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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Change in Perceived Pain: scale

Secondary outcome measures

Anxiety Scores

Heart Rate

Level of simulator sickness

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

582,076 Total Patients Enrolled

Courtney A McNamara, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

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

How many subjects are currently being recruited for this research?

"Affirmative. Per clinicaltrials.gov, this research is actively seeking volunteers and was first announced on July 16th 2021 with recent updates to the study made June 3rd 2022. This trial requires 200 participants from a single location."

Answered by AI

Is this experiment including elderly participants?

"The age parameters for this study are between 5 and 21 years."

Answered by AI

What are the eligibility requirements for participating in this clinical trial?

"To be eligible for this study, potential participants must meet a series of criteria: they need to experience pain and are required to be between the ages of 5 and 21. The overall goal is to recruit 200 individuals who meet these qualifications."

Answered by AI

Are there opportunities for involvement in this clinical trial?

"Yes, clinicaltrials.gov confirms that this medical study is still in the recruitment stage. Originally posted on July 16th 2021 and last updated on June 3rd 2022, it seeks 200 volunteers from a single centre to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Goggle Utilization for Venipuncture Distraction

2021. "Virtual Reality Goggle Utilization for Venipuncture Distraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479735.

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