Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000729527
Ethics application status
Approved
Date submitted
12/04/2024
Date registered
13/06/2024
Date last updated
13/06/2024
Date data sharing statement initially provided
13/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effect of virtual reality distraction techniques on pain and anxiety in pediatric dental patients during local anesthesia administration.
Scientific title
Evaluating the effect of virtual reality distraction techniques on pain and anxiety in pediatric dental patients during local anesthesia administration.
Secondary ID [1] 311957 0
Nil known
Universal Trial Number (UTN)
U1111-1302-7119
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in Children's Dental Patients 333555 0
Anxiety in Pediatric Dental Patient 333798 0
Condition category
Condition code
Anaesthesiology 330241 330241 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Virtual reality (VR) distraction technique uses VR goggles distraction (showing a 3D children's cartoon show) versus the ordinary screen during infiltration Local Anesthesia Administration in children aged 6-12 years old in The Dental clinics of the College of Dentistry at Qassim University, Saudi Arabia.
the treated children will be randomly divided into two equal groups: the study group (using the VR distraction technique) and the control group (using an ordinary screen show ).
The VR goggles will be applied 10 minutes before the local anesthesia administration and removed 5 minutes after the local anesthesia injection is complete. A General dentist will perform all the procedures.
Intervention code [1] 328416 0
Behaviour
Comparator / control treatment
During the Infiltration Local Anesthesia Administration for Children, cartoon movies are shown on an ordinary screen for 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 337988 0
1-Dental Pain (a composite primary outcome)
Timepoint [1] 337988 0
Participants will be randomly assigned to a VR goggles distraction or screen group.
1- FLACC: will be measured for both groups of Participants exactly at the time of the Local Anesthesia administration.
2- The wong-Baker FACES pain rating scale will be measured for both groups of Participants immediately after finishing the local anesthesia procedure.
Secondary outcome [1] 433995 0
Dental Anxiety (this will be assessed as a composite outcome’)
Timepoint [1] 433995 0

1-Heart rates (HR) using a pulse oximeter will be will be measured for both groups of Participants in three-time intervals:
a- At baseline measurement, before the dental procedure, the participant will be given a pulse oximeter to record their heart rate and obtain baseline pain and anxiety levels.
b- exactly the time of the Local Anesthesia administration for the participant.
c. immediately after finishing the local anesthesia procedure for the participant'.
2- MCDAS(f): will be used in a Follow-up measurement. The participant will fill out the Modified Child Dental Anxiety Scale (MCDAS(f)) after 24 hours and again after a week to assess long-term pain and anxiety levels

Eligibility
Key inclusion criteria
1. Children aged 6 to 12 years old
2. .Scheduled to undergo dental treatment involving local infiltration anesthesia
3. Able to understand and communicate using the Arabic language
4. .Have no history of neurological or psychological disorders
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of subjects into study and control groups uses a simple randomization table created by computer software (computerized sequence generation) to decode the coming patients and assign them to either the control or study group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analyzed using SPSS (Statistical Package for Social Science) program with appropriate statistical methods to determine the association between VR distraction and pain and anxiety levels in pediatric dental patients undergoing infiltration anesthesia. The descriptive statistics will perform to summarize the demographic and clinical characteristics of the study population, including age, sex, and types of dental procedures. Mean, and standard deviation will be used for continuous variables, while frequency and percentages will be used for categorical variables. We will use a mixed-effects model for repeated measures to evaluate the primary outcome of pain and anxiety levels during infiltration anesthesia. This will enable us to evaluate differences in pain and anxiety levels between the two groups at different time points. Also will perform a subgroup analysis to assess whether or not the effect of VR distraction on pain and anxiety levels during infiltration anesthesia differs by age, sex, or type of dental procedure. The statistical significance level will be set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/02/2024
Date of last participant enrolment
Anticipated
Actual
23/05/2024
Date of last data collection
Anticipated
Actual
27/05/2024
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26246 0
Saudi Arabia
State/province [1] 26246 0
Qassim

Funding & Sponsors
Funding source category [1] 316294 0
Self funded/Unfunded
Name [1] 316294 0
Country [1] 316294 0
Primary sponsor type
Individual
Name
Thiyezen Abdullah Aldhelai, College of Dentistry , Qassim University
Address
Country
Saudi Arabia
Secondary sponsor category [1] 318481 0
None
Name [1] 318481 0
Address [1] 318481 0
Country [1] 318481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315114 0
Committee of Research Ethics, Deanship of Scientific Research, Qassim University.
Ethics committee address [1] 315114 0
Ethics committee country [1] 315114 0
Saudi Arabia
Date submitted for ethics approval [1] 315114 0
01/06/2023
Approval date [1] 315114 0
25/01/2024
Ethics approval number [1] 315114 0
24-74-05
Ethics committee name [2] 315116 0
Taibah University College of Dentistry , Research Ethics Committee (TUCD-REC)
Ethics committee address [2] 315116 0
Ethics committee country [2] 315116 0
Saudi Arabia
Date submitted for ethics approval [2] 315116 0
04/12/2023
Approval date [2] 315116 0
03/01/2024
Ethics approval number [2] 315116 0
TUCDREC/051223/TAlDhelai

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133714 0
Dr Thiyezen Abdullah AlDhelai
Address 133714 0
Saudi Arabia, 51452, Qassim, Buraydah, Al Mulaida, beside Saudi Aramco (Qassim Branch) and Prince Nayef bin Abdulaziz international Airport.
Country 133714 0
Saudi Arabia
Phone 133714 0
+966581168075
Fax 133714 0
Email 133714 0
[email protected]
Contact person for public queries
Name 133715 0
Thiyezen Abdullah AlDhelai
Address 133715 0
Saudi Arabia, 51452, Qassim, Buraydah, Al Mulaida, beside Saudi Aramco (Qassim Branch) and Prince Nayef bin Abdulaziz international Airport.
Country 133715 0
Saudi Arabia
Phone 133715 0
+966581168075
Fax 133715 0
Email 133715 0
[email protected]
Contact person for scientific queries
Name 133716 0
Thiyezen Abdullah AlDhelai
Address 133716 0
Saudi Arabia, 51452, Qassim, Buraydah, Al Mulaida, beside Saudi Aramco (Qassim Branch) and Prince Nayef bin Abdulaziz international Airport.
Country 133716 0
Saudi Arabia
Phone 133716 0
+966581168075
Fax 133716 0
Email 133716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results only,
When will data be available (start and end dates)?
Immediately following publication, no end date determine
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
contact the Principal Investigator via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22180Ethical approval    387664-(Uploaded-12-04-2024-21-17-48)-Study-related document.pdf
22181Ethical approval    387664-(Uploaded-12-04-2024-21-18-12)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.