The effect of childbearing counseling with motivational interview approach on reproductive motivation and self-efficacy of women reproductive age: A randomized controlled trial study
Determining the impact of childbearing counseling with a motivational interview approach on fertility motivation and self-efficacy of women of reproductive age
Design
Randomized controlled trial
Settings and conduct
Women in the age group of 18-40 years referring to comprehensive health centers of Sharq Headquarters in Tehran are selected as available. Each of the women whose desire to have children score is low (0-3) and medium (3-7), and who meet the study entry criteria, are randomly placed in two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women 18-40 years old
An only child aged 18 months and older
Iranian and living in Tehran
Low or moderate desire to have children based on the Miller Fertility
Preferences Questionnaire
Internet and smartphone access
Having at least an elementary education
Willingness to participate in the study
Exclusion criteria:
Maternal or fetal medical contraindications for pregnancy
Drug addiction
History or current severe chronic medical illness
Known severe mental illness
Speech and hearing disorders
Intervention groups
Childbearing counseling is individual, 6 consecutive sessions and the duration of each session is 50 minutes. The content of the sessions includes stages of change, ambivalences of subsequent childbearing, advantages and disadvantages of subsequent childbearing, future values and goals of childbearing, temptation to return, and strategies to prevent return.
Main outcome variables
Changing the score of childbearing motivation and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230130057274N3
Registration date:2024-03-15, 1402/12/25
Registration timing:prospective
Last update:2024-03-15, 1402/12/25
Update count:0
Registration date
2024-03-15, 1402/12/25
Registrant information
Name
Hajar Adib-Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
adibrad2015@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of childbearing counseling with motivational interview approach on reproductive motivation and self-efficacy of women reproductive age: A randomized controlled trial study
Public title
The effect of childbearing counseling with motivational interview approach on reproductive motivation and self-efficacy of women reproductive age
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18-40 years old
An only child aged 18 months and older
Iranian and living in Tehran
Low or moderate desire to have children based on the Miller Fertility Preferences Questionnaire
Internet and smartphone access
Having at least an elementary education
Willingness to participate in the study
Exclusion criteria:
Maternal or fetal medical contraindications for pregnancy
Drug addiction
History or current severe chronic medical illness
Known severe mental illness
Speech and hearing disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into two groups after applying the entry and exit criteria in the form of random allocation using the alternative block method. The size of the blocks is 4 and using the statistical software, 4 blocks will be produced 30 times. Considering that sampling is done in six centers, a sample list of 120 items will be produced. Using this randomly generated list, the participants are assigned to two groups of 60 people. The random sequence of people in the intervention or control groups is done through block building with a ratio of 1:1, and the researcher cannot predict the placement of the next person in any of the two groups.
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
Health Research Institute - Babol University of Medical Sciences (Research Ethics Committee)
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2024-02-18, 1402/11/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.182
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
childbearing motivation
Timepoint
Before the intervention, immediately and three months after the end of the intervention
Method of measurement
Miller's Childbearing Motives Questionnaire
2
Description
self-efficacy
Timepoint
Before the intervention, immediately and three months after the end of the intervention
Method of measurement
Maternal self-efficacy questionnaire
Secondary outcomes
1
Description
Reproductive Preference
Timepoint
Before the intervention, immediately and three months after the end of the intervention
Method of measurement
Miller Reproductive Preference Questionnaire
2
Description
Ready for change
Timepoint
Before the intervention, immediately and three months after the end of the intervention
Method of measurement
Readiness for change Questionnaire
Intervention groups
1
Description
Intervention group: Childbearing counseling is based on individual motivational interviews and combined sessions (face-to-face and non-face-to-face) which include 6 consecutive sessions (one session per week) and the duration of each session is 50 minutes. The arrangement of the meetings in the intervention group is a combination of one meeting between face-to-face and virtual. The contents of the sessions include: the first session: the stages of change, the second session: the ambivalences of the next childbearing, the third session: the advantages and disadvantages of the next childbearing, the fourth session: the values and goals of the future of childbearing, the fifth session: the temptation to return, the sixth session: strategy to prevent return.
Category
Lifestyle
2
Description
Control group: This group of women does not receive the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of East Tehran headquarters affiliated to Shahid Beheshti University of
Full name of responsible person
Mahbobeh Faramarzi
Street address
School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9595
Email
mahbob330@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.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