A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Needles are frequently required for routine medical procedures. Children with severe hemophilia require intensive intravenous (IV) therapy to treat and prevent life-threatening bleeding and undergo hundreds of IV procedures. Fear of needle-related procedures may lead to avoidance of future health care and poor clinical outcomes. Virtual reality (VR) is a promising distraction technique during procedures, but barriers to commercially available VR platforms for pediatric health care purposes have prevented widespread use. OBJECTIVE: We hypothesized that we could create a VR platform that would be used for pediatric hemophilia care, allow clinician orchestration, and be safe and feasible to use for distraction during IV procedures performed as part of complex health care. METHODS: We created a VR platform comprising wireless, adjustable, disposable headsets and a suite of remotely orchestrated VR games. The platform was customized for a pediatric hemophilia population that required hands-free navigation to allow access to a child's hands or arms for procedures. A hemophilia nurse observing the procedure performed orchestration. The primary endpoint of the trial was safety. Preliminary feasibility and usability of the platform were assessed in a single-center, randomized clinical trial from June to December 2016. Participants were children with hemophilia aged 6-18 years. After obtaining informed consent, 25 patients were enrolled and randomized. Each subject, 1 caregiver, and 1 hemophilia nurse orchestrator assessed the degree of preprocedural nervousness or anxiety with an anchored, combined modified visual analog (VAS)/FACES scale. Each participant then underwent a timed IV procedure with either VR or standard of care (SOC) distraction. Each rater assessed the distraction methods using the VAS/FACES scale at the completion of the IV procedure, with questions targeting usability, engagement, impact on procedural anxiety, impact on procedural pain, and likability of the distraction technique. Participants, caregivers, and nurses also rated how much they would like to use VR for future procedures. To compare the length of procedure time between the groups, Mann-Whitney test was used. RESULTS: Of the 25 enrolled children, 24 were included in the primary analysis. No safety concerns or VR sickness occurred. The median procedure time was 10 (range 1-31) minutes in the VR group and was comparable to 9 (range 3-20) minutes in the SOC group (P=.76). Patients in both the groups reported a positive influence of distraction on procedural anxiety and pain. Overall, in 80% (34/45) of the VR evaluations, children, caregivers, and nurses reported that they would like to use VR for future procedures. CONCLUSIONS: We demonstrated that an orchestrated, VR environment could be developed and safely used during pediatric hemophilia care for distraction during IV interventions. This platform has the potential to improve patient experience during medical procedures. TRIAL REGISTRATION: Clinical Trials.gov NCT03507582; https://clinicaltrials.gov/ct2/show/NCT03507582 (Archived by WebCite at http://www.webcitation.org/73G75upA3).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".