Back to resultsEFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
Primary Purpose
Dental Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Virtual Reality Glasses (VR)
White noise
Basic behavior management techniques
Sponsored by
About this trial
This is an interventional other trial for Dental Anxiety
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. 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
Sites / Locations
- Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Virtual Reality Glasses (VR)
White noise
Basic behavior management techniques
Arm Description
Outcomes
Primary Outcome Measures
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.
Pulse rate
The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06071117
Brief Title
EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Glasses (VR)
Arm Type
Experimental
Arm Title
White noise
Arm Type
Active Comparator
Arm Title
Basic behavior management techniques
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Virtual Reality Glasses (VR)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
White noise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Basic behavior management techniques
Intervention Description
Children allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used.
Primary Outcome Measure Information:
Title
Dental anxiety assessment
Description
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.
Time Frame
up to one week
Title
Pulse rate
Description
The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.
Time Frame
up to one week
Title
Level of cooperation
Description
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.
Time Frame
up to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla A Aly, BDS
Phone
01007632241
Ext
+2
Email
nahla.aly.dent@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla A Aly, BDS
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amina M AbdElrahman, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karin ML Dowidar, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tarek Omar, PhD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahla A Aly, BDS
Phone
01007632241
Email
nahla.aly.dent@alexu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
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