Protocol summary

Study aim
Oral health is a very important and decisive component in the overall health of children. Toddlers are exposed to a variety of risk factors for maintaining good oral health, and it is clear that these risk factors can be controlled solely by parents. This education might lead to irreversible decline and the increasing level of oral children health .Needless to say, toddlers are at one of the most sensitive times. When necessary ,health-related behaviors are formed, which is not possible except with parental awareness and education. Mothers of children in this age group in the form of virtual online questionnaires.
Design
Audio-visual content that contains educational messages about the importance of early childhood visits to the dentist, how to feed children to reduce and control dental caries, how to take care of newborns teeth , how to transmit cariogenic bacteria from mother to child and tips on maternal oral health in relation to the child are prepared and produced.
Settings and conduct
In this experimental study, we collect 100 mothers with children aged 1 to 3 years through the virtual network of Instagram and consider them as the target community.
Participants/Inclusion and exclusion criteria
Mothers should have access to the Internet and the social network Instagram, the mother should be the main caregiver of the child in the family and the mothers should have children aged 12 to 36 months. Exclusion criteria are non-cooperation during the study.
Intervention groups
Mothers in the experimental group will receive the desired educational content online in the form of a 1-2 minute animation with audio-visual content.
Main outcome variables
The level of awareness created in mothers will be assessed by a questionnaire whose reliability has been proven.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131102015238N4
Registration date: 2021-02-20, 1399/12/02
Registration timing: registered_while_recruiting

Last update: 2021-02-20, 1399/12/02
Update count: 0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Simin Z. Mohebbi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
smohebbi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Animation Programming with Text-Based Education on the Self-Declared Knowledge and Practice of Oral Health in Toddlers’ Mothers
Public title
Animation Programming in Comparison with Text-Based Education on Oral Health in Toddlers’ Mothers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who have access to the Internet and the social network Instagram. Mothers who are the main caregiver of the child in the family. Mothers with children of 12 to 36 months
Exclusion criteria:
Lack of cooperation during the project
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by assigned random numbers with computer software
Blinding (investigator's opinion)
Double blinded
Blinding description
The information about the assignment of each participant to the study groups is coded and through this the research facilitators, evaluators of the results and statistical analysts are blind to it.
Placebo
Not used
Assignment
Parallel
Other design features
Parents of toddlers, as the main caregivers of children have an important role in creating a positive attitude towards oral health in their children from the earliest years of life, and these orders are provided to parents in the context of proper education.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences Faculty of Dentistry
Street address
Karegar Street, Tehran University of Medical Sciences Faculty of Dentistry
City
Tehran
Province
Tehran
Postal code
81631
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.110

Health conditions studied

1

Description of health condition studied
Oral health medicine
ICD-10 code
K08
ICD-10 code description
Other disorders of teeth and supporting structures

Primary outcomes

1

Description
Knowledge of oral health
Timepoint
after completion of intervention
Method of measurement
Questionnaire

2

Description
Practice of Oral Health
Timepoint
after completion of intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Mothers with children 1 to 3 years old are collected through the virtual network Instagram and are considered as the target community. At least three "1-2 minute" animations in series with audio-visual content that contain educational messages about the importance of early childhood visits to the dentist, how to feed children to reduce and control dental caries, how to take care of teeth ¬ Toddler's tips, how to transmit cariogenic bacteria from mother to child, and tips on mother-to-child oral hygiene related to the child will be sent to them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Street address
End of North Kargar Street, Adjacent to the Atomic Energy Organization, High School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
smohebbi@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd, Ghods St, Central Organization of the University, Sixth Department of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Tehran University of Medical Sciences, Research Deputy
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community Oral Health Deptartment
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+218 8015960
Email
smohebbi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community Oral Health Deptartment
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+218 8015960
Email
smohebbi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community Oral Health Deptartment
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+218 8015960
Email
smohebbi@tums.ac.ir

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
Comparing the Effects of Animation Programming with Text-Based Education on the Self-Declared Knowledge and Practice of Oral Health in Toddlers’ Mothers.
When the data will become available and for how long
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
To whom data/document is available
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view.
Under which criteria data/document could be used
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view.
From where data/document is obtainable
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
What processes are involved for a request to access data/document
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
Comments
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