Effect of a Virtual Reality Environment Using a Domed Ceiling Screen on Procedural Pain During Intravenous Placement in Young Children: A Randomized Clinical Trial

Abstract

Importance: Distraction using virtual reality (VR) has been found to provide a clinically significant reduction in the experience of pain during various painful procedures. Commercially available VR systems usually require the user to wear a head-mounted display helmet, which can be challenging for young children, and whether VR can reduce pain during intravenous (IV) placement in young children is currently unknown.

Objective: To determine whether a VR environment using a novel domed ceiling screen reduces distress among children over the course of IV placement compared with standard care in a pediatric emergency department.

Design, setting, and participants: This randomized clinical trial was conducted from June 3, 2020, to February 8, 2021, at an urban tertiary academic children's hospital. Included were children aged 6 months to 4 years undergoing IV placement in the pediatric emergency department.

Intervention: Children in the intervention group lay on a bed to experience a VR animation using a domed ceiling screen during the IV placement procedure, which was performed as usual. Children in the control group also lay on a bed during the procedure but did not view a VR animation.

Main outcomes and measures: The primary outcome was pain scores measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 4 time points during IV placement: immediately after the child lay down on the bed (T1), the moment the tourniquet was applied (T2), the moment a sterile alcohol swab was applied (T3), and the moment the needle penetrated the skin (T4).

Results: Of the 88 children included in the final analysis, 44 received VR distraction (median [IQR] age, 24.0 [14.5-44.0] months; 27 boys [61.4%]), and 44 received standard care (median [IQR] age, 23.0 [15.0-40.0] months; 26 boys [59.1%]). The median [IQR] FLACC scores at T4 were 6.0 (1.8-7.5) in the intervention group and 7.0 (5.5-7.8) in the control group. The ordinal logistic regression model showed that children in the VR intervention group vs the control group had a lower probability of higher FLACC scores (odds ratio, 0.53; 95% CI, 0.28-0.99; P = .046).

Conclusions and relevance: The findings of this trial indicate that displaying VR using a domed ceiling screen may be an effective distraction method that reduces distress in young children undergoing IV placement.

Trial registration: isrctn.org Identifier: KCT0005122.

Figure 1.. Study Protocol

EMT indicates emergency medical technician; FLACC, Face, Legs, Activity, Cry, and Consolability; IV, intravenous; T0-T4, time points; VR, virtual reality.

Figure 2.. Flow Diagram for Study

ITT indicates intention to treat; IV, intravenous; PP, per protocol; VR, virtual reality.

Figure 3.. Percentage Stacked Bar Chart of Face, Legs, Activity, Cry, and Consolability (FLACC) Scale Scores by Group and Time Point

Responses in each of the 5 FLACC categories are scored between 0 (green) and 2, for a maximum total score of 10 (red), with higher scores indicating greater pain intensity. The time points during intravenous placement were as follows: T1, immediately after the child lay down on the bed; T2, the moment the tourniquet was applied; T3, the moment a sterile alcohol swab was applied; T4, the moment the needle penetrated the skin.