Explanatory phenomenological study of childbearing and parenting of primiparas women ,design,implementation and evaluation of empowerment program based on theory of planned behavior: mixed method study
Design implementation and evaluation of primipara women empowerment program based on TPB theory and phenomenological study
Design
Randomized clinical trial with control group
Settings and conduct
Health centers of Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusive criteria:Primipara,20to30 ages,healthy baby,less than 9 months.
Exclusive criteria:Phsycological patient.responsible for family.withdrawal women
Intervention groups
Effect of educational intervention and educational package about primipara women empowerment program
Main outcome variables
The constructs of theory of planned behavior: awareness,attitude, subjective norms ,perceived behavioural control, behavioural intention, behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180123038487N1
Registration date:2018-10-14, 1397/07/22
Registration timing:prospective
Last update:2018-10-14, 1397/07/22
Update count:0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Nilowfar Salighehdar iran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6687 4437
Email address
salighehdarnilowfar5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-20, 1397/07/28
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanatory phenomenological study of childbearing and parenting of primiparas women ,design,implementation and evaluation of empowerment program based on theory of planned behavior: mixed method study
Public title
Evaluation of empowerment program on primipara women based on theory
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
They are primiparas.
They are in rage of 20 to 30 ages.
They are in 9 months after from birth.
Exclusion criteria:
They are not psychological patient.
They are not responsible of family.
They are not withdrawal women.
They do not have abnormal baby.
Age
From 20 years old to 30 years old
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
It is done with simple randomization by random number table with cluster unit.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Qods st.Poor sina st.Health collage.TUMS
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.TUMS.VCR.REC.1397.033
Health conditions studied
1
Description of health condition studied
Enable primipara women about childbearing and parenting after interventional-educational program based on theory
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Enable of primipara women based on evaluation of constructs of TPB
Timepoint
Before, exact after intervention,4 months after intervention
Method of measurement
Questionnaire (empowerment program of primipara based on TPB)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 sessions include meeting, educational package,,discussion based on qualitative study,theory and need assessment before of study.After intervention it is done post test and 4 months after that with valid and reliable instrument ( questionnaire).
Category
Lifestyle
2
Description
Control group:without educational intervention and with pretest and post test according to intervention group.Finally it is given to them educational package for their participation.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tehran University of Medical Sciences
Full name of responsible person
Nilowfar Salighehdar Iran
Street address
Qods st.Poor sina st. Health collage
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6687 4437
Email
salighehdarnilowfar5@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Qods st.LPoorsina st.Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8899 2663
Email
esmaeelm@tums.ac.ir
Web page address
http://rmo.tums.ac.ir/
Grant name
Dr Mohammad Ali Sahraian
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hassan Eftekhar Ardebily
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Qods st.Poor sina st.Health collage.Health education and Promotion department
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6687 4437
Email
Eftkhara@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hassan Eftekhar Ardebili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Qods st.Poor sina st.Health collage.Health education and Promotion department
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6687 4437
Email
Eftkhara@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hassan Eftekhar Ardebily
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Qods st.Poor sina st.Health collage.Health education and Promotion department
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6687 4437
Email
Eftkhara@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Just results of research without private data of samples are presented.
When the data will become available and for how long
Accessible 6 months after printing of results
To whom data/document is available
Instructors and students
Under which criteria data/document could be used
Complete and innovation
From where data/document is obtainable
TUMS.Health collage.Library
What processes are involved for a request to access data/document
Search in library of collage(Health) and find it.Then you use of data of dissertation