EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER

Study Overview
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Brief Summary
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The present study aims to assess and compare the effectiveness of distraction technique using virtual reality glasses and white noise with basic behavior guidance techniques on dental anxiety in children with Attention Deficit/ Hyperactivity Disorder.

Official Title
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EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER(A RANDOMIZED CONTROLLED CLINICAL TRIAL)

Conditions
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Dental Anxiety

Intervention / Treatment
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* Device: Virtual Reality Glasses (VR)
* Other: White noise
* Behavioral: Basic behavior management techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist. All children should be on stimulant medication. No previous dental experience. Children with scores 2 or 3 during preoperative assessments according to the Frankl behavioral Rating Scale. Children with at least one erupted first permanent molar with ICDAS II scoring (0-2). Written consent of the legal guardian. Exclusion Criteria: Children with physical disabilities or other psychiatric disorders. Children with visual or hearing disabilities. Patients requiring emergency treatment

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Glasses (VR)<br> | Device: Virtual Reality Glasses (VR)<br>* Children allocated to this group will be distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies will be shown to the children and played from YouTube. The VR glasses will be then introduced to the children. The children will be given time to accommodate with the device before starting the procedure. The VR glasses will be applied during the dental examination and charting<br>|
| Active Comparator: White noise<br> | Other: White noise<br>* Wireless kids' headphones∗ will be introduced to the children allocated to this group. They will be given some time to accommodate with the headphones. Then, the white noise will be played and children will be asked to concentrate on the music during the procedure. White noise stimulus will be set at 70 decibels, within the normal conversation volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise will be calibrated using a portable digital sound level meter<br>|
| Sham Comparator: Basic behavior management techniques<br> | Behavioral: Basic behavior management techniques<br>* Children allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental anxiety assessment | This will be assessed using Facial Image Scale (FIS). The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling. | up to one week | 
| Pulse rate | The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110. | up to one week | 
| Level of cooperation | Venham's Behavior rating scale (VBRS) will be used to evaluate the overall child's behavior. The changes will be recorded to assess the change in the child's cooperation during the procedure. Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint. The operator will assign a score to each child based on the child's behavior by analysis of the recorded videotape. | up to one week |