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Protocol summary
A clinical trial with two control and intervention arms, available sampling method, in the comprehensive health center of Sorkheh city (Semnan province), in order to collect information before assigning people to the control and intervention groups, from the demographic questionnaire and the researcher-made questionnaire of male participation in Women's pre-pregnancy care and the standard questionnaire to evaluate men's knowledge, attitude and performance regarding reproductive health before having children, which will be used by the couple, and the stages of change questionnaire which will be completed by men.
A clinical trial with two control and intervention arms, available sampling method, in the comprehensive health center of Sorkheh city and Semnan Health Center , in order to collect information before assigning people to the control and intervention groups, from the demographic questionnaire and the researcher-made questionnaire of male participation in Women's pre-pregnancy care and the standard questionnaire to evaluate men's knowledge, attitude and performance regarding reproductive health before having children, which will be used by the couple, and the stages of change questionnaire which will be completed by men.
A clinical trial with two control and intervention arms, available sampling method, in the comprehensive health center of Sorkheh city (and Semnan province)Health Center , in order to collect information before assigning people to the control and intervention groups, from the demographic questionnaire and the researcher-made questionnaire of male participation in Women's pre-pregnancy care and the standard questionnaire to evaluate men's knowledge, attitude and performance regarding reproductive health before having children, which will be used by the couple, and the stages of change questionnaire which will be completed by men.
کارآزمایی بالینی دارای دو بازوی کنترل و مداخله، روش نمونه گیری در دسترس، در مرکز جامع سلامت شهرستان سرخه (استان سمنان)، جهت جمع آوری اطلاعات قبل از تخصیص افراد به گروه کنترل و مداخله، از پرسشنامه دموگرافیک و پرسشنامه محقق ساخته مشارکت مردان در مراقبت های پیش از بارداری زنان و پرسشنامه استاندارد ارزیابی دانش، نگرش و عملکرد مردان در مورد سلامت باروری پیش از فرزندآوری که توسط زوج و پرسشنامه مراحل تغییر که توسط مردان تکمیل می شود استفاده خواهد شد.
کارآزمایی بالینی دارای دو بازوی کنترل و مداخله، به روش نمونه گیری طبقه ای متناسب و تصادفی سازی مرکزی، در مرکز جامع سلامت شهرستان سرخه و مرکز بهداشت شهرستان سمنان ، جهت جمع آوری اطلاعات قبل از تخصیص افراد به گروه کنترل و مداخله، از پرسشنامه دموگرافیک و پرسشنامه محقق ساخته مشارکت مردان در مراقبت های پیش از بارداری زنان و پرسشنامه استاندارد ارزیابی دانش، نگرش و عملکرد مردان در مورد سلامت باروری پیش از فرزندآوری که توسط زوج و پرسشنامه مراحل تغییر که توسط مردان تکمیل می شود استفاده خواهد شد.
