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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
Study Summary
This trial will test if virtual reality can reduce dental fear/anxiety and improve behavior in kids during 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Change in behavior on the FLACCS scale
Change in behavior on the FRANKL Scale
+1 moreSecondary outcome measures
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
~1630
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,248 Total Patients Enrolled
Carla Angela Alvarez, DMDStudy ChairHerman Ostrow School of Dentistry Pediatric Department
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child needs medication to undergo dental procedures.My child has a developmental disability.My child does not speak English or Spanish.I am between 6 and 18 years old.My child feels dizzy or sick when moving.I need at least two dental sealants, one for each half of my mouth, determined during a dental exam.My child does not have sensory issues that would affect their participation in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality
- Group 2: Basic Behavior Guidance Techniques
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I take part in this medical experiment?
"This medical study is looking for 50 minors aged 6 to 18 that suffer from anxiety and dental-related issues. To qualify, they must present themselves the Herman Ostrow School of Dentistry Pediatric Dental Clinic or Children's Dental Health Clinic at Long Beach Memorial Hospital for an initial/periodic examination and be deemed in need of two or more restorative appointments. Additionally, participants are required to meet American Society Anesthesiologist classifications I or II."
Answered by AI
Are any new enrollees being accepted for this experiment?
"Per the information available on clinicaltrials.gov, this research trial is no longer in need of participants as it was last updated on October 14th 2022. Despite that fact, there are still 49 other trials actively accepting candidates at present."
Answered by AI
Does this experimental procedure allow for elderly participants aged 75 and above?
"This medical research is seeking to enroll children aged 6 years or older but not yet 18."
Answered by AI
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