Comparing the effectiveness of midwifery counseling with a motivational interview approach on the decision of Single child couples and Single child women in having children
Comparing the effectiveness of midwifery counseling with a motivational interview approach on the decision of Single child couples and Single child women in having children
Design
The study is carried out as a parallel clinical trial with a control group on 126 married women with one child and using the allocation sequence which is produced based on the block method in volume 6, the participants are randomly assigned to 3 groups
Settings and conduct
Gonbad health centers are socio-economically divided into three floors. From each floor, one center is randomly selected. A total of 126 women with inclusion criteria were selected from among the clients and randomly placed in three groups. Intervention group 1 receives five sessions of individual or group motivational counseling and intervention group 2 receives five sessions of motivational counseling with a spouse and control group. Before the intervention, after the intervention and one month after the intervention, the amount of decision-making for childbearing is collected using a standard questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Iranian, Gonbad citizen, Tendency to participate in the study and fill out the informed consent form, Married women, Being at reproductive age, No contraindications for pregnancy, Have a child two years or older, Literate, Ability to participate in virtual classes, Individuals who received low and average scores from the decision-making questionnaire for childbearing. Exclusion criteria; Positive pregnancy test before intervention
Intervention groups
Intervention 1: 5 sessions of motivational interview are held once a week individually or in groups. Intervention 2: 5sessions of motivational interview are held once a week، in pairs and the control group receives routine training.
Main outcome variables
Deciding to have children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210223050473N1
Registration date:2021-09-09, 1400/06/18
Registration timing:registered_while_recruiting
Last update:2021-09-09, 1400/06/18
Update count:0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Saeideh Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3323 7203
Email address
ranjbarsaide@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of midwifery counseling with a motivational interview approach on the decision of Single child couples and Single child women in having children
Public title
Comparing the effectiveness of midwifery counseling with a motivational interview approach on the decision of Single child couples and Single child women in having children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian
Gonbad Citizen
Tendency to participate in the study and fill out the informed consent form
Married women
Being at reproductive age
No contraindications for pregnancy
Have a child two years or older
Literate
Ability to participate in virtual classes
Individuals who received low and average scores from the decision-making questionnaire for childbearing
Exclusion criteria:
Positive pregnancy test before intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation sequence is generated using the block method with a volume of 6. These blocks are randomly designed in the software and then groups equal to a are assigned to the first intervention group, b to the second intervention group and c to the control group. As participants gradually enter the study, the 6-volume block method is used to assign participants to groups. To hide the assignment sequence, we give it to someone outside the research team. In each center, the expert, after registering the participants in the study, contacts the person with the test sequence and assigns the person to the desired group.
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 Shahroud University of Medical Sciences
Street address
Shahroud, Haftam Tir Square - Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.SHMU.REC.1400.042
Health conditions studied
1
Description of health condition studied
Fertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Deciding to have children
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
Questionnaire for decision to have children
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Participants in counseling with a motivational interview approach, which is one of the new methods of counseling and has a specific protocol, will receive an individual session of 60 to 90 minutes to 5 weeks per week based on the content prepared by the researcher.
Category
N/A
2
Description
Intervention group 2: Participants in counseling with the approach of motivational interviewing, which is one of the new methods of counseling and has a specific protocol, will receive a weekly session of 60 to 90 minutes to 5 weeks based on the content prepared by the researcher.
Category
N/A
3
Description
Control group: Routine training during the intervention and after the intervention will receive a counseling session with a motivational approach
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonbad Kavoos Health Center
Full name of responsible person
Saeideh Ranjbar
Street address
East Taleghani Street, Gonbad Health Center
City
Gonbad Kavoos
Province
Golestan
Postal code
4971767333
Phone
+98 17 3323 7203
Email
ranjbarsaide@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
Shahroud, Haftam Tir Square - Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
emamian@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
Saeideh Ranjbar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Taleghani Street, Gonbad Health Center
City
Gonbad Kavoos
Province
Golestan
Postal code
4971767333
Phone
+98 17 3323 7203
Email
Ranjbarsaide@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Saeideh Ranjbar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Taleghani Street, Gonbad Health Center
City
Gonbad Kavoos
Province
Golestan
Postal code
497176733
Phone
+98 17 3323 7203
Email
Ranjbarsaide@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Saeideh Ranjbar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
East Taleghani Street, Gonbad Health Center
City
Gonbad Kavoos
Province
Golestan
Postal code
4971767333
Phone
+98 17 3323 7203
Email
ranjbarsaide@jmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
Regarding the sharing of participants' personal data, information about the initial outcome is shared
When the data will become available and for how long
Start time of access period 6 months after printing the results
To whom data/document is available
Researchers are allowed to access the data
Under which criteria data/document could be used
Use of available data to advance the objectives of the study is permitted
From where data/document is obtainable
To receive information, they can be contacted via the following email
ranjbarsaide@gmail.com
What processes are involved for a request to access data/document
The applicant's request will be answered within a period of one week