Protocol summary

Study aim
1. Determining the effect of motivational counseling on fertility preferences of couples married 2. Determining the effect of motivational counseling on the motives of couples about to have children
Design
This research is a parallel randomized clinical trial with two arms, one intervention group and the other control group, which includes 5 centers in 5 regions of Mashhad.
Settings and conduct
The research environment includes 5 centers (Center No. 1, Vakil Abad, Center No. 2, Vahdat, Center No. 3, Quds Al-Azil Center, Center No. 4, Saman, and Center No. 5, Imam Reza Vanjati) Jame Salamat, Mashhad. that all services such as conducting pre-marriage tests, organizing pre-marriage counseling classes and, if necessary, referring couples for genetic tests are performed in this center. 2. Counseling sessions: Zohin counseling sessions will be held in 5 comprehensive health centers in Mashhad.
Participants/Inclusion and exclusion criteria
Age 18-35 years Literacy for reading and writing Muslim, Iranian, resident ms Being on the threshold of the first marriage Not having a mental illness Not having physical and mental disabilities not having a medical prohibition for pregnancy, The drop criterion Exit c Having a history of divorce Being a divorce debtor Being an unwanted borrower A history of abuse Having a history of depression History of infertility in the family
Intervention groups
Cs. For the purpose of sampling, first the questionnaire is filled consciously, then among the group of madahlah and the control group, the questionnaires of Demograqik, then the fertility motivation questionnaire (Miller) and the fertility preferences questionnaire (Miller) were given to the couples who met the criteria for entering the study. They were asked to complete these questionnaires individually without consulting others
Main outcome variables
Motivations for having children Fertility preferences

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240228061123N1
Registration date: 2024-06-29, 1403/04/09
Registration timing: retrospective

Last update: 2024-06-29, 1403/04/09
Update count: 0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
masome mokram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 9250
Email address
zoharadradrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-31, 1403/01/12
Expected recruitment end date
2024-06-01, 1403/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational counseling on fertility preferences and childbearing motivations of couples on the verge of marriage
Public title
The effect of motivational counseling on fertility preferences and childbearing motivations of couples on the verge of marriage
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-35 years Be literate Being on the threshold of the first marriage Not having a mental illness, not having a physical and mental disability, not having a medical prohibition for pregnancy, Muslim, Iranian, resident of Mashhad
Exclusion criteria:
Having a history of divorce Being a child of divorce Being an unwanted child A history of having a license history of depression History of infertility in the family
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence generation sites are used for randomization. This site randomly places the number of people in the study groups in order of entry. These numbers are written in sheets according to the order of placement in the groups that show the individual's allocation and are placed in envelopes to prevent the allocator's opinion from being applied. The allocating person is asked to open the envelope of the same number as the people enter according to the person's number and the person's group is determined In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researchers to have the same number of samples assigned to each of the studied groups in cases where intermediate analyzes are needed during the sampling process. The size of all the blocks is equal and we will use 4 blocks in this experiment
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences
Street address
HAFt-tir
City
SHAHRoD
Province
Semnan
Postal code
36147-73943
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.SHMU.REC.1402.166

Health conditions studied

1

Description of health condition studied
Status of the study: Investigating the fertility motivation and preferences of couples on the verge of marriage in two intervention and control groups with motivational counseling and no motivational counseling.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
inFertility motive/Fertility preferences
Timepoint
Samples at one month and then two months after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:couples are selected from health centers with pre-marriage counseling clinics. Qualified couples completed the demographic questionnaire, fertility plans and motivation questionnaire after completing the questionnaire.Then, in the intervention group, a motivational counseling program will be conducted for each couple within a month. At the end of the meditation period and two months after that, the questionnaire is completed again online.
Category
Behavior

2

Description
Control group: couples are selected from health centers with pre-marriage counseling clinics. Couples who meet the entry criteria, after completing the questionnaire, completed the demographic and fertility motivation questionnaire. At the end of the intervention period and two months after that, the couples' fertility motivation level The questionnaire will be evaluated online
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
l1. محیط پژوهش شامل 5 مرکز ( مرکز شماره 1وکیل آباد مرکز شماره 2 وحدت مرکز شماره 3 قدس وسیلو مرکز
Full name of responsible person
Professor Pour Heydari
Street address
The research environment includes 5 centers (Vakil Abad Center No. 1, Vahdat Center No. 3, Qods Al-Azil Center No. 4, Saman Center No. 5, and Imam Reza Vanjati Center No.
City
mshd
Province
Razavi Khorasan
Postal code
09330275213
Phone
+98 51 3869 9250
Email
zoharadradrad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Behzad Garmabi
Street address
Haft Tir St
City
SHahrd
Province
Semnan
Postal code
73955-36147
Phone
+98 23 3239 5054
Email
vcr@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
Masoume Mokaram Rad
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Sayad Shirazi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9179986835
Phone
+98 51 3869 9250
Email
zoharadradrad@gmil.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masoume Makram Rad
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Sayad Shirazi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9179986835
Phone
+98 51 3869 9250
Email
zoharadradrad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masume Mokaram Rad
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Saiad Shirazi
City
Mashhad
Province
Razavi Khorasan
Postal code
9179986835
Phone
+98 51 3869 9250
Email
zoharadradrad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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