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Virtual Reality Goggles for Procedural Pain in Children

N/A

Recruiting

Led By Courtney A McNamara, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Must not have

Patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study.

Patient (>18) or Parent or guardian (for patient < 18) that does not speak English, Spanish or Arabic will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 hour prior to venipuncture and again immediately after venipuncture

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether virtual reality goggles can help reduce pain and anxiety during venipuncture for hospitalized children.

Who is the study for?

This trial is for hospitalized children and young adults aged 5-21 who are scheduled for a venipuncture. It's not suitable for those who don't speak English, Spanish or Arabic, refuse topical anesthetic cream, can't use VR due to physical or developmental reasons, have discomfort with goggles (like recent neurosurgery), photosensitive seizures, or infections like scabies, lice, COVID-19.

What is being tested?

The study tests if virtual reality goggles can reduce pain and anxiety during venipuncture in patients aged 5-21 compared to the standard care which includes a topical anesthetic. Participants will be randomly assigned to either receive standard care alone or with the addition of VR goggles.

What are the potential side effects?

There may be no direct side effects from using virtual reality goggles; however, some individuals might experience discomfort wearing them especially after certain medical procedures like neurosurgery or if they have conditions such as migraines.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am willing to use Lidocaine/Prilocaine cream.

Select...

I (or my guardian) can communicate in English, Spanish, or Arabic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 hour prior to venipuncture and again immediate after venipuncture

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 hour prior to venipuncture and again immediate after venipuncture

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 hour prior to venipuncture and again immediate after venipuncture for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Perceived Pain Scale

Secondary study objectives

Change in Anxiety Scores

Change in Heart Rate

Change in Level of simulator sickness

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VR goggle with venipunctureExperimental Treatment1 Intervention

Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture.

Group II: no VR goggle with venipunctureActive Control1 Intervention

Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Goggles

2023

N/A

~110

0 / 2Eligibility criteria met