Protocol summary

Study aim
The effect of educational intervention based on planned behavioral theory in Fertility intention of women with one child in Qom City
Design
After random selection of 10 health center , using the names registered in the electronic system of the household case and random selection of 20 women in each center, which has a single child in random conditions, randomly Simple in both experimental and control groups (each group is 10)
Settings and conduct
After sampling in health centers of Qom province and evaluating the validity and reliability of the questionnaire, 52 completed researcher-made questions were completed for both the experimental and control groups. After initial need assessment, at least 4 training sessions were conducted for the control group and the effective people in their decision making and after Three months later, the intention of women's pregnancy and changes in the theory of planned behavior have been investigated .
Participants/Inclusion and exclusion criteria
women between 18 to 40 years old with one child, who is at least 24 months old; having a healthcare record in health centers and having no pregnancy plans for the next three years.Exclusion criteria: secondary infertility, women who have absolute or contraindications Relative prevention for pregnancy. women who have problems with their husbands or suffering from social pathological, or women who do not use permanent contraception methods,
Intervention groups
At least, four training sessions in groups of five are held for 50 women in the intervention group and those affecting their intention of pregnancy based on initial needs assessment. Moreover, the instructional medium is given to them. The routine training will be conducted in 50 control groups.
Main outcome variables
Frequency of fertility intent Knowledge score about one-child consequences Motivation Score Against Childbirth

General information

Reason for update
Acronym
tpb
IRCT registration information
IRCT registration number: IRCT20181105041558N1
Registration date: 2019-03-26, 1398/01/06
Registration timing: retrospective

Last update: 2019-03-26, 1398/01/06
Update count: 0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
masumeh farshid moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3774 3871
Email address
m.farshidmoghadam95@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on planned behavioral theory in Fertility intention of women with one child
Public title
effect of education intervention in Fertility intention of women with one child
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women between 18 to 40 years old with one child, who is at least 24 months old consenting for participation in study having a healthcare record in community centers having no pregnancy plans for the next three years
Exclusion criteria:
secondary infertility women who have absolute contraindications to pregnancy they are not to get pregnant till further notice women who have problems with their husbands, suffering from social pathological, women who do not use permanent contraception methods lack of consent to participate in the study and lack of continuous presence in education sessions (more than one session of absence). widows or divorced women
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In each health center, the names of the women who have only one child are listed using electronic health record (HER), and ten names are selected using systematic random sampling. Then five names are assigned to the intervention group and five names to the control group using coin tossing.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
One of the advisory professors from Australia

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.ARAKMU.REC.1397.141

Health conditions studied

1

Description of health condition studied
.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fertility intention of women(18-40year) with one child
Timepoint
Three months after the last EDUCATIONAL session
Method of measurement
questionnaire was designed by the researcher

Secondary outcomes

empty

Intervention groups

1

Description
At least, four training sessions in groups of five are held for 50 women in the intervention group and those affecting their intention of pregnancy based on initial needs assessment. Moreover, the instructional medium including the book and pamphlet of the consequences of having one-child, advanced age pregnancy complications, and the video of the effect of having one-child on the family health is given to them. The members of the intervention group have access to their instructor’s telephone counseling whenever they wish.
Category
Behavior

2

Description
Control group: For 50 ONE-CHILD MOTHER in the control group, only routine training is provided
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Health Center
Full name of responsible person
Masoumeh Farshid Moghadam
Street address
20 m Shahid Beheshti
City
qom
Province
Ghoum
Postal code
3719965654
Phone
+98 25 3670 0427
Email
qomoh1@yahoo.com
Web page address
http://oh.muq.ac.ir/index.aspx?fkeyid=&siteid=125&pageid=6637

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mohammad argomandzadegan
Street address
Basij Square - Arak University of Medical Sciences Complex
City
arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Fax
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa/page/3876/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Mahboubeh Khorsandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Golestan Cove, Building No. 2 of Medical Sciences
City
arak
Province
Markazi
Postal code
38181-4-6851
Phone
+98 86 3366 4615
Email
khorsandi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboubeh Khorsandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Golestan Cove, Building No. 2 of Medical Sciences
City
arak
Province
Markazi
Postal code
6851-4-38181
Phone
+98 86 3366 4615
Email
khorsandi@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
maasumeh farshid moghadam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Golestan Cove, Building No. 2 of Medical Sciences
City
arak
Province
Markazi
Postal code
6851438181
Phone
+98 86 3366 4615
Email
maasumeh_123@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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