The effect of online men's reproductive health education before childbearing on knowledge, attitudes, and behaviors of preconception health in couples
Design
The randomized clinical trial with a control group and parallel design, without blinding, will be conducted on168 couples (84 couples in each group). 4 random blocks with a 1: 1 allocation ratio will be used for randomization. Thus, after listing all possible situations of block 4 and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into intervention and control groups. For allocation concealment, the type of intervention will be written on paper and kept in a series of opaque envelopes.
Settings and conduct
This study will be performed in Bushehr, Iran. Eligible participants will be recruited through the SIB system in Bushehr health centers and will be randomly divided into intervention and control groups. The intervention group will receive men's preconception health-related education designed by the research team, and the control group will receive routine preconception health education.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 15-50 years old for men and 18-45 years old for women; intend to have children in the next year.
Exclusion criteria: employees and students of the Bushehr University of Medical Sciences; having a history of infertility treatment; known chronic disease; spouse pregnancy
Intervention groups
The intervention group will receive group education based on the importance of preconception health in men and a healthy lifestyle. The control group will receive routine preconception education in women.
Main outcome variables
Knowledge and attitude of men's preconception health; healthy behaviors before conception; satisfaction with education
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052271N1
Registration date:2022-05-21, 1401/02/31
Registration timing:prospective
Last update:2022-05-21, 1401/02/31
Update count:0
Registration date
2022-05-21, 1401/02/31
Registrant information
Name
Zeinab Rabiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3962
Email address
zeinab.rabiei66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-12-01, 1401/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online men's reproductive health education before childbearing on knowledge, attitudes, and behaviors of preconception health in couples
Public title
The effect of online men's reproductive health education before childbearing on knowledge, attitudes, and behaviors of preconception health in couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian
Literacy for reading and writing
َAge 15-50 years old for men and 18-45 years old for women
Intend to have children
Have the consent and cooperation to participate in the study
Exclusion criteria:
Reluctance to continue collaboration at any stage of research
Employees and students of the University of Medical Sciences
Having a history of infertility treatment
Having a known chronic disease
Spouse being pregnant
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
336
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible couples will be randomly assigned into two groups using block randomization with a block size of 4 and an allocation ratio of 1:1. Thus, after listing all possible situations of 4 blocks and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into intervention and control groups. For allocation concealment, each couple will receive a code and all codes will be kept in an opaque envelope until the time of intervention. Sequencing of allocation and preparation of envelopes will be done by a person that will not involve in sampling and data collection. The researcher and the participant will not aware of the groups and the intervention that they received until the commencement of the intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Present intervention is the result of designing a men's reproductive health program before childbearing by the research team.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Tehran Ave.
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.SHMU.REC.1400.015
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Men's preconception health knowledge
Timepoint
Before, end and 2 months after intervention
Method of measurement
Researcher made questionnaire
2
Description
Attitude to men's preconception health
Timepoint
Before, end and 2 months after intervention
Method of measurement
Researcher made questionnaire
Secondary outcomes
1
Description
Healthy behaviors before having children
Timepoint
Before, and 2 months after intervention
Method of measurement
Researcher made questionnaire
2
Description
Satisfaction with preconception education
Timepoint
ٍEnd of the intervention
Method of measurement
Researcher made questionnaire
Intervention groups
1
Description
Intervention group: the intervention will consist of four group education sessions (each group with 14 couples) and online on Skyroom.Three sessions of non-sexual content will be conducted by a reproductive health specialist (researcher), and one session of sexual content will be conducted by a general practitioner and a reproductive health specialist (for men and women, respectively).Session 1: Defining male reproductive health and individual and non-individual risk factors affecting reproductive health before childbirth - Reproductive lifestyle plan, Healthy lifestyle and nutritional recommendations before childbearing, the effect of parental age on fertility, and neonatal outcomes. Session 2: The effect of chronic diseases in men on reproductive health and drugs that have a negative effect on sperm and fertility. Session 3: The best time for intercourse for pregnancy and fertility chance in the month - sexually transmitted infections and their effect on reproductive and fetal health. Session 4: The physiological changes that occur during pregnancy and how to adapt to them. The content of the educational intervention was designed based on the needs of men (resulting from a qualitative study), the opinion of experts, and the most up-to-date studies in the field of men's preconception health.
Category
Other
2
Description
Control group: will receive routine preconception education from health centers, and the researcher will not be involved.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers affiliated to Bushehr University of Medical Sciences
Full name of responsible person
Zahra Motaghi
Street address
Haft Tir Square - Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 3962
Email
zmotaghi8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Haftam Tir Square , Shahroud University of Medical Sciences and Health Services,Vice President of Research and Technology
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 6714
Email
pishgiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
1
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
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Motaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Reproductive Health, School of Medicine, Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 3962
Email
zmotaghi8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zeinab Rabiei
Position
Ph.D. candidate in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences, Haft Tir Square
City
ُShahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 3962
Email
zeinab.rabiei66@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
zeinab rabiei
Position
Ph.D. candidate in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences, Haft Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 3962
Email
zeinab.rabiei66@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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data can be published after the accomplishment of the dissertation
When the data will become available and for how long
One year after completing the dissertation
To whom data/document is available
Bushehr and Shahroud University of Medical Sciences- Academic researchers
Under which criteria data/document could be used
Data will be available after publication in journals
From where data/document is obtainable
zeinab rabiei, Email:zeinab.rabiei66@gmail.com
What processes are involved for a request to access data/document
The information will be available through the publication of the article. But if more information is needed, the request should be sent via email.