@article{guingo_efficacy_2026,

title = {Efficacy of Virtual Reality vs. Tablet Games for Pain and Anxiety in Children Undergoing Bone Pins Removal: Randomised Clinical Trial},

author = {E. Guingo and M. H. Debeurme and R. P. Santos and S. Addab and P. Rainville and S. Bouchard and K. Chougui and A. Tsimicalis and M. -L. Nault and T. Ducruet and O. Ledjiar and M. Noel and K. St-Arneault and C. Cotes-Turpin and N. Hung and P. Ouimet and S. Parent and J. Gardner and M. Bernstein and S. Le May},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-105004216228&doi=10.1111%2Fjan.16991&partnerID=40&md5=9200a82b5c9572abcc5170e9c9d6142b},

doi = {10.1111/jan.16991},

issn = {03092402 (ISSN)},

year  = {2026},

date = {2026-01-01},

journal = {Journal of Advanced Nursing},

volume = {82},

number = {2},

pages = {1791–1802},

abstract = {Aims: To verify the efficacy of virtual reality compared to tablet games for pain and anxiety management in children undergoing percutaneous bone pin and/or suture removal procedures. Design: Randomised clinical trial using two parallel groups: (1) virtual reality or (2) tablet game. Methods: Three-center, randomised pragmatic clinical trial, using a parallel design with two groups (experimental group: immersive virtual reality; active comparator: tablet games). Children aged 6–17 requiring percutaneous pins and/or sutures were recruited between 2020 and 2022 from three outpatient orthopaedic clinics in paediatric hospitals. Pain was measured with the Numerical Rating Scale and anxiety with the Child Fear Scale before and immediately after the procedure. Results: A total of 188 participants were assigned to either the virtual reality group (96 participants) or the tablet group (92 participants). At the first assessment, there was no noticeable difference between the two groups in terms of pain or anxiety levels. However, further analysis revealed that participants aged 13 and older in the virtual reality group experienced significantly lower anxiety. Conclusion: Virtual reality was not more efficacious than games on a tablet for pain and anxiety of children undergoing removal of bone pins or sutures. However, virtual reality demonstrated a benefit in reducing anxiety for teenagers, particularly those aged 13-older. Implication for the Professional and/or Patient Care: Virtual reality games provide an immersive, non-pharmacological alternative of for anxiety management of teenagers during pins and/or sutures removal. Impact: This study showed that a virtual reality game may help reduce anxiety during pins and/or sutures removal procedures in patients aged 13 years and older. Reporting Method: We adhered to the CONSORT checklist for reporting results. Patient or Public Contribution: A patient partner reviewed the study design, methods and final manuscript. Trial Registration: NCT03680625. © 2025 The Author(s). Journal of Advanced Nursing published by John Wiley & Sons Ltd.},

keywords = {Adolescent, analgesia, Anxiety, Bone Nails, Child, Children, clinical trial, comparative study, controlled study, female, human, Humans, intramedullary nailing, male, multicenter study, Pain Management, procedural pain, procedures, randomized controlled trial, Therapy, video game, Video Games, virtual reality},

pubstate = {published},

tppubtype = {article}

}

@article{delangle_speaking_2026,

title = {Speaking face-to-face with a virtual avatar to reduce anxiety in students who stutter: Tool development and pilot study results},

author = {M. Delangle and A. Moïse-Richard and A. -L. Leclercq and D. Labbé and S. Bouchard and S. Andrews and L. Ménard},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-105028302364&doi=10.1016%2Fj.jfludis.2026.106194&partnerID=40&md5=af0d246f9187ee19796f36456887400b},

doi = {10.1016/j.jfludis.2026.106194},

issn = {0094730X (ISSN)},

year  = {2026},

date = {2026-01-01},

journal = {Journal of Fluency Disorders},

volume = {87},

abstract = {Purpose Speaking in class is challenging for students who stutter. Cognitive-behavioral therapy (CBT) with exposure in virtual reality (VR) emerges as a promising intervention for treating speaking anxiety in pediatric populations. This pilot study tested if real-time avatar-based VR can elicit anxiety responses while remaining acceptable to youth who stutter. Method Twelve students who stutter (aged 9–18) were randomly assigned to a single training session conducted either (1) in VR with a realistic avatar controlled live by their SLP, or (2) in role-play with their SLP, before facing a real actor. We assessed system acceptability, anxiety levels and perceived self-efficacy. Results The VR system was well accepted and elicited physiological arousal comparable to real-life interactions. Although participants reported experiencing less anxiety during VR, skin conductance level showed higher arousal; suggesting a divergence between the subjective report and physiological response. Finally, one training session (either in VR or with the SLP) did not produce gains in self-efficacy or decrease in anxiety related to the final real-actor conversation. Conclusion This study demonstrates evidence that the potential use of immersive VR could represent an acceptable and viable complementary strategy for SLP treatment, that could control exposure parameters while evoking physiological responses similar to real-life contexts. The differences between subjective and physiological measures suggest that VR is inducing anxiety responses differently than it was perceived. Further research could investigate the use of VR as anxiety interventions for students who stutter and should be explored across multi-session studies to understand their therapeutic effect. © 2026 The Authors.},

