Investigating the effect of educational intervention based on reproductive health literacy on attitudes towards childbearing and fertility knowledge of married women employees
General purpose:Determining the effect of education intervention based on reproductive health literacy on attitudes towards childbearing and fertility knowledge of married women employees at Shiraz University of Medical Sciences 2024
Design
unblinded clinical trial, random allocation to intervention and control groups, 90 samples
Settings and conduct
Research environment: administrative staff of Shiraz University of Medical Sciences
According to the entry and exit criteria, the participants are invited to participate in the study and are randomly divided into two intervention and control groups.In the intervention group, after the pre-test, the intervention is conducted in the form of reproductive health literacy classes. Immediately and 4 weeks after the intervention, the relevant questionnaires are completed in the two groups and the data is interpreted.
Participants/Inclusion and exclusion criteria
Entry requirements: being married and of childbearing age, having no history of infertility, currently living with your spouse and....
Conditions of non-entry: incomplete completion or non-completion of the questionnaire and.....
Intervention groups
intervention group: after the pre-test, the intervention is conducted in the form of reproductive health literacy classes by the researcher in five sessions, each session lasting 45-60 minutes, twice a week.
control group:there will be no intervention, but at the end of the study, in order to maintain educational justice, the educational content will be provided to the control group in the form of a booklet.
Main outcome variables
Fertility knowledge; attitude towards childbearing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240507061690N1
Registration date:2024-05-19, 1403/02/30
Registration timing:prospective
Last update:2024-05-19, 1403/02/30
Update count:0
Registration date
2024-05-19, 1403/02/30
Registrant information
Name
Zahra Yazdanpanahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4256
Email address
yazdanz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-18, 1403/03/29
Expected recruitment end date
2024-10-20, 1403/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on reproductive health literacy on attitudes towards childbearing and fertility knowledge of married women employees
Public title
Investigating the effect of reproductive health literacy educational intervention on attitudes towards childbearing and fertility knowledge
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married and in reproductive age (18-49)
No history of infertility
They are currently living with their husbands
Childless or single child with at least 2 years delay in re-pregnancy
Working in the administrative units of Shiraz University of Medical Sciences
Iranian nationality
Consent to participate in the research and complete the informed consent form
Not suffering from diagnosed and treated physical diseases that may affect pregnancy
Absence of mental illness and use of psychiatric drugs, psychotropic drugs, narcotics and alcoholic beverages.
Exclusion criteria:
Incomplete completion or non-completion of the questionnaire
Unwillingness to continue participating in the research after entering the study or during follow-up
Failure to participate in more than two sessions in the training program
Divorce from spouse during the study
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
This research will be done by easy or accessible sampling method. According to the fact that 90 people (45 people in the intervention group - 45 people in the control group) are needed and there are many administrative departments in the University of Medical Sciences, so that there is no interaction between education in the intervention group and the control group, 4 centers were randomly assigned to The control group and 4 centers are assigned to the intervention group. 11-12 people from each center will be included in the study by easy sampling.
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 in Research of Nursing and Midwifery Faculties, Management and Medical Information
Street address
Faculty of Nursing and Midwifery,Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.009
Health conditions studied
1
Description of health condition studied
fertility knowledge
ICD-10 code
ICD-10 code description
2
Description of health condition studied
attitudes towards childbearing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of attitude towards childbearing: In this research, the meaning of attitude towards childbearing is the total score obtained by married women employees of Shiraz University of Medical Sciences by answering the questionnaire of attitude towards fertility and childbearing by Soderberg et al. (2013). A higher score indicates a positive attitude. It is to fertility and childbearing.
Timepoint
Before, immediately and 4 weeks after the intervention
Method of measurement
Soderberg et al.'s Attitudes toward fertility and childbearing scale
Secondary outcomes
1
Description
Fertility knowledge score:The basis of measuring fertility knowledge is the total score obtained by married women employees of Shiraz University of Medical Sciences by responding to the Cardiff fertility knowledge scale. A higher score indicates more fertility knowledge.
Timepoint
Before, immediately and 4 weeks after the intervention
Method of measurement
Cardiff Fertility Knowledge Scale
Intervention groups
1
Description
Intervention group: First, a pre-test is conducted in the intervention group, and demographic questionnaires, Soderberg's attitude towards childbearing and Cardiff fertility knowledge are completed before intervention in the intervention group. In the intervention group, after the pre-test, the intervention is conducted in the form of reproductive health literacy training classes by the researcher in five face-to-face sessions, each session lasting 45-60 minutes, twice a week. The content of the trainings will include: meeting the participants and explaining the program, getting to know the concept of fertility, getting to know the causes of infertility, getting to know the consequences of delaying having children and getting to know the new methods of maintaining fertility. In order to complete the content of each session and learn more, the participants of the intervention group are also given a booklet and they are asked to read the contents of each session before the start of the next session. After completing the intervention in the intervention group, Questionnaires of attitudes towards having children and fertility knowledge will be examined by the participants in two occasions, immediately and after 4 weeks of training.
Category
Other
2
Description
Control group: First, a pre-test is conducted in the control group, and demographic questionnaires, Soderberg's attitude towards childbearing and Cardiff fertility knowledge are completed before the intervention in the control group. The control group, which entered the study at the same time as the intervention group, will be examined immediately and after 4 weeks of the intervention in terms of attitude towards childbearing and fertility knowledge. It should be noted that there will be no intervention in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical sciences
Full name of responsible person
Zahra Yazdanpanahi
Street address
in front of Fars Regional Electric Company,next to Hazrat Fatima Al-Zahra Mosque, Karimkhan Zand Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 917 315 5992
Email
yazdanz@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Vahid Hosseini
Street address
in front of Fars Regional Electric Company,next to Hazrat Fatima Al-Zahra Mosque, Karimkhan Zand Blvd,Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
yazdanz@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Yazdanpanahi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
yazdanz@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Asma Zandavi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery of Hazrat Fatemeh (PBUH), entrance of Namazi Hospital, Namazi Square,Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
asmazandavii76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
• Observance of ethical principles in the publication of the results (when publishing the study results, it will be avoided to provide any information that leads to the disclosure of people's information).
• The results were published in such a way that the names of the participants will not be revealed.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
• The general results of the research will be provided to the research units and university officials.
Under which criteria data/document could be used
•Any copying of the entire thesis or part of it is allowed only with the supervisor's approval.
• All intellectual rights of this work belong to Shiraz University of Medical Sciences and cannot be transferred to a third party without the written permission of the university.
• It is not allowed to use the information and results in the thesis without mentioning the reference
From where data/document is obtainable
Study participants can be in contact with the researcher at all hours of the week and raise their questions and doubts. Address: Shiraz, Namazi Square, Faculty of Nursing and Midwifery. 09363418136- Asma Zandavi
What processes are involved for a request to access data/document
• Obtaining an official letter of introduction from Hazrat Fatemeh College of Nursing and Midwifery and obtaining permission from the Research Vice-Chancellor to access research documents from the Faculty and Shiraz University of Medical Sciences.