کارآزمایی بالینی دارای دو بازوی کنترل و مداخله، به روش نمونه گیری در دسترسطبقه ای متناسب و تصادفی سازی مرکزی، در مرکز جامع سلامت شهرستان سرخه (استانو مرکز بهداشت شهرستان سمنان)، جهت جمع آوری اطلاعات قبل از تخصیص افراد به گروه کنترل و مداخله، از پرسشنامه دموگرافیک و پرسشنامه محقق ساخته مشارکت مردان در مراقبت های پیش از بارداری زنان و پرسشنامه استاندارد ارزیابی دانش، نگرش و عملکرد مردان در مورد سلامت باروری پیش از فرزندآوری که توسط زوج و پرسشنامه مراحل تغییر که توسط مردان تکمیل می شود استفاده خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Sorkheh comprehensive health center
Name of recruitment center - Persian: مرکز جامع سلامت شهرستان سرخه
Full name of responsible person - English: Sohrab Yadalhi
Full name of responsible person - Persian: سهراب یدالهی
Street address - English: Basij Blvd
Street address - Persian: بلوار بسیج
City - English: Sorkhe
City - Persian: سرخه
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3551710145
Phone: +98 23 3361 3876
Fax:
Email: sakineh.zarei.1363@gmail.com
Web page address:
Name of recruitment center - English: Sorkheh comprehensive health center
Name of recruitment center - Persian: مرکز جامع سلامت شهرستان سرخه
Full name of responsible person - English: Sohrab Yadalhi
Full name of responsible person - Persian: سهراب یدالهی
Street address - English: Basij Blvd
Street address - Persian: بلوار بسیج
City - English: Sorkhe
City - Persian: سرخه
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3551785397
Phone: +98 23 3361 3876
Fax:
Email: sorkhe.behdasht@semums.ac.ir
Web page address:
Name of recruitment center - English: Sorkheh comprehensive health center Name of recruitment center - Persian: مرکز جامع سلامت شهرستان سرخه Full name of responsible person - English: Sohrab Yadalhi Full name of responsible person - Persian: سهراب یدالهی Street address - English: Basij Blvd Street address - Persian: بلوار بسیج City - English: Sorkhe City - Persian: سرخه Province: Semnan Country: Iran (Islamic Republic of) Postal code: 35517101453551785397 Phone: +98 23 3361 3876 Fax: Email: sakineh.zarei.1363sorkhe.behdasht@gmail.comsemums.ac.ir Web page address:
#2
Name of recruitment center - English: Semnan health center
Name of recruitment center - Persian: مرکز بهداشت شهرستان سمنان
Full name of responsible person - English: Shiraze Maani
Full name of responsible person - Persian: شیرازه معانی
Street address - English: West Shahid Rajaei
Street address - Persian: خیابان شهید رجایی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3513698883
Phone: +98 23 3332 2274
Fax:
Email: Behdashti@sem-ums.ac.ir
Web page address:
Name of recruitment center - English: Semnan health center Name of recruitment center - Persian: مرکز بهداشت شهرستان سمنان Full name of responsible person - English: Shiraze Maani Full name of responsible person - Persian: شیرازه معانی Street address - English: West Shahid Rajaei Street address - Persian: خیابان شهید رجایی City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3513698883 Phone: +98 23 3332 2274 Fax: Email: Behdashti@sem-ums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behzad Garmabi
Full name of responsible person - Persian: بهزاد گرمابی
Street address - English: 7 Tir Ave
Street address - Persian: خیابان 7 تیر
City - English: Shahrood
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 7395536147
Phone: +98 23 3239 5054
Fax: +98 23 3239 5009
Email: info@shmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behzad Garmabi
Full name of responsible person - Persian: بهزاد گرمابی
Street address - English: 7 Tir Ave
Street address - Persian: خیابان 7 تیر
City - English: Shahrood
City - Persian: شاهرود
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3614773943
Phone: +98 23 3239 5054
Fax: +98 23 3239 5009
Email: info@shmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Behzad Garmabi Full name of responsible person - Persian: بهزاد گرمابی Street address - English: 7 Tir Ave Street address - Persian: خیابان 7 تیر City - English: Shahrood City - Persian: شاهرود Province: Semnan Country: Iran (Islamic Republic of) Postal code: 73955361473614773943 Phone: +98 23 3239 5054 Fax: +98 23 3239 5009 Email: info@shmu.ac.ir Web page address:
Protocol summary
Study aim
Determining the effectiveness of midwifery counseling with a motivational interview approach on men's participation in pre-pregnancy care
Design
Randomized clinical trial of parallel type with two arms, without blinding, Restricted randomization of block randomization type with blocks of four, allocation sequence is generated by the software.
Settings and conduct
A clinical trial with two control and intervention arms, available sampling method, in the comprehensive health center of Sorkheh city and Semnan Health Center , in order to collect information before assigning people to the control and intervention groups, from the demographic questionnaire and the researcher-made questionnaire of male participation in Women's pre-pregnancy care and the standard questionnaire to evaluate men's knowledge, attitude and performance regarding reproductive health before having children, which will be used by the couple, and the stages of change questionnaire which will be completed by men.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age under 50 years for men and 15-45 years for women and intention to have children in the next year; Exclusion criteria: wife being pregnant.
