Comparative study of the effect of music playback and use of 3D Audiovisual glasses on pain and severity of anxiety rate during injection in 4-10 year-old children referred to Anzali s Dental Clinic
Comparison of two methods of playing music and using 3D audio-visual glasses in controlling pain and anxiety during injection in children 4-10 years old
Design
Intervention clinical trial with control group, block randomization in which all possible modes will be written for 3 sessions of treatment in terms of receiving the intervention and 6 modes or blocks will be created. Then 5 people will be randomly placed in each block up to 30 people.
Settings and conduct
Samples are randomly blocked from children referred to the pediatric ward of Anzali Dental Clinic, which will be injected and treated by a final year student.
Participants/Inclusion and exclusion criteria
Children 4-10 years old who need infusion injection behind the maxilla and refer to the clinic of Anzali School of Pediatrics.
Non-entry criteria: need for medical treatment to cooperate; medical problems such as history of seizures, gastrointestinal disorders, eye problems, autism and any mental or psychological illness that according to the Frankl scale is negative or completely negative cooperation.
Intervention groups
Depending on the blocks in which they are randomly placed, the children will be shown Tom and Jerry cartoons through 3D glasses for 1 minute, Uncle Purang's music will be played through headphones, or basic behavioral control will be used. Basic Behavior The dentist communicates with the patient through speech without the use of distraction (using glasses or playing music).
Main outcome variables
Pain score on FLACC criterion; anxiety intensity score on FIS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210108049963N1
Registration date:2021-02-03, 1399/11/15
Registration timing:prospective
Last update:2021-02-03, 1399/11/15
Update count:0
Registration date
2021-02-03, 1399/11/15
Registrant information
Name
Seyedeh nazanin Mazloumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3282 8204
Email address
nazanin_mazloumi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-06, 1399/11/18
Expected recruitment end date
2021-02-23, 1399/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of music playback and use of 3D Audiovisual glasses on pain and severity of anxiety rate during injection in 4-10 year-old children referred to Anzali s Dental Clinic
Public title
A comparative study of two methods of playing music and the use of 3D audio-visual glasses in controlling pain and anxiety during injection in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Requires one examination session and three sessions of dental treatment and requires infiltration injection behind the maxilla
Parental consent patient
The child's consent to the use of distractions
Good general health
Do not enter children who have epilepsy
According to the Frankel scale, positive cooperation (accepts treatment, sometimes shows cautious behavior, sometimes reluctant to follow a dentist but follows him directly) or completely positive (reports dentist That the child has a lot of cooperation in the work process and laughs and enjoys)
Lack of pediatric dental history (be the first visit to the dentist)
Exclusion criteria:
Need medication to cooperate
Medical problems such as history of seizures or seizure disorders, gastrointestinal or balance disorders, eye problems, autism and any other mental illness
Children who have a negative or completely negative cooperation according to the Frankl scale
The presence of any abscess in the area of the injection site
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly blocked from children referred to the pediatric ward of Anzali Dental Clinic, which will be injected and treated by a final year student under the supervision of a pediatric dentist.
Block randomization will be done in such a way that all possible modes will be written for 3 sessions of treatment in terms of receiving the intervention and 6 modes or blocks will be created. Then 5 people will be randomly placed in each block to get 30 people in the blocks.
Block 1: The first session of music - the second session of video - the third session of behavioral control
Block 2: The first session of music - The second session of behavioral control - The third session of video
Block 3: The first session of the video - the second session of music - the third session of behavioral control
Block 4: The first session of the video - the second session of behavioral control - the third session of music
Block 5: The first session of behavioral control - the second session of video - the third session of music
Block 6: The first session of behavioral control - the second session of music - the third session of video
Blinding (investigator's opinion)
Single blinded
Blinding description
The FLACC criteria will be used to assess the child's pain. The recording of this scale is done by the assistant so that he does not know the type of intervention, in other words, the study will be done single-blind. The child's face, legs, activity, crying, and submissiveness are assessed. This criterion is classified from zero (completely calm) to 10 (severe pain / anxiety).
