Little NIRVANA for Procedural Anxiety

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nationwide Children's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.

Eligibility Criteria

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.

Inclusion Criteria

I am between 2 and 8 years old.

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

Exclusion Criteria

I speak English or Dutch.

Those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)

Treatment Details

Interventions

• Little NIRVANA (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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)

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

KU Leuven

Collaborator

Trials

587

Recruited

200,340,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+