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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071117
• Other study ID #: 0646-03/2023
• Status: Completed
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Dental Anxiety

Intervention

Device:
• Virtual 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.

Other:
• White 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

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

Locations

Country	Name	City	State
Egypt	Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pulse rate	The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.	up to one week
Primary	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