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

NCT06071117 | Completed

• 1 other identifier: 0646-03/2023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Virtual Reality Glasses (VR)

EXPERIMENTAL

Device: Virtual Reality Glasses (VR)

White noise

ACTIVE COMPARATOR

Other: White noise

Basic behavior management techniques

SHAM COMPARATOR

Behavioral: Basic behavior management techniques

Interventions

Virtual Reality Glasses (VR) DEVICE

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. 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 treatment.

Virtual Reality Glasses (VR)

White noise OTHER

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

White noise

Basic behavior management techniques BEHAVIORAL

Children allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used.

Basic behavior management techniques

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with physical disabilities or other psychiatric disorders.
• Children with visual or hearing disabilities.
• Patients requiring emergency treatment

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt

Alexandria, Egypt

Location

Study Officials

• Nahla A Aly, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Amina M AbdElrahman, PhD

  Alexandria University

  STUDY DIRECTOR

• Karin ML Dowidar, PhD

  Alexandria University

  STUDY CHAIR

• Tarek Omar, PhD

  University of Alexandria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical instructor at pediatric dentistry department

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: July 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)