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

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Device: Virtual Reality Glasses (VR); Other: White noise; Behavioral: Basic behavior management techniques

• Registration Number: NCT06071117
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-06
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Glasses (VR)	Virtual Reality Glasses (VR)	-
White noise	White noise	-
Basic behavior management techniques	Basic behavior management techniques	-

Primary Outcome Measures

Name	Time	Method
Pulse rate	up to one week	The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.
Level of cooperation	up to one week	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.
Dental anxiety assessment	up to one week	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.

Trial Locations

Locations (1)

Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt; 🇪🇬 Alexandria, Egypt