A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study

• DOI: 10.2196/38619
• Publication Date: 2023-01-09T17:56:52Z
• Authors: Katell Le Du; Anne-Lise Septans; Frédéric Maloisel; Hélène Vanquaethem; Anna Schmitt; Marielle Le Goff; Aline Clavert; Marie Zinger; Hugues Bourgeois; Olivier Dupuis; Fabrice Denis; Stéphane Bouchard
• Keywords: Male; Adult; Aged, 80 and over; Original Paper; Adolescent; Biopsy; Computer applications to medicine. Medical informatics; R858-859.7; Virtual Reality; Pain; Middle Aged; 3. Good health; Young Adult; 03 medical and health sciences; 0302 clinical medicine; Bone Marrow; Humans; Female; Public aspects of medicine; RA1-1270; Aged

Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented several phase 2 trials, but comparison with standard treatments large, randomized studies is needed.In this open-label, multicenter, randomized, 3 trial, we evaluated safety and efficacy a novel VR therapy solution context bone marrow biopsy.Bliss software 4 imaginary interactive environments dimensions binaural sound (head-mounted display). Efficacy intensity was using visual analog scale (VAS; score from 0 to 10) immediately after biopsy. Secondary end points were anxiety tolerance. Modified intention-to-treat analysis performed.Overall, 126 patients previously untreated or suspected malignant hemopathy between September 6, 2018, May 18, 2020, randomly assigned 1:1 ratio receive prevention mixture nitrous oxide/oxygen (MEOPA; n=63) (n=63) before during We excluded 8 final (3 MEOPA group 5 group). All received local anesthesia (lidocaine) Follow-up limited 1 month Participants' median age 65.5 (range 18-87) years, 54.2% (64/118) male. The average 3.5 (SD 2.6, 95% CI -1.6 8.6) 3.0 2.4, -1.7 7.7) group, without any significant differences age, sex, center, (P=.26). Concerning anxiety, 67.5% (79/117; fear questionnaire) afraid biopsy, scores moderate very high 26.3% (30/114; revised Spielberger State-Trait Anxiety Inventory biopsy 9.0% (10/114) all patients, difference groups (P=.83). Immersion well tolerated by majority (54/57, 95%) group.The did not significantly differ both arms. tolerated, satisfaction nurses, physicians high. could be an alternative treatment case contraindication intolerance MEOPA.ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194.