The aim of this survey is to evaluate the effect of visual distraction on dental anxiety(measured by Venham picture test and pulse rate) of children while receiving dental treatment under local anesthesia
The participants are selected from 4-5 years old patients that presented for treatment at the pediatric department of the school of Dentistry, Tehran University of Medical Science.
The inclusion criteria for the patients are: (1) general health, (2) no previous dental experience involving local anesthetic administration for the last 2 years and (3) pulpotomy and ssc treatment plan required for primary molars in lower quadrants.
exclusion criteria:1) previous unpleasant experience
in dental setting (2)mental or physical disability 3) sound lower primary molars with minimal treatment needs.
sample size: 28
intervention:
In the first group after local anesthesia administration, treatment procedure is done while a silent cartoon is playing on the monitor in front of each child. The second visit in this group is without any distraction aid and the procedure is carried out under normal dental setup using conventional Tell- show- Do method.
The second group experience the first visit with no distraction and conventional Tell- show- Do is used as a behavior guidance method. Visual distraction in this group is implemented in the second visit using a silent cartoon playing on the monitor .
Treatment procedures are similar in both groups during two sessions including inferior alveolar nerve block as local anesthesia, pulpotomy and stainless steel crown treatment of lower primary molars.
primary outcomes:In both groups preoperative and postoperative anxiety level is rated with Venham Picture Test (VPT) at the beginning and the end of each session respectively, as well as pulse rate(PR). Patient behavior is scored using Frankl Behavior Rating Scale in each appointment
time of intervention :9 am
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080135434N1
Registration date:2017-08-11, 1396/05/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-11, 1396/05/20
Registrant information
Name
Zohreh Estaki
Name of organization / entity
Pediatric Department, School of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5801
Email address
z-estaki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
dental school
Expected recruitment start date
2017-09-10, 1396/06/19
Expected recruitment end date
2017-12-10, 1396/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of visual distraction on children’s anxiety during dental treatment: A cross over randomized clinical trial
Public title
effect of cartoon on dental anxiety in children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:(1) general good health, (2) no previous dental experience involving local anesthetic administration for the last 2 years and (3) pulpotomy and ssc treatment required for primary molars in lower quadrants.
exclusion criteria:1) previous unpleasant experience
in dental setting (2)mental or physicall disability 3) sound lower primary molars with minimal treatment needs
Age
From 4 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of school of dentistry, Tehran University of Medical Sciences
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Postal code
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1396.2849
Health conditions studied
1
Description of health condition studied
dental anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
pulse rate
Timepoint
before and after dental procedure
Method of measurement
with tactile sensation
2
Description
anxiety level
Timepoint
before and after dental procedure
Method of measurement
by venham picture test
3
Description
child behaviour
Timepoint
before, during and after dental procedure
Method of measurement
by frankl behaviour iscale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: visual distraction by playing a silent cartoon during dental procedure
control group: conventional behaviour guidance method (tell- show - do) is used during dental procedure
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
pediatric department of dental school ,Tehran University of Medical Sciences
Full name of responsible person
dr Zohreh Estaki
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Sara Ghadimi
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Dentistry, Tehran University of Medical Sciences
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
pediatric department of dental school, Tehran University of Medical Sciences
Full name of responsible person
Dr Zohreh Estaki
Position
post graduate student
Other areas of specialty/work
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Postal code
Phone
+98 21 8801 5801
Fax
+98 21 8801 5801
Email
z-estaki@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
pediatric department of dental school, Tehran University of Medical Sciences
Full name of responsible person
Dr Zohreh Estaki
Position
post graduate student
Other areas of specialty/work
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Postal code
Phone
+98 21 8801 5801
Fax
+98 21 8801 5801
Email
z-estaki@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
pediatric department of dental school, Tehran University of Medical Sciences
Full name of responsible person
Dr Zohreh Estaki
Position
post graduate student
Other areas of specialty/work
Street address
Enghelab Sq, North Kargar St, after Atomic Energy Organization
City
Tehran
Postal code
Phone
+98 21 8801 5801
Fax
+98 21 8801 5800
Email
z.estaki@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)