The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children

Study Overview
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Brief Summary
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The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE)(NIVRE) and Non Immersive Virtual Reality in children having dental anxiety.The main question[s] it aims to answer are: Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with self-reported dental anxiety scale; Malay translated Modified Child Dental Anxiety Scale faces version (MMCDASf)? Does preoperative IVRE and NIVRE has any effect on dental anxiety in children measured with physiological measure, Pulse Rate(PR)? Is there any difference in dental anxiety measured using MMCDASf and PR between IVRE,NIVRE and control group at pre-test and post-test? What is the correlation between self-reported MMCDASf and physiological measure PR?

Detailed Description
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Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.

Official Title
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The Effects of Preoperative Immersive and Non Immersive Virtual Reality Exposure on Dental Anxiety in Children: A Randomised Control Trial

Conditions
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Dental Anxiety

Intervention / Treatment
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* Behavioral: Virtual Reality Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 9-12 years old. Children who can understand and complete the MMCDASf questionnaire with a score of 19 and above. Children who requires fissure sealants on sound permanent tooth. Exclusion Criteria: Children requiring emergency dental treatment for pain, trauma or facial cellulitis. Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months. Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems Parents who refuse to allow their children to participate in the trial.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Immersive and Non immersive Virtual Reality
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive Virtual Reality Exposure<br>Immersive Virtual Reality Dental Game for 15 minutes. Participants will be actively involved with the game, in placing restorations, scaling virtually playing the role of the dentist. | Behavioral: Virtual Reality Exposure<br>* Virtual Reality device using the immersive dental game.<br>|
| Active Comparator: Non Immersive Virtual Reality Exposure<br>Participants will be made to watch dental related cartoon passively while sitting using the Virtual Reality device for 15 minutes. | Behavioral: Virtual Reality Exposure<br>* Virtual Reality device using the immersive dental game.<br>|
| No Intervention: Control Group<br>Participants will be waiting for 15 minutes as usual prior to their treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MMCDASf score | Malay translated Modified Child Dental Anxiety Scale faces version | 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulse Rate | Will be measured using Pulse Oximeter | 10 minutes prior to Intervention and immediately after intervention followed by dental treatment on the same day |