A new option in pain prevention with a therapeutic virtual reality solution in bone marrow biopsy context: results of an open-label randomized multicenter phase III study (REVEH Trial) (Preprint)

BACKGROUND Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain, has been documented in several phase II trials but comparison with standard treatments in large-randomized studies are needed. OBJECTIVE In this open-label multicenter randomized phase III trial (ClinicalTrials.gov identifier: NCT 03483194), we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow (BM) biopsy. METHODS Bliss© is a VR software with four imaginary interactive environments in three dimensions with a binaural sound (head-mounted display). Efficacy was evaluated on pain intensity using a visual analog scale (score from 0-10) immediately after the biopsy. The primary endpoint was patient-assessed pain intensity after BM procedure, with a visual analog scale (VAS). Secondary endpoints were anxiety and tolerance. Overall, 126 patients with previously documented untreated or suspected malignant hemopathy between September 6, 2018, and May 18, 2020, were randomly assigned in a 1:1 ratio to receive pain prevention with a mixture of nitrous oxide/oxygen (MEOPA) (n=63) or VR (n=63) before and during BM biopsy. All patients received local anesthesia (lidocaine) before biopsy. Modified intention-to-treat analysis was performed. RESULTS Participants’ median age was 65.5 (range 18-87) years and 54.2% of patients were male. The average pain intensity was 3.5 (SD 2.6) for the MEOPA group and 3.0 (SD 2.4) for the VR group without any significant difference in age, sex, center or hemopathy (P=.26). Concerning anxiety, 67.5% of patients were afraid before the biopsy and anxiety scores were moderate to very high in 26.3% of patients before the biopsy (fear of pain and revised STAI questionnaires) and 9.0% after the biopsy for all patients without any significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority of patients in the VR group. CONCLUSIONS The intensity of pain and did not significantly differ between both arms. VR was well tolerated, and satisfaction of patients, nurses and physicians was very high. Virtual reality could be an alternative treatment in case of contraindication or intolerance to MEOPA. CLINICALTRIAL ClinicalTrials.gov identifier: NCT 03483194