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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]

none

Universal Trial Number (UTN)

U1111-1250-5770

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain

Anxiety

Children behavior

Inferior alveolar nerve block

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Anaesthesiology

Pain management

Mental Health

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]

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]

Change in physiological pulse rate
The measurement will be done using Finger Pulse Oximetry

Timepoint [1]

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]

Children compliance
The measurement will be done by a blinded investigator using Houpt behavioral rating scale

Timepoint [2]

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]

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]

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]

Patient satisfaction
Patient satisfaction will be assessed using Wong-Baker Faces scale

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Syrian Arab Republic

State/province [1]

Hama

Funding & Sponsors

Funding source category [1]

University

Name [1]

Hama University

Address [1]

Dental College, Hama University, Banks St., Hama, Syria.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical and Scientific Committee of dental research, Hama University

Ethics committee address [1]

Dental College, Hama University, Banks Street, Hama, Syria

Ethics committee country [1]

Syrian Arab Republic

Date submitted for ethics approval [1]

05/06/2019

Approval date [1]

05/07/2019

Ethics approval number [1]

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

Dr Moaaz aljabi

Address

Dental College, Hama University,
Banks St.
Hama, PO Box 30621

Country

Syrian Arab Republic

Phone

+963935256347

Fax

[email protected]

Contact person for public queries

Name

Moaaz aljabi

Address

Dental College, Hama University,
Banks St.
Hama, PO Box 30621

Country

Syrian Arab Republic

Phone

+963935256347

Fax

[email protected]

Contact person for scientific queries

Name

Moaaz aljabi

Address

Dental College, Hama University,
Banks St.
Hama, PO Box 30621

Country

Syrian Arab Republic

Phone

+963935256347

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7677	Ethical approval			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically