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Clinical Trials/NCT06071117
NCT06071117
Completed
Not Applicable

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

Alexandria University1 site in 1 country48 target enrollmentJuly 10, 2023
ConditionsDental Anxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Anxiety
Sponsor
Alexandria University
Enrollment
48
Locations
1
Primary Endpoint
Pulse rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2023
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nahla Aly

clinical instructor at pediatric dentistry department

Alexandria University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pulse rate

Time Frame: up to one week

The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.

Level of cooperation

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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