Virtual reality (VR) to reduce anxiety in children in the plaster room: a study protocol for a randomised controlled trial

BACKGROUND: Paediatric fractures are highly prevalent and are most often treated with plaster. The removal of plaster is often an anxious experience for children. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings. This study aims to investigate the effect of VR on the anxiety level of children with fractures that undergo plaster removal or replacement in the plaster room. METHODS: This study is designed as a randomised controlled trial (RCT). The sample size is 270 patients, aged 5 to 17 years, with a fracture of the upper or lower extremity treated with plaster. The intervention group will be distracted with VR goggles and headphones during the replacement or removal of the plaster, whereas the control group will receive standard care. As a primary outcome, the level of anxiety will be measured with the Child Fear Scale (CFS). Secondary outcomes include anxiety reduction (difference between CFS after and CFS before plaster procedure) and Numeric Rating Scales (NRS) pain and satisfaction. Additionally, the children’s fastest heart rate during the procedure will be recorded. An unpaired samples t-test or a Mann-Whitney U test (depending on the data distribution) will be used to analyse the data. DISCUSSION: When completed, this trial will provide evidence on the potential role of VR in children with fractures treated with plaster. The purpose is to increase the quality of healthcare by decreasing anxiety and possibly pain perception of children during a plaster procedure. TRIAL REGISTRATION: Netherlands Trial Register NL9065. Registered on 27 November 2020