@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{khadra_effects_2020,

title = {Effects of a projector-based hybrid virtual reality on pain in young children with burn injuries during hydrotherapy sessions: A within-subject randomized crossover trial},

author = {C. Khadra and A. Ballard and D. Paquin and C. Cotes-Turpin and H. G. Hoffman and I. Perreault and J. -S. Fortin and S. Bouchard and J. Théroux and S. Le May},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85084390816&doi=10.1016%2fj.burns.2020.04.006&partnerID=40&md5=07c94e6c0d5a26e5c2ead8068f0f7f0c},

doi = {10.1016/j.burns.2020.04.006},

issn = {03054179 (ISSN)},

year  = {2020},

date = {2020-01-01},

journal = {Burns},

volume = {46},

number = {7},

pages = {1571–1584},

abstract = {Aim: The aim of this study was to examine the effect of a water-friendly Projector-Based Hybrid Virtual Reality (VR) dome environment combined with standard pharmacological treatment on pain in young children undergoing burn wound care in hydrotherapy. Methods: This study was a prospective, within-subject crossover trial of 38 children aged 6 months to 7 years old (mean age = 1.8 years old). Each hydrotherapy procedure was divided into two equivalent wound care segments (No hybrid VR during one segment vs. Hybrid VR during the other segment, treatment order was randomized). Pain was measured using the 0–10 FLACC (Face, Legs, Activity, Cry Consolability scale) and the 0–10 NRS-obs (Numerical Rating Scale-obs). Results: Projector-Based Hybrid VR significantly reduced procedural pain levels measured by the FLACC (p = 0.026) and significantly increased patients' comfort levels (p = 0.002). Patients' pain levels rated by the nurses using the NRS-obs were non-significant between both groups (p = 0.135). No side effects were reported. Conclusion: Projector-Based Hybrid VR helped in reducing the pain related to hydrotherapy procedures in young children with burn wound injuries. This is the first study using virtual reality distraction with young children, and our findings are especially important because a large percentage of pediatric burn patients are very young. Additional research and development are recommended. Trial registration: ClinicalTrials.gov, NCT02986464, registered on June 12, 2016. © 2020 Elsevier Ltd and ISBI},

note = {Publisher: Elsevier Ltd},

keywords = {article, burn, Burns, Child, clinical article, clonidine, complication, controlled study, Cross-Over Studies, crossover procedure, Distraction, Face Legs Activity Cry Consolability scale, female, human, Humans, hydromorphone, hydrotherapy, infant, ketamine, male, midazolam, morphine, numeric rating scale, Pain, pain measurement, paracetamol, Preschool, preschool child, procedural pain, Prospective Studies, prospective study, randomized controlled trial, rating scale, virtual reality},

pubstate = {published},

tppubtype = {article}

}