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Effectiveness of educational intervention using the integration of planning behavior theory and stages of change model on childbearing intention couples without children

Protocol summary

Study aim
Determining the effectiveness of educational intervention based on the structures of the theory of planned behavior and stages of change on the intention to have children in couples
Design
Randomized parallel groups clinical trial with control group, phase 3 on 30 couples, for randomization of quadruple blocks A (intervention group) and B (control group) by randomly choosing one of the blocks AABB/BBAA/ABAB/BAAB/ABBA/BBBA will be done.
Settings and conduct
This study will be conducted in Farmanfarmaian Health Center, Tehran city, in couples who meet the inclusion critreia. The educational intervention in the intervention group will be in the 5 sessions of 60 minutes, and the control group will not receive any education during the study, and after completing the study, the educational materials will be presented to them in the form of an educational package.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 40 years, willing to participate in the study, not having children, in the preconception and conception stages to have children, having been married for 2 years or more, being Iranian, not having any contraindications for pregnancy, no known infertility, Use of contraceptive methods, lack of mental disability that prevents education Exclusion criteria: Reluctance of each couple to continue, lack of participation in more than one training session, diagnosis of couple's infertility during study, diagnosis of chronic diseases during study, severe conflicts in couple
Intervention groups
The intervention group consists of 15 couples in the preconception and conception stages of having children who will participate in training sessions. The control group consists of 15 couples in the preconception and conception stages who will not receive educational intervention.
Main outcome variables
Stages of behavior change; Attitude, behavioral control, normative beliefs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220618055210N2
Registration date: 2023-10-03, 1402/07/11
Registration timing: registered_while_recruiting

Last update: 2023-10-03, 1402/07/11
Update count: 0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Maryam Moridi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 4368
Email address
ma.moridi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of educational intervention using the integration of planning behavior theory and stages of change model on childbearing intention couples without children
Public title
The effectiveness of educational intervention on the intention to have children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years Willing to participate in the study Not having children In the pre-contemplation stage or contemplating the intention to have children Having been married for 2 years or more Being Iranian Not having any contraindications for pregnancy No known infertility Use of contraceptive methods Lack of mental disability that prevents education
Exclusion criteria:
Reluctance of each couple to continue lack of participation in more than one training session Diagnosis of a couple's infertility during the study Diagnosis of chronic diseases during the study Severe conflicts in a couple
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
People will be assigned to one of the intervention or control groups using the block randomization method. In this way, the identified people who volunteer to participate in the research are randomly assigned into two intervention and control groups using the 4 block method. The letter A is for the intervention group and the letter B is for the control group; Then, write down all the alternating combinations of letters AA and BB, which are 6 different combinations (AABB/BBAA/ABAB/BAAB/ABBA/BBBA), and one combination is randomly selected from combinations 1 to 6. For example, if the combination of AABB is chosen, it means that the first and second people will be in the intervention group and the next two people will be in the control group, and this process will continue until the quorum sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Dr. Mirkhani St. (East Nusrat), Toohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.TUMS.FNM.REC.1402.013

Health conditions studied

1

Description of health condition studied
Intention to have children
ICD-10 code
Z33.1
ICD-10 code description
Pregnant state, incidental

Primary outcomes

1

Description
Stages of changing childbearing intention, attitude, normative beliefs and behavioral control
Timepoint
Data will be collected before the study, immediately after and six months after the intervention.
Method of measurement
Data collection will be done using a questionnaire of demographic characteristics and a questionnaire designed based on the structures of the theory of planned behavior and stages of change of the trans-theoretical theory.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It will be done on childless couples who have been married for at least 2 years and are in the pre-contemplation and contemplation stages about having children. They will receive educational intervention during 5 sessions.
Category
Behavior

2

Description
Control group: It will be done on childless couples who have been married for at least 2 years and are in the pre-contemplation and contemplation stages about having children. They will not receive any educational intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Farmanfarmaian Primary Health Center
Full name of responsible person
Maryam Moridi
Street address
Dr. Mirkhani St., Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4221
Email
ma.moridi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Dr. Mirkhani St. (East Nusrat), Toohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4221
Email
ma.moridi@yahoo.com
Grant name
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
Maryam Moridi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Fax
Email
ma.moridi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Moridi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Fax
Email
ma.moridi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Moridi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Fax
Email
ma.moridi@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
Not applicable
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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