TY  - JOUR
AU  - Le Du, Katell
AU  - Septans, Anne-Lise
AU  - Maloisel, Frédéric
AU  - Vanquaethem, Hélène
AU  - Schmitt, Anna
AU  - Le Goff, Marielle
AU  - Clavert, Aline
AU  - Zinger, Marie
AU  - Bourgeois, Hugues
AU  - Dupuis, Olivier
AU  - Denis, Fabrice
AU  - Bouchard, Stéphane
PY  - 2023
DA  - 2023/2/15
TI  - 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
JO  - J Med Internet Res
SP  - e38619
VL  - 25
KW  - virtual reality
KW  - VR
KW  - bone marrow
KW  - biopsy
KW  - pain
KW  - digital therapeutics
KW  - digital health
KW  - eHealth
KW  - RCT
KW  - randomized controlled trial
KW  - clinical trial
KW  - distraction
KW  - imagery
KW  - imagination
KW  - imaginary
KW  - immersive environment
KW  - interactive environment
KW  - head-mounted display
KW  - medical procedure
KW  - satisfaction
KW  - safety
KW  - efficacy
KW  - effectiveness
AB  - Background: Evidence regarding the analgesic effect of distraction through immersion in virtual reality (VR) for care-induced pain has been documented in several phase 2 trials, but comparison with standard treatments in large, randomized studies is needed. Objective: In this open-label, multicenter, randomized, phase 3 trial, we evaluated the safety and efficacy of a novel VR therapy solution for distraction in the context of bone marrow biopsy. Methods: Bliss is a VR software with 4 imaginary interactive environments in 3 dimensions with binaural sound (head-mounted display). Efficacy regarding pain intensity was evaluated using a visual analog scale (VAS; score from 0 to 10) immediately after the biopsy. Secondary end points were anxiety and tolerance. Modified intention-to-treat analysis was performed. Results: 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 the bone marrow biopsy. We excluded 8 patients from the final analysis (3 in the MEOPA group and 5 in the VR group). All patients received local anesthesia (lidocaine) before biopsy. Follow-up was limited to 1 month after the biopsy. Participants’ median age was 65.5 (range 18-87) years, and 54.2% (64/118) of patients were male. The average pain intensity was 3.5 (SD 2.6, 95% CI –1.6 to 8.6) for the MEOPA group and 3.0 (SD 2.4, 95% CI –1.7 to 7.7) for the VR group, without any significant differences in age, sex, center, and hemopathy (P=.26). Concerning anxiety, 67.5% (79/117; fear of pain questionnaire) of the patients were afraid before the biopsy, and anxiety scores were moderate to very high in 26.3% (30/114; revised Spielberger State-Trait Anxiety Inventory questionnaire) of the patients before the biopsy and 9.0% (10/114) after the biopsy for all patients, without a significant difference between the 2 groups (P=.83). Immersion in VR was well tolerated by the majority (54/57, 95%) of patients in the VR group. Conclusions: The intensity of pain did not significantly differ between both arms. VR was well tolerated, and the satisfaction of patients, nurses, and physicians was very high. VR could be an alternative treatment in case of contraindication or intolerance to MEOPA. Trial Registration: ClinicalTrials.gov NCT03483194; https://clinicaltrials.gov/ct2/show/NCT03483194 
SN  - 1438-8871
UR  - https://www.jmir.org/2023/1/e38619
UR  - https://doi.org/10.2196/38619
UR  - http://www.ncbi.nlm.nih.gov/pubmed/36790852
DO  - 10.2196/38619
ID  - info:doi/10.2196/38619
ER  -