Clinical trial · Interventional
Little NIRVANA for Pediatric Pain and Anxiety
Augmented Reality for Managing Pediatric Anxiety and Pain During Disasters - A Randomized Pilot Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Emergency Medicine | — | UNRESOLVED | — |
| IV Access | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Procedural Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Little NIRVANA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
- interventionNames
- Other: Little NIRVANA
- type
- NO_INTERVENTION
- label
- Control
- 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)
Primary outcomes (2)
- measure
- Proxy reported pain
- timeFrame
- Immediately following the PIV line placement
- description
- 0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 8 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available