Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada
Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892.
Intravenous (IV) insertions are among the most performed procedures for children seeking medical care; they are often a painful and stressful experience for both children and their caregivers. Paediatric distress and pain that is inadequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for both the family and clinical team. We hypothesise that distraction via an immersive virtual reality (VR) experience may reduce the associated distress for children undergoing IV insertions.
This two-armed randomised controlled superiority trial will be conducted in a Canadian paediatric emergency department and will aim to enrol 80 children overall. Children will be randomised to receive either departmental standard of care alone or standard of care plus an immersive VR experience. Children 6-17 years of age who are undergoing IV insertion and have topical anaesthetic application will be considered for inclusion. Our primary objective is to compare the reduction of distress between the two study arms. The primary outcome will be the child's observed distress score as measured by the Observational Signs of Behavioral Distress-Revised tool. Secondary outcomes include the child's pain intensity and fear, parental anxiety, satisfaction with the IV procedure, as well as adverse events. Recruitment launched in September 2020 and is expected to end in March 2022.
This study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent will be obtained from parents or guardians, and assent from children. Study data will be submitted for publication irrespective of results. This study is funded through a Women and Children's Health Research Institute Innovation grant. Purchase of the VR equipment was facilitated through a Stollery Children's Hospital Foundation small equipment grant.
NCT04291404Cite Now.
静脉（IV）插入是儿童寻求医疗护理时最常进行的操作之一；对于儿童及其护理人员来说，这通常是一种痛苦和压力大的体验。如果未能充分治疗儿科患者的不适和疼痛，可能会导致儿童感到恐惧和不合作，从而需要反复进行 IV 尝试，这不仅会使儿童感到沮丧，也会使整个家庭和临床团队感到沮丧。我们假设通过沉浸式虚拟现实（VR）体验进行分散注意力可能会减轻接受 IV 插入的儿童的相关不适。
这项在加拿大儿科急诊部门进行的双臂随机对照优势试验将总共招募 80 名儿童。将儿童随机分配接受部门标准护理或标准护理加沉浸式 VR 体验。将考虑纳入 6-17 岁正在接受 IV 插入且已应用局部麻醉的儿童。我们的主要目标是比较两种研究臂之间的不适感减少情况。主要结局将是通过观察行为困扰修订工具（Observed Signs of Behavioral Distress-Revised tool）测量的儿童观察到的不适评分。次要结局包括儿童的疼痛强度和恐惧、父母的焦虑、对 IV 程序的满意度以及不良事件。招募于 2020 年 9 月启动，预计将于 2022 年 3 月结束。
这项研究已获得阿尔伯塔大学健康研究伦理委员会的批准。将从父母或监护人处获得知情同意，并从儿童处获得同意。无论结果如何，研究数据都将提交发表。这项研究是通过妇女和儿童健康研究所创新资助获得资金的。购买 VR 设备是通过斯特罗利儿童医院基金会的小型设备资助促成的。
NCT04291404。
