Protocol summary

Study aim
Determining the effect of an educational program on childbearing intention in women referring to comprehensive health centers in Koohdasht city in the condition of Covid pandemic 19
Design
Clinical trial with a control group, randomized, phase 2 on 80 women referred to comprehensive health centers. Numbered cards were used for randomization.
Settings and conduct
According to the conditions of covid-19, first the test group will be divided into four groups of 10 people and the intervention program will be taught during 3 sessions while observing social distancing in a large educational space in the health center of Kohdasht city. The first session included discussions related to the importance and benefits of having children and its relationship with the mother's age and explanations about the covid-19 pandemic, the second session included discussions such as healthy lifestyles and the consequences and problems of single children, and the third session included discussions such as training and pregnancy care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age between 18 and 45 years. 2. No known mental disorders as well as other physical disorders 3. Not currently pregnant. Exclusion criteria: 1. Reluctance to continue cooperation in research. 2. Having more than two sessions of absence during the training course. 3. Get pregnant during training sessions.
Intervention groups
Intervention group: The intervention program will be taught to the women of the intervention group in 3 sessions. Control group: do not receive any training.
Main outcome variables
Individuals' scores on the Attitude to Fertility and Childbearing Scale psychometered by Baezat et al.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220515054859N1
Registration date: 2022-07-29, 1401/05/07
Registration timing: registered_while_recruiting

Last update: 2022-07-29, 1401/05/07
Update count: 0
Registration date
2022-07-29, 1401/05/07
Registrant information
Name
somayeh seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3262 7887
Email address
somayeh.seifi63@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational program on childbearing intention in women referring to comprehensive health centers
Public title
Effect of an Educational Program on Childbearing Intention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. The person has a desire to participate in research. 2. Be between 18 and 45 years old. 3. The person (based on the opinion of the treating physician and the medical record) has no known mental disorders as well as other physical disorders in a way that causes dysfunction. 4. Have at least elementary education (depending on the nature of the intervention program), be able to communicate. 5. Have not participated in educational sessions before and now (any other research in the field of relevant study and intention to have children and its teachings). 6. Have Iranian nationality. 7. Not currently pregnant.
Exclusion criteria:
1. Reluctance to continue cooperation in research. 2. Having more than two sessions of absence during the training course. 3. Creating severe stressful events during the intervention. 4. Existence of any physical or mental problems in such a way that he is not able to participate in the study. 5. Get pregnant during training sessions.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into two groups of 40 test and control. In this way, 40 cards with number one and 40 cards with number two will be placed in a sealed envelope and on the day of random division of research units, they will be asked to choose one card. People who are assigned number one will be in the test group and people who will be assigned the number 2 will be in the control group.
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 isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Isfahan.
City
isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.120

Health conditions studied

1

Description of health condition studied
Intention to have children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Individuals' scores on the Attitude to Fertility and Childbearing Scale psychometered by Baezat et al.
Timepoint
Before intervention and after intervention
Method of measurement
Attitude to Fertility and Childbearing Scale psychometered by Baezat et al.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After identifying the groups and completing the questionnaires (pre-test), the intervention program will be taught to the women in the test group in 3 sessions. Thus, according to the conditions of Covid 19, first, the experimental group will be divided into four groups of 10 people and will be trained by observing social distance in a large training space. The educational space will be disinfected before and after the class. The first session includes: - The importance of having children from a sociological and psychological point of view (emotions and feelings of being a mother) - Awareness of the benefits of having children - The relationship between mother's age and having children - Consequences of delay in having children and delay in having the first child - Pandemic of Covid-19 The second session includes: - healthy lifestyle - the consequences and problems of single children - the consequences of the age gap between parents and children and the third session includes: - pre-pregnancy training to reduce people's worries and fears - the right time for pregnancy - training on pregnancy symptoms and how to deal with An- Correct pregnancy care for having children.
Category
Behavior

2

Description
Control group: They do not receive any training or intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Health Center of Kuhdasht
Full name of responsible person
Zahra Fazeli
Street address
No. 8, Esmat street, 30 meters second, Shahid Rajaei town,Kuhdasht.
City
Kuhdasht
Province
Lorestan
Postal code
6841657174
Phone
+98 66 3262 7887
Email
zahrafazeli699920@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Street address
Hezar Jerib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Position
Assistant Professor of Midwifery and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Hezar Jerib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8175845491
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
zahra boroumandfar
Position
Assistant Professor of Midwifery and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Hezar Jerib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8175845491
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayeh Sadat Seifi
Position
Master student of public health
Latest degree
Master
Other areas of specialty/work
Public Health
Street address
No. 20, Nastaran 5 Alley, North Jihad St., Koohdasht
City
koohdasht
Province
Lorestan
Postal code
6841766117
Phone
+98 66 3262 6416
Email
somayeh.seifi63@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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