Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000706875
Ethics application status
Approved
Date submitted
19/04/2020
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of virtual reality and anaglyph 3D glasses on children's behavior
Scientific title
Effectiveness of Virtual Reality Eyeglasses Compared to Anaglyph 3D Glasses on Children's Behavior During Inferior Alveolar Nerve Block :Randomized Controlled Trial
Secondary ID [1] 301065 0
none
Universal Trial Number (UTN)
U1111-1250-5770
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 317124 0
Anxiety 317125 0
Children behavior 317126 0
Inferior alveolar nerve block 319882 0
Condition category
Condition code
Oral and Gastrointestinal 315283 315283 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 317819 317819 0 0
Pain management
Mental Health 317820 317820 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
66 Eligible Children aged 4-9 years will be randomly enrolled into three groups:
Group A: Using virtual reality (VR) eyeglasses as a distraction aid
Group B: Using anaglyph 3D glasses as a distraction aid
Group C: Control group (No distraction aid will be provided)
Children will be informed of the group assignment after randomization to minimize patient expectations and/or disappointment.
Children and parents will remain in private unit before being transferred into the dental clinic. Parents will be given a written and verbal description of what to expect when they enter the clinic. All Cartoons will be rated ‘E’ for ‘everyone’ and will be self-selected by children from a variety of 10 Cartoon shows.
Parents and patient will be escorted into the clinic where standard pre-anesthesia procedures will be carried out prior to inferior alveolar nerve block (IANB) in all three groups. Then, Pulse-oximeter will be placed on children's index before the induction of dental anesthesia and the reading will be recorded.
Before the administration of anesthesia, children in group A and group B will be given VR eyeglasses and anaglyph 3D glasses to wear respectively while children in group C will act as a control group. After that, 1.7ml of 2% lidocaine with epinephrine 1:100000 will be administered as an inferior alveolar nerve block by pediatric dentistry residents.
During anesthesia period, readings of the pulse oximeter will be recorded. Houpt and FLACC scale will be scored by an external investigator.
Children who received IANB will be asked to evaluate their experience using Wong-Baker faces pain scale.
The maximum possible duration of the intervention will be at least 5 minutes up to 15 minutes.
A research investigator will monitor VR eyeglasses and anaglyph glasses adherence until the cartoon show is over then both devices will be taken off.
Intervention code [1] 317369 0
Behaviour
Comparator / control treatment
No intervention device will be given ( Standard care which include a comfortable environment with a quiet, kid-friendly zone, patient will not wear virtual reality eyeglasses nor anaglyph glasses)
Control group
Active

Outcomes
Primary outcome [1] 323524 0
Change in physiological pulse rate
The measurement will be done using Finger Pulse Oximetry
Timepoint [1] 323524 0
Heart pulse rate will be assessed in two time interval stages: (1) five minutes after the patient is seated comfortably on the dental chair,.
(2) five minutes following the injection of the anesthetic drug.
Primary outcome [2] 323525 0
Children compliance
The measurement will be done by a blinded investigator using Houpt behavioral rating scale
Timepoint [2] 323525 0
It will be assessed during the whole process of the induction of dental anesthesia ( approximately one-two minutes ).
The assessment will be done every 20 seconds by the investigator, and an overall assessment score will be documented after the end of the whole procedure.
Primary outcome [3] 325842 0
Pain
The measurement will be done by a blinded investigator using FLACC pain rating Scale
The assessment will be done every 30 seconds by the investigator, and an overall assessment score will be documented after the end of the whole procedure.
Timepoint [3] 325842 0
It will be assessed during the whole process of the induction of dental anesthesia ( approximately one-two minutes ).
The will be done every 30 seconds by the investigator. and an overall assessment score will be documented after the end of the whole procedure.
Secondary outcome [1] 382162 0
Patient satisfaction
Patient satisfaction will be assessed using Wong-Baker Faces scale
Timepoint [1] 382162 0
It will be assessed immediately after the induction of anesthesia.

Eligibility
Key inclusion criteria
1) children requiring Inferior alveolar nerve (IAN) Block
2) aged between 4-9 years
3) American Society of Anesthesiologists (ASA) physical status I
Minimum age
4 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with developmental disabilities or chronic illnesses, those on psychoactive medications or children having repeated surgery.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization for children will be done using a randomization table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using g-power 3.1 software. The significance level was set at 0.05 and the power of the study was set to be 0.80.
Based on One-way Anova test, it was estimated that 60 patients were required.

Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA).

- The normality of distribution of the date will be verified by Kolmogorov-Smirnov normality test.
- If the data were normally distributed, One-way Anova test will be applied.
- if the data were not normally distributed, Mann Whiteny-U test will be applied.
- Interrater reliability will be tested using Cohen's Kappa measure.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
20/10/2021
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 22498 0
Syrian Arab Republic
State/province [1] 22498 0
Hama

Funding & Sponsors
Funding source category [1] 305508 0
University
Name [1] 305508 0
Hama University
Country [1] 305508 0
Syrian Arab Republic
Primary sponsor type
University
Name
Hama University
Address
Dental College, Hama University, Banks St., Hama, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 305908 0
None
Name [1] 305908 0
Address [1] 305908 0
Country [1] 305908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305819 0
Ethical and Scientific Committee of dental research, Hama University
Ethics committee address [1] 305819 0
Dental College, Hama University, Banks Street, Hama, Syria
Ethics committee country [1] 305819 0
Syrian Arab Republic
Date submitted for ethics approval [1] 305819 0
05/06/2019
Approval date [1] 305819 0
05/07/2019
Ethics approval number [1] 305819 0

Summary
Brief summary
Children anxiety during induction of anesthesia may lead to multiple complications that might interrupt treatment session.
Furthermore, anxiety is also related with postoperative maladaptive behavior changes. stress situation that is associated with operative anxiety will increase cortisol levels in blood which might increase the risk of infection and delay healing postoperatively.
In this context, the use of pharmacological and non-pharmacological methods has been reported to be effective in reducing anxiety during preoperative period.
However, the anxiolytic methods are heading in the favor of the non-pharmacological interventions instead of the pharmacological ones due to their superior or equal effect.
Distraction, one of the non-pharmacological methods, has been researched in a diversity of medical and dental procedures as an easy intervention to achieve, economical, and simple approach that reduce anxiety and upsetting behavior in children patients.
Thus, the aim of this study was to evaluate the effectiveness of VR eyeglasses compared to anaglyph 3D glasses on children behavior and compliance during intra-oral anesthesia,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101710 0
Dr Moaaz aljabi
Address 101710 0
Dental College, Hama University,
Banks St.
Hama, PO Box 30621
Country 101710 0
Syrian Arab Republic
Phone 101710 0
+963935256347
Fax 101710 0
Email 101710 0
[email protected]
Contact person for public queries
Name 101711 0
Dr Moaaz aljabi
Address 101711 0
Dental College, Hama University,
Banks St.
Hama, PO Box 30621
Country 101711 0
Syrian Arab Republic
Phone 101711 0
+963935256347
Fax 101711 0
Email 101711 0
[email protected]
Contact person for scientific queries
Name 101712 0
Dr Moaaz aljabi
Address 101712 0
Dental College, Hama University,
Banks St.
Hama, PO Box 30621
Country 101712 0
Syrian Arab Republic
Phone 101712 0
+963935256347
Fax 101712 0
Email 101712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7677Ethical approval  [email protected]



Results publications and other study-related documents

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