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Behavioural Intervention

Little NIRVANA for Procedural Anxiety

Columbus, OH

N/A

Waitlist Available

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

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

Must have

Patients 2-8 years of age (inclusive)

All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED)

Must not have

Non-English speaking (Little NIRVANA is currently only available in English and Dutch)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately following the piv line placement

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using an augmented reality tool called Little NIRVANA can help reduce anxiety and pain in children aged 2-8 years during the insertion of peripheral intravenous (PIV

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Who is the study for?

This trial is for children aged 2-8 who are experiencing pain and anxiety during emergency hospital visits, specifically for peripheral intravenous (PIV) insertions. The study is looking to include those who can safely use augmented reality (AR) alongside a numbing cream.Check my eligibility

What is being tested?

The Little NIRVANA system, an augmented reality tool, is being tested to see if it helps reduce pain and anxiety in kids during PIV placement in the ER. It's compared with just using numbing cream to find out if it makes these procedures easier without causing delays or extra attempts.See study design

What are the potential side effects?

Since Little NIRVANA involves AR technology, side effects might be minimal but could include discomfort from wearing the device or distraction-related issues. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am between 2 and 8 years old.

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I am getting a PIV line placed while in the emergency department.

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Exclusion Criteria

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

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I speak English or Dutch.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately following the piv line placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately following the piv line placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately following the piv line placement for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proxy reported anxiety

Proxy reported pain

Secondary study objectives

Proxy reported AR experience

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: Intervention GroupExperimental Treatment1 Intervention

Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement

Group II: ControlActive Control1 Intervention

Treatment as usual - participants will receive a topical anesthetic cream but will not use the Little NIRVANA (other distraction methods available in the ED are allowed)

0 / 3Eligibility criteria met