Department of General and Visceral Surgery, Ulm University Hospital, Ulm, Germany.
Department of General, Visceral and Transplantation Surgery, Heidelberg University, Heidelberg, Germany.
BMJ Open. 2023 Sep 13;13(9):e074738. doi: 10.1136/bmjopen-2023-074738.
Intravenous access port implantation is commonly performed under local anaesthesia, which offers advantages such as increased patient satisfaction and resource savings compared with general anaesthesia. However, patients may experience increased perioperative stress and anxiety in the operating room setting without general anaesthesia. Virtual reality (VR) distraction or hypnosis during surgery under local anaesthesia may help patients to auditorily and visually separate from their real environment and engage with a virtual environment through hypnorelaxing guidance. Previous studies suggested that VR hypnosedation may reduce the use of sedatives or general anaesthesia, and may offer additional benefits such as reducing postoperative pain and nausea, and promoting faster patient discharge.
The VIP trial is a randomised controlled pilot trial comparing the usage of VR during port implantation with the current standard of care (local anaesthesia and analgosedation if needed). A total of 120 adult patients are included after screening for eligibility and obtaining informed consent. Patients are randomised preoperatively in a 1:1 ratio to the trial groups. The main outcomes are change of perioperative anxiety and pain. Further outcomes include patient satisfaction and tolerability, perioperative analgesia and sedation, occurrence of postoperative nausea, vomiting and VR sickness symptoms, surgeon's satisfaction, procedure duration, postoperative complications until postoperative day 30 and patient willingness to hypothetically undergo port implantation again under the same conditions.
The VIP trial has been approved by the Ethics Committee of the Medical Faculty of Ulm University (reference number 03/22). If the intervention demonstrates that VR can effectively reduce perioperative anxiety and pain, it may become a novel standard of care to minimise the need for analgosedation or general anaesthesia in port implantation procedures and improve patient outcomes. The results will be submitted to a peer-reviewed journal in the field and will be presented at applicable conferences to ensure rigorous evaluation and access for the academic community.
German Clinical Trials Register: DRKS00028508; registration date 15 March 2022; Universal Trial Number: U1111-1275-4995.
静脉输液港植入术通常在局部麻醉下进行，与全身麻醉相比，局部麻醉具有增加患者满意度和节约资源的优势。然而，在没有全身麻醉的手术室环境下，患者可能会经历更多的围手术期应激和焦虑。在局部麻醉下手术时使用虚拟现实（VR）分散注意力或催眠，可能有助于患者听觉和视觉上与真实环境分离，并通过催眠放松指导与虚拟环境互动。先前的研究表明，VR 催眠可能减少镇静剂或全身麻醉的使用，并可能提供额外的益处，如减少术后疼痛和恶心，并促进患者更快出院。
VIP 试验是一项随机对照试验，比较了在输液港植入术中使用 VR 与当前的标准护理（局部麻醉和必要时使用镇痛镇静）。经过筛选符合条件并获得知情同意后，共纳入 120 名成年患者。患者在术前以 1:1 的比例随机分为试验组。主要结局是围手术期焦虑和疼痛的变化。进一步的结局包括患者满意度和耐受性、围手术期镇痛和镇静、术后恶心、呕吐和 VR 病症状的发生、外科医生的满意度、手术时间、术后 30 天内的并发症以及患者在相同条件下再次接受输液港植入的意愿。
VIP 试验已获得乌尔姆大学医学学部伦理委员会的批准（编号 03/22）。如果该干预措施证明 VR 能有效减轻围手术期焦虑和疼痛，它可能成为一种新的标准护理，以减少输液港植入术中镇痛镇静或全身麻醉的需求，并改善患者结局。研究结果将提交给该领域的同行评议期刊，并在相关会议上展示，以确保学术团体的严格评估和获取。
德国临床试验注册中心：DRKS00028508；注册日期 2022 年 3 月 15 日；通用试验编号：U1111-1275-4995。
