80 Distraction in the ED using Virtual reality for Intravenous Needs in Children to Improve comfort -the DEVINCI project: A Pilot RCT
Authors: Trottier Evelyne D , Osmanlliu Esli , Bailey Benoit , Lagacé Maryse , Sanchez Marisol , Certain Melanie , Khadra Christelle , Thériault Corinne , Paquin David , Cotes Turpin Casey , Le May Sylvie 
Published: August 2020

Abstract

Background
Venipuncture is a frequent cause of pain and distress in the pediatric emergency department (ED). Healthcare professionals must optimize patient comfort during such procedures, given the associated short- and long-term adverse events. Distraction, which can improve patient experience, remains the most studied psychological intervention. Virtual reality (VR) is a method of immersive distraction that can contribute to the multi-modal management of procedural pain and distress. Its use in the healthcare setting has become more accessible due to the development of more portable and affordable systems.

Objectives
The primary outcome of this study was to determine the feasibility and acceptability of a VR distraction device in the pediatric ED.
The secondary outcomes were to examine the preliminary effects of the addition of VR to standard practice on children’s pain, distress, and memory of pain associated with venipunctures in the pediatric ED.

Design/Methods
This pilot RCT was performed at a tertiary pediatric centre. Children 7-17 years old requiring a venipuncture in the ED were recruited. Participants were randomized to either a control group (standard care) or intervention group (standard care+VR).
A priori feasibility and acceptability criteria were established following expert consensus (nurses/physicians working in the ED):
- 80% of families approached for recruitment consent to participate;
- 80% of recruited patients finish the game as planned (intervention group);
- Mean &gt;7 on the 0-10 satisfaction scale (patients/parents/healthcare providers);
- No serious adverse events.
The principal clinical outcome was the mean level of procedural pain as measured by the verbal numerical rating scale (VNRS). Auto-evaluation of procedural-related distress was performed using the Child Fear Scale (CFS). The level of distress related to the procedure was also evaluated by proxy using the Procedure Behavior Check List (PBCL). Memory of pain was measured at 24h using the VNRS. Side effects were documented.

Results
A total of 63 patients were recruited between December 2018 and April 2019 (one was excluded as the venipuncture was later cancelled).
The results showed feasibility and acceptability of VR in the pediatric ED with:
-79% recruitment rate of eligible families
-90% rate of VR game completion as per protocol (reason for not completing the game: prior headache, wanting to see, VR not working well) and
-overall high mean satisfaction levels.
In addition, there was a significantly higher level of satisfaction among healthcare providers in the intervention group, and 93% of those were willing to use this technology again for the same procedure.
Regarding clinical outcomes, there was no significant difference between groups in self-reported procedural pain, but evaluation of distress by proxy (10/40 vs 13.2/40, p = 0.007) and memory of pain at 24 hours (2.4 vs 4.2, p = 0.027) were significantly lower in the intervention group. Venipuncture was successful on first attempt in 23/31 patients (74%) in the VR group and 15/30 (50%) patients in the control group (p = 0.039). Five of the 31 patients (16%) in the VR group reported side effects, which were mild and self-resolving.

Conclusion
The addition of VR to standard of care for pain and distress management related to venipunctures in the pediatric ED is a feasible and acceptable intervention. Side effects related to VR were few and self-resolving. Both experimental groups were similar with respect to self-reported procedural pain. A lower level of procedural distress, lower memory of pain at 24 hours, and higher venipuncture first attempt success rate were observed in the VR group.