Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial

PURPOSE: Hypnosis is useful for diminishing distress during medical procedures. This study investigated the efficacy of virtually augmented self-hypnosis as an adjunctive non-pharmacological method for procedural pain and anxiety relief during endovascular interventions (EVI). METHODS: We compared an immersive distraction experience (clinicaltrials.gov identifier NCT04561596) featuring virtual reality (VR) using a head-mounted display versus treatment as usual (TAU). Patients followed the “Aqua” module (Oncomfort™) consisting of a scuba dive and breathing exercises. They experienced a self-induced dissociative state similar to clinical hypnosis without direct intervention of a professional. Enrollment followed a 1:1 randomized open study (VR or TAU). Patients’ feelings were evaluated just before and after the procedure, and 3 months following intervention. Anxiety was evaluated using the State Trait Anxiety Inventory (STAI) and pain (sensory, emotional, and memory) with a visual analogue scale (VAS). RESULTS: This study included 100 patients. Mean anxiety (pre-post) was significantly reduced within groups and between groups (difference of 4.2 points, p = 0.016). The percentage of responders to anxiety lowering were 76 and 46% for VR and TAU, respectively (p = 0.004). The two groups did not significantly differ in mean sensory-intensity and affective emotional pain (pre-post) using VAS, in negative memories concerning remembered pain at 3 months (difference > 1 from immediate post-procedural reported pain intensity), mean procedural time, or the need for analgesic or sedative drugs. CONCLUSIONS: VR self-hypnosis has the potential to improve the management of patients’ distress during radiological procedures. It is safe and effective for reducing anxiety during EVI.