Sample
anxiety, pain
MAY, RECRUITMENT
A total of 126 patients were enrolled between September 6, 2018, and May 18, 2020, in 5 centers in France: Le Mans (n=80), Strasbourg (n=32), Bordeaux (n=8), Saint-Mandé (n=5), and Angers (n=1). Trial recruitment stopped after inclusion of the target population. We excluded 3 patients before randomization (2 patients did not meet the inclusion criteria, and 1 patient withdrew consent), and 5 patients were excluded after randomization from the final analysis (intensity of pain not documented: 4 patients in the VR group and 1 patient in the MEOPA group). An additional 3 patients did not complete the VR session in the VR group: 1 patient refused VR after the short demonstration and then also refused MEOPA, 1 patient was intolerant, and 1 patient experienced unbearable anxiety. The 2 latter patients both received MEOPA during the biopsy. They were excluded from the per-protocol analysis but included in the intention-to-treat analysis (CONSORT diagram. MEOPA: mixture of nitrous oxide/oxygen; VR: virtual reality.