keywords = {Adolescent, adult, Anxiety, Arousal, article, Avatar, avoidance behavior, Canada, Child, clinical article, cognitive behavioral therapy, complication, controlled study, distance learning, ecological validity, electrocardiogram, electrodermal response, exposure, female, Heart Rate, heart rate variability, human, Humans, Liebowitz Social Anxiety Scale, Likert scale, male, nonverbal communication, physiological stress, Pilot Projects, pilot study, procedures, psychology, questionnaire, randomized controlled trial, role playing, School-age children, Self Concept, Self Efficacy, self report, Signal processing, skin conductance, social anxiety, speech, student, Students, Stuttering, Therapy, treatment outcome, virtual reality, virtual reality exposure therapy},

pubstate = {published},

tppubtype = {article}

}

@article{alessandra_preselected_2026,

title = {Preselected and preferred immersive virtual reality versus narrative alone to induce post-stress relaxation in patients with pulmonary arterial hypertension: A pilot study on perceived stress and heart rate},

author = {G. Alessandra and D. M. Beatrice and C. Sara and M. Roberta and V. Martina and K. Patrycja and B. Maurizio and B. Luca and D. V. Laura Adelaide and B. Stéphane},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-105029595132&doi=10.1111%2Fbjhp.70059&partnerID=40&md5=b86f0151066a7923d8854913cbd54318},

doi = {10.1111/bjhp.70059},

issn = {1359107X (ISSN)},

year  = {2026},

date = {2026-01-01},

journal = {British Journal of Health Psychology},

volume = {31},

number = {1},

abstract = {Objectives: Several studies have shown the effectiveness of immersive virtual reality (IVR)-based relaxation techniques in alleviating stress within the general population. However, few data are available on patients, or on the effectiveness of different scenarios in inducing relaxation. This pilot study aims to compare the effectiveness of three relaxation techniques—preselected IVR (IVR-PS), preferred IVR (i.e. chosen by the participant from different alternatives—IVR-PR), and narrative alone (CTR)—in reducing physiological and psychological stress in 16 pulmonary arterial hypertension (PAH) female patients (N = 16, average age: 46 ± 10.66 years; average education: 13.31 ± 3.8 years; mean duration of illness: 8.56 ± 5.24 years) following an acute stress. Methods: Patients performed a mental stress test followed by three different relaxation sessions presented in a randomized order on three separate occasions. Self-perceived stress, level of relaxation, and heart rate (HR) were monitored during the sessions. Participants' ratings of their experiences were also collected. Results: The results indicated that the three relaxation methods were equally effective in reducing perceived stress induced by acute stress and in lowering HR. However, greater cognitive activation was reported in the two IVR conditions compared with the narrative condition. Conclusions: This is the first study to show evidence of the impact of IVR on a rare population. Despite the lack of significant differences between the two IVR and narrative-alone conditions in physiological and subjective relaxation, more than half of the participants expressed a subjective preference for the virtual experience, especially for the preferred one. © 2026 The Author(s). British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.},

keywords = {adult, controlled study, female, Heart Rate, human, Humans, hypertension, Immersive virtual reality, mental stress, Middle Aged, Narration, pathophysiology, physiology, Pilot Projects, pilot study, procedures, Psychological, psychology, Pulmonary, pulmonary arterial hypertension, pulmonary hypertension, randomized controlled trial, rehabilitation, relaxation, Relaxation Therapy, relaxation training, Stress, Therapy, verbal communication, virtual reality},

pubstate = {published},

tppubtype = {article}

}

@article{orskov_virtual_2025,

title = {Virtual reality-based exposure with 360° video as part of cognitive behavioral therapy for social anxiety disorder: a three-arm randomized controlled trial},

author = {P. T. Ørskov and E. Runge and T. T. H. Sainte-Marie and M. T. Ernst and L. Clemmensen and C. H. Dalsgaard and M. B. Lichtenstein and S. Bouchard},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-105009844371&doi=10.3389%2Ffrvir.2025.1588181&partnerID=40&md5=eb28bc502f030b1af4bff5592815253b},

