Determining the effect of educational program based on the theory of planned behavior on the childbearing intention in couples without children
Design
Randomized parallel groups clinical trial with control group, phase 3 on 116 participants, without blinding. A table of random numbers is used for randomization.
Settings and conduct
The target population is couples referring to Andimeshk health centers, the research environment of Andimeshk Comprehensive Health Centers. The research samples will be selected from the centers . They will be randomly divided into two control and intervention groups (58 people in each group). two questionnaires of demographic and constructs of the Theory of Planned Behavior will be completed by participants. The intervention group will receive 3 sessions of 45-60 minute focusing on the constructs of the Theory of Planned Behavior. Immediately and one month after the end of the sessions, both groups will complete questionnaire and finally the scores of both groups will be compared to evaluate the effect of education.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 45 years, not having children, Having been married for 2 years or more, unwilling to have children in the next 2 years, and exclusion criteria: pregnancy, having contraindications to pregnancy
Intervention groups
The intervention group will receive three educational sessions focusing on the constructs of the Theory of Planned Behavior. The control group will receive routine care .
Main outcome variables
Measuring the score of the constructs of the Theory of Planned Behavior Questionnaire before, immediately and one month after the intervention in the intervention and control groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250111064350N1
Registration date:2025-01-21, 1403/11/02
Registration timing:prospective
Last update:2025-01-21, 1403/11/02
Update count:0
Registration date
2025-01-21, 1403/11/02
Registrant information
Name
Nazanin Nikfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 0000
Email address
nazanin.nikfard1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-07-06, 1404/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Educational Program Based on The Theory of Planned Behavior on The Childbearing Intention in Childless Couples
Public title
Effect of Educational Program Based on The Theory of Planned Behavior on The Childbearing Intention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45years
Not having children
Being Literate
Having been married for 2 years or more
Unwillingness to have children in the next 2 years
Exclusion criteria:
Pregnancy
Having contraindications for pregnancy
Unwilling to participate in the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected by convenience sampling method, then divided into two groups using simple randomization method (random number table), one group is considered as control group and one group is considered as intervention group. To conceal allocation, the type of intervention is written on paper and numbered consecutively inside opaque envelopes (numbers 0-4 for the first group, numbers 5-9 for the second group) and will be delivered by the center secretary to the people referring to the study.
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 committee of Jundi Shapour Ahvaz University of Medical Sciences
Street address
Esfand Estreet, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
00986135715794
Approval date
2024-12-21, 1403/10/01
Ethics committee reference number
IR.AJUMS.REC.1403.513
Health conditions studied
1
Description of health condition studied
childbearing intention
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of childbearing intention based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior
2
Description
The score of attitude based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior
3
Description
The score of subjective norms based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior
4
Description
The score of behavioral control based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior
5
Description
The score of intention based on the theory of planned behavior
Timepoint
Before intervention, immediately after intervention and one month after intervention
Method of measurement
Researcher made questionnaire based on the Theory of Planned Behavior
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The educational intervention for the test group will consist of three 45-60 minute sessions (lecture, group discussion, educational video, and presentation of pamphlets and educational books) focusing on the structures of the theory of planned behavior regarding children, the importance and status of children from the perspective of the religion of Islam and the verses of the Quran, the benefits of children, the disadvantages of childlessness, and strategies for dealing with problems related to children.
Category
Behavior
2
Description
Control group: receive routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected health centers of Andimshek city
Full name of responsible person
Nazanin nikfard
Street address
Andimshek Health and Treatment Network, in front of Sarvandi Stadium, Enghelab street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 4263 0401
Email
hn-ank@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoush Zaker Kish
Street address
Esfand Street, Golestsn highway
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
aduaum@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Esfand Estreet, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Abbaspoor_z762@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Esfand Estreet, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Abbaspoor_z762@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Esfand Estreet, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Abbaspoor_z762@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