Main aim: comparison of the Tell-Show-Do method effect on 4-10 years old children anxiety during dental treatment with use of the Tiny Dentist computer game. Specific aim: comparison of Tell-Show-Do method with the Tiny Dentist computer game on children's anxiety due to Venham-Frankel anxiety index; Minor aims: comparison of Tell-Show-Do method with the Tiny Dentist computer game on children's heart rate during treatment; comparison of Tell-Show-Do method with the Tiny dentist computer game on children's encountered pain due to Wong-Baker pain index; applicable aim: wide use of the Tiny Dentist computer game to control children's anxiety during treatment in Dental clinics if there is a significant difference beside Tell-Show-Do method.
Design
Clinical Trial with control group - parallel - double blinded - randomized
Settings and conduct
Double blinded study held in School of Dentistry, Tehran University of Medical Sciences. Tell-Show-Do for control & Tiny Dentist for intervention.
Participants/Inclusion and exclusion criteria
Study entry criteria: age 4-10 years of old; no history of dental or medical treatment; treatment plan: Oral hygiene education, brushing, infiltration anesthesia, Class II amalgam filling or pulpotomy.
Study exit criteria: systemic diseases, psychic disorders, physical or mental retardation; teeth pain at visit; children having mobile phones or personal tablets; history of playing with the Tiny Dentist application.
Intervention groups
After examination & profile completion & before treatment, the procedure will be explained to intervention group by the Tiny Dentist application & they will play with it for 5 minutes.
Main outcome variables
Venham-Frankel Index; heart rate; Wong-Baker Index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190720044281N1
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Amirreza Tahersoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 3942
Email address
a.reza.t.soltani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Tiny Dentist game on 4 – 10 years old children's anxiety compared with Tell-Show-Do method
Public title
Effect of computer game on children's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 4-10 years old;
No dental or medical history;
Treatment plan: Oral hygiene education, brushing, infiltration anesthesia, Class II amalgam filling or pulpotomy
Exclusion criteria:
Systemic diseases, psychic disorders, physical or mental retardation
Teeth pain at visit
Children having mobile phone or personal tablets
History of playing with the Tiny Dentist application
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation - Flip coin method
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of the Outcome Evaluator: Given that the anxiety control method is not included in the evaluation documents (Patient profile, Recorded film of treatment procedure and evaluation paper), the evaluators are unaware of the anxiety control method in each patient.
Blinding of Data Analyzer: Considering that the control & intervention groups are distinguished from the each other by number & they are not named, then the analyst is also unaware of which group is control or intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in research committee, School of Dentistry, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, School of dentistry, North karegar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.041
Health conditions studied
1
Description of health condition studied
Dental Anxiety (This condition is not a disease)
ICD-10 code
F41
ICD-10 code description
Anxiety
Primary outcomes
1
Description
Anxiety
Timepoint
During Treatment
Method of measurement
Venham-Frankel Anxiety Index
Secondary outcomes
1
Description
Heart Rate
Timepoint
Before & after anesthesia, before & after intervention, during treatment
Method of measurement
Pulse-oximeter Device
2
Description
Encountered pain
Timepoint
During treatment
Method of measurement
Wong-Baker index
Intervention groups
1
Description
Intervention group: Use of the Tiny Dentist application
Category
Treatment - Other
2
Description
Control group: Tell-Show-Do method
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Alireza Heydari
Street address
School of Dentistry TUMS, North karegar st., Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
a1001heidari@gmail.com
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
Amirali Sohrabpour
Street address
Central Building of Tehran University of Medical Sciences: No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8163 3686
Fax
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Alireza Heydari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
School of dentistry TUMS, North karegar St., Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
a1001heidari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Ghadimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
School of Dentistry TUMS, North Karegar st., Tehran
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 4279 4000
Email
sghadimi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirreza Tahersoltani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 102, zerehpoush 18th st., North karegar st., Tehran
City
Tehran
Province
Tehran
Postal code
1438835884
Phone
+98 21 8801 3942
Email
a.reza.t.soltani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is still no base for data publishing regarding information privacy.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Age & gender
Heart rate
Venham-Frankel index
Wong-Baker index
When the data will become available and for how long
After publishing the letter
To whom data/document is available
Researchers
Journal authorities
Under which criteria data/document could be used
Systematic Review performers
From where data/document is obtainable
Study General Author/PI
What processes are involved for a request to access data/document