(1)The effect of simulated dental game on the children′s pain and anxiety in the first session of dental treatment (2)This clinical trial was performed on 50 children aged 4-7 years old who were referred to a private clinic in 2 groups(n=25) (3).At the examination session Wong-Baker FACES Pain Rating Scale test and heart rate were measured.then simulated dental game was given to the study group. The children were randomly divided into two groups (n=25), study (game) and control. At the treatment session, heart rate was measured in 5 stages. At the end of treatment WBS test was measured again (4) No previous experience of dental visit (5)Simulated dental game was given to the children of study group (6)Pain and anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120531236N1
Registration date:2017-07-19, 1396/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-19, 1396/04/28
Registrant information
Name
Fateme Alidadi
Name of organization / entity
Dentistry Student
Country
Iran (Islamic Republic of)
Phone
+98 917 641 8110
Email address
alidadi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of simulated dental game on the children′s pain and anxiety in the first session of dental treatment
Public title
The effect of simulated dental game on the children′s pain and anxiety4-7 years old in the first session of dental treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: They have no previous experience of hospitalization and dental visit; At least need to the same elective treatment in the mandibular. Exclusion criteria: Necessity for using aggressive behavior management technique; Necessity for parental presence.
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundi shapur University of Medical Science, Ethics Committee
Street address
Ground floor, Department of Development Research and Technological University of Medical Sciences and Health Services Ahvaz, City University
City
Ahvaz
Postal code
61357-15794
Approval date
2016-04-16, 1395/01/28
Ethics committee reference number
IR.AJUMA.REC.1395.11
Health conditions studied
1
Description of health condition studied
The Relation Between Dental Simulation and Dental Anxiety in Children at First dental Session
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before treatment. After treatment
Method of measurement
WBS test
2
Description
Anxiety
Timepoint
Before treatment,Sitting on dentistry unit, Injection, Using turbine, Using angle, End of treat ment
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group : Simulated dental game given children of study group
Category
Prevention
2
Description
Control group : No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, School of Dentistry
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Rearch and Technological Development Jundishapur University of Medical Science
Full name of responsible person
Mohsen Safi
Street address
Ground floor, Department of Development Research and Technological University of Medical Sciences and Health Services Ahvaz, City University
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Rearch and Technological Development Jundishapur University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Ahvaz University of Medical ScienceS
Full name of responsible person
Dr leila Basir
Position
Professor of Pediatric Dentistry, Professor and Head of Department
Other areas of specialty/work
Street address
Department of Pediatrics, College of Dentistry, Golestan St, Ahvaz
City
ahvaz
Postal code
Phone
+98 61 3320 5170
Fax
Email
BASIR_1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Dentistry, Ahvaz University of Medical ScienceS
Full name of responsible person
Dr Razie Meshki
Position
Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Department of Pediatric, College of Dentistry, Golestan St, Ahvaz
City
ahvaz
Postal code
Phone
+98 61 3320 5170
Fax
Email
Dr.raziemeshki@GMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Alidadi
Position
Dental Student
Other areas of specialty/work
Street address
School of Dentistry, Ahvaz University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz
Postal code
Phone
+98 917 641 8110
Fax
Email
alidadi.fateme313@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)