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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06071117
Enrollment
48
Registered
2023-10-06
Start date
2023-07-10
Completion date
2023-12-01
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

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.

Interventions

DEVICEVirtual Reality Glasses (VR)

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.

OTHERWhite noise

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

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dental anxiety assessmentup to one weekThis 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.
Pulse rateup to one weekThe pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.
Level of cooperationup to one weekVenham'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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026