Determining the effect of intervention based on BASNEF model on parenting stress and self-efficacy of mothers referring to comprehensive health centers
Design
A Clinical trial with two groups of control and intervention, randomized ,Over 80 clients
Settings and conduct
Controlled clinical trial with The two-group study (intervention, control) is a three-stage study (before the intervention, immediately after the intervention and the third post-partum visit);random.
Participants/Inclusion and exclusion criteria
Iranian nationality،Minimum education،Willingness to cooperate,Primiparous mother،Lack of severe psychological and physical disorders, Having virtual learning facilities.،A healthier baby that is kept at home.,The first visit of Postpartum
Intervention groups
Intervention groups: In this group, mothers' education is virtual, including 4 two-hour online sessions with topics (welcoming parents and how to communicate with the baby, emotional care of the baby, principles of breastfeeding, diseases related to the baby) and an individual session (training The mother will be accompanied by one of the influential people (by the researcher) with the supervision and participation of the supervisor (faculty of the Department of Midwifery and Reproductive Health). Provide written and online videos and content related to parenting and self-efficacy to mothers, as well as forming virtual groups for interaction and discussion; will be done. Mothers are divided into 4 virtual groups of 10 people to receive educational materials and interaction and discussion. The researcher and supervisor in all these groups are to guide mothers, provide scientific materials and answer questions.Control groups: There is no training in this group and after the study, the baby care training booklet will be placed.
Main outcome variables
Parenting stress, mothers' self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210921052539N1
Registration date:2022-02-08, 1400/11/19
Registration timing:prospective
Last update:2022-02-08, 1400/11/19
Update count:0
Registration date
2022-02-08, 1400/11/19
Registrant information
Name
Fatemeh Torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3440 2289
Email address
fati.torabi.g@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-02, 1400/12/11
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the BASNEF model on parenting stress and self-efficacy on mothers referring to comprehensive health centers
Public title
The effect of the BASNEF model on parenting stress and self-efficacy on mothers referring to comprehensive health centers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Minimum elementary education
Willingness to cooperate
Primiparous mother
Lack of severe psychological and physical disorders listed in the apple's health system.
Absence of heart disease, and motion sickness and any disease.
Having virtual learning facilities.
A healthy baby kept at home.
The first visit of Postpartum (3-5 days old baby)
Exclusion criteria:
Premature delivery and low Apgar score and require special care
Existence of heart, motor and any other diseases that prevent the baby from taking on responsibilities.
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, first one of the two health centers number one and two in Isfahan is selected by coin tossing method and the list of health community service centers is prepared. Then four centers are selected from the list of centers using a table of random numbers in each center. The control and intervention group is done randomly (with cards 1 and 2) to randomly allocate samples.
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 Isfahan University of medical sciences.
Street address
Ms. Fatemeh Torabi's room;School of Nursing and Midwifery,Isfahan University of Medical Sciences;Hazard jerib street.
City
Isfahan
Province
Isfehan
Postal code
8871773949
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.MUI.NuREMA.REC.1400.085
Health conditions studied
1
Description of health condition studied
Not applicable in study.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Parental stress,
Timepoint
Before the intervention, immediately after the intervention, the third post-partum care visit
Method of measurement
questionnaire PSI(Parenting Stress Index)
2
Description
Efficacy
Timepoint
Before the intervention, immediately after the intervention, the third post-partum care visit
Method of measurement
Scherrer questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: In this group, mothers' education is virtual, including 4 two-hour online sessions with topics (welcoming parents and how to communicate with the baby, emotional care of the baby, principles of breastfeeding, diseases related to the baby) and an individual session (training The mother will be accompanied by one of the influential people (by the researcher) with the supervision and participation of the supervisor (faculty of the Department of Midwifery and Reproductive Health). Provide written and online videos and content related to parenting and self-efficacy to mothers, as well as forming virtual groups for interaction and discussion; will be done. Mothers are divided into 4 virtual groups of 10 people to receive educational materials and interaction and discussion. The researcher and supervisor in all these groups are to guide mothers, provide scientific materials and answer questions.In addition, videos and educational materials are posted virtually after each online session related to the contents of the same session in the mothers' group, and the formation of virtual groups for interaction and discussion; will be done. In this way, mothers are divided into 4 virtual groups of 10 people to receive educational materials and interact and discuss parental attitudes. The researcher and supervisor are present in all these groups to guide mothers, present scientific materials and answer questions and are educators.
Category
Prevention
2
Description
Control group: Control groups: There is no training in this group and after the study, the baby care training booklet will be placed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hamzeh Comprehensive Health Service Center
Full name of responsible person
Fateme Torabi
Street address
In front of the housing bank ;St. Fourth;Amir Hamzeh Town;Isfahan ;Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Fadaei Comprehensive Health Service Center
Full name of responsible person
Fateme Torabi
Street address
Ghezelbash Alley; Next to the Municipality of District Five; Hakim Nezami Street, Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@gmail.com
3
Recruitment center
Name of recruitment center
Baharestan Comprehensive Health Service Center
Full name of responsible person
Fateme Torabi
Street address
Next to the Emergency room 115:Behesht Street; Baharestan ;Isfahan Town; Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mansoor Siavash
Street address
The deputy of search and technology ,Building 4, Isfahan University of Medical Sciences, .Hazar Jerib street, Isfahan Town,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
emrc@mui.ac.ir
Web page address
http://isid.research.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Torabi
Position
Instructor of Midwifery faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery ,Isfahan University of Medical Sciences, Hazar Jerib St., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatrme Torabi
Position
Science Committee of Faculty of Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, School of Nursing and Midwifery, School of Nursing and Midwifery;Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Torabi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery., Isfahan University of Medical Sciences and Health Services., Hazar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7153
Email
Fati.torabi.g@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
the effect of the BASNEF model on parenting stress and self-efficacy on mothers referring to comprehensive health centers
When the data will become available and for how long
After the end of the results
To whom data/document is available
Responsible author, consultant, guide
Under which criteria data/document could be used
For practical purposes and review the results
From where data/document is obtainable
Responsible author
What processes are involved for a request to access data/document
By email of the responsible author:Tati.torabi.g@gmail.com