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

Sponsor
Alexandria University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06071117
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
11.7
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Glasses (VR)
  • Other: White noise
  • Behavioral: Basic behavior management techniques
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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)
Actual Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality Glasses (VR)

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 and played from YouTube. 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 charting
Active Comparator: White noise

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
Sham Comparator: Basic behavior management techniques

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Pulse rate [up to one week]

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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 10 Years
Sexes Eligible for Study:
All
Accepts 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.

  • Children with scores 2 or 3 during preoperative assessments according to the Frankl behavioral Rating Scale.

  • Children with at least one erupted first permanent molar with ICDAS II scoring (0-2).

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

  • Principal Investigator: Nahla A Aly, BDS, Alexandria University
  • Study Director: Amina M AbdElrahman, PhD, Alexandria University
  • Study Chair: Karin ML Dowidar, PhD, Alexandria University
  • Study Director: Tarek Omar, PhD, University of Alexandria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nahla Aly, clinical instructor at pediatric dentistry department, Alexandria University
ClinicalTrials.gov Identifier:
NCT06071117
Other Study ID Numbers:
  • 0646-03/2023
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Oct 6, 2023