doi = {10.3389/frvir.2025.1588181},

issn = {26734192 (ISSN)},

year  = {2025},

date = {2025-01-01},

journal = {Frontiers in Virtual Reality},

volume = {6},

abstract = {Background: Social anxiety disorder (SAD) has a high prevalence and an early onset. It often persists well into adulthood, turning into a chronic disorder. Cognitive behavioral therapy (CBT) is effective in treating SAD, but real-life exposure conducted as part of CBT is often costly and time-consuming, and imaginary exposure might lack realism and intensity. Virtual reality (VR)-based exposure using 360° video offers a promising way to deliver exposure therapy. Objective: To develop a complete psychotherapeutic treatment program including CBT with VR-based exposure using 360° videos (CBT-ExpVR) for adult patients with SAD and to test the treatment effect using the Social Interaction Anxiety Scale (SIAS) as the primary outcome. Methods: This three-arm randomized controlled trial involved 51 participants who were recruited through self-referral. The interventions took place at Center for Digital Psychiatry in Denmark. Participants were randomized via computer program to CBT-ExpVR, CBT with in vivo exposure (CBT-Exp), or an active control group offered VR relaxation (RlxVR). Afterwards, participants assigned to RlxVR were re-randomized to one of the two CBT interventions. Allocation was not blinded. Results: Intention-to-treat analysis showed that participants receiving CBT-ExpVR reported significantly fewer symptoms of social anxiety at post-treatment compared to pre-treatment, β = −14.89, 95% CI (−18.64, −11.14), p < 0.0001. At post-treatment, no difference in treatment effect was found between CBT-ExpVR and CBT-Exp, β = 3.643, 95% CI (−1.727, 9.013)},

note = {Publisher: Frontiers Media SA},

keywords = {360° video, cognitive behavioral therapy, exposure, randomized controlled trial, social anxiety disorder, virtual reality},

pubstate = {published},

tppubtype = {article}

}

@article{bouchard_conducting_2025,

title = {Conducting exposure in virtual reality for the treatment of social phobia does lead to change in dysfunctional beliefs},

author = {S. Bouchard and H. Forget},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-105023856314&partnerID=40&md5=db4c4e86d7c32b544fe28c7fb6f9172b},

issn = {15548716 (ISSN)},

year  = {2025},

date = {2025-01-01},

journal = {Annual Review of CyberTherapy and Telemedicine},

volume = {23},

pages = {258–264},

abstract = {This study used data from a randomized control trial on cognitive behavior therapy for social phobia testing the effectiveness of exposure conducted in virtual reality. Measures of cognitive mechanisms had been collected but never analyzed. The study was motivated by a recent publication mentioning that potential aversive outcomes of being judged in virtual reality and by virtual characters have no objective negative consequence in daily life. A sample of 51 adults completed outcome and cognitive mechanism measures at a pretreatment, after 14 weeks of treatment or being on a waiting list, and at a 6-month follow-up. Results demonstrate that conducting exposure in virtual reality led to reductions in dysfunctional beliefs about the perceived consequences of feared social threats, about the likelihood of these feared threats occurring, as well as an increase in perceived self-efficacy to face social situations. These changes were statistically significant when compared to the waiting list condition, remained stable at the 6-month follow-up, and were no less important than when exposure was conducted in vivo. All predictors significantly correlated (p < .001) with the two measures of treatment outcome. Further analyses of cognitive mechanism measures predicting treatment outcomes revealed that, when controlling for shared variance, changes in perceived likelihood and in self-efficacy contributed significantly to patients’ improvement, whereas the role of perceived consequences was only a predictor of self-efficacy. © 2025, Interactive Media Institute. All rights reserved.},

keywords = {adult, article, clinical article, cognitive behavioral therapy, controlled study, exposure, female, follow up, hospital admission, human, in vivo study, Liebowitz Social Anxiety Scale, male, multiple regression, predictors of outcome, randomized controlled trial, social anxiety disorder, social phobia, Social Phobia Scale, threat, treatment duration, Treatment mechanisms, treatment outcome, virtual reality},

pubstate = {published},

tppubtype = {article}

}

@article{bogie_using_2024,

title = {Using virtual reality to improve verbal episodic memory in schizophrenia: A proof-of-concept trial},

author = {B. J. M. Bogie and C. Noël and F. Gu and S. Nadeau and C. Shvetz and H. Khan and M. -C. Rivard and S. Bouchard and M. Lepage and S. Guimond},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85186986986&doi=10.1016%2fj.scog.2024.100305&partnerID=40&md5=a15c598b45b8f44a40b25fe5fd078a06},

