Investigating the effect of an educational intervention based on the preced model on the quality of life of pregnant women referring to the health centers of Arak city during the COVID-19 pandemic.
Study on the effect of educational intervention based on precede model on the quality of life in pregnant women referring to health centers in Arak duration of pandemic COVID-19
Design
Clinical trial work for control group with parallel groups, without blinding, with simple randomization based on the entry list is performed on 120 mothers of 12 to 24 weeks.
Settings and conduct
Standardized questionnaire is completed by the samples and then based on this assessment and determination of their quality of life score, test group is trained in field of increasing the quality of life. The control group receive routine care. There is no case of blinding.
Participants/Inclusion and exclusion criteria
Healthy expectant mothers in the second trimester of pregnancy in Arak, who are not infected with COVID and do not have mental and physical diseases affecting the quality of life, who have access to the social network with a smartphone, will be invited to participate in the study. The exclusion criteria include the mother's unwillingness to participate in the study is migration from Arak city or suffering from mental and physical diseases affecting the quality of life during pregnancy, not actively participating in face-to-face or non-face-to-face training sessions during the training intervention.
Intervention groups
Educational interventions will be presented to the case group in offline and online educational sessions based on the lesson plan. One month later, the intervention effect will be evaluated.
The control group received education and routine care of the health system.
Investigating the effect of an educational intervention based on the preced model on the quality of life of pregnant women referring to the health centers of Arak city during the COVID-19 pandemic.
Public title
Investigating the effect of an educational intervention based on the Persed model on the quality of life of pregnant women during the Corona pandemic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers in the second trimester of pregnancy living in the city of Arak, whose pregnancy is registered in the electronic file
Do not have covid
Do not have any high-risk pregnancy or mental and physical diseases affecting the quality of life based on the mother's health record
Have a smartphone and have access to social networks
Exclusion criteria:
Unwillingness to participate in the study
Migration from the city of Arak
Suffering from mental and physical diseases affecting the quality of life during pregnancy
Lack of active attendance in face-to-face or non-face-to-face training sessions during the training intervention
Age
No age limit
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
The list of pregnant mothers from 12 to 24 weeks covered in Arak urban health centers was prepared from the Sib system, 120 mothers were selected and 60 of them were randomly assigned to the intervention group and 60 to the control group. According to the order of entering the Excel list. In all ten research centers, the names of the first people entering the control group and the rest were included in the test group.
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 Arak University of Medical Sciencesl Sciences
Street address
alamolhoda bolivar،Arak medical university
City
Arak
Province
Markazi
Postal code
3818146851
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.ARAKMU.REC.1400.252
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life variable score
Timepoint
Before starting the intervention and after the intervention
Method of measurement
A standard researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In addition to routine trainings, standard trainings in 2 online sessions and 4 offline sessions, a pamphlet and 15 educational poster files sent in the WhatsApp group related to the research are presented to this group.
Category
Behavior
2
Description
Control group: They receive routine training in the health system.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak urban health centers
Full name of responsible person
Khorsandi Mahboobeh
Street address
Faculty of Health, Golestan, Mustafa Khomeini town,
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 6234
Email
khorsandi.mahboobeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 6234
Email
khorsandi.mahboobeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Drkhorsandi Mahboobeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health ,Mustafa Khomeini settlement, Golestan district
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 6234
Email
dr.khorsandi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
dr.Khorsandi Mahboobe
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Health, Mustafa Khomeini settlement, Golestan district,
City
Arak
Province
Markazi
Postal code
3814135959
Phone
+98 86 3366 6234
Email
dr.khorsandi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamzehlouyan Akram
Position
student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Alamolhoda bolivar
City
Arak
Province
Markazi
Postal code
3814135959
Phone
+98 86 3366 6234
Email
ahamzehlouyan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual data is not allowed to be published
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data related to the main outcome can be shared
When the data will become available and for how long
Access period starts 6 months after publication
To whom data/document is available
Health care workers and researchers in the field of health education
Under which criteria data/document could be used
The questionnaire will be shared in the target group for the use of the applicants and to repeat the research
From where data/document is obtainable
To receive documents, refer to the responsible author
What processes are involved for a request to access data/document
By sending an email, the researcher-made questionnaire will be sent to the applicant within a week.