Cardiothoracic and Vascular Division, Department of Diagnostic and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Center for Primary Care and Public Health (Unisanté), University of Lausanne, Epalinges, Switzerland.
PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.
Endovascular interventions (EVI) are increasingly performed as minimally-invasive alternatives to surgery and have many advantages, including a decreased need for general anesthesia. However, EVI can be stressful for patients and often lead to anxiety and pain related to the procedure. The use of local anesthetics, anxiolytics, and analgesic drugs can help avoid general anesthesia. Nevertheless, these drugs have potential side effects. Alternative nonpharmacological therapies can improve patients' experience during conscious interventions and reduce the need for additional medications. The added value of virtually augmented self-hypnosis (VA-HYPO) and its potential to reduce pain and anxiety during peripheral and visceral arterial and venous EVI is unknown. This is a prospective two-arm trial designed to randomize 100 patients in two groups according to the use or not of VA-HYPO during peripheral EVI as a complementary nonpharmacological technique to improve patient comfort. The main objective is to compare per-procedural anxiety, and the secondary aim is to compare the rated per-procedural pain in both groups. The potential significance is that VA-HYPO may improve patients' experience during peripheral and visceral arterial and venous EVI and other minimally invasive interventions performed under local anesthesia. Trial registration: Our study is registered on clinicaltrials.gov, with trial registration number: NCT04561596.
血管内介入治疗（EVI）作为手术的微创替代方法，应用日益广泛，具有许多优点，包括减少全身麻醉的需求。然而，EVI 可能会给患者带来压力，经常导致与手术相关的焦虑和疼痛。局部麻醉剂、镇静剂和镇痛药的使用可以帮助避免全身麻醉。然而，这些药物有潜在的副作用。替代非药物治疗可以改善患者在清醒介入期间的体验，并减少对额外药物的需求。虚拟增强自我催眠（VA-HYPO）的附加价值及其在周围和内脏动脉和静脉 EVI 中降低疼痛和焦虑的潜力尚不清楚。这是一项前瞻性双臂试验，旨在根据周围血管介入治疗中是否使用 VA-HYPO 将 100 名患者随机分为两组，作为一种补充性非药物技术，以改善患者的舒适度。主要目的是比较术前焦虑，次要目的是比较两组患者的术中疼痛评分。潜在意义在于，VA-HYPO 可能会改善患者在周围和内脏动脉和静脉 EVI 以及其他在局部麻醉下进行的微创介入治疗期间的体验。试验注册：我们的研究在 clinicaltrials.gov 上注册，试验注册号：NCT04561596。
