The purpose of this study is Comparison of the effect of different methods of multimedia distraction on pain and anxiety of 5-9 years old children during dental treatment
Design
Clinical trials with control group, with parallel, non-random groups
Settings and conduct
This study will be conducted at the private clinic of Hamad Sarlak, a pediatric dentistry specialist in Arak. For each patient, according to the groups designated in a meeting, the cartoon is silently or soundly distributed and in the other session the patient is considered as a control. In the treatment sessions at certain times, the level of anxiety is measured by heart rate, SEM, and FAS.
Participants/Inclusion and exclusion criteria
The criteria for entering this study will be that the participants in this project should be genetically and systemically healthy and have no adverse history of dentistry, and in terms of cooperation in the positive or Definitely positive status. Frankl's position. All patients Need for Bilateral Palpotomy D or E Maxillary Teeth. The exclusion criteria are the lack of patient collaboration for attending the third and fourth sessions of treatment
Intervention groups
First Intervention:Spoken Cartoon, Second Intervention:Silent Carton, Third Intervention (Control): No Cartoon Playing
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042820N1
Registration date:2019-05-08, 1398/02/18
Registration timing:registered_while_recruiting
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Sara Jafari mofrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3272 2483
Email address
s_jafari73@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-13, 1398/01/24
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of different methods of multimedia distraction on pain and anxiety of 5-9 years old children during dental treatment
Public title
effect of different methods of multimedia distraction on pain and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Genetically and systemically healthy
Do not have a bad history of dentistry
In terms of cooperation, positive or Definitely Positive is to be categorized by Frankl
Need for Bilateral Palpotomy D or E Maxillary Teeth
Exclusion criteria:
Lack of cooperation for attending medical sessions
Age
From 5 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Academic Complex of the Great Prophet, Basij Square,Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.ARAKMU.REC.1397.259
Health conditions studied
1
Description of health condition studied
The amount of pain and anxiety of a child during dental treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pulse rate
Timepoint
The pulse rate in each treatment is measured three times and recorded by the dentist's assistant. 1 minute after the start of the method of disturbing the senses. 2. During local anesthetic injection. 3. At pulp exposure.
Method of measurement
To measure the heart rate and oxygen saturation, Microlife AG, Widnau, Switzerland (OXY 300) will be used by placing the probe on the left hand side of the baby's finger.
2
Description
faces pain rating
Timepoint
The FPR criterion is measured at the end of treatment
Method of measurement
The FPR is scored and recorded by the child using the FPR image.
3
Description
Sound Eye Motor pain(SEM)
Timepoint
The SEM criterion is measured and recorded at the time of anesthetizing injection
Method of measurement
The SEM criterion evaluates the status of the sounds, eyes, and child movements according to the SEM table and recorded by the dentist's assistant.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: spoken cartoon, a 30-minute cartoon Tom and Jerry on a 17-inch LCD display on the dental unit's arm, about 120 cm from the patient's eyes
Category
Prevention
2
Description
Intervention group: silent cartoon, a 30-minute cartoon Tom and Jerry on a 17-inch LCD display on the dental unit's arm, about 120 cm from the patient's eyes
Category
Prevention
3
Description
Control group:In this study, each person is considered as a controller and receives one session of one of the interventions and the other session does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Hamid Sarlak's office Pediatric Dentistry
Full name of responsible person
Hamid Sarlak
Street address
Fifth Floor,Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
City
Arak
Province
Markazi
Postal code
3813634159
Phone
+98 86 3222 3794
Email
Dr.hamidsarlak@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Arjmandzadegan
Street address
Academic Complex of the Great Prophet,Basij Square,Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Email
mmatinam81@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Sarlak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Fifth Floor,Mir Ahmad Building, Azod Corner, Shahid Beheshti Street
City
Arak
Province
Markazi
Postal code
3813634159
Phone
+98 86 3222 3794
Email
Dr.hamidsarlak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sara Jafari Mofrad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Narges Hostel, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+27 6632722486
Email
S_jafari73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sara Jafari Mofrad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Narges Hostel, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 66 3272 2483
Email
S_jafari73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data are publishable
When the data will become available and for how long
one year after publishing results
To whom data/document is available
All researcher in universities and research centers
Under which criteria data/document could be used
There are no conditions
From where data/document is obtainable
Dr Hamid Sarlak
What processes are involved for a request to access data/document
Request a person by email
Investigating university affiliation of the requesting person
Send information via email
The maximum time of this process is one month.