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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
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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
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Secondary ID [1]
296631
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None
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Universal Trial Number (UTN)
U1111-1224-1057
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pre-operative Anxiety
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Children compliance during anesthesia
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Condition category
Condition code
Oral and Gastrointestinal
309173
309173
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Mental Health
309243
309243
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312942
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Behaviour
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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)
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
308141
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(t0) = Baseline ( in the waiting room)
(t1) = in the operation room and during anesthesia induction.
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Primary outcome [2]
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Change in physiological pulse rate
The measure will be done using using finger Pulse Oximeter
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Assessment method [2]
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Timepoint [2]
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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.
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Primary outcome [3]
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Children compliance
The measure will be done by a blinded investigator using Houpt behavioral rating scale
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Assessment method [3]
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Timepoint [3]
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It will be assessed during the whole process of the induction of dental anesthesia ( approximately one minute )
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Secondary outcome [1]
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Patient satisfaction
Patient satisfaction will be assessed using Wong-Baker Faces scale
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Assessment method [1]
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Timepoint [1]
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It will be assessed immediately after the induction of anesthesia have been performed.
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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
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Minimum age
6
Years
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Maximum age
10
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children with developmental disabilities or chronic illnesses, those on psychoactive medications or children having repeated surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
30/11/2018
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Actual
30/11/2018
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Date of last participant enrolment
Anticipated
30/12/2018
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Actual
30/12/2018
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Date of last data collection
Anticipated
30/12/2018
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Actual
30/12/2018
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Sample size
Target
64
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Accrual to date
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Final
64
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Recruitment outside Australia
Country [1]
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Syrian Arab Republic
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State/province [1]
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Damascus
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Damascus University
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Address [1]
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Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
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Country [1]
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Syrian Arab Republic
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Primary sponsor type
University
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Name
Damascus University
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Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
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Country
Syrian Arab Republic
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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none
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Country [1]
300842
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethical and Scientific Committee of dental research
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Ethics committee address [1]
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Dental College, Damascus University, Al-Mazzeh Street, Damascus, Syria
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Ethics committee country [1]
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Syrian Arab Republic
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Date submitted for ethics approval [1]
301956
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10/09/2018
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Approval date [1]
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20/10/2018
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Ethics approval number [1]
301956
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Zuhair AlNerabieah
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Address
88662
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Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
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Country
88662
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Syrian Arab Republic
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Phone
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+963969960118
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
88663
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Dr Zuhair AlNerabieah
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Address
88663
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Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
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Country
88663
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Syrian Arab Republic
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Phone
88663
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+963969960118
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Fax
88663
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Email
88663
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[email protected]
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Contact person for scientific queries
Name
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Dr Zuhair AlNerabieah
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Address
88664
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Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
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Country
88664
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Syrian Arab Republic
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Phone
88664
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+963969960118
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Fax
88664
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Email
88664
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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