Investigating the effectiveness of educational intervention based on Transtheoretical model in self-care behaviors of oral and dental health of students
Determining the effectiveness of educational intervention based on the Transtheoretical model in self-care behaviors of oral and dental health of students
Design
The clinical trial has two intervention and control groups, with parallel, single-blind and randomized groups, and the intervention is carried out on 88 students. A simple random method is used for sampling.
Settings and conduct
The present study will be conducted in 4 public primary schools for girls and boys in Shahreza city, which are selected by multi-stage sampling from all schools in Shahreza. The intervention will be conducted in the form of face-to-face training regarding self-care of oral and dental health based on a Transtheoretical model using a combination of teaching methods in the classroom. In this study, all people in the intervention and control groups are unaware of their placement in the intervention or control group and are considered as blind people.
Participants/Inclusion and exclusion criteria
Entry requirements:
Being in the first three stages of preparation for change according to the Transtheoretical model
Completing the informed consent form to participate in the study
Non-entry conditions:
Having underlying diseases according to the opinion of the dentist
Age below 11 years and above 13 years
Intervention groups
The intervention of the present study includes oral and dental health self-care training based on a Transtheoretical model for the intervention group, while the control group will not receive any training.
Main outcome variables
frequency of cleaning behavior; frequency of use of each cleaning tool
The final result: the amount of dental plaque
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241008063294N1
Registration date:2024-12-21, 1403/10/01
Registration timing:registered_while_recruiting
Last update:2024-12-21, 1403/10/01
Update count:0
Registration date
2024-12-21, 1403/10/01
Registrant information
Name
Negin Akbarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5322 6074
Email address
neginakbarpoor79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-15, 1403/09/25
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of educational intervention based on Transtheoretical model in self-care behaviors of oral and dental health of students
Public title
Investigating the effect of education on oral and dental health self-care behaviors of students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the first three stages of preparation for change according to the transtheoretical model
Completing the informed consent form to participate in the study
Exclusion criteria:
Having underlying diseases according to the opinion of the dentist
Age below 11 years and above 13 years
Age
From 11 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomness
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, all the participants of the intervention and control groups, which include students aged 11 to 13 years, are considered as blind people.
Placebo
Not used
Assignment
Parallel
Other design features
The educational intervention of the present study is designed based on the Transtheoretical model.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences., Hezar Jerib Street., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-12-14, 1403/09/24
Ethics committee reference number
IR.MUI.DHMT.REC.1403.163
Health conditions studied
1
Description of health condition studied
Oral and dental health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy
Timepoint
Measuring self-efficacy at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention
Method of measurement
Questionnaire created by a researcher to measure the constructs of the Transtheoretical model
2
Description
Perceived benefits
Timepoint
Measuring perceived benefits at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention
Method of measurement
Questionnaire created by a researcher to measure the constructs of the Transtheoretical model
3
Description
Perceived barriers
Timepoint
Measuring perceived barriers at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention
Method of measurement
Questionnaire created by a researcher to measure the constructs of the Transtheoretical model
4
Description
Frequency of cleaning behavior
Timepoint
Measuring the frequency of cleaning behavior at the beginning of the intervention (before the start of the intervention), 2 and 6 months after the intervention
Method of measurement
Questionnaire created by a researcher to measure the constructs of the Transtheoretical model
5
Description
The frequency of using each of the cleaning tools
Timepoint
Measuring the frequency of using each of the cleaning tools at the beginning of the intervention (before the intervention), 2 and 6 months after the intervention
Method of measurement
Questionnaire created by a researcher to measure the constructs of the Transtheoretical model
Secondary outcomes
1
Description
The amount of dental plaque based on the grouping of dental plaque index
Timepoint
Measurement of dental plaque at the beginning of the study (before the start of the intervention) and six months after the intervention
Method of measurement
Through a dentist's examination with direct observation and grouping based on dental plaque index
Intervention groups
1
Description
Intervention group: The researcher visits the selected schools at a specific time and with prior coordination and provides the parental consent form to the school principal to be sent and completed by the parents. After completing the parental consent forms, students who have the completed parental consent form will be included in the study. It should be noted that since the target group is elementary school students, verbal consent will be obtained from them to participate in the study. The educational program includes 4 sessions for students and 1 session for parents and teachers of the students, and each session is implemented for 45 to 60 minutes for the intervention group. The educational content is provided based on reliable sources from the Isfahan Provincial Health Office and the Faculty of Dentistry. The educational content mainly includes familiarizing students with the mouth and tooth structure, the benefits and obstacles of observing oral and dental hygiene, creating a sense of self-efficacy, tooth cleaning behaviors, and the correct use of oral and dental cleaning tools. In fact, the educational content of the study is determined and adjusted in accordance with the structures of the Transtheoretical model and the results of the pre-test. Training is conducted in groups using a combination of lecture, question and answer, practical demonstration, individual statements, brainstorming, and group discussion methods in each training session. During training classes, media such as pamphlets (distributed to all attendees in the class for home study), books, posters, educational films, and photographs are used to enhance learning.
Category
Behavior
2
Description
Control group: will not receive any educational intervention. The control group will not receive any educational intervention. The control group will have to wait to receive the intervention and, if the intervention has a positive result, will receive the written content of the educational sessions after the end of the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Four primary schools in Shahreza city
Full name of responsible person
Negin Akbarpour
Street address
Amiral Momenin school., Next to Farhangian Consumption Cooperative Company., Shahid Motahari Blvd., Shahreza
City
Shahreza
Province
Isfehan
Postal code
8619788986
Phone
+98 31 5322 3065
Email
neginakbarpoor79@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Research and Technology Vice-Chancellor., Building No. 4, Isfahan University of Medical Sciences and Healthcare Services., Hezar Jerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
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
Negin Akbarpour
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences., Hezar Jerib St., Shiraz Gate., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
neginakbarpoor79@gmail.com
Web page address
https://mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Akbarpour
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences., Hezar Jerib St., Shiraz Gate., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
neginakbarpoor79@gmail.com
Web page address
https://mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Akbarpour
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences., Hezar Jerib St., Shiraz Gate., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
neginakbarpoor79@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Start access after printing the results
To whom data/document is available
All people working in academic, scientific and industrial sectors are able to receive data.
Under which criteria data/document could be used
1- Using information to conduct scientific and research studies
2- Not changing information and observing ethical standards
From where data/document is obtainable
1- Conductors and authors of the research project 2- Research vice-chancellor of the university and the relevant educational institution (Isfahan University of Medical Sciences).
Ways of communication with the executors of the research project:
1- Ms. Negin Akbarpour, address: Subsection11., Hakim nasrollah Ave., Shahreza., Isfahan, contact number: 09210430855, email address: neginakbarpoor79@gmail.com
2- Dr. Hossein Shahnazi, Address: Department of Health Education., Faculty of Health., Isfahan University of Medical Sciences., Hezar Jerib Street., Isfahan, contact number: 09133360148, email address: h_shahnazi@yahoo.com.
What processes are involved for a request to access data/document
After the person's request is made by calling or emailing the project organizers and checking the scientific and moral qualification of the applicant, the information will be provided to him in the shortest possible time.