siences
Full name of responsible person
Seiede Olia Mousavi
Position
Graduate Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St,Tohid Sq.
City
Tehran
Postal code
Phone
+98 911 252 2397
Fax
Email
helia6110@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Scinces
Full name of responsible person
Mehrnaz Geranmayeh
Position
Post graduate of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat st.,Tohid sq.
City
Tehran
Postal code
Phone
+98 91224828111
Fax
Email
geranmay@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Mehrnaz Geranmayeh
Position
Post graduate of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat st.,Tohid sq.
City
Tehran
Postal code
Phone
+98 912 218 2811
Fax
Email
granmay@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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