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 — OTHER
    Augmented 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 Group
    Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
  • No Intervention: Control
    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)

Primary Outcome Measure

Proxy reported pain [ Time Frame: Immediately following the PIV line placement ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

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