An interventional study of Little NIRVANA in Acute Pain, Procedural Anxiety and Pediatric ALL, sponsored by Nationwide Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Supportive care
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.
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 130 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
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Exclusion Criteria:
Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
Other: Little NIRVANA
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)
Augmented reality (AR) digital solution where children interact with the game using a magic wand
Also known as: Augmented Reality
Proxy reported pain
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum)-10(maximum), with higher score indicating worse pain.
Time frame: Immediately following the PIV line placement
Proxy reported anxiety
0-10 Numerical Rating Scale (NRS) (proxy reported by parent and proceduralist), 0(minimum )-10(maximum), with higher score indicating worse anxiety.
Time frame: Immediately following the PIV line placement
Proxy reported AR experience
0-10 Numerical Rating Scale (NRS) (proxy-reported - intervention arm only), 0(minimum )-10(maximum), with higher score meaning better outcome. Asked for fun, engagement, and satisfaction with the AR.
Time frame: Immediately following the PIV line placement
Plan to share: No
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Nationwide Children's Hospital