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Virtual Reality Experimental for Tooth Decay

N/A

Recruiting

Research Sponsored by Children's Hospital Colorado

Eligibility Criteria Checklist

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

Must have

Ages 5-17 years old

Patients undergoing general anesthesia with mask induction for dental procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in operating room at induction

Awards & highlights

Study Summary

"This trial aims to see if a virtual reality program can help reduce anxiety in children before surgery. Patients will be divided into two groups: one receiving standard care and the other receiving standard care plus the virtual

Who is the study for?

This trial is for pediatric patients with dental diseases who are about to undergo anesthesia. They must be eligible for standard care by a Certified Child Life Specialist. Specific inclusion and exclusion criteria details were not provided.Check my eligibility

What is being tested?

The study compares two approaches: one group receives usual support before surgery, while the other gets the same support plus distraction via a VR program called Gurney Journey during transport to anesthesia.See study design

What are the potential side effects?

Since this trial involves non-invasive virtual reality software as an intervention, side effects may include dizziness or nausea from VR use but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 5 and 17 years old.

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I will be put to sleep with a mask for dental work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ perioperative, transport to operating room, in operating room

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~perioperative, transport to operating room, in operating room

This trial's timeline: 3 weeks for screening, Varies for treatment, and perioperative, transport to operating room, in operating room for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Induction Compliance Checklist

modified Yale Preoperative Anxiety Scale

Secondary outcome measures

The Pediatric Behavioral Induction Assessment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality ExperimentalExperimental Treatment1 Intervention

Standard CCLS care and distraction with Virtual Reality

Group II: Standard CCLS careActive Control1 Intervention

Standard CCLS care

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital ColoradoLead Sponsor

116 Previous Clinical Trials

5,132,757 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently ongoing patient enrollments for this clinical trial?

"As per the details available on clinicaltrials.gov, this current research investigation is actively seeking eligible individuals. The trial was initially made public on March 1st, 2024 and underwent its latest revision on February 22nd of the same year."

Answered by AI

How large is the patient population participating in this medical study?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking participants. Originally shared on March 1st, 2024, with the most recent update being on February 22nd, 2024, there are openings for 58 patients at a single site."

Answered by AI