Assessing the effectiveness of a fertility education program on the motivation of childbearing among girls attending premarital counseling centers: a randomized controlled trial
Assessing the impact of a fertility education program on the motivation of childbearing among girls attending premarital counseling centers
Design
Eighty participants will be randomly assigned to two groups: an intervention group that will receive both routine premarital counseling and a fertility education program, and a control group that will receive only routine premarital counseling.
Settings and conduct
This study will be conducted at the premarital counseling center in Babol city. Eligible participants, identified as girls about to get married, will be invited to participate after providing written informed consent. Demographic information, fertility knowledge, motivation to childbearing and attitudes will be assessed using questionnaires following an explanation of the study's objectives and importance.
Participants/Inclusion and exclusion criteria
Inclusion criteria include Iranian girls aged 18 to 35 referring to the premarital counseling center. Exclusion criteria include medical sciences students or employees and those with known chronic physical or mental illnesses.
Intervention groups
The intervention group will receive both routine premarital counseling and a 3-week virtual fertility education program consisting of text messages and short films. The control group will receive only routine premarital counseling. Upon study completion, the control group will have the option to access the fertility education program content.
Main outcome variables
Fertility knowledge; Fertility motivation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056451N3
Registration date:2024-10-04, 1403/07/13
Registration timing:prospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Fatemeh Bakouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3232 2589
Email address
bakouei2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-11, 1403/07/20
Expected recruitment end date
2025-01-29, 1403/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of a fertility education program on the motivation of childbearing among girls attending premarital counseling centers: a randomized controlled trial
Public title
The effectiveness of an educational program on the motivation of childbearing among girls
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian citizenship
At least elementary education
Age 18 to 35 years
Attending to pre-marriage counseling centers
Having access to a phone equipped with an application required to send educational content
Having a desire to participate in the study
Exclusion criteria:
Medical sciences students or staff
Known chronic physical and mental diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly assigned to either the control or intervention group using a 1:1 block randomization method with blocks of four. To ensure concealment of allocation, only the first supervisor will have access to the randomization list, which will be generated using Random Allocation Software. The researcher will communicate participant eligibility to the supervisor, who will then provide the group assignment based on the block file prepared by the statistics consultant.
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
Research Ethics Committees of Health Research Institute - Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2024-09-08, 1403/06/18
Ethics committee reference number
IR.MUBABOL.HRI.REC.1403.105
Health conditions studied
1
Description of health condition studied
Motivation to have children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fertility knowledge
Timepoint
Before and one month after the intervention
Method of measurement
Cardiff Fertility Knowledge Scale
2
Description
Fertility motivation
Timepoint
Before and one month after the intervention
Method of measurement
Miller's Fertility Motivation Questionnaire
Secondary outcomes
1
Description
Attitude to fertility
Timepoint
Before and one month after the intervention
Method of measurement
Questionnaire of attitudes towards fertility and child bearing
Intervention groups
1
Description
Intervention group:The intervention group will receive both routine premarital counseling and a 3-week virtual fertility education program based on the latest guidelines from the American Society of Reproductive Medicine, the European Society of Human Reproduction and Embryology, and the Iranian Ministry of Health and Medical Education. The program will consist of text messages and short films of one to two minutes.
Category
Behavior
2
Description
Control group:The control group will receive only routine premarital counseling
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Premarital counseling center of Babol city
Full name of responsible person
Fatemeh Bakouei
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology: Dr. Mehdi Rajab Nia
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 315 8440
Email
bakouei2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5313
Email
bakouei2004@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