determination effect of educational intervention based on self-efficacy theory on the promotion of behaviors related to oral and dental hygiene of adolescents through a mobile application
Design
A clinical trial with a control group. Randomized. Phase 2 for 40 people. A repeated random block method with 4 blocks is used for randomization.
Settings and conduct
The sampling stage among the teenagers who obtained low scores in relation to oral and dental hygiene behaviors in the descriptive stage will be invited to participate in the randomized clinical trial study. The sampling method in this research is simple random sampling. It; so that 4 schools are randomly selected from the urban girls' schools; during the implementation of the intervention, the control group will not receive any training; And finally, immediately, one month and three months after the intervention, questionnaires will be distributed in both groups and information will be collected.
Participants/Inclusion and exclusion criteria
1- Female students aged 13-15 years 2- Residents of Shushtar city 3- Do not have oral and dental diseases 4- Do not have underlying diseases 5- Are studying 6- Having a smartphone and the ability to use it 7- Having consent Consciously to participate in the study 8-Participation in most of the educational intervention sessions, not having any of the above items exclusion criteria
Intervention groups
40 students are present in the intervention group and they are trained using a mobile application designed for self-efficacy in oral and dental health promotion behaviors. The intervention group does not receive any training.
Main outcome variables
The average score of knowledge, attitude, self-efficacy, and performance related to oral and dental hygiene
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200120046204N1
Registration date:2022-10-13, 1401/07/21
Registration timing:prospective
Last update:2022-10-13, 1401/07/21
Update count:0
Registration date
2022-10-13, 1401/07/21
Registrant information
Name
Seiedeh zahra Marashi
Name of organization / entity
Tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 61 3627 8656
Email address
z.marashi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-08, 1402/01/19
Expected recruitment end date
2023-06-09, 1402/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title: The effect of educational intervention based on self-efficacy theory on promoting adolescent oral health behaviors through a mobile application
Public title
An educational intervention to promote behaviors related to oral and dental hygiene of adolescents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female students aged 13-15 years
- A resident of Shushtar city
Do not have oral and dental disease
Don't have any underlying disease
They are studying
Having a smartphone and the ability to use it
Having informed consent to participate in the study
Participating in most educational intervention sessions
Exclusion criteria:
Female students should not be 13-15 years old
Do not live in Shushtar city.
Have oral and dental disease
Have a background knowledge
are not studying
Not having a smart phone and the skill to use it
Lack of informed consent to participate in the study
Failure to participate in most educational intervention sessions
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of the samples will be done to maintain balance in the number of people assigned to the two control and test groups and to obtain the maximum power in the study by the method of repeated random blocks with blocks of 4. These repeating random blocks will be done for each floor separately. To implement this method, to maintain the randomness of the allocation of people, before starting the sampling, 6 combinations of four letters A (participant in the test group) and B (participant in the control group) are formed as follows:
AABB
ABAB
ABBA
BABA
BBAA
BAAB
Then, using six-sided dice with the numbers 1 to 6 on each side, according to the number that appears on the dice each time, the order of assigning the participants to the test and control groups in each class is as follows: It is determined independently.
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 Tarbiat Modares University of Medical Sciences
Street address
Tarbiat modares univercity., Bridge Nasr., Jalal Al Ahmad.,Tehran
City
Tehran
Province
Tehran
Postal code
111 -14115
Approval date
2022-09-24, 1401/07/02
Ethics committee reference number
IR.MODARES.REC.1401.125
Health conditions studied
1
Description of health condition studied
Promotion of behaviors related to oral and dental hygiene
ICD-10 code
Z00-Z13
ICD-10 code description
Persons encountering health services for examination and investigation
Primary outcomes
1
Description
The average score of knowledge related to oral and dental hygiene
Timepoint
in three time periods before the intervention, one month, and three months after the intervention
Method of measurement
Standard questionnaire of awareness
2
Description
The average score of attitude related to oral and dental hygiene
Timepoint
in three time periods before the intervention, one month, and three months after the intervention
Method of measurement
Standard questionnaire of attitude
3
Description
The average score of self-efficacy related to oral and dental hygiene
Timepoint
in three time periods before the intervention, one month, and three months after the intervention
Method of measurement
Standard questionnaire of self-efficacy
4
Description
The average score of performance related to oral and dental hygiene
Timepoint
in three time periods before the intervention, one month, and three months after the intervention
Method of measurement
Standard questionnaire of performance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1- The amount of oral hygiene in the intervention group(13-15-year-old female students) is first measured by a questionnaire. Then, this group receives mobile- based training during six sessions. Each session is 45 minutes of training. Each session is based on the theory of self-efficacy. The first session: Familiarization of students with mouth and teeth and diseases caused by non-observance of oral and dental hygiene. The second session: introducing students to the importance of oral and dental hygiene. The third session: introducing students to the importance of believing in their ability to observe oral and dental hygiene and preventing future dental problems. The fourth session: familiarizing the students with the importance of mastery experience, and observational experience in the prevention of oral and dental diseases. The fifth session: The role of verbal persuasion, physical and emotional state in the prevention of oral and dental diseases. The sixth session: Questions and answers.
Category
Prevention
2
Description
Control group: The amount of oral hygiene information in this group is only measured by questionnaire and no training(intervention) in this group is presented
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
First secondary schools of Shushtar city
Full name of responsible person
Mustafa Abedipour
Street address
Seyyed Mohammad Gulabi Blvd
City
shushtar
Province
Khouzestan
Postal code
6451763834
Phone
+98 61 2211 0101
Email
z.marashi@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdullahzadeh
Street address
Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran
City
Tehran
Province
Tehran
Postal code
111- 14115
Phone
+98 21 8288 2009
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
The University of Tarbiat Modares
Full name of responsible person
Seiedeh Zahra Marashi
Position
Doctoral Student of Health Education and Health Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 61 3627 8656
Email
z.marashi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Alireza Hidarnia
Position
Professor, Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 61 3627 8656
Email
hidarnia@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tabiat Modares
Full name of responsible person
Seiedeh Zahra Marashi
Position
Doctoral Student of Tarbiat Modares
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences No.1., Nasr Bridge., Jalal Al Ahmad Highway.,Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 61 3627 8656
Email
z.marashi@modares.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
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Demographic information of the target group will not be shared and only general statistics will be published.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be accessible to researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Contact via email zahra73m@yahoo.com
What processes are involved for a request to access data/document
There is no special condition. It will be answered as soon as possible