Multimedia and virtual reality effect on distraction and oral health education in 4 to 6 year old children
Design
Clinical trial with parallel groups, without blinding, randomized, on 60 patients. A random number table will be used for randomization.
Settings and conduct
This study will be performed in Tabriz School of Dentistry. Children are randomly divided into four groups. There will be 2 sessions of treatment. In the first session, oral health education will be provided in all groups. Health education will be done using VR glasses in the first group, TV in the second group, tablet in the third group and TSD( Tell-Show-Do) in the last group. In the second session, restorative treatment of the lower alveolar block in all 4 groups of patients will be performed using one of the VR, TV, tablet and TSD methods that the cartoon will broadcast. The level of anxiety and behavior of children will be measured. The plaque index will be re-examined in two follow-up periods one month apart.
Participants/Inclusion and exclusion criteria
Admission: Children 4 to 6 years. No history of dental treatment. Has at least one repairable tooth in the mandible.
Withdrawal: Has symptoms of anxiety. Evidence of respiratory disease or Covid disease 19. No need for emergency dental treatment. Lack of parental cooperation. Pulp exposure
Intervention groups
Intervention 1: Health education with VR headset
Second intervention: health education with television
Intervention 3: Health education with tablet
Intervention 4: Health Education with TSD (Tell-Show-Do)
Main outcome variables
Oral health
Anxiety
Behavior
plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210103049926N1
Registration date:2021-08-28, 1400/06/06
Registration timing:registered_while_recruiting
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
ozra golsanamlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3384 6713
Email address
dr.golsanamlou92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-20, 1400/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multimedia and virtual reality effect on distraction and oral health education in 4-6 year old children
Public title
The impact of media on children's oral health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children should be 4 to 6 years old.
Children should not have any dental treatment history.
Children should have at least 1 tooth that need restorative treatment.
Exclusion criteria:
Children have major anxiety disorders.
Symptoms of respiratory disease or Covid 19 disease are seen in the child.
Children need emergency dental treatment.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 children with inclusion criteria will enter the study. These people will be randomly divided into 4 groups. The method of randomization is simple and its unit is individual. The randomization tool is a table of random numbers. In order to hide the random allocation, sealed envelopes will be used.
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
Ethnic commitee of Tabriz university of medical sciences
Street address
Golgasht Ave., Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.TBZMED.REC.1400.292
Health conditions studied
1
Description of health condition studied
Oral health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Oral health promotion that evaluated by plaque index
Timepoint
2 times evaluating oral health promotion at one month intervals
Method of measurement
Plaque index
2
Description
Anxiety
Timepoint
Evaluating anxiety during tooth restoration
Method of measurement
Faces version of the Modified Child Dental Anxiety Scale questionnaire
3
Description
Evaluating Behavior
Timepoint
Evaluating behavior during tooth restoration
Method of measurement
Frankel Behavior Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a VR headset and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using VR method and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.
Category
Behavior
2
Description
Intervention group2: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a television and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using television and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.
Category
Behavior
3
Description
Intervention group3: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using a tablet and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using tablet and by playing a part of Tom and Jerry cartoon, and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.
Category
Behavior
4
Description
Control group: In the first session, the tools used by the usual method of behavioral control technique will be introduced to children. Also, to determine the initial oral health status of the child, plaque detection pills and plaque index will be calculated. In this group, Brushing with horizontal method will be taught to children and their parents by using usual method tell-show-do (TSD) and playing a cartoon about How to brush. In the second session, class one or two restoration of the first or second mandibular primary molars with injecting inferior alveolar nerve block will be done using TSD , and the anxiety and behavior of children Will be assessed. At the end of session the subjects’ anxiety will be measured by Faces version of the Modified Child Dental Anxiety Scale and their behavior will be recorded based on the Frankel Classification Scale. The improvement of oral health will be re-examined in two follow-up session by the plaque index.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشکده دندانپزشکی دانشگاه علوم پزشکی تبریز
Full name of responsible person
Naser Asl Aminabadi
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
aslaminabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mozhgan Kachoui
Street address
3rd floor, No 2 Central Building , Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
dent.fac@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ozra Golsanamlou
Position
Post graduated student of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht st.dentistry faculty, pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3384 6713
Fax
Email
dr.golsanamlou92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Aslaminabadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
aslaminabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ozra Golsanamlou
Position
Post graduated student of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Golgasht st.dentistry faculty, pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3384 6713
Fax
Email
dr.golsanamlou92@gmail.com
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
Undecided - It is not yet known if there will be 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