The study is a clinical trial research. 48 children at the age of 5 to 7 are selected by the examiner after being studied in initial examination and filling SCARED (Screen for Child Anxiety Related Disorder, Parents version) questionnaire by the parents to detect anxiety disorders. The patients are divided into two groups of laughing intervention and neutral intervention. For the members of group A, the children watch a cartoon movie of funny selection scenes in a relaxed atmosphere like a waiting room for 10 minutes before entering the pediatric dental clinic and a fortnight after that, the same treatment is done after watching a neutral movie. For the members of group B, at the first session of treatment, a neutral movie is played for 10 minutes under the foregoing conditions for the funny movie and a fortnight after that, at the second session, the same treatment is done after watching a funny movie.
Child’s anxiety in the initial stage of treatment is measured by the MCDASF (Modified Child Dental Anxiety Scale Faces, Iranian Version) questionnaire and the pain by Wong Baker Faces. Furthermore, child’s behavior in treatment is registered by the second dentist in MES (Sound, Eye, Motor Scale) measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072235212N1
Registration date:2017-10-01, 1396/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-01, 1396/07/09
Registrant information
Name
azadeh horri
Name of organization / entity
kerman university midical science
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 3815
Email address
a_horri@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of laughter on reducing dental anxiety and pain during dental procedures in children 5-7 years
Public title
The effect of laughter on reducing dental anxiety and pain during child's dental procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include :
The child is in the age group of 7-5 years; The examination session is the first meeting of the child's dentistry; The child has no history of a specific illness and is currently in good health; Having no history of hospitalization; In recent months, there is no experience of the death of a friend or close relative; No History of family-specific problems and must live with parents; Two molars have repairable caries under local anesthesia in one jaw; Has not used a sedative before dental treatment.
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Vice Chancellry, Kerman University of Medical Sciences
Street address
Tahmasebabad Crossroads, Building Department, Research and Technology
City
Kerman
Postal code
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.kmu.REC.1394.505
Health conditions studied
1
Description of health condition studied
The effect of laughter on reducing anxiety and pain during dental procedures in 5 to 7 years old childs
ICD-10 code
F41.9
ICD-10 code description
Disorders in which manifestation of anxiety is the major symptom and is not restricted to any particular environmental situation. Depressive and obsessional symptoms, and even some elements of phobic anxiety, may also be present, provided that they are cl
Primary outcomes
1
Description
Anxiety
Timepoint
Ten minutes after intervention
Method of measurement
MCDAS questionaire
Secondary outcomes
1
Description
Pain
Timepoint
After dental treatment
Method of measurement
Wong baker's Scale
Intervention groups
1
Description
Playing neutral movie in the control group
Category
Behavior
2
Description
Playing funny videos in the intervention group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman faculty of dentistry
Full name of responsible person
Doctor Sima Joukar
Street address
Shafa Street, Faculty of dentistry, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Doctor Abbas Pardakhti
Street address
Tahmasebabad Crossroads, Building Department of Science and Technology of Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman Univesity of Medical Sciences, School of Dentistry
Full name of responsible person
Doctor Sima Joukar
Position
Resident of Pediatric Dentistry
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa Street, Jomhori Islami Blvd, Kerman, Iran Kerman
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
Dr.simajoukar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Faculty of Dentistry
Full name of responsible person
Doctor Azadeh Horri
Position
Assistant professor, Department of Pediatric Dentistry
Other areas of specialty/work
Street address
Pediatric Dentistry Department, School of Dentistry, Shafa street, Jomhori Islami Blvd, Kerman, Iran
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
A_horri@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Faculty of Dentistry
Full name of responsible person
Doctor Azadeh Horri
Position
Assistant professor, Department of Pediatric Dentistry
Other areas of specialty/work
Street address
Shafa street, Kerman Faculty of Dentistry
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)