Also, the child's anxiety will be assessed immediately after the infiltration injection in the posterior maxilla using the FIS (facial image scale). Previously, the assistant explained the smileys and how to show the feeling to the child, and after the injection, the child is asked to mark the appropriate smile depending on the degree of discomfort.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
In front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St.
City
Rasht
Province
Guilan
Postal code
4194173774
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.GUMS.REC.1399.503
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F93.2 Soci
ICD-10 code description
In this disorder there is a wariness of strangers and social apprehension or anxiety when encountering new, strange, or socially threatening situations. This category should be used only where such fears arise during the early years, and are both unusual
Primary outcomes
1
Description
Pain score on FLACC criteria
Timepoint
During injection of infiltrator behind the maxilla
Method of measurement
The FLACC criterion will be used to assess the child's pain. The recording of this scale is done by the assistant so that he does not know the type of intervention. The state of the child's face, legs, activity, crying and surrender are evaluated. This criterion is classified from zero (completely calm) to 10 (severe pain / anxiety).
2
Description
Anxiety score on the FIS scale
Timepoint
During injection of infiltrator behind the maxilla
Method of measurement
The child's anxiety will be assessed immediately after the infiltration injection in the posterior part of the maxilla using a facial image scale (FIS), in which the assistant first explains the smileys and how to show the feeling to the child and asks the child after the injection. Depending on the degree of discomfort, mark the appropriate face.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will visit 4 times a week, in the first session will be examined and prescribed radiographs and recorded medical and dental history and completed the file and fluoride prophylaxis. Children who interact negatively or completely negatively with the Frankel scale will be excluded from the study. In the second, third, and fourth sessions, the children will receive the necessary dental treatment, and depending on the block in which they are randomly placed, the first intervention for them is a full-length cartoon for 1 minute while injected with 3D glasses ( Shinecon VR model) is played
Category
Prevention
2
Description
Intervention group: Uncle Purang's music is played by headphones for 1 minute during injection
Category
Prevention
3
Description
Control group:In the basic behavioral control group, the dentist communicates with the patient through speech without the use of distraction (using glasses or playing music).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric ward of Anzali Dental Clinic
Full name of responsible person
Seyedeh nazanin mazloumi
Street address
30 meters boulevard
City
Bandar anzali
Province
Guilan
Postal code
4314637758
Phone
+98 13 4455 3185
Fax
+98 13 4455 3184
Email
ib@gums.ac.ir
Web page address
https://www.gums.ac.ir/ib
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
In front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Web page address
https://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh hedyeh daneshvar
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
In front of Caspian and Padideh restaurants, 2 km towards Fooman, Saravan belt, end of Lakan road, Gas Sq.
City
Rasht
Province
Guilan
Postal code
73774 41941
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
dr.daneshvar@gums.ac.ir
Web page address
https://www.gums.ac.ir/dental
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh hediyeh daneshvar
Position
Specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
In front of Caspian and Padideh restaurants, 2 km towards Fooman, Saravan belt, end of Lakan road, Gas Sq.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
dr.daneshvar@gums.ac.ir
Web page address
https://www.gums.ac.ir/dental
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh nazanin mazloumi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
In front of Caspian and Padideh restaurants, 2 km towards Fooman, Saravan belt, end of Lakan road, Gas Sq.
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6406
Fax
+98 13 3348 6423
Email
Nazanin_mazloumi@yahoo.com
Web page address
https://www.gums.ac.ir/dental
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data such as information about reducing pain and anxiety during infiltration injection is shared
When the data will become available and for how long
After printing the results
To whom data/document is available
Dentists, Pediatricians, researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using intervention groups such as 3D glasses or music instead of basic behavioral control to reduce pain and anxiety
From where data/document is obtainable
Guilan University of Medical Sciences International Campus Library
What processes are involved for a request to access data/document
Visit the library site of Bandar Anzali International Faculty and search for defended dissertations and approved research projects from 2020onwards