Little NIRVANA for Pediatric Pain and Anxiety

NCT ID: NCT06795126

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Little NIRVANA

Intervention Type: OTHER

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

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Little NIRVANA

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

Intervention Type: OTHER

Other Intervention Names

Augmented Reality

Eligibility Criteria

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Chang

Emergency Medicine Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

U1IMC43532

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00004268

Identifier Type: -

Identifier Source: org_study_id