@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{germain_effectiveness_2009,

title = {Effectiveness of cognitive behavioural therapy administered by videoconference for posttraumatic stress disorder},

author = {V. Germain and A. Marchand and S. Bouchard and M. -S. Drouin and S. Guay},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-61549135353&doi=10.1080%2f16506070802473494&partnerID=40&md5=9bfd33dc3db498732e98add612ba938a},

doi = {10.1080/16506070802473494},

issn = {16512316 (ISSN)},

year  = {2009},

date = {2009-01-01},

journal = {Cognitive Behaviour Therapy},

volume = {38},

number = {1},

pages = {42–53},

abstract = {Telehealth, or health care via videoconferencing, constitutes a clinical option that makes it possible to treat patients remotely. A growing number of studies have demonstrated that telehealth is a feasible and effective method for diagnostic interviews and psychiatric consultations. However, few studies have assessed the effectiveness of psychotherapy given by videoconference. This study examines the effectiveness of cognitive behavioural therapy (CBT) administered by videoconference for posttraumatic stress disorder (PTSD). Forty-eight participants with PTSD were recruited for the study: 16 in the videoconferencing condition and 32 in a control face-to-face condition. Each participant received CBT for 16 to 25 weeks and completed various questionnaires before and after treatment. The results show a significant decline in the frequency and severity of posttraumatic symptoms after treatment in both conditions. A clinical improvement in overall functioning was also observed. No significant difference was observed in the effectiveness of the two therapeutic conditions. The examination of effect sizes supports these results. A number of clinical implications and certain avenues for future research are discussed.},

keywords = {Adaptation, adult, aged, article, clinical article, clinical effectiveness, Cognitive behavioural therapy, cognitive therapy, controlled study, Effectiveness, female, Follow-Up Studies, health care delivery, human, Humans, intervention study, interview, male, mental function, Middle Aged, outcome assessment, Patient Acceptance of Health Care, Personality Inventory, Post-Traumatic, posttraumatic stress disorder, Psychological, Remote Consultation, Stress Disorders, telepsychotherapy, teletherapy, treatment outcome, videoconferencing},

pubstate = {published},

tppubtype = {article}

}