Intervention groups
Five sessions of motivational interview for couples, one session per week and each session in 45-60 minutes for the intervention group. At the end of the study, a training session with the content of pre-pregnancy health and childbearing for the control group.
Main outcome variables
Couple's knowledge and attitude towards men's prenatal care; Men's participation in women's pre-pregnancy care including wife's companionship, wife's health recommendations, wife's financial and emotional support and man's awareness of women's problems and health in pre-pregnancy care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231214060361N1
Registration date:2024-01-06, 1402/10/16
Registration timing:prospective
Last update:2025-09-10, 1404/06/19
Update count:1
Registration date
2024-01-06, 1402/10/16
Registrant information
Name
Sakineh Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3342 2032
Email address
sakineh.zarei.1363@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of counseling on midwifery with a motivational interview approach on men's participation in preconception care
Public title
Evaluation of the effectiveness of motivational interview approach on men's participation in preconception care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing
Being Iranian
Age below 50 years for men and 15-45 years for women
Intend to have children in the next year
Consent and cooperation to participate in the study
Exclusion criteria:
Staff and students of the University of Medical Sciences
Having a history of infertility treatment (according to the person's statement)
Having a known chronic disease
Wife being pregnant
Participation in similar programs
Difficulty in communicating such as blindness and deafness and any cognitive impairment
Poor health of the child or previous children
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:
102
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the restricted randomization method of the block randomization type. . The size of all the blocks is equal and we will use 4 blocks in this experiment. We will have 6 blocks in this order (BABA, BBAA, AABB, BAAB, ABBA, ABAB) and the blocks will be numbered. A will be the test group and B will be considered as the control group. In blocks of 4, two allocations to the intervention group and two allocations to the control group are considered.
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 Shahrood University of Medical Sciences
Street address
7 Tir Ave
City
Shahrood
Province
Semnan
Postal code
7395536147
Approval date
2023-11-28, 1402/09/07
Ethics committee reference number
IR.SHMU.REC.1402.138
Health conditions studied
1
Description of health condition studied
Preconception care
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Couple's knowledge and attitude towards men's preconception care
Timepoint
Before the start of the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Questionnaire to evaluate the knowledge, attitude and performance of married men regarding pre-pregnancy care.
2
Description
Men's involvement in women's prenatal care
Timepoint
Before the start of the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Questionnaire to evaluate the knowledge, attitude and performance of married men regarding pre-pregnancy care
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Five sessions of motivational interview for couples, one session per week and each session lasts 45-60 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sorkheh comprehensive health center
Full name of responsible person
Sohrab Yadalhi
Street address
Basij Blvd
City
Sorkhe
Province
Semnan
Postal code
3551785397
Phone
+98 23 3361 3876
Email
sorkhe.behdasht@semums.ac.ir
2
Recruitment center
Name of recruitment center
Semnan health center
Full name of responsible person
Shiraze Maani
Street address
West Shahid Rajaei
City
Semnan
Province
Semnan
Postal code
3513698883
Phone
+98 23 3332 2274
Email
Behdashti@sem-ums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Behzad Garmabi
Street address
7 Tir Ave
City
Shahrood
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
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
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
Shahroud University of Medical Sciences
Full name of responsible person
Sakineh Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 731, 19 East , 2 Sablan St , Rosie Town
City
Semnan
Province
Semnan
Postal code
3519954446
Phone
+98 23 3342 2032
Email
sakineh.zarei.1363@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Sakineh Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 731, 19 East , 2 Sablan St , Rosie Town
City
Semnan
Province
Semnan
Postal code
3519954446
Phone
+98 23 3342 2032
Fax
Email
sakineh.zarei.1363@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Sakineh Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 731, 19 East , 2 Sablan St , Rosie Town
City
Semnan
Province
Semnan
Postal code
3519954446
Phone
+98 23 3342 2032
Email
sakineh.zarei.1363@gmail.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