Protocol summary

Summary
The present study evaluated the impact of pictorial story on behavioral feedback, pain perception and situational anxiety considering intelligent quotient during dental treatment in pediatric dental patients. Eighty children, aged 6–7 years, attending the Department of Paediatric Dentistry of Tabriz University of Medical Sciences took part in this study. Participants' intelligent quotient was assessed using Rayven's Progressive Matrices and their childhood anxiety related disorders was evaluated by Screen for Child Anxiety Related Disorders (SCARED) parent version scale. Subjects were randomly allocated to one of two experimental groups: listening to pictorial story about going to dentistry or listening to pictorial story about going to barber. After listening to pictorial story, subjects entered a dental setting for treatment. The subjects' pain perception, then, was assessed using Wong-Baker Fasces Pain Rating Scale and situational anxiety measured by Faces version of the Modified Child Dental Anxiety Scale. Subjects' behavior was assessed using Sound Eye Motor scale during dental treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904264385N1
Registration date: 2011-03-03, 1389/12/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-03-03, 1389/12/12
Registrant information
Name
Ali Vafaei
Name of organization / entity
Dental faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1525 7311
Email address
vafaiib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2010-08-21, 1389/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of pictorial story on 6-7-year-old children behavioral feedback considering intelligent quotient during dental treatment
Public title
The impact of pictorial story on 6-7-year-old children behavioral feedback considering intelligent quotient during dental treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 6 and 7 years, Existence of carious primary molars necessitating administration of an anesthetic agent, Exclusion criteria: History of unpleasant experiences in medical settings, Previous experience of dental treatment, Audiovisual impairment, History of pain secondary to pulpitis favoring a biased context due to special pain status such as hyperalgesia or allodynia, Mental disabilities, presence of childhood anxiety related disorders, SCARED questionnaire score > 25
Age
From 6 years old to 7 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Approval date
2010-12-27, 1389/10/06
Ethics committee reference number
8950

Health conditions studied

1

Description of health condition studied
situational anxiety
ICD-10 code
F90
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring

Primary outcomes

1

Description
situational anxiety
Timepoint
immediatly after dental intervention
Method of measurement
modified children dental anxiety scale

Secondary outcomes

1

Description
disruptive behavior
Timepoint
during treatment
Method of measurement
SEM scale

Intervention groups

1

Description
narrating pictorial story about going to dentist
Category
Behavior

2

Description
narrating pictorial story about going to barber
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz dental faculty
Full name of responsible person
Dr. Naser Asl Aminabadi
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Vice chancellor for Research, Tabriz University of Medical Sciences, Daneshgah Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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 Pediatric Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Position
DDS, MSc, Associate professor
Other areas of specialty/work
Street address
Tabriz Dental Faculty, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1335 5965
Fax
Email
aslaminabadi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Vafaei
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
No. 310, Dr beheshty St.
City
Tabriz
Postal code
5136996836
Phone
+98 41 1525 7311
Fax
Email
alivafaiitbzmed@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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