Clinical trial to evaluate the effectiveness of using computer games with role playing method in reducing children situational anxiety in dental treatment
Objectives: To determine the effect of play therapy in reducing dental anxiety of children.
Study design: A randomized clinical trial with a parallel design carried out on 40 children aged between 6 and 8 years to ascertain the comparative efficacy of role playing with dentist games on tablet in reducing the dental anxiety of children during dental treatment.
In this double blind study, Children separately and without linking together are treated and evaluator is blind too. The phase of this study is 2-3.
Setting and conduct: Forty children were randomly divided into two groups: Control (Holst technique), role playing (Holst technique and playing with dental games). Holst technique is done in both groups but in case group, computer games are used too and children are done role playing. All the children experienced treatment with or without role playing and the anxiety was assessed using MCDAS test( is for evaluate the anxiety of children in School age and has high reliability and validity ) before and after treatment.
Participants including major eligibility criteria: Inclusion criteria are nothing systemic disease and developmental and mental disorders and cooperative children. It was confirmed that they have no previous experience of hospitalization and dental visit. Had caries lesion in one of the primary mandibular molars and needed a pulpotomy with restoration treatment. Also exclusion criteria are Children with Frankel 1, 2. Children that did not play dental games at home and anti-cooperative parent.
Intervention: The first group was control and in the intervention group, role playing was done.
Main outcome measures: Primary outcome variable was severity of anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011217935N6
Registration date:2016-05-08, 1395/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2016-01-25, 1394/11/05
Expected recruitment end date
2016-02-24, 1394/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effectiveness of using computer games with role playing method in reducing children situational anxiety in dental treatment
Public title
Efficacy of role playing in reduce anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The children with no systemic disease and developmental and mental disorders and cooperative children. It was confirmed that they have no previous experience of hospitalization and dental visit. Had caries lesion in one of the primary mandibular molars and needed a pulpotomy with restoration treatment.
Exclusion criteria: Children with Frankel 1, 2. Children that did not play dental games at home and anti-cooperative parent.
Age
From 6 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Children was divided into two groups according to the table of random numbers.
Double blind: Children separately and without linking together are treated and evaluator is blind too.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Emam street, faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.SSU.REC.1394.93
Health conditions studied
1
Description of health condition studied
Management of anxiety during dental treatment
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood
Primary outcomes
1
Description
ُSevere of anxiety
Timepoint
Before and immediate after treatment
Method of measurement
MCDAS test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group ,the dentist introduces children with only dentistry instruments
Category
Behavior
2
Description
Intervention group: dentist introduces instruments and also uses video games.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Maryam Ebrahimian
Street address
Emam street, faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Fateme Ezoddini Ardakani
Street address
Emam street, faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
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 of Shahid Sadoughi University of Medical Sciences of Yazd
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
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Maryam Ebrahimian
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Emam street, faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
ebrahimian.maryam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
dr. Zahra Bahrololoomi
Position
Associate professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Emam street, faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3621 2222
Fax
Email
zbahrololoom@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Maryam Ebrahimian
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)