Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.
Foundation for Orthopaedic Research, Care & Education, Amphia Hospital, Breda, The Netherlands.
Trials. 2022 Jul 15;23(1):565. doi: 10.1186/s13063-022-06488-2.
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.
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.
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.
Netherlands Trial Register NL9065 . Registered on 27 November 2020.
儿科骨折非常常见,通常采用石膏固定治疗。拆除石膏对儿童来说常常是一种焦虑的体验。虚拟现实(VR)已被证明可有效分散儿童注意力,并降低他们在其他临床环境中的焦虑感。本研究旨在探讨 VR 对在石膏室接受石膏拆除或更换的骨折儿童焦虑水平的影响。
本研究设计为随机对照试验(RCT)。样本量为 270 名年龄在 5 至 17 岁、上肢或下肢骨折、采用石膏固定治疗的患者。干预组将在更换或拆除石膏时使用 VR 护目镜和耳机进行分散注意力,而对照组将接受常规护理。主要结局是使用儿童恐惧量表(CFS)测量焦虑水平。次要结局包括焦虑程度的降低(石膏操作前后 CFS 的差异)和数字评分量表(NRS)疼痛和满意度。此外,还将记录患儿在操作过程中的最快心率。将使用独立样本 t 检验或曼-惠特尼 U 检验(取决于数据分布)分析数据。
当试验完成后,它将提供 VR 在接受石膏治疗的骨折儿童中的潜在作用的证据。目的是通过降低焦虑感,可能减轻儿童在石膏处理过程中的疼痛感知,从而提高医疗保健质量。
荷兰临床试验注册中心 NL9065。于 2020 年 11 月 27 日注册。