Determining the effect of cognitive-behavioral counseling on fertility preferences and attitudes towards fertility and childbearing in single-child women referring to health centers in Zanjan province in 2023
Design
A randomized controlled clinical trial with parallel groups with 50 participants. The rand function of Excel software was used for randomization.
Settings and conduct
Sampling will be done in health centers of Zanjan province (Tarom county, Abbar city). First, 50 eligible women are randomly selected and then randomly assigned to the intervention and control groups. The intervention group will receive 9 counseling sessions in person. The participants will complete self-report questionnaires before the intervention, immediately after the intervention and two months after the last counseling session.
Participants/Inclusion and exclusion criteria
All single women eligible to bear children whose names are registered in Sib system and do not intend to get pregnant
Intervention groups
The people of the intervention group will participate in 9 sessions of 60-90 minutes, two sessions of cognitive-behavioral counseling for anxiety per week, which will be provided by the researcher. The control group will receive usual care.
Main outcome variables
Attitude towards fertility and childbearing, fertility preferences
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160608028352N11
Registration date:2023-10-28, 1402/08/06
Registration timing:prospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral counseling on fertility preferences and attitudes towards fertility and childbearing in single-child women
Public title
The effect of cognitive-behavioral counseling on fertility preferences and attitudes towards fertility and childbearing in single-child women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Sufficient literacy (at least middle school)
Being married
Single-child women who are eligible to have children based on the protocol of 2023
Using contraceptive methods (natural or modern methods)
A resident of Zanjan province
Exclusion criteria:
Absence of more than 2 sessions
Unwanted pregnancy for any reason
Existence of acute and chronic diseases and suffering from them
Existence of marital problems or addiction of one parent to drugs or alcohol
Having any mental or physical disability
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be convenient and allocation will be blocked randomization. For this purpose, four-person blocks have been created to determine the two groups of intervention and control. The sample size in the two groups is 50 participants, so the allocation of participants in the intervention and control groups by random selection of 13 four-person blocks (50 people) will be done. The rand function of Excel software will be used for randomization.
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
The ethics Committee of Zanjan University of Medical Sciences
Street address
The ethics committee of Zanjan University of Medical Sciences, north side of Azadi Blvdedical Sciences, first floor
City
Zanjan
Province
Zanjan
Postal code
4525613113
Approval date
2023-10-17, 1402/07/25
Ethics committee reference number
IR.ZUMS.REC.1402.173
Health conditions studied
1
Description of health condition studied
Single-child
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Attitudes towards fertility and childbearing
Timepoint
Before the intervention, immediately after the intervention and two months after the last counseling
Method of measurement
Questionnaire of attitudes towards fertility and child bearing
2
Description
Fertility preferences
Timepoint
Before the intervention, immediately after the intervention and two months after the last counseling
Method of measurement
Miller fertility preferences questionnaire 1995
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The people of the intervention group will participate in nine sessions of 60-90 minutes, two sessions of cognitive-behavioral counseling for anxiety per week, which will be provided by the researcher. The participants of the intervention group will be divided into two groups of eight and one group of nine. The researcher will be taught the content of sessions and counseling with a cognitive-behavioral approach to anxiety in person by a psychologist consultant and also in the form of online or face-to-face workshops.
Category
Behavior
2
Description
Control group: Participants in this group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Attached health center
Full name of responsible person
Elham Mohammadi
Street address
Attached Health Center, East 1st, Tawheed St
City
Abbar
Province
Zanjan
Postal code
4591646880
Phone
+98 24 3282 2673
Email
e.mohammadi9270@gmail.com
2
Recruitment center
Name of recruitment center
Non-attached health center
Full name of responsible person
Elham Mohammadi
Street address
Non-attached health center, Imam Khomeini square
City
Abbar
Province
Zanjan
Postal code
4591646880
Phone
+98 24 3282 5052
Email
e.mohammadi9270@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, Northside Boulevard Azadi, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Elham Mohammadi
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3286 3222
Email
e.mohammadi9270@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
r.kharaghani@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham Mohammadi
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3286 3222
Email
e.mohammadi9270@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After completion of the study, information on the main outcome will be shared.
When the data will become available and for how long
Starting the access period from 2024
To whom data/document is available
Data and documentation will be available to medical researchers.
Under which criteria data/document could be used
The data can be used to study, give a citation, create new ideas, and practically apply in medical centers.
From where data/document is obtainable
Email to e.mohammadi9270@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.