Comparison effect of virtual reality glasses and audio distraction in reducing anxiety and pain during inferior alveolar nerve block in children aged 7 to 10 years
Comparison effect of virtual reality glasses and audio distraction in anxiety and pain during inferior alveolar nerve block in children aged 7 to 10 years
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 45 children aged 7-10 years will be selected by available sampling from among the children referred to the Yazd Dental School clinic and need inferior alveolar nerve block. Heart rate and blood pressure will be measured before and after the injection. We measure blood pressure and heart rate before and after injection in all three groups and use three questionnaires to measure pain and anxiety subjectively.
Participants/Inclusion and exclusion criteria
7-10 year old children referred to the pediatric department of Yazd University of Medical Sciences Faculty of Dentistry.
The inclusion criteria include the presence of caries in the mandibular deciduous teeth that require lower alveolar block injection, no history of intraoral injection, no allergy to lidocaine, no history of pain due to pulp inflammation, no primary anxiety disorder and no unsuccessful and unfavorable experience in It was subject to medical treatment.
Intervention groups
In the first intervention group, the child uses virtual reality glasses during anesthesia injection.
In the second intervention group, the child uses headphones during anesthesia injection.
In the control group, injections are performed routinely.
Main outcome variables
FLACC index score; WBFP index score; changes in blood pressure; heart rate changes; FIS index score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230614058486N1
Registration date:2023-06-24, 1402/04/03
Registration timing:registered_while_recruiting
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Kazem Vaez
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 0820 4050
Email address
m.irannezhad@stu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-18, 1402/03/28
Expected recruitment end date
2023-08-19, 1402/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of virtual reality glasses and audio distraction in reducing anxiety and pain during inferior alveolar nerve block in children aged 7 to 10 years
Public title
Comparison effect of virtual reality glasses and audio distraction in reducing anxiety and pain during inferior alveolar nerve block in children aged 7 to 10 years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of caries in the mandibular primary teeth that requires inferior alveolar nerve block injection
Exclusion criteria:
history of intraoral injection
allergic to Lidocaine
History of pain due to pulp inflammation
Primary anxiety disorder
Unsuccessful and adverse experience with medical treatments
History of anesthesia injection
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
A statistical consultant, who had no role in patient selection or outcome evaluation, prepared three lists of 15 people. Three lists were generated by simple random sampling using computer randomization methods. This list showed the type of injection in the treatment session. Patients were assigned a number based on the order of referral, and this number was one of the interventions based on which of the three lists it was located in.
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 Yazd University of Medical Sciences
Street address
No. 5, sixth floor, block A, Noor tower , jam e jam Ave., Sameyi Blvd.
City
Yazd
Province
Yazd
Postal code
8949193118
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1401.072
Health conditions studied
1
Description of health condition studied
pain and anxeity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain and anxiety using: FLACC index score; WBFP index score; changes in blood pressure; heart rate changes; FIS index score
Timepoint
Before and immediately after the intervention
Method of measurement
Pain and stress using: FLACC index score; WBFP index score; changes in blood pressure; Changes in heart rate with wrist sphygmomanometer and FIS index score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the first intervention group, the child uses virtual reality glasses during anesthesia injection. Tools used in virtual reality include audio-visual glasses connected to a mobile phone that will play a similar cartoon during dental treatment.
Category
Treatment - Devices
2
Description
Intervention group: Second intervention group: For children participating in the second intervention group, there is no picture and only the sound of the cartoon will be played (headset).
Category
Treatment - Devices
3
Description
Control group: In the control group, the work is done without any of these devices and with usual and routine distraction methods for the patient.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of pediatric dentistry, Yazd Faculty of Dentistry
Full name of responsible person
Kazem Vaez
Street address
No. 5, sixth floor, block A, Noor tower , jam e jam Ave., Sameyi Blvd.
City
Yazd
Province
Yazd
Postal code
8949193118
Phone
+98 35 8204 0500
Email
vaez.kazem@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi Abarghouei
Street address
Shahid Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 7254 7500
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Zahra bahrololoomi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Yazd Faculty of Dentistry , Emam Reza sq
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 7254 7500
Email
zbahrololoom@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Zahra bahrololoomi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Yazd Faculty of Dentistry , Emam Reza sq
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 7254 7500
Email
zbahrololoom@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Kazem Vaez
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 5 , sixth floor , bloc A , Noor tower , Jam e jam Ave. , Sameyi Blvd
City
Yazd
Province
Yazd
Postal code
8949193118
Phone
+98 35 0820 4050
Fax
Email
M.irannezhad@stu.ac.ir
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