Little NIRVANA for Pediatric Pain and Anxiety
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Nationwide Children's Hospital
- Study ID
- NCT06795126
- Status
- Enrolling By Invitation
Conditions
- Acute Pain
- Emergency Medicine
- IV Access
- Pediatric ALL
- Procedural Anxiety
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 8 Years
- Healthy Volunteers
- Not accepted
Interventions
- Little NIRVANA — OTHERAugmented reality (AR) digital solution where children interact with the game using a magic wand
Study Details
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.
Key Dates
- Start date
- Nov 15, 2025
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 130 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Intervention GroupParticipants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
- No Intervention: ControlTreatment 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)
Primary Outcome Measure
Proxy reported pain [ Time Frame: Immediately following the PIV line placement ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | - |
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