Little NIRVANA for Pediatric Pain and Anxiety

Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Pain; Emergency Medicine; Pediatric ALL; Procedural Anxiety; IV Access
• Intervention / Treatment: Other: Little NIRVANA

Detailed Description

This is a two-group randomized clinical trial of 65 dyads of subjects and their parent and 65 proceduralists. Children will be randomly assigned to either the Little NIRVANA intervention group or a standard of care control group. Legal guardians of children in both groups will answer questions about their child's prior history of needle procedures, current pain/anxiety, medications taken prior to ED arrival, and video game experience. Children assigned to the intervention will play the game during the PIV placement, while children in the control group will receive the standard of care. The proceduralist performing the PIV placement and the parent will answer questions after the PIV placement about their perception of the child's pain and anxiety and questions about the Little NIRVANA experience for those children who were in the intervention group. This study has one visit that is completed during their ED stay.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients undergoing PIV line placement (peripheral IV order placed while patient is in the ED);
• Patients 2-8 years of age (inclusive)

Exclusion Criteria:

• Non-English speaking (Little NIRVANA is currently only available in English and Dutch);
• those for whom utilizing AR is deemed not feasible by the attending ED physician (e.g., critical illness)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)
Experimental: Intervention Group; Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement	Other: Little NIRVANA; Augmented reality (AR) digital solution where children interact with the game using a magic wand; Other Names: Augmented Reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proxy reported pain	0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.	Immediately following the PIV line placement
Proxy reported anxiety	0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum )-10(maximum), with higher score indicating worse anxiety.	Immediately following the PIV line placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proxy reported AR experience	0-10 Numerical Rating Scale (NRS) (proxy-reported - intervention arm only), 0(minimum )-10(maximum), with higher score meaning better outcome. Asked for fun, engagement, and satisfaction with the AR.	Immediately following the PIV line placement

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: KU Leuven; Health Resources and Services Administration (HRSA)

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Augmented Reality; Distraction; AR
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Anxiety Disorders; Acute Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: STUDY00004268; U1IMC43532 (Other Grant/Funding Number: Health Resources and Services Administration (HRSA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No