Little NIRVANA for Pediatric Pain and Anxiety

Not Applicable

Not yet recruiting

• Conditions: Acute Pain; Procedural Anxiety; Pediatric ALL; Emergency Medicine; IV Access

• Registration Number: NCT06795126
• Lead Sponsor: Nationwide Children's Hospital

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Start: 2025-03-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proxy reported AR experience	Immediately following the PIV line placement	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States