Distraction in the Emergency department using Virtual reality for INtravenous procedures in Children to Improve comfort (DEVINCI): a pilot pragmatic randomized controlled trial.

Objectives: Intravenous (IV) procedures cause pain and distress in the pediatric emergency department (ED). We studied the feasibility and acceptability of virtual reality distraction for patient comfort during intravenous procedures.

Methods: Children were randomized to a control (standard care) or intervention group (standard care + virtual reality). Thresholds for feasibility and acceptability (primary outcomes) were determined through a priori established criteria. The level of procedural pain (principal clinical outcome) and distress, as well as memory of pain at 24 h were collected and reported as medians (Q1, Q3) for each group.

Results: 63 patients were enrolled, with a high rate of recruitment (78.8%) and game completion (90.3%). Patients, parents and, healthcare providers reported high satisfaction levels. There were no serious adverse events. Five of the 30 patients (16.7%) exposed to virtual reality reported mild side effects. Self-reported procedural pain (verbal numerical rating scale: 3 (1, 6)/10 vs 3 (1, 5.5)/10, p = 0.75) was similar between groups. Further exploratory clinical measures were reported for the intervention and control groups, respectively: self-rated distress during the procedure (Child Fear Scale: 1 (0, 2)/4 vs 2 (0, 3)/4); distress evaluated by proxy during the procedure (Procedure Behavior Check List: 8 (8, 9)/40 vs 10 (8, 15)/40); memory of pain at 24 h (VNRS: 2 (1, 3)/10 vs 4 (2, 6.5)/10).

Conclusion: The addition of virtual reality to standard care is feasible and acceptable for pain and distress management during IV procedures in the pediatric ED. Occasional mild, self-resolving side effects were observed in the intervention group. Self-reported pain during the procedure was similar between groups. CLINICALTRIALS.

Gov Identifier: NCT03750578.