@article{le_du_new_2023,

title = {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},

author = {K. Le Du and A. -L. Septans and F. Maloisel and H. Vanquaethem and A. Schmitt and M. Le Goff and A. Clavert and M. Zinger and H. Bourgeois and O. Dupuis and F. Denis and S. Bouchard},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85148250546&doi=10.2196%2f38619&partnerID=40&md5=e27bfbd3d4c42f8850daf70bdf60b384},

doi = {10.2196/38619},

issn = {14388871 (ISSN)},

year  = {2023},

date = {2023-01-01},

journal = {Journal of Medical Internet Research},

volume = {25},

abstract = {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. © 2023 Journal of Medical Internet Research. All rights reserved.},

note = {Publisher: JMIR Publications Inc.},

keywords = {80 and over, Adolescent, adult, aged, alprazolam, Anxiety, article, Biopsy, blood pressure measurement, Bone Marrow, bone marrow biopsy, clinical trial, controlled study, demographics, digital health, digital therapeutics, Distraction, Effectiveness, efficacy, eHealth, female, follow up, head-mounted display, hematologic disease, human, human tissue, Humans, hypertension, imagery, imaginary, imagination, Immersive environment, Intention to Treat Analysis, interactive environment, leukemia, lidocaine, local anesthesia, lymphoma, major clinical study, male, medical procedure, Meopa, Middle Aged, monoclonal immunoglobulinemia, multicenter study, myelodysplastic syndrome, myeloma, myeloproliferative disorder, myeloproliferative neoplasm, nitrous oxide plus oxygen, open study, Pain, pain intensity, pain measurement, paracetamol, phase 3 clinical trial, prospective study, questionnaire, randomized controlled trial, RCT, relaxation training, safety, satisfaction, solid malignant neoplasm, State Trait Anxiety Inventory, very elderly, virtual reality, visual analog scale, VR, Young Adult},

pubstate = {published},

tppubtype = {article}

}

@article{guitard_exposure_2019,

title = {Exposure to a standardized catastrophic scenario in virtual reality or a personalized scenario in imagination for Generalized Anxiety Disorder},

author = {T. Guitard and S. Bouchard and C. Bélanger and M. Berthiaume},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85073896961&doi=10.3390%2fjcm8030309&partnerID=40&md5=b80f2e6602416c35dd8e36fd8b19c803},

doi = {10.3390/jcm8030309},

issn = {20770383 (ISSN)},

year  = {2019},

date = {2019-01-01},

journal = {Journal of Clinical Medicine},

volume = {8},

number = {3},

abstract = {The cognitive behavioral treatment of generalized anxiety disorder (GAD) often involves exposing patients to a catastrophic scenario depicting their most feared worry. The aim of this study was to examine whether a standardized scenario recreated in virtual reality (VR) would elicit anxiety and negative affect and how it compared to the traditional method of imagining a personalized catastrophic scenario. A sample of 28 participants were first exposed to a neutral non-catastrophic scenario and then to a personalized scenario in imagination or a standardized virtual scenario presented in a counterbalanced order. The participants completed questionnaires before and after each immersion. The results suggest that the standardized virtual scenario induced significant anxiety. No difference was found when comparing exposure to the standardized scenario in VR and exposure to the personalized scenario in imagination. These findings were specific to anxiety and not to the broader measure of negative affect. Individual differences in susceptibility to feel present in VR was a significant predictor of increase in anxiety and negative affect. Future research could use these scenarios to conduct a randomized control trial to test the efficacy and cost/benefits of using VR in the treatment of GAD. © 2019 by the authors. Licensee MDPI, Basel, Switzerland.},

note = {Publisher: MDPI},

keywords = {adult, anxiety assessment, article, avoidance behavior, clinical article, cognitive avoidance questionnaire, cognitive behavioral therapy, Cognitive exposure, disease severity, DSM-IV, Exposure in virtual reality, fatigue, female, gatineau presence questionnaire, generalized anxiety disorder, Generalized Anxiety Disorder (GAD), human, human experiment, imagination, immersive tendencies questionnaire, Likert scale, male, Middle Aged, mini international neuropsychiatric interview, penn state worry questionnaire, Personalized scenario, Positive and Negative Affect Schedule, Positive and Negative Syndrome Scale, Presence Questionnaire, psychotherapy, questionnaire, Simulator Sickness Questionnaire, Standardized scenario, task performance, test retest reliability, time series analysis, virtual reality},

pubstate = {published},

tppubtype = {article}

}