Comparison of oral health promotion program among visually impaired adolescents of special schools of Mashhad using braille pamphlet and Audio-tactile Performance Technique
Evaluation of oral health promotion program among visually impaired adolescents of special schools in Mashhad using braille pamphlet and Audio-tactile Performance Technique in comparison with control group
Design
A controlled, two-parallel, single-blind, simple-randomized clinical trial of 90 participants.
Settings and conduct
It will be done in Mashhad special schools.
Oral health education is carried out in three phases (basic, three months later, six months later) to visually impaired adolescents, and its effects are investigated.
The person collecting the data and those doing the statistical analysis are unaware of the groups.
Participants/Inclusion and exclusion criteria
Congenital, totally visually impaired adolescents
Bring the parental consent form
Intervention groups
group1: receiving oral health education through braille pamphlet
group2: receiving oral health education through Audio-tactile Performance Technique
Main outcome variables
After six months, the participants will be examined by a questionnaire. The data will be evaluated in three parts: knowledge, attitude, and how to deal with dental trauma.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059848N1
Registration date:2023-12-14, 1402/09/23
Registration timing:prospective
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Mahtab Mottaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3766 5718
Email address
mottaghim961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral health promotion program among visually impaired adolescents of special schools of Mashhad using braille pamphlet and Audio-tactile Performance Technique
Public title
Comparison of the effect of braille pamphlet and Audio-tactile Performance Technique on the oral health of visually impaired adolescents
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Congenital, totally visually impaired adolescent
bring the parental consent form
Age 10 to 19 years
Exclusion criteria:
Unwillingness to participate in the study
Age
From 10 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a table of random numbers at the cluster level.
A table of random numbers is prepared in the range [0, 1). According to the number of groups and participants in each group, a number is selected from the table of random numbers for each participant. The numbers are sorted from big to small; the first 30 numbers are in the first group, the second 30 numbers are in the second group, and the third 30 numbers are in the third group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Different individuals will do data collection and education of the participants. The person who collects data (either through a questionnaire or through oral examinations will be unaware of the groups. Also, the statistical consultant will not be aware of the groups when performing statistical evaluations.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Ethics Committee of the Faculty of Dentistry of Mashhad University of Medical Sciences
Street address
Mashhad, University Street, next to Hoizeh Cinema, Qorshi Building, Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-01-18, 1401/10/28
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1401.124
Health conditions studied
1
Description of health condition studied
Evaluating the level of knowledge, attitude, and information about how to deal with dental trauma in visually impaired adolescents.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of awareness of the participants in the form of knowledge score
Timepoint
before the intervention and six months after the intervention
Method of measurement
questionnaire
2
Description
The level of awareness of the participants in the form of attitude score
Timepoint
before the intervention and six months after the intervention
Method of measurement
questionnaire
3
Description
The level of awareness of the participants about how to deal with dental trauma.
Timepoint
before the intervention and six months after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Determination of DMFT (Decayed, Missing, Filled Teeth) index.
Timepoint
before the intervention three, and six months after the intervention
Method of measurement
Clinical examination
2
Description
Determination of OHI (Oral Hygiene Index).
Timepoint
before the intervention three, and six months after the intervention
Method of measurement
Clinical examination
3
Description
Determination of DI (Debris Index).
Timepoint
before the intervention three, and six months after the intervention
Method of measurement
Clinical examination
4
Description
Determination of BOP (Bleeding on Probing) index.
Timepoint
before the intervention three, and six months after the intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group 1: Oral health education will be received using a braille pamphlet at the beginning of the study and three months after the survey. Participants read Braille pamphlets in the presence of an attendant.
Category
Behavior
2
Description
Intervention group 2: Oral health education will be received by 3D models with a lecture (Audio-tactile Performance technique) at the beginning of the study and three months after the survey.
Category
Behavior
3
Description
Control group: No oral health education will provide for this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid school
Full name of responsible person
Saeed Doolabi
Street address
Faramarz Abbasi 5, Omid Blind Education Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9197973579
Phone
+98 51 3605 9533
Email
DoolabiSaeed1345@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR. Saber Babazadeh
Street address
Mashhad dentistry schoolm Vakilabad blvd, MAshhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9500
Email
mottaghim961@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahtab Mottaghi
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 17, sixth Hejrat Ave., Sazemane ab Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185875647
Phone
+98 51 3766 5718
Email
mahmottaghi1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahtab Mottaghi
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 17, sixth Hejrat Ave., Sazemane ab Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185875647
Phone
+98 51 3766 5718
Email
mahmottaghi1999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahtab Mottaghi
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 17, sixth Hejrat Ave., Sazemane ab Blvd., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185875647
Phone
+98 51 3766 5718
Email
mahmottaghi1999@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
Part of the data related to the main outcome can be shared after de-identification.
When the data will become available and for how long
The access period starts from 1402
To whom data/document is available
These data will be accessible to researchers working in academic institutions.
Under which criteria data/document could be used
If the data is used for cross-sectional studies.
From where data/document is obtainable
Mahtab Mottaghi
mahmottaghi1999@gmail.com
What processes are involved for a request to access data/document
When composing an email, clearly outline the reasons why the data is necessary.