Comparison of the Effect of Metal and Cartoon Syringes on Dental Anxiety and Pain Perception of Healthy Children Aged 6-8 Years Attending to Babol University of Medical Sciences: A Clinical Trial
Objective: This study aims to compare the effect of the cartoon and metal syringes on pain perception and dental anxiety of children.
Design: Two twenty-set groups of cooperative healthy children aged 6-8 years.
Setting and conduct: In the cross-over clinical trial, two twenty-set groups of cooperative healthy children aged 6-8 years were tested within two treatment sessions. At the beginning of the first and second appointments, the metal and cartoon syringes were respectively displayed to the first group in reveres to the second group of children and the dental anxiety was assessed by Children's Fear Survey Schedule-Dental Subscale (CFSS-DS),Venham Picture Test (VPT) and Facial Image Scale (FIS). Score of pain was also evaluated by Face Scale at the end of sessions. Statistical analysis of data was done using the T-test and paired T-test with the significance level at p<0.05.
Participants: Six to eight year-old children with no systemic, mental or psychological diseases who had two decayed primary maxillary first molars which needed pulpotomy and were not previously under local anesthesia.
Interventions: Displaying the mental or cartoon syringes to children within two dental appointments.
Primary outcome: The score of dental anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040421519N2
Registration date:2015-06-08, 1394/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Samane Gharekhani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
s.gharekhani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Metal and Cartoon Syringes on Dental Anxiety and Pain Perception of Healthy Children Aged 6-8 Years Attending to Babol University of Medical Sciences: A Clinical Trial
Public title
Dental Anxiety and Pain Concerning the Appearance of Dental Injector
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children who had at least two decayed upper primary first molars which needed pulpotomy
No history of local anesthesia.
Exclusion criteria:
History of systemic diseases, mental or psychological disorders and acute pain.
Age
From 6 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz street, Babol
City
Babol
Postal code
Approval date
2011-01-24, 1389/11/04
Ethics committee reference number
30/2865/ژ/پ
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Score of anxiety
Timepoint
Immediately following the intervention
Method of measurement
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Venham Picture Test (VPT) and Facial Image Scale (FIS)
Secondary outcomes
1
Description
Pain
Timepoint
At the end of treatment
Method of measurement
Face scale
Intervention groups
1
Description
Intervention: Displaying the conventional stainless steel dental syringe to the children of group 1 and 2, at the beginning of the first and second treatment sessions respectively. In overall two times for a couple of minutes.
Category
Treatment - Devices
2
Description
Intervention: Displaying the cartoon covered stainless steel syringe to the children of group 2 and 1 at the beginning of the first and second treatment sessions respectively. In overall, two times for a couple of minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganj Afrooz street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Babol 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
Department of Pediatrics
Full name of responsible person
Samane Gharekhani
Position
Assistant Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj Afrooz street, Babol
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
sgharekhani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatrics
Full name of responsible person
Mitra Tabari
Position
Assistant Professor
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj Afrooz street, Babol
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
mitra.tabari3@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Samane Gharekhani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)