Double-blind randomised , phase 3 , parallel clinical trial without control group
Settings and conduct
A double-blind randomized clinical trial with 42 patients divided into 4 groups by 4 blocks and the type of intervention inside the sealed envelopes was determined:
First group use dentist bling application before dentistry operation
Second group use virtual reality in dentistry operation
Participants/Inclusion and exclusion criteria
Inclusion criteria: co-operative / first dentistry operation
Exclusion criteria: Indication of pulpectomy / extraction / abscess /restoration
Systemic disease
Intervention groups
One group is given the dentist bling game application, which is a dental game to learn about dentistry, and the other group is given virtual reality glasses in which animation is played to distract the child.
Main outcome variables
Investigating the effect of dental game applications in controlling children's fear, investigating the effect of dental game applications in children's anxiety, investigating the effect of virtual reality glasses in controlling children's fear, investigating the effect of virtual reality glasses in controlling children's anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220123053803N1
Registration date:2022-07-02, 1401/04/11
Registration timing:registered_while_recruiting
Last update:2022-07-02, 1401/04/11
Update count:0
Registration date
2022-07-02, 1401/04/11
Registrant information
Name
Arman Khosravi Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 6304
Email address
armankhosravinezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Smartphone application vs virtual reality effect on 5-8years old children fear & anxiety in first dentistry operation
Public title
Application vs virtual reality effect on kids fear & anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Co-operative kids (not in group Frankl's class 1 and in group 2-3-4)
First dentistry operation
5-8years
Randomization is done with 4 random blocks and this process is done by someone other than the operator. In this process, Excel software is used and finally the information of each group (virtual reality or application) is placed in closed envelopes and these envelopes are opened only when the operator wants to perform the treatment. There are also possibilities for both types of treatment and it is not clear in advance which treatment is to be performed and the envelopes are numbered in the same order in which they are randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding the person who fills in the questionnaires with the child after the treatment and also the person who is responsible for evaluating the questionnaire data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of Medical Sciences
Street address
تهران، اتوبان نواب، ابتدای خانی آباد نو، خیابان ماهان(شهید زلفی)، روبروی پارک شریعتی، دانشکده دندانپزشکی پردیس بین الملل
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1400.186
Health conditions studied
1
Description of health condition studied
Fear
ICD-10 code
F40.23
ICD-10 code description
Blood, injection, injury type phobia
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Comparison of virtual reality and application on anxiety index
Comparison of virtual reality and applications on the fear index
Timepoint
While first dentistry operation
Method of measurement
Dental Subscale Children's Fear Survey Schedule
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group is the group that uses virtual reality glasses during the first dental treatment and an animation is played inside the virtual reality glasses so that the child does not get distracted from the surrounding environment and also reduces fear and anxiety during the treatment.
Category
Treatment - Devices
2
Description
The other group are children who are given the dentist bling game application before the treatment session to play, and this program makes the child familiar with the dental environment and tools so that he experiences less fear and anxiety during the treatment session.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
International Campus of Tehran University of Dentistry
Full name of responsible person
Arman Khosravi Nejad
Street address
In front of Shariaty Park , Mahan St , KhaniAbad No , Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
dentistyic@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javad Kharazifard
Street address
In front of shariaty Park , Mahan St , KhaniAbad No , Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5585 1151
Email
dentistyic@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
Arman Khosravi Nejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 14 , No 28 , Afshari Blvd , North Ekhtiarie , Pasdaran
City
Tehran
Province
Tehran
Postal code
1958743651
Phone
+98 21 2277 6304
Fax
Email
Armankhosravinezhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arman Khosravi Nejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 14 , No 28 , Afshari Blvd , North Ekhtiarie , Pasdaran
City
Tehran
Province
Tehran
Postal code
1958743651
Phone
+98 21 2277 6304
Fax
Email
Armankhosravinezhad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arman Khosravi Nejad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 14 , No 28 , Afshari Blvd , North Ekhtiarie , Pasdaran
City
Tehran
Province
Tehran
Postal code
1958743651
Phone
+98 21 2277 6304
Fax
Email
Armankhosravinezhad@yahoo.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