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Trial registered on ANZCTR


Registration number
ACTRN12618001906246
Ethics application status
Approved
Date submitted
17/11/2018
Date registered
23/11/2018
Date last updated
19/02/2019
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
19/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of virtual reality box on children's pre-oprative anxiety and behavior
Scientific title
Effectiveness of using virtual reality (VR) Box in the waiting room on Pre-operative Anxiety and Children compliance during inferior alveolar (IAN) Block
Secondary ID [1] 296631 0
None
Universal Trial Number (UTN)
U1111-1224-1057
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-operative Anxiety 310456 0
Children compliance during anesthesia 310457 0
Condition category
Condition code
Oral and Gastrointestinal 309173 309173 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 309243 309243 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible Children will be randomized into two groups:
Group A: Using VR Box in the waiting room
Group B: Control group
Children will be informed of the group assignment after randomization to minimize patient expectations and/or disappointment (e.g. anticipation of watching VR and then being randomized to another arm of the study). Two research Investigators will score a baseline modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF).

Children and parents will remain in private unit before being transferred into the operating room (OR). Parents will be given a written and verbal description of what to expect when they enter the OR. All Cartoons will be rated ‘E’ for ‘everyone’ and will be self-selected by children from a variety of 10 Cartoon shows.

At least 20 min after the intervention (VR box or none), parent and patient will be escorted into the OR where standard pre-anesthesia procedures will be carried out prior to IAN Block.
The maximum possible duration of the intervention will be at least 25 minutes up to 1 hour.

A research investigator will monitor VR box adherence until the cartoon show is over then VR box will be taken off.

A second mYPAS-SF will be performed by the same Investigators during the period of pulse oximeter placement, and the induction of dental anesthesia (1.7ml of 2% lidocaine with epinephrine 1:100000 will be administered as an inferior alveoler nerve block by pediatric dentistry residents).
During anesthesia period, readings of the pulse oximeter will be recorded and Houpt scale will be scored.
Children who received IAN block will be asked to evaluate their experience using Wong-Baker faces pain scale.
Intervention code [1] 312942 0
Behaviour
Comparator / control treatment
No intervention device will be given ( Standard care which include a comfortable environment with a quiet, kid-friendly play, reading, and activity zone, patient will not wear virtual reality eyeglasses)
Control group
Active

Outcomes
Primary outcome [1] 308141 0
Preoperative anxiety
The measure will be done by two blinded investigators using Modified Yale Preoperative Anxiety Scale – Short From (mYPAS-SF) to assess preoperative anxiety.
Lowest and highest possible scores in this scale are ranged from 22 to 100 respectively. Lower values represent lower preoperative anxiety.
Timepoint [1] 308141 0
(t0) = Baseline ( in the waiting room)
(t1) = in the operation room and during anesthesia induction.
Primary outcome [2] 308142 0
Change in physiological pulse rate
The measure will be done using using finger Pulse Oximeter
Timepoint [2] 308142 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 [3] 308145 0
Children compliance
The measure will be done by a blinded investigator using Houpt behavioral rating scale
Timepoint [3] 308145 0
It will be assessed during the whole process of the induction of dental anesthesia ( approximately one minute )
Secondary outcome [1] 354074 0
Patient satisfaction
Patient satisfaction will be assessed using Wong-Baker Faces scale
Timepoint [1] 354074 0
It will be assessed immediately after the induction of anesthesia have been performed.

Eligibility
Key inclusion criteria
Inclusion criteria :
1) children requiring Inferior alveolar nerve (IAN) Block
2) aged between 6–10 years
3) American Society of Anesthesiologists (ASA) physical status I
Minimum age
6 Years
Maximum age
10 Years
Gender
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 randomisation for children will be done using a randomisation table created by computer software
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)
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 a student's t-test, it was estimated that 64 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, student's t-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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21042 0
Syrian Arab Republic
State/province [1] 21042 0
Damascus

Funding & Sponsors
Funding source category [1] 301210 0
University
Name [1] 301210 0
Damascus University
Address [1] 301210 0
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country [1] 301210 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 300842 0
None
Name [1] 300842 0
None
Address [1] 300842 0
none
Country [1] 300842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301956 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 301956 0
Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 301956 0
Syrian Arab Republic
Date submitted for ethics approval [1] 301956 0
10/09/2018
Approval date [1] 301956 0
20/10/2018
Ethics approval number [1] 301956 0

Summary
Brief summary
Children anxiety during preoperative period may lead to multiple complications that might interrupt treatment session. For example, lower anesthesia induction compliance
Furthermore, preoperative anxiety is also related with postoperative maladaptive behavior changes. stress situation that is associated with preoperative 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.

the aim of this study was to evaluate the effectiveness of VR BOX in the waiting room on the preoperative anxiety and its consequent effect on children’s compliance during induction of dental anesthesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88662 0
Dr Zuhair AlNerabieah
Address 88662 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88662 0
Syrian Arab Republic
Phone 88662 0
+963969960118
Fax 88662 0
Email 88662 0
Zuhairmajid@gmail.com
Contact person for public queries
Name 88663 0
Dr Zuhair AlNerabieah
Address 88663 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88663 0
Syrian Arab Republic
Phone 88663 0
+963969960118
Fax 88663 0
Email 88663 0
Zuhairmajid@gmail.com
Contact person for scientific queries
Name 88664 0
Dr Zuhair AlNerabieah
Address 88664 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 88664 0
Syrian Arab Republic
Phone 88664 0
+963969960118
Fax 88664 0
Email 88664 0
Zuhairmajid@gmail.com

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?
Study protocol
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary