The Effect of Educational Intervention on oral health behaviors health and quality of life in covid 19 among elementary school students in schools promoting health : Based on the Theory of Planned Behavior
Determining the effect of education based on the planned behavior model in improving oral health behaviors of students
Design
Randomized control trial, parallel group of 2 primary schools for the control and intervention group are selected by lot. The selection of participants in the study will be by lottery. The sample size for each group is 50 people.
Settings and conduct
This study is done in Shazand city. First, the questionnaire is completed by students. After analyzing the information and examining the educational needs of students, the educational intervention in the intervention group is based on the planned behavior model and preferences are done through Shad virtual network. One month After the intervention, the questionnaires are completed again and the previous information and after the intervention are analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: employment in the fifth and sixth grades, filling out the consent form by the students' guardians and having a minimum of 11 and a maximum of 12 years
Intervention groups
The present study is an educational intervention that is performed with the participation of 100 students in two experimental and control groups (50 people each). Controls will also receive routine school-based health-promoting training.
Main outcome variables
1- Awareness 2Attitude 3-Abstract norms 4-Controlling perceived behavior 5-Behavioral intention 6 Preventive behaviors 7Quality of life related to oral health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220404054412N1
Registration date:2022-05-24, 1401/03/03
Registration timing:retrospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Maryam Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3822 3148
Email address
maryammohammadi2510@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
2022-03-01, 1400/12/10
Actual recruitment end date
2022-03-06, 1400/12/15
Trial completion date
2022-04-14, 1401/01/25
Scientific title
The Effect of Educational Intervention on oral health behaviors health and quality of life in covid 19 among elementary school students in schools promoting health : Based on the Theory of Planned Behavior
Public title
The effect of education on oral health behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Employment to study in the fifth and sixth grades of primary schools in Shazand city and having a minimum age of 11 years and a maximum of 12 years
Filling in the consent form by the student guardian
Exclusion criteria:
Students drop out before interventions
Immigrating to another school and not participating in the educational program
Age
From 11 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be clustered randomly. After coordination with Shazand city education, to determine the samples, first 4 schools are randomly selected from the health promotion schools of Shazand region (6 primary schools of health promoters), then two schools are in the control group and two schools are in the intervention group. And then 50 people from each school will be randomly selected from the list of students for the control and intervention 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 Sciences
Street address
Arak, Shahid Shiroudi Street, Alam al-Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.ARAKMU.REC.1400.314
Health conditions studied
1
Description of health condition studied
Oral health behaviors among students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Awareness about oral health
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
2
Description
Attitudes about oral health
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
3
Description
Abstract norms about oral health
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
4
Description
Controlling perceived behavior regarding oral health
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
5
Description
Behavioral intention about oral health
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
6
Description
Oral health behaviors
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
7
Description
Quality of life related to mouth and tooth
Timepoint
Before training and one month after training
Method of measurement
Researcher-made questionnaire
Secondary outcomes
1
Description
Quality of life related to mouth and tooth
Timepoint
Before and one month after training
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
Intervention group:
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health promoting schools covered by shazand county education
Full name of responsible person
Dr. Raheleh Soltani
Street address
Jihad Street
City
Shazand
Province
Markazi
Postal code
381963345
Phone
+98 86 3822 3841
Email
maryammohammadi2510@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Raheleh Soltani
Street address
Arak- Shahid Shiroudi Street- Alam al-Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3822 3148
Email
maryammohammadi2510@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
Dr. Raheleh Soltani
Position
Associate Professor, School of Public Health, Arak University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Arak- Shahid Shiroudi Street- Alam al-Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
shadi8685@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Raheleh Soltani
Position
Associate Professor, School of Public Health, Arak University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Arak- Shahid Shiroudi Street- Alam al-Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
shadi8685@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Postgraduate Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Arak- Shahid Shiroudi Street- Alam al-Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3822 3148
Email
maryammohammadi2510@gmail.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
Not applicable
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