Determining the effect of Counseling with a motivational interviewing approach on child bearing intention in single child women
Design
A clinical trial with a control group, one-sided blind,90 people, randomization
Settings and conduct
The research project is one of the comprehensive health centers in Yazd that has the highest one-child statistics. Names are extracted from the Sib system and then invited during phone calls, if they meet the criteria for entry and obtaining consent. Random allocation of sample is performed by statistician with respect to consolidation. In each group, demographic questionnaire and childbearing intention questionnaire will be completed in person before intervention. In the intervention group, 5 group sessions counseling with motivational interviewing approach and once a week and each session will be 60 minutes in person. Both intervention and control groups will also provide educational booklets on the benefits of childbearing.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Married women with a healthy child over 2 years of age
2- Use of contraceptive methods
3- Having informed consent to participate in the study
4 was Iranian.
Exit Criteria:
Unwillingness to participate in research
Positive pregnancy test before intervention
3- Participation in parenting counseling sessions
4To Suffer or History of Infertility
Existence of any absolute prohibition of pregnancy
6. Mental illness or under medical treatment
7 Smoking and Drugs
8 Stressful events in the past 6 months
Intervention groups
Intervention group: motivational interview approach along with a booklet on the benefits of childbearing and the control group: booklet on the benefits of childbearing.
Main outcome variables
The score of intention to have children in women with one child in the intervention and control groups, before, immediately and two months after the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231108059992N1
Registration date:2024-05-31, 1403/03/11
Registration timing:registered_while_recruiting
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Bahare Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 1528
Email address
bahare.am1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of counseling with motivational interviewing approach on child bearing intention in single child women
Public title
Investigating the effect of counseling with motivational interviewing approach on child bearing intention in single child women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women with a healthy child over 2 years old
Use of contraceptive methods
Having informed consent to participate in the study
Being Iranian
Exclusion criteria:
Unwillingness to participate in research
Positive pregnancy test before intervention
Participating in parenting counseling sessions
Having or history of infertility
The existence of any absolute prohibition of pregnancy
Suffering from mental illnesses (such as schizophrenia, severe depression, psychosis, etc.) under medical treatment based on medical record information or statements
Using any tobacco and drugs and drinking alcohol
Occurrence of stressful events in the last 6 months (emigration, divorce, death of relatives,...)
Age
No age limit
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
Using spss software (from the menu transform/compute variableL/ - RV.NORMAL option) a list of 90 zeros and ones will be produced. Also, a column of random numbers in front of this column will be added to the file using random number generation in this software. After sorting the data from small to large for the generated random numbers, the zero list of a result with the new order will be available to the researcher.
Random allocation is carried out by a statistician in compliance with concealment, which means that neither the women nor the researcher will know which group each woman is assigned to.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Timsar Fallahi St., Bu Ali St., in front of the infertility research center
City
yazd
Province
Yazd
Postal code
8917738493
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.SSU.REC.1402.090
Health conditions studied
1
Description of health condition studied
Investigating the effect of counseling with a motivational interview approach on the willingness to have children of single women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The fertility tendency score in the fertility tendency scale questionnaire, which has a minimum score of 19 and a maximum score of 95
Timepoint
Before the intervention, immediately after the intervention and 2 months after the intervention
Method of measurement
The questionnaire of desire to be fertile contains 19 items and has 4 sub-scales of positive motives for having children, priorities, concerns about having children and social beliefs. Based on a 5-point Likert scale from 1 (completely disagree) to 5 (I completely agree) the ranking and the minimum and maximum score are 19 and 95 respectively)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Counseling with a motivational interview approach and an educational booklet about the benefits of parenting, 5 group sessions (groups of 15 people) and once a week and each session is 60 minutes in person. Counseling sessions include issues with the consequences of delay in pregnancy, the benefits and disadvantages of having a single child for the family and the child, expressing feelings and concerns about the desire to have a second child and having a single child, increasing self-confidence to make changes with the confidence scale and identifying strengths and Support (strengthening the sense of self-efficacy) and cognitive preparation for change (the birth of a second child), explaining the relationship between thoughts and feelings and behavior, training and identifying intellectual traps; It was wrong and problematic thinking habits in the field of raising children and teaching goal-setting skills. Also, an educational booklet with chapters such as the challenges of having a single child, the consequences of delaying pregnancy, how to prepare for the arrival of a second child, the benefits of having a child for the family, the complications of birth control methods, unwanted pregnancy, abortion and its complications, and the necessary care after knowing Pregnancy was prepared.
Category
N/A
2
Description
Control group: Educational booklet on the benefits of childbearing
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd comprehensive health centers
Full name of responsible person
Bahare Amiri
Street address
No. 14, Koche 13, 52 meters, Imam Shahr
City
Yazd
Province
Yazd
Postal code
8917738493
Phone
+98 35 3525 1528
Email
bahare.am1999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Shahid Sadoughi School of Nursing and Midwifery
City
Yazd
Province
Yazd
Postal code
8917738493
Phone
+98 35 3525 1528
Email
bahare.am1999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Bahare Amiri
Position
masters student in couseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 14, Koche 13, 52 meters, Imam Shahr
City
yazd
Province
Yazd
Postal code
8917738493
Phone
+98 35 3525 1528
Email
bahare.am1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Bahare Amiri
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
52 meters, imam shahr, koche 13, No.14
City
Yazd
Province
Yazd
Postal code
8917738493
Phone
+98 35 3525 1528
Email
bahare.am1999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Bahare Amiri
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
52 meters, Imam Shahr, Koche 13, No. 14
City
Yazd
Province
Yazd
Postal code
8917738493
Phone
+98 35 3525 1528
Email
bahare.am1999@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
All details will be accessible.
When the data will become available and for how long
The access period starts 6 months after the publication of the article
To whom data/document is available
All people in the field of medical sciences
Under which criteria data/document could be used
In case of research work
From where data/document is obtainable
email
What processes are involved for a request to access data/document
It is enough to state the reason for using the data in the form of an email message.