Little NIRVANA for Pediatric Pain and Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Little NIRVANA.
- Who it may be relevant to
- Registry conditions: Acute Pain, Procedural Anxiety, Pediatric ALL, Emergency Medicine. Basic parameters: 2 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study
Overview
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.
Interventions
- Other Little NIRVANA
Augmented reality (AR) digital solution where children interact with the game using a magic wand
Primary outcome measures
- Proxy reported pain [Time frame: Immediately following the PIV line placement]
- Proxy reported anxiety [Time frame: Immediately following the PIV line placement]
Secondary outcome measures (1)
- Proxy reported AR experience [Time frame: Immediately following the PIV line placement]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT06795126 · STUDY00004268 · U1IMC43532