Virtual reality (VR) to reduce anxiety in children in the plaster room

Rationale: Fractures occur frequently in children in the Netherlands. In our hospital, we see about 2000 fractures in children each year. The most fractures are treated with plaster, some in combination with k-wires. For children the application or removal of plaster (and the potential k-wires) is often an anxious experience [Katz et al. 2001, Carmichael et al. 2005].
Virtual Reality (VR) goggles are used in clinical settings to distract patients from anxious situations. A positive effect of VR goggles on anxiety and pain perception and therefore on the quality of healthcare is shown in children in several other situations, such as blood draw, dental procedures, vaccinations and treatment of burns [Won et al. 2017, Rao et al. 2019, Eijlers et al. 2019, Özalp et al. 2019, Chen et al 2020]. As far as we know, the effect of VR goggles and headphones during plastering has not yet been investigated. Our hypothesis is that the use of VR goggles connected to headphones will lower the anxiety of children in the plaster room.

Objective: This study aims to evaluate the effect of VR goggles on the anxiety level of children aged between 5 and 17 years in the plaster room that undergo application, replacement of removal of plaster with or without k-wires in situ.

Study design: Randomised controlled trial

Study population: Children between the age of 5 and 17 years who need treatment with, replacement or removal of plaster (with or without k-wires in situ) due to a fracture in the arm or leg.

Intervention: One group gets VR goggles and headphones during the plaster application/replacement/removal and the other group receives usual care without the VR goggles and headphones.

Main study parameters/endpoints: Primary outcome: Anxiety (child) (measured after the plaster intervention) using the Child Fear Scale (CFS).

Secondary outcome measure: Anxiety reduction (child) (difference between the CFS score before and after the plaster intervention), NRS Pain (child) (immediately before and after the plaster intervention), NRS Satisfaction (child and parent/guardian) (immediately after the plaster intervention), Heart rate (child) (during the plaster intervention).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjective scores to fill out, and a (non-invasive) measurement of the heart rate. The benefit of the study is to provide an answer to the question if the use of VR goggles and headphones reduces anxiety in children with fractures in the plaster room. There is a minimal risk during the procedure, complications of the procedure are very rare.

Our hypothesis is that the use of VR goggles with headphones will lower the anxiety of children in the plaster room.

Only one scheduled visit for the plaster intervention and questionnaires.

Control group: Standard care with an additional finger pulse oximeter.
Intervention group: Standard care with additional virtual Reality goggles, connected headphones, and a finger pulse oximeter.