The effect of video games on self assessment and reaction to pain during anesthesia injection of lower alveolar nerve block in children 6 to 9 years.
Design
The present study is a one-way randomized controlled clinical trial. Using the sample size formula, 17 people in each group were calculated. It should be noted that the researcher increased the number of samples to 30 people in each group to increase the accuracy of the study. Children are selected by available sampling method. Children from 6 to 9 years old are assigned to the control group and the distraction group based on the random number table.
Settings and conduct
The present study is a single-blind randomized controlled clinical trial. The statistical population includes 60 children referred to the pediatric dentist's office. The ACC and Wong-Baker FL are measured during injection.
Participants/Inclusion and exclusion criteria
Children without previous experience with LA in dentistry
No gag reflex
Participants in the study are children 6-9 years old.
Patients , who needed dental treatment in lower arch
Patients , who needed anesthesia injection of lower alveolar nerve block
The presence of parents with the child.
Not having verbal and auditory disorders, absence of acute and chronic diseases
Having the ability to communicate;
Intervention groups
The vote of both groups uses a standard text to create verbal distraction. For the main injection, a 2% carpol lidocaine containing 1.80000pinephrine will be used. For the intervention group, 5 minutes before the lower alveolar nerve block anesthesia injection, the distraction process begins with a video game on a mobile phone given to the subjects. . The video game used was related to SEGA's Sonic series games.
Main outcome variables
reaction to pain during anesthesia injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201124049479N1
Registration date:2021-08-16, 1400/05/25
Registration timing:retrospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Azam Nahvi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 5176
Email address
a.nahvi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of video games on self assessment and reaction to pain during anesthesia injection of lower alveolar nerve block in children 6 to 9 years
Public title
The effect of video games on self assessment and reaction to pain during anesthesia injection of lower alveolar nerve block in children 6 to 9 years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children without previous experience with LA in dentistry
No gag reflex
Participants in the study are children 6-9 years old.
Patients , who needed dental treatment in lower arch
Patients , who needed anesthesia injection of lower alveolar nerve block
The presence of parents with the child.
Not having verbal and auditory disorders, absence of acute and chronic diseases
Having the ability to communicate;
Exclusion criteria:
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Children are assigned individually to the control group and distraction group based on a table of random numbers by simple randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data Analyzer The person who analyzed the data collected during the study was blinded by coding the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Caspian Boulevard
City
Sari
Province
Mazandaran
Postal code
48157339710
Approval date
2020-08-31, 1399/06/10
Ethics committee reference number
1399.567
Health conditions studied
1
Description of health condition studied
Anesthesia injection of the lower alveolar nerve block
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
reaction to pain during anesthesia injection
Timepoint
in intervention
Method of measurement
FLACC scale-Wong-Baker
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 5 minutes before the anesthetic injection of the inferior alveolar nerve block, the process of creating distraction begins with a video game on a mobile phone that is given to the subjects. At the end of the injection and before starting occupational therapy, the subjects can use the game. The video game used is related to the Sonic series games from SEGA company
Category
Behavior
2
Description
Control group: For initial mucosal anesthesia, a cotton ball soaked in 20% topical benzocaine gel is used for 30 seconds 30 seconds after drying the mucosa with a sterile gauze. For the main injection, a 2% carpol lidocaine containing 1.8000pinephrine (Daroo Pakhsh, Tehran, Iran) and a needle with a 27 gauge are used.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Dr. Nahvi
Full name of responsible person
ََAzam Nahvi
Street address
Farhang Ave, 15 Khordad Ave.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
Azamnahvi.pedodontist@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saidi
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
azamnahvi.pedodontist@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Nahvi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
azamnahvi.pedodontist@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Nahvi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
azamnahvi.pedodontist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Nahvi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
azamnahvi.pedodontist@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available