Determining the effect of counseling based on Fugg's model on childbearing behavior of single women in Mashhad.
Design
A clinical trial with a control group, zero phase on 72 single-child women, with parallel groups, randomized, random allocation with blocks of four
Settings and conduct
The samples will be selected from the people who have come to the center to take care of their children for at least 2 years or to take care of the mother herself. Counseling based on the fog model in three face-to-face sessions in the middle of the week for mothers and the duration of each session is 60 90 minutes, based on the structures of the fog model (this model has 3 structures) will be performed. Blinding: The sampling conducted in this study is multi-stage, for this basis, the research population is divided into four classes (urban areas) and in the next stage, two comprehensive urban health centers are selected from each area and each center is randomly selected. One center is assigned to the intervention and the other to the control.
Participants/Inclusion and exclusion criteria
Entry criteria: single mothers with health records, child age at least 2 years.
Exclusion criteria: absence from more than one counseling session and non-participation in the post-test.
Intervention groups
Intervention group: Counseling based on the fugg model by the researcher in the form of three face-to-face sessions for mothers on the day of referral, following the services provided in the form of routine care, for 60 to 90 minutes based on the structures of the fog model will be.
Control group: they receive the usual care.
Main outcome variables
Independent: Counseling based on the Fugg model
Related: Childbearing behavior in single-child women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240503061636N1
Registration date:2024-06-08, 1403/03/19
Registration timing:registered_while_recruiting
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Mahdie Estaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 1729
Email address
estajim981@moms.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-26, 1403/03/06
Expected recruitment end date
2025-01-25, 1403/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on the fogg’s model on childbearing behavior of single-child women.
Public title
The effect of counseling based on the fogg’s model on childbearing behavior of single-child women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Single mothers with health record
no record of pre-pregnancy care
living in Mashhad
Iranian nationality
having contraceptive method
child age at least 2 years
having a mobile phone with the ability to record audio content
not having any contraindications for re-pregnancy
the absence of diagnosed infertility.
Exclusion criteria:
Absence in more than one counseling session
not participating in the post-test
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
First, among the 5 comprehensive health centers of Mashhad city as classes, 2 centers were selected by lottery method and then in each floor, comprehensive health service centers were selected as clusters, 4 clusters from each floor were selected by lottery method and within each cluster and Databases related to them, easy sampling will be done until the desired volume is reached. In this way, people who are eligible to enter the research and meet the criteria for entering the study, will be entered by random allocation in blocks of four.
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 Mashhad University of Medical Sciences
Street address
Vakil Abad Street, Ferdowsi University of Mashhad, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.002
Health conditions studied
1
Description of health condition studied
Childbearing behavior of single women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changing the childbearing behavior of single women in the form of discontinuing the contraceptive method and filing a pre-pregnancy case.
Timepoint
Before and one month after the end of counseling sessions
Method of measurement
questionnaire
Secondary outcomes
1
Description
Positive pregnancy test
Timepoint
1 month to 6 months after the last counseling session
Method of measurement
Positive pregnancy test
Intervention groups
1
Description
Intervention group: After random allocation in the intervention group, counseling based on Fogg model by the researcher in the form of three face-to-face sessions for mothers on the day of referral, in the continuation of the services provided in the form of routine care, for 60 to 90 minutes based on the model structures. Fugue (this model has 3 structures) will be.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of Mashhad
Full name of responsible person
Mahdie Estaji
Street address
No. 3, Fazilah St.,Tohid town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617965581
Phone
+98 905 362 6879
Email
Estajim981@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Third floor, University of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdie Estaji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 3, Fazilat St., Tawheed town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617965581
Phone
+98 905 362 6879
Email
Estajim981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mrs. Dr. Mahbobe Firozi
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vakil Abad Street, Ferdowsi University ofMashhad, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
FirooziM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdie Estaji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 3, Fazilat St., Tawheed town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617965581
Phone
+98 905 362 6879
Email
Estajim981@mums.ac.ir
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