This trial aims to assess the acceptability, feasibility, and safety of BioVirtualPed, a biofeedback-based virtual reality (VR) game designed to reduce pain, anxiety, and fear in children undergoing medical procedures. An Oculus Quest 2 headset was used in the VR experience, respiratory data was captured using an ADXL354 accelerometer, and these data were integrated into the game with ArdunioUno software. The sample of this study consisted of 15 pediatric oncology patients aged 6 to 12 years between July and August 2023. BioVirtualPed's acceptability, feasibility, and safety were evaluated through child and expert feedback, alongside metrics including the System Usability Scale, Wong-Baker Pain Rating Scale, Child Fear Scale, Child Anxiety Scale-Status, Satisfaction Scoring, and various feasibility and safety parameters. Regarding the acceptability, the expert evaluation showed a mean score of 122.5 ± 3.53, indicating high usability for the system. All children provided positive feedback, and both children and their mothers reported high satisfaction with using BioVirtualPed. The BioVirtualPed was feasible for reducing children's pain, fear, and anxiety levels. All the children complied with the game, and no one withdrew from the trial. BioVirtualPed did not cause symptoms of dizziness, vomiting, or nausea in children and was found to be safe for children. The findings showed that BioVirtualPed meets the following criteria: feasibility, user satisfaction, acceptability, and safety. It is a valuable tool to improve children's experience undergoing port catheter needle insertion procedures. Integration of VR interventions with BioVirtualPed into routine nursing care practices has the potential to effectively manage the pain, anxiety, and fear experienced by children undergoing medical procedures. The safety, feasibility, and acceptability results are promising for further research and integration into pediatric healthcare practice.

中文翻译：

---

基于生物反馈的儿童虚拟现实游戏 (BioVirtualPed)：可行性试验

该试验旨在评估 BioVirtualPed 的可接受性、可行性和安全性，这是一款基于生物反馈的虚拟现实 (VR) 游戏，旨在减轻接受医疗手术的儿童的疼痛、焦虑和恐惧。 VR体验中使用了Oculus Quest 2耳机，使用ADXL354加速度计捕获呼吸数据，并使用ArdunioUno软件将这些数据集成到游戏中。这项研究的样本包括 2023 年 7 月至 8 月期间 15 名 6 至 12 岁的儿科肿瘤患者。 BioVirtualPed 的可接受性、可行性和安全性通过儿童和专家反馈以及系统可用性量表、Wong-Baker 疼痛评级等指标进行评估量表、儿童恐惧量表、儿童焦虑量表-状态、满意度评分以及各种可行性和安全参数。在可接受性方面，专家评价平均分为122.5±3.53，表明系统可用性较高。所有孩子都提供了积极的反馈，孩子和他们的母亲都对使用 BioVirtualPed 表示非常满意。 BioVirtualPed 可以减轻儿童的疼痛、恐惧和焦虑水平。所有的孩子都遵守了游戏，没有人退出试验。 BioVirtualPed 不会引起儿童头晕、呕吐或恶心的症状，并且被发现对儿童是安全的。调查结果表明 BioVirtualPed 满足以下标准：可行性、用户满意度、可接受性和安全性。它是改善儿童接受端口导管针插入手术体验的宝贵工具。将 VR 干预措施与 BioVirtualPed 整合到日常护理实践中，有可能有效管理接受医疗手术的儿童所经历的疼痛、焦虑和恐惧。安全性、可行性和可接受性结果有望进一步研究并融入儿科医疗实践。