Comparison between the influence of two methods of Visual Pedagogy, namely Poster and Educational Movie, on Tooth-brushing autonomy in 10-12-year-old Autistic Children
To evaluate the effectiveness of visual pedagogy via poster or educational movie on tooth-brushing abilities in autistic children
Design
Randomised controlled trial, single-blinded, parallel-group trial Randomisation was accomplished using random blocks of 64 participants
Settings and conduct
Fifty -six autistic eligible children aged 10-12 with mild autism, having the ability of speaking and simple conversations, will participate. The children are divided into two groups of poster and film by random blocking and should brush their teeth at least once daily. Children are being assessed in their own homes with the presence of their caregiver at the baseline (before education), and one and three months later. a blue toothbrush is used for the upper jaw and red for the lower jaw. The tooth-brushing process by the FONES method will be divided into 5 stages consisting of 24 steps. A Likert type scoring from 1 to 5 will be specified for each step. Finally, the average score of each of the 5 stages, and the autonomy score, that is derived from all stages will be calculated. The assessor is blind in follow-up times.
Poster group:
16 pictures with white background, will demonstrate the steps by a human model. Posters are installed in the toothbrushing area.
Film group:
Silent film with a white background will demonstrate the tooth brushing and should be seen before brushing by tablet and then as many times as the child wants.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Age between 10 to 12
2. Mild autism
3.Parental motivation to cooperate
Exclusion Criteria:
1. Systemic diseases
2. Moderate and severe Autism
3. Mental retardation
Intervention groups
Intervention Group:The ones who are being trained with movie
Control Group: The ones who are being trained via Poster
Main outcome variables
Changes in tooth-brushing autonomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090429001861N6
Registration date:2021-06-15, 1400/03/25
Registration timing:registered_while_recruiting
Last update:2021-06-15, 1400/03/25
Update count:0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Katayoun Salem
Name of organization / entity
Tehran Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0966
Email address
nastaranegar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the influence of two methods of Visual Pedagogy, namely Poster and Educational Movie, on Tooth-brushing autonomy in 10-12-year-old Autistic Children
Public title
the influence of two methods of Visual Pedagogy on Tooth-brushing autonomy in Autistic Children
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mild Autism
Age between 10-12 years
Parental motivation to cooperate
Exclusion criteria:
Other Systemic diseases
other Mental disability
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Children will be divided into two groups by permuted randomization block method. First, they will be specified to quadruple blocks, which randomly contain two a (poster) and two b(film). Randomization will take place by the methodologist who is not involved with the execution of the study. The examiner will not be informed about the randomization process. The whole process will occur with the aid of the rand option of the Excel software. With the rand option of this software 4 numbers are generated. the two firsts are assigned to a and the two seconds are assigned to b. then they are ranked from the highest to the lowest, forming a block. This process will be repeated 16 times until all of the blocks are formed. After the specification of the samples, information will be handed to the examiner in 64 closed envelopes. The examiner will open each envelope according to the sample codes, after the first evaluation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator and data analyzer were Blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical science
Street address
No. 9, 9th Nezestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2020-01-02, 1398/10/12
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.002
Health conditions studied
1
Description of health condition studied
Autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
autonomy score
Timepoint
Before the intervention, one month after the beginning of visual pedagogy, three months after the beginning of visual pedagogy
Method of measurement
Observation and filling the template for measuring the autonomy, designed based on the Lopez study. The template has no specific name. https://doi.org/10.1007/s40368-018-0396-y
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before any intervention, the toothbrushing performance will be observed and recorded. Then, a muted educational movie will be delivered to parents. The film should be viewed once before the brushing procedure. To avoid child distraction, unnecessary information is not given to children through this film. Since autistic children desire to repeat the tasks, they are allowed to watch the film as many times as they desire. To help the child to distinguish better, a blue toothbrush is used for the upper jaw and a red one for the lower jaw. Furthermore, the teacher's attire will be white; and the film will be muted for better concentration of the child. Tooth brushing is demonstrated by one of the teachers. The FONES brushing technique will be taught. Toothbrushing will be performed under the supervision of parents. Toothbrushes and toothpaste are given to study participants by a responsible investigator. The method of toothbrushing also is trained to parents for comprehensive supervision. The toothbrushing procedure will be divided into 5 stages including 24 steps as following: Stage one, preparation including, 1: taking the toothbrush, 2: opening the toothpaste, 3: pressing the toothpaste, 4: putting toothpaste on the toothbrush, 5: closing the toothpaste cap. Stage two, brushing the occlusal surfaces in 4 quadrants including, 6: upper left, 7: upper right, 8: lower left, 9: lower right. Stage three brushing the buccal surfaces including,10:upper right, 11: upper anterior teeth, 12: upper right, 13: lower right, 14: lower anterior, 15: lower left. The fifth stage is the end of brushing, including; 22: rinsing the mouth, 23: cleaning the brush, 24: putting the brush in its place. The performance of toothbrushing will be evaluated after one and three months by a blinded investigator.
Category
Rehabilitation
2
Description
Control group: An educational poster will be placed where the kid brush his-her teeth. The poster included 24 steps of toothbrushing in 16 pictures. The FONES model of toothbrushing will be instructed. The pictures are provided according to a human model with white background. The child may see the pictures as many times as he/she wants.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Aein-e-Mehrvarzi Autism School
Full name of responsible person
Samane Fayyaz
Street address
No. 32, Ghadiri Alley, SaadatAbad Ave
City
Tehran
Province
Tehran
Postal code
1693935134
Phone
+98 21 8868 2780
Email
Samanef.1361@gmail.com
Web page address
https://autismschool.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi, DDS.MSِ
Street address
No. 9, 9th Neyestan Alley., Pasdaran., Islamic Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
katayoun.salem@gmail.com
Grant name
none
Grant code / Reference number
none............
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Katayoun Salem
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Hospital Dentistry
Street address
Islamic Azad Dental School.No.9, 9th Neyestan Ave., Pasdaranestan, Pasdaran,
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
0098 21 22564571/3
Email
katatyoun.salem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Katayoun Salem
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan Ave., Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
0098 21 22564571/3
Email
katayoun.salem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Katayoun Salem
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Pediatric and Hospital Dentistry
Street address
No. 9, ninth Neyestan Alley., Pasdaran,
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
katayoun.salem@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Film: The recorded videos' of toothbrushing steps can be shared as the outcome.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The documents will be shared only to the publisher, and does not available for public use.
Under which criteria data/document could be used
Any academic usage should be with the collaboration of main authors.
From where data/document is obtainable
1.Katayoun Salem
Tehran Azad Dental school, Department of Pediatric Dentistry, 9th Neyestan, Pasdaran, Tehran
cell: 0098 9122174076
email: katayoun.salem@gmail.com
2. Rojin Adabdokht
Tehran Azad Dental school, Department of Pediatric Dentistry, 9th Neyestan, Pasdaran, Tehran
cell: 0098912 2349907
rojinadabdokht@gmail.com
What processes are involved for a request to access data/document
The documents will be available after publishing, and to receive the documents for reappraisal of results, the request should be sent to responsible author.