Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001321639
Ethics application status
Approved
Date submitted
1/07/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of age and gender on the effectiveness of audiovisual distraction on pain and dental anxiety in children
Scientific title
The influence of age and gender on the effectiveness of audiovisual distraction on pain and anxiety during inferior alveolar nerve block in children: a randomized controlled trial
Secondary ID [1] 310020 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental anxiety 330547 0
Condition category
Condition code
Anaesthesiology 327389 327389 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants were randomly allocated into three groups. Group 1 (Control group): Inferior alveolar nerve block (IANB) administrated with Tell-Show-Do (TSD) technique. Group 2: IANB administrated. Virtual reality box ‘VR Box’ was used for audiovisual distraction as an entertainment system, which can block the visual field of the child completely and the sound were delivered by a wireless headphone.
Group 3: IANB administrated. Tablet device was used for audiovisual distraction. The tablet is capable of playing MP4 audio-visual files, was fixed on the hand of the dental chair using tablet holder.
VR Box and tablet device was used as means of distraction during performing IANB by a dentist. The intervention was delivered for one time at Damascus University.
Intervention code [1] 326441 0
Treatment: Other
Comparator / control treatment
IANB administrated by a dentist with Tell-Show-Do (TSD) technique, which is a basic behavior management technique.
The TELL phase involves an age appropriate explanation of the procedure. The SHOW phase is used to demonstrate a procedure up to the point where the instrument is performed. The DO phase is then initiated and the treatment is performed.
Control group
Active

Outcomes
Primary outcome [1] 335260 0
Anxiety levels using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale
Timepoint [1] 335260 0
Within the first minute of injection
Primary outcome [2] 335262 0
Pain levels using the Wong-Baker Faces Pain Rating Scale
Timepoint [2] 335262 0
Five minutes following the injection
Primary outcome [3] 335263 0
Change in pulse rate using pulse oximeter
Timepoint [3] 335263 0
five minutes after the patient is seated comfortably on the dental chair, (2) five minutes following the injection
Secondary outcome [1] 423655 0
Behavior rate Houpt behavior rating scale
Timepoint [1] 423655 0
Within the first minute of injection

Eligibility
Key inclusion criteria
1. No previous dental experience.
2. Healthy children.
3. Children that are definitely positive or positive according to Frank scale.
Minimum age
6 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Special Health Care Needs (SHCNs)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/03/2023
Date of last participant enrolment
Anticipated
Actual
24/05/2023
Date of last data collection
Anticipated
Actual
24/05/2023
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 25620 0
Syrian Arab Republic
State/province [1] 25620 0

Funding & Sponsors
Funding source category [1] 314198 0
University
Name [1] 314198 0
Damascus University
Country [1] 314198 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
Mawia Karkoutly
Address
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 316117 0
Individual
Name [1] 316117 0
Nada Bshara
Address [1] 316117 0
Nada Bshara, Damascus University, Mazzeh Highway, Damascus, Syria
Country [1] 316117 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313325 0
Institutional Review Board at Damascus University
Ethics committee address [1] 313325 0
Ethics committee country [1] 313325 0
Syrian Arab Republic
Date submitted for ethics approval [1] 313325 0
Approval date [1] 313325 0
01/03/2023
Ethics approval number [1] 313325 0

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

Contacts
Principal investigator
Name 127738 0
Dr Mawia Karkoutly
Address 127738 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 127738 0
Syrian Arab Republic
Phone 127738 0
+963992647528
Fax 127738 0
Email 127738 0
[email protected]
Contact person for public queries
Name 127739 0
Mawia Karkoutly
Address 127739 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 127739 0
Syrian Arab Republic
Phone 127739 0
+963992647528
Fax 127739 0
Email 127739 0
[email protected]
Contact person for scientific queries
Name 127740 0
Mawia Karkoutly
Address 127740 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 127740 0
Syrian Arab Republic
Phone 127740 0
+963992647528
Fax 127740 0
Email 127740 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?
Demographic data
Outcomes
When will data be available (start and end dates)?
Currently available with no end date
Available to whom?
Editors/reviewers
None has reviewed or edited research publications yet.
Available for what types of analyses?
Descriptive (frequencies, percentages)
How or where can data be obtained?
On a reasonable request by emailing the principal investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



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.