A comparative evaluation of audial and visual behavioral management techniques on the anxiety of 6-12 year old children undergoing dental treatment:a clinical trial
Determining the effect of audial and visual behavioral control methods on the level of anxiety of children undergoing dental treatment
Design
Clinical trial with control group, with 2 parallel groups, double-blind, randomized allocation, on 90 patients.
Settings and conduct
Patients referred to the pediatric dentistry department of Shahid Beheshti University are randomly assigned to one of the three groups: control (usual behavioral control including tell-show-do), audial group (play music) and visual group (play cartoons by tablet). All treatments will be performed by one dentist (pediatric resident). The child's anxiety will be checked according to MCDAS (child's self-report), heart rate and blood oxygen level (pulse oximetry), the level of acceptance of the child by asking her/him and will be confirmed by the relevant instructor. The data is collected by a person who is not aware of the treatment steps and then checked and compared in spss software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age of the child is between 6 and 12 years
Lack of previous experience in dentistry
Dental treatments that require anesthesia.
Absence of mental and systemic diseases
Non-entry criteria:
.Complex and time-consuming treatment
· Unusual non-cooperation of the child
· dissatisfaction of the patient's parents to participate in the study
Intervention groups
Control group: tell-show-do
Intervention groups: audial group, visual group
the child's favorite story, poem or song is played by handsfree.
and child's favorite cartoon will be played without sound for the child.
Main outcome variables
Child's anxiety level by MCDAS; heart rate and blood oxygen level by pulse oximetry; child acceptance level
General information
Reason for update
Acronym
MCDAS (Faces version of Modified child dental anxiety scale)
IRCT registration information
IRCT registration number:IRCT20230106057065N1
Registration date:2023-01-11, 1401/10/21
Registration timing:registered_while_recruiting
Last update:2023-01-11, 1401/10/21
Update count:0
Registration date
2023-01-11, 1401/10/21
Registrant information
Name
Fateme Kalantari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4434 1610
Email address
fa.kalantari1995@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-16, 1401/09/25
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of audial and visual behavioral management techniques on the anxiety of 6-12 year old children undergoing dental treatment:a clinical trial
Public title
A comparative evaluation of audial and visual behavioral management techniques on the anxiety of children undergoing dental treatment:a clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the child is between 6 and 12 years
No previous experience in dentistry
Dental treatments that require anesthesia
Absence of mental and systemic diseases
Exclusion criteria:
Complex and time-consuming treatment
Unusual non-cooperation of the child
Dissatisfaction of the patient's parents to participate in the study
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule
According to the sample size, 3 intervention groups are placed inside balls in a lottery container, and referring patients randomly remove the balls from the container without replacement.
Blinding (investigator's opinion)
Double blinded
Blinding description
Informed consent was obtained from the patient's parents to participate in the 3 groups: tell-show-do, audio, video randomly selected by their child.
Collection of physiological information pulse rate and oxygen saturation level of blood (pulse oximetry) and information related to the child's anxiety level (MCDAS) and her level of acceptance are collected by a person who is not aware of the intervention and study.
The collected data is also analyzed by a person who is not aware of the study.
It should be noted that the intervention is performed by one person, who is a pediatric dentistry resident.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Faculty of Dentistry, Shahid Beheshti University, Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.SBMU.DRC.REC.1401.088
Health conditions studied
1
Description of health condition studied
The level of anxiety of children undergoing dental treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
MCDAS: The child's anxiety level is reported by the emoticons shown by the child.
Timepoint
Before-during-after treatment
Method of measurement
by emoticons and MCDAS questions
2
Description
Pulse rate
Timepoint
Before-during-after treatment
Method of measurement
pulse oximeter
3
Description
Blood oxygen saturation level
Timepoint
Before-during-after treatment
Method of measurement
pulse oximeter
4
Description
Child acceptance rate
Timepoint
After treatment
Method of measurement
by 3 questions that are asked by the blinded person and the last question includes a visual analog scale that is reported by the child.
5
Description
Age of the patient
Timepoint
Before treatment
Method of measurement
Demographic information sheet
6
Description
gender of the patient
Timepoint
Before treatment
Method of measurement
Demographic information sheet
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Tell-show-do, In this method, all the tools used are explained to the child before the treatment.
Category
Behavior
2
Description
Intervention group: Audial group, In this method, the child's favorite story, poem, song or music is played by hands-free.
Category
Behavior
3
Description
Intervention group: Visual group, in this method, the child's favorite cartoon is played without sound.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Faculty of Dentistry
Full name of responsible person
Fateme Kalantari
Street address
Daneshjou Boulevard, velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
fa.kalantari1995@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Kalantari
Street address
Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 935 914 4941
Email
fa.kalantari1995@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Kalantari
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
fa.kalantari1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Kalantari
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Science, Daneshjou Boulvard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
Email
fa.kalantari1995@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Kalantari
Position
Resident of pediatric dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Science, Daneshjou Boulvard, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
Email
fa.kalantari1995@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data collected from the study and analysis can be published without mentioning the names of the participants.
When the data will become available and for how long
Beginning of the access period after 1402
To whom data/document is available
Collected data without mentioning the names of the participants will be provided to the researchers for reference if needed to conduct other studies.
Under which criteria data/document could be used
To conduct other studies
From where data/document is obtainable
To access the data, send a message to the email of Fateme Kalantari.
What processes are involved for a request to access data/document
After receiving the email, the data will be sent with permission from the relevant instructor.