Efficacy of behavior management techniques to prevent unnecessary anesthesia in uncooperative children referred to dental hospital of Tabriz University, 2012
Background and aims: Despite risks and side effects of general anesthesia (GA), a considerable number of referrals are made due to lack of cooperation in children for dental treatments. The present study aimed at evaluating the efficacy of behavior management techniques to prevent unnecessary GA in uncooperative children referred to a dental hospital.
Materials and methods:The study included a total sample of eighty 3-6 year-old uncooperative children referred by general (29 cases) and pediatric dentists (51 cases) to a dental hospital for treatment under GA. Subjects were randomly divided into experimental (E, n = 40) and control (C, n = 40) groups. Behavior management techniques and behavior shaping were used for children in group E, whereas children in group C were solely guided by behavior shaping. Existence of any systemic disease or mental retardation and severe cognitive deficits based on medical chart review, psychosocial histories, or available psychological assessment data. parents refusing to sign the written informed consent, child who was referred to the hospital because of the suffering from a traumatic dental injury were the exclusion criteria of our study. The child’s behavior during treatment was assessed according to Frankl behavior scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080614030N2
Registration date:2013-09-23, 1392/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Saba Aghaee
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5963
Email address
saba_aghaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of behavior management techniques to prevent unnecessary anesthesia in uncooperative children referred to dental hospital of Tabriz University, 2012
Public title
Efficacy of behavior management techniques to prevent unnecessary anesthesia in uncooperative children referred to dental hospital of Tabriz University, 2012
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 3-6 year old uncooperative children referred to dental hospital to be treated under general anesthesia. Exclusion criteria: existence of any systemic disease or mental retardation and severe cognitive deficits based on medical chart review, psychosocial histories, or available psychological assessment data; parents refusing to sign the written informed consent; a child who was referred to the hospital because of the suffering from a traumatic dental injury; a child who needed onward referral for oral surgery; parents not being willing to consent for treatment with LA even if this was the advice of the assessor.
Age
From 3 years old to 6 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)
Single 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
2012-09-17, 1391/06/27
Ethics committee reference number
9252
Health conditions studied
1
Description of health condition studied
uncooperativeness
ICD-10 code
F-90
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring
Primary outcomes
1
Description
Uncooperativeness
Timepoint
Before and after dental intervention
Method of measurement
Frankl behavior scale
Secondary outcomes
empty
Intervention groups
1
Description
case : applying behavior shaping and behavior management techniques such as tell show do, voice control and body restrain
Category
Behavior
2
Description
control: applying behavior shaping
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
Research department of Tabriz University of Medical Sciences
Full name of responsible person
Dr Naser Asl Aminabadi
Street address
Tabriz university, Golgasht street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research department of 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, 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, 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 Saba Aghaee
Position
DDS, Postgraduate student
Other areas of specialty/work
Street address
Department Of Pediatric Dentistry, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1331 3514
Fax
Email
saba_aghaee@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)