Little NIRVANA for Pediatric Pain and Anxiety

NCT06795126 | Enrolling By Invitation

• 2 other identifiers: STUDY00004268U1IMC43532
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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; Pediatric ALL; Procedural Anxiety; Emergency Medicine; IV Access

Keywords

AR; Pain; Anxiety; Augmented Reality; Distraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Proxy reported AR experience

  Immediately following the PIV line placement

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Little NIRVANA

Control

NO 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)

Interventions

Little NIRVANA OTHER

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

Also known as: Augmented Reality

Intervention Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• KU Leuven: collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Acute Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 27, 2025
• Study Start: November 15, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)