What side effects are associated with this type of intervention?

Common treatments for dental anxiety, such as biofeedback relaxation, audio-visual distraction, and virtual reality, generally have minimal side effects. Biofeedback relaxation and audio-visual distraction are typically well-tolerated, with no significant adverse effects reported. Virtual reality, used as a distraction technique, may cause mild side effects such as dizziness, nausea, or eye strain in some individuals. Overall, these non-pharmacological interventions are considered safe and effective for reducing dental anxiety.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments of dental anxiety, particularly those similar to virtual reality distraction techniques. Generally, treatments for dental anxiety have included behavioral management strategies and pharmacological interventions such as benzodiazepines and nitrous oxide sedation. Virtual reality as a distraction technique is an emerging area of study and has not yet been widely established or approved by the FDA for dental anxiety treatment.

What other types of research exist?

Promising alternatives to Virtual Reality for dental anxiety include: <ol> <li>Biofeedback: Utilizes real-time monitoring of physiological responses to help patients manage anxiety through techniques like deep breathing and relaxation.</li> <li></li> </ol> Mobile Apps: Apps like QuitGuide and quitSTART, which offer behavioral therapy tools, motivational messaging, and coping strategies, can be adapted for dental anxiety. 3. Social Network Platforms: Leveraging platforms like Twitter, Facebook, and WhatsApp to provide support and anxiety management resources. 4. Cognitive Behavioral Therapy (CBT): Digital CBT programs tailored for dental anxiety can help patients reframe negative thoughts and reduce anxiety. 5. Augmented Reality (AR): Similar to VR, AR can provide immersive experiences that distract and calm patients during dental procedures.

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Virtual Reality for Pediatric Dental Anxiety

N/A

Recruiting

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after sealant placement with virtual reality, immediately after sealant placement with basic behavior guidance techniques

Awards & highlights

Summary

This trial investigates if using a VR headset with interactive games can reduce anxiety and pain in children aged 6-18 during dental sealant procedures. The VR system aims to distract children, making them less aware of the procedure and more comfortable. Virtual reality (VR) has been shown to effectively reduce anxiety and pain in children during various dental procedures.

Who is the study for?

This trial is for children aged 6-18 who need at least two dental sealants and are healthy (ASA I or II). They must be comfortable with wearing VR goggles without discomfort, dizziness, or motion sickness. Kids with seizures, developmental disabilities, significant cognitive disorders, or those needing sedation for treatment are excluded.

What is being tested?

The study tests if virtual reality can reduce anxiety and pain during dental procedures compared to basic behavior guidance techniques. Using a split-mouth cross-over design, each child experiences both methods in random order while getting dental sealants.

What are the potential side effects?

There may not be direct side effects from the interventions as they're non-invasive; however, some children might experience discomfort or dizziness with the VR headset. Those prone to motion sickness could also have issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 minutes after the completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 minutes after the completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes after the completion of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Change in behavior on the FLACCS scale

Change in behavior on the FRANKL Scale

+1 more

Secondary study objectives

Parent Satisfaction

Patient Satisfaction

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual RealityExperimental Treatment1 Intervention

The virtual reality system being used for research purposes is the RelievRx by AppliedVR which is an immersive virtual reality device that includes a goggle headset and remote control. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters, and settings with age-appropriate content.

Group II: Basic Behavior Guidance TechniquesActive Control1 Intervention

The control sample will include basic behavior guidance techniques and is standard of care. The use of basic behavior guidance techniques is common in pediatric dentistry and is not unique to this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality

2017

Completed Phase 3

~1580

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Distraction techniques, such as virtual reality (VR), are commonly used to manage dental anxiety by diverting the patient's attention away from the dental procedure. VR creates an immersive environment that engages multiple senses, thereby reducing the patient's focus on the dental treatment and associated anxiety. This method is particularly effective because it can significantly lower perceived pain and anxiety levels, making dental visits more tolerable. For patients with dental anxiety, these techniques are crucial as they can improve cooperation during procedures, enhance the overall dental experience, and potentially reduce the avoidance of necessary dental care.

The effect of concordance in the treatment of clients with dental anxiety.

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

936 Previous Clinical Trials

1,613,441 Total Patients Enrolled

Carla Angela Alvarez, DMDStudy ChairHerman Ostrow School of Dentistry Pediatric Department

Media Library

Virtual Reality Clinical Trial Eligibility Overview. Trial Name: NCT05585905 — N/A

Dental Anxiety Research Study Groups: Virtual Reality, Basic Behavior Guidance Techniques

Dental Anxiety Clinical Trial 2023: Virtual Reality Highlights & Side Effects. Trial Name: NCT05585905 — N/A

Virtual Reality 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585905 — N/A

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