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VR Therapy for Pain and Anxiety During Medical Procedures

N/A

Recruiting

Led By Jeffrey I Gold, PhD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

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

Must have

Children who are 7-21 years old

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 minutes to one hour before procedure

Awards & highlights

Study Summary

This trial will test whether virtual reality can help reduce pain and anxiety for children during painful procedures like IV sticks and cast removals.

Who is the study for?

This trial is for children aged 7-21 who speak English, undergoing painful medical procedures like IV placements or cast removals. They must be developing normally as reported by parents and not taking pain or anxiety medication, have no seizure history, flu-like symptoms, cognitive disorders, sensory deficits, or motion sickness.Check my eligibility

What is being tested?

The study tests if VR headsets (Samsung Gear VR, Merge VR, Oculus Go) can reduce pain and anxiety in kids during medical procedures at CHLA. It measures their comfort levels through what they and their caregivers say.See study design

What are the potential side effects?

There are no medicinal side effects since this is a non-pharmaceutical intervention. However, there may be risks of discomfort from wearing the VR headset or experiencing virtual reality itself.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 7 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ peri-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~peri-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and peri-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Child Presence Questionnaire

Child Satisfaction Survey

Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older

+6 more

Secondary outcome measures

CAMPIS-R

Other outcome measures

Demographic Survey

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR RandomizationExperimental Treatment3 Interventions

Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction.

Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Samsung Gear VR

2017

N/A

~110

Merge VR

2017

N/A

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,075,772 Total Patients Enrolled

AppliedVR Inc.Industry Sponsor

10 Previous Clinical Trials

2,371 Total Patients Enrolled

Jeffrey I Gold, PhDPrincipal InvestigatorChildren's Hospital Los Angeles

3 Previous Clinical Trials

578 Total Patients Enrolled

Media Library

Merge VR Clinical Trial Eligibility Overview. Trial Name: NCT04268901 — N/A

Allergy Research Study Groups: Standard of Care (No VR) Randomization, VR Randomization

Allergy Clinical Trial 2023: Merge VR Highlights & Side Effects. Trial Name: NCT04268901 — N/A

Merge VR 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268901 — N/A

Frequently Asked Questions

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

What are the requirements for enrollment into this experiment?

"This experiment seeks 700 individuals with allergies between the ages of 7 and 21. Eligible candidates must have a history of hypersensitivity."

Answered by AI

How many participants have been selected for this clinical trial?

"Affirmative. Information present on clinicaltrials.gov reveals that this clinical trial is presently determining participants; the initial post was made February 19th, 2016 and it was last updated March 28th, 2022. A total of 700 subjects will be enrolled from a single site."

Answered by AI

Is this research endeavor still welcoming new participants?

"The information on clinicaltrials.gov indicates that recruitment for this trial is still ongoing; the study was first posted on February 19th 2016 and recently refreshed on March 28th 2022."

Answered by AI