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Little NIRVANA for Pediatric Pain and Anxiety

NCT06795126 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Acute Pain
  • Procedural Anxiety
  • Pediatric ALL
  • Emergency Medicine
  • IV Access

Interventions

OTHER

Little NIRVANA

Augmented reality (AR) digital solution where children interact with the game using a magic wand

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-04-30
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06795126 on ClinicalTrials.gov