Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age.
Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age.
Design
The randomized clinical trial study will be conducted in the form of three parallel groups (two intervention groups and one control group).Since the nature of the intervention was not able to conceal the samples and researchers, blinding will not be applicable in this study. The random function of Excel software will be used for randomization.
Settings and conduct
A sample of 81 children aged 5 to 10 years will be selected from among the children referred to the clinic of Azad Univercity of Dentistry in Tehran and in need of inferior alveolar nerve block. Physiological levels of anxiety will be measured using blood oxygen saturation percentage and pulse rate before and after injection. The intensity of anxiety is measured using the FACES test before and after the injection, and it will be measured using the SEM test during and after the injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
5 to 10 years old children, Inferior alveolar nerve block to be mandatory for dental treatment, Obedient children based on Frankel's classification (positive and completely positive)
Exclusion criteria:
Previous dental experience, Current Systemic disease, Current Medically controlled Psychiatric disease, Hospitalization history
Intervention groups
In the first intervention group, the child actively participates in the fidget spinner game during anesthesia injection. In the second intervention group, the child passively uses headphones during anesthesia injection. In the control group, injections are performed routinely.
Main outcome variables
changes in oxygen saturation percentage; pulse rate changes; FACES index changes; Changes in the SEM index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230829059296N1
Registration date:2023-09-06, 1402/06/15
Registration timing:prospective
Last update:2023-09-06, 1402/06/15
Update count:0
Registration date
2023-09-06, 1402/06/15
Registrant information
Name
Niayesh Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 9828
Email address
nia78e@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2024-01-04, 1402/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age.
Public title
Comparative Evaluation of Passive and Active Distraction Techniques on Anxiety Level during Anesthetic Injection among Children of 5 to 10 years of Age.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
5 to 10 years old children
Inferior Alveolar Nerve Block to be mandatory for dental treatment
Obedient children based on Frankel's classification (positive and completely positive)
Exclusion criteria:
Previous Dental Experience
Current Systemic Disease
Current Medically Controlled Psychiatric Disease
Hospitalization History
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, samples are selected by convenience sampling. In this way, the samples that met the conditions for entering the study are chosen. In the second stage, the random assignment of samples is done by the random sequence created on the statistical website www.randomizer.org with a ratio of 1:1:1 to three groups of active(fidget spinner game), passive (listening to music), and control so that in each group, 27 people are included.
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
Ethical Commitee,Deputy of Research , Dental school , Tehran Islamic Azad University
Street address
No:4; 10th Neyestan; Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.092
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
Primary outcomes
1
Description
changes in oxygen saturation percentage
Timepoint
Before and immediately after injection.
Method of measurement
A pulse oximeter device on the finger
2
Description
Pulse rate changes
Timepoint
Before and immediately after injection
Method of measurement
A pulse oximeter device on the finger
3
Description
changes in FACES index
Timepoint
Before and immediately after injection
Method of measurement
FACES index score
4
Description
Changes in the SEM index
Timepoint
During injection and immediately after injection
Method of measurement
SEM index score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fidget Spinner game group (active entertainment); Patients in this group are introduced to the fidget spinner before the injection, and they are asked to actively participate in this game during the injection of the inferior alveolar block.
Category
Behavior
2
Description
Intervention group: group listening to music (passive distraction); The child is asked to listen to the music played through headphones. To minimize bias, instead of allowing children to choose their favorite music, a piece of music was played during the injection
Category
Behavior
3
Description
Control group: No special distraction method is used for them during the injection.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Tehran Islamic Azad University
Full name of responsible person
Niayesh Ebrahimi
Street address
No:4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nia78e@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No:4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nia78e@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dental School, Tehran Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Niayesh Ebrahimi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, Saeedi Ave., South Sarrafha Blvd., Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998863465
Phone
+98 21 8868 9828
Email
nia78e@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sepide Majzoobi
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No:4, 10th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
se.majzoubi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Niayesh Ebrahimi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 4, Saeedi Ave., South sarafha Blv., Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998863465
Phone
+98 21 8868 9828
Email
nia78e@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
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