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

NCT ID: NCT06071117

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Virtual Reality Glasses (VR)

Group Type EXPERIMENTAL

Virtual Reality Glasses (VR)

Intervention Type DEVICE

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.

White noise

Group Type ACTIVE_COMPARATOR

White noise

Intervention Type OTHER

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

Basic behavior management techniques

Group Type SHAM_COMPARATOR

Basic behavior management techniques

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Nahla Aly

clinical instructor at pediatric dentistry department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahla A Aly, BDS

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Amina M AbdElrahman, PhD

Role: STUDY_DIRECTOR

Alexandria University

Karin ML Dowidar, PhD

Role: STUDY_CHAIR

Alexandria University

Tarek Omar, PhD

Role: STUDY_DIRECTOR

University of Alexandria

Locations

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Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0646-03/2023

Identifier Type: -

Identifier Source: org_study_id

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