Dental AnxietyNCT06071117
EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
A study testing Virtual Reality Glasses (VR), White noise and Basic behavior management techniques in people with Dental Anxiety, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Virtual Reality Glasses (VR), White noise and Basic behavior management techniques
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with physical disabilities or other psychiatric disorders.
- Children with visual or hearing disabilities.
- Patients requiring emergency treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt
Alexandria
About this study
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)
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.
- Conditions
- Dental Anxiety
- Being tested
- Virtual Reality Glasses (VR), White noise, Basic behavior management techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Glasses (VR)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 noiseOther
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 techniquesBehavioural
Children allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses (VR) | Experimental | Not described Receives: Device: Virtual Reality Glasses (VR) |
| White noise | Active comparator | Not described Receives: Other: White noise |
| Basic behavior management techniques | Sham comparator | Not described Receives: Behavioral: Basic behavior management techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one week
Pulse rate
The pulse rate will be measured using a pulse oximeter. Normal range is considered from 70-110.
Measured: up to one week
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.
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Aly, Alexandria University
- Investigators
- Nahla A Aly, BDS, Principal investigator, Alexandria UniversityAmina M AbdElrahman, PhD, Study director, Alexandria UniversityKarin ML Dowidar, PhD, Study chair, Alexandria UniversityTarek Omar, PhD, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071117
- Sponsor's protocol ID
- 0646-03/2023
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06071117
- Acronym / sponsor ID
- 0646-03/2023
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses (VR) | Experimental | Device: Virtual Reality Glasses (VR) |
| White noise | Active comparator | Other: White noise |
| Basic behavior management techniques | Sham comparator | Behavioral: Basic behavior management techniques |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with physical disabilities or other psychiatric disorders.
- Children with visual or hearing disabilities.
- Patients requiring emergency treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual Reality Glasses (VR) |
| White noiseWireless 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 | Other | White noise |
| Basic behavior management techniquesChildren allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used. | Behavioural | Basic behavior management techniques |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nahla A Aly, BDS principal investigator
Alexandria University
Amina M AbdElrahman, PhD study director
Alexandria University
Karin ML Dowidar, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses (VR), White noise and Basic behavior management techniques in people with Dental Anxiety, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental anxiety assessment (time frame: up to one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.