Clinical trial NCT06795126: Little NIRVANA for Pediatric Pain and Anxiety
Official title: Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - a Randomized Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Pain
Procedural Anxiety
Pediatric ALL
Emergency Medicine
IV Access
Keywords: AR
Pain
Anxiety
Augmented Reality
Distraction
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Health Resources and Services Administration (HRSA)
First posted: 2025-01-27
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Proxy reported pain
timeFrame: Immediately following the PIV line placement
measure: Proxy reported anxiety
timeFrame: Immediately following the PIV line placement
Secondary outcomes:
measure: Proxy reported AR experience
timeFrame: Immediately following the PIV line placement
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: