Little NIRVANA for Pediatric Pain and Anxiety

Nationwide Children's Hospital

Status: Invitation-only

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

Treatments: Other: Little NIRVANA

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06795126

U1IMC43532 (Other Grant/Funding Number)

STUDY00004268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Little NIRVANA

Control

No Intervention group

Description:

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)