Little NIRVANA for Procedural Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Little NIRVANA, an augmented reality tool, can reduce pain and anxiety for young children needing an IV during emergency room visits. The researchers aim to determine if using this AR tool with a numbing cream eases the procedure more than using the cream alone. The trial includes two groups: one uses Little NIRVANA and the cream, while the other uses only the cream. It targets children aged 2-8 who need an IV in the emergency room and can understand English or Dutch. As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve children's experiences during medical procedures.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that Little NIRVANA is safe for managing anxiety and pain in children?
Research shows that the Little NIRVANA augmented reality (AR) tool helps children manage pain and anxiety during medical procedures. Studies have found that similar AR tools are safe and effectively distract children, reducing stress during these procedures.
Although detailed safety data specifically for Little NIRVANA is not yet available, AR use in healthcare is generally well-accepted. Other studies on AR have shown it to be a safe way to reduce pain and anxiety without causing additional side effects. Based on this evidence, Little NIRVANA is expected to be a safe choice for children during peripheral intravenous (PIV) insertions.12345Why are researchers excited about this trial?
Researchers are excited about Little NIRVANA because it offers a new way to tackle procedural anxiety using augmented reality (AR). Unlike traditional methods that rely solely on topical anesthetics or simple distraction techniques, Little NIRVANA combines a topical anesthetic cream with an AR digital solution to engage patients during procedures like PIV line placements. This innovative approach aims to reduce anxiety by immersing patients in a virtual experience, potentially making procedures less stressful and more comfortable.
What evidence suggests that Little NIRVANA is effective for managing procedural anxiety in children?
Research shows that Little NIRVANA, a tool using augmented reality (AR), helps reduce anxiety and pain during stressful procedures. Studies have found that gaming technology like Little NIRVANA can distract and calm children and their caregivers in these situations. A review of multiple studies has confirmed that virtual reality (VR) methods effectively reduce anxiety and pain for children during medical procedures. In this trial, participants in the intervention group will use Little NIRVANA along with a numbing cream, which might help children feel less anxious and more comfortable during IV insertions in medical settings.24678
Are You a Good Fit for This Trial?
This trial is for children aged 2-8 who are experiencing pain and anxiety during emergency hospital visits, specifically for peripheral intravenous (PIV) insertions. The study is looking to include those who can safely use augmented reality (AR) alongside a numbing cream.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Little NIRVANA AR intervention or standard care during PIV line placement
Follow-up
Participants are monitored for anxiety and pain immediately following the PIV line placement
What Are the Treatments Tested in This Trial?
Interventions
- Little NIRVANA
Trial Overview
The Little NIRVANA system, an augmented reality tool, is being tested to see if it helps reduce pain and anxiety in kids during PIV placement in the ER. It's compared with just using numbing cream to find out if it makes these procedures easier without causing delays or extra attempts.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a topical anesthetic cream and will use Little NIRVANA AR digital solution during PIV line placement
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor
KU Leuven
Collaborator
Health Resources and Services Administration (HRSA)
Collaborator
Citations
1.
uzleuven.be
uzleuven.be/en/news/little-nirvana-gaming-technology-distracts-children-during-stressful-or-painful-proceduresLittle Nirvana: gaming technology distracts children during ...
These tests show that Little Nirvana is very effective in distracting and calming both children and their carers during stressful procedures.
Outcomes of Providing Children Aged 7-12 Years With ...
This study provides initial evidence that Lumi Nova may be associated with improved outcomes for those aged 7-12 years seeking anxiety treatment in real-world ...
3.
researchgate.net
researchgate.net/publication/344317922_An_immersive_virtual_reality_game_to_train_spatial_attention_orientation_after_stroke_A_feasibility_studyAn immersive virtual reality game to train spatial attention ...
Results The new VR setup showed high usability (mean score 10.2, SD 1.85; maximum score 12) and no relevant side effects (mean score 0.833, SD 0.834; maximum ...
The impact of virtual reality cognitive behavioral therapy on ...
For procedural anxiety among children and youth, results from a. 648 meta-analysis show VRET to be effective in lowering anxiety during ...
The Effects of Virtual Reality on Procedural Pain and ...
The present study is a systematic review and meta-analysis of studies that have used VR to reduce procedural pain and anxiety in children.
Little NIRVANA
Innovation project on virtual reality experience helping kids fight pain. Little-NIRVANA an integrated & interactive pain management solution for children.
Comfort care in needle procedures for children - Little Nirvana
The little NIRVANA team developed an interactive and multisensory toolkit to reduce anxiety and tension in children during medical procedures. Our approach is ...
Augmented Reality Distraction for Reducing Pain in ...
This randomized controlled trial evaluates the effectiveness of augmented reality (AR) as a distraction technique to reduce procedural pain and anxiety in ...
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