doi = {10.1016/j.scog.2024.100305},

issn = {22150013 (ISSN)},

year  = {2024},

date = {2024-01-01},

journal = {Schizophrenia Research: Cognition},

volume = {36},

publisher = {Elsevier Inc.},

abstract = {Background: Schizophrenia is associated with impairments in verbal episodic memory. Strategy for Semantic Association Memory (SESAME) training represents a promising cognitive remediation program to improve verbal episodic memory. Virtual reality (VR) may be a novel tool to increase the ecological validity and transfer of learned skills of traditional cognitive remediation programs. The present proof-of-concept study aimed to assess the feasibility, acceptability, and preliminary efficacy of a VR-based cognitive remediation module inspired by SESAME principles to improve the use of verbal episodic memory strategies in schizophrenia. Methods: Thirty individuals with schizophrenia/schizoaffective disorder completed this study. Participants were randomized to either a VR-based verbal episodic memory training condition inspired by SESAME principles (intervention group) or an active control condition (control group). In the training condition, a coach taught semantic encoding strategies (active rehearsal and semantic clustering) to help participants remember restaurant orders in VR. In the active control condition, participants completed visuospatial puzzles in VR. Attrition rate, participant experience ratings, and cybersickness questionnaires were used to assess feasibility and acceptability. Trial 1 of the Hopkins Verbal Learning Test – Revised was administered pre- and post-intervention to assess preliminary efficacy. Results: Feasibility was demonstrated by a low attrition rate (5.88 %), and acceptability was demonstrated by limited cybersickness and high levels of enjoyment. Although the increase in the number of semantic clusters used following the module did not reach conventional levels of statistical significance in the intervention group, it demonstrated a notable trend with a medium effect size (t = 1.48},

note = {Publisher: Elsevier Inc.},

keywords = {adult, article, clinical article, clinical assessment, Cognitive remediation therapy, cybersickness, disease severity, dizziness, Ecological treatment, Episodic memory, exclusion VR criteria questionnaire, feasibility study, female, Hopkins verbal learning test, human, male, mini international neuropsychiatric interview, nausea, outcome assessment, Positive and Negative Syndrome Scale, Proof of concept, questionnaire, randomized controlled trial, schizophrenia, scoring system, Semantic encoding, Semantics, task performance, training, Verbal memory, virtual reality, vr experience questionnaire},

pubstate = {published},

tppubtype = {article}

}

@article{belleville_efficacy_2023,

title = {Efficacy of a Therapist-Assisted Self-Help Internet-Based Intervention Targeting PTSD, Depression, and Insomnia Symptoms After a Disaster: A Randomized Controlled Trial},

author = {G. Belleville and M. -C. Ouellet and V. Békés and J. Lebel and C. M. Morin and S. Bouchard and S. Guay and N. Bergeron and S. Ghosh and T. Campbell and F. P. Macmaster},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85140981202&doi=10.1016%2fj.beth.2022.08.004&partnerID=40&md5=261383919bbdaa149ac0eeb6d3317fc0},

doi = {10.1016/j.beth.2022.08.004},

issn = {00057894 (ISSN)},

year  = {2023},

date = {2023-01-01},

journal = {Behavior Therapy},

volume = {54},

number = {2},

pages = {230–246},

publisher = {Elsevier Inc.},

abstract = {This study aimed at evaluating the efficacy of an online CBT intervention with limited therapist contact targeting a range of posttraumatic symptoms among evacuees from the 2016 Fort McMurray wildfires. One hundred and thirty-six residents of Fort McMurray who reported either moderate PTSD symptoms (PCL-5 ≥ 23) or mild PTSD symptoms (PCL-5 ≥ 10) with moderate depression (PHQ-9 ≥ 10) or subthreshold insomnia symptoms (ISI ≥ 8) were randomized either to a treatment (n = 69) or a waitlist condition (n = 67). Participants were on average 45 years old, and mostly identified as White (82%) and as women (76%). Primary outcomes were PTSD, depression, and insomnia symptoms. Secondary outcomes were anxiety symptoms and disability. Significant Assessment Time × Treatment Condition interactions were observed on all outcomes, indicating that access to the treatment led to a decrease in posttraumatic stress (F[1,117.04] = 12.128},

note = {Publisher: Elsevier Inc.},

keywords = {adult, Anxiety, article, clinical effectiveness, clinical feature, cognitive behavioral therapy, controlled study, Depression, disaster, Disasters, disease severity, e-mental health, female, human, Humans, insomnia, Internet-Based Intervention, major clinical study, male, Middle Aged, natural disaster, physical disability, Post-Traumatic, posttraumatic stress disorder, psychotherapist, PTSD, randomized controlled trial, risk factor, Sleep Initiation and Maintenance Disorders, Stress Disorders, telepsychotherapy, treatment outcome, wildfire},

pubstate = {published},

tppubtype = {article}

}

@article{remacle_can_2023,

title = {Can teaching simulations in a virtual classroom help trainee teachers to develop oral communication skills and self-efficacy? A randomized controlled trial.},

author = {A. Remacle and S. Bouchard and D. Morsomme},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85152896047&doi=10.1016%2fj.compedu.2023.104808&partnerID=40&md5=990f5fff277e3edf28e78b1fab80022c},

doi = {10.1016/j.compedu.2023.104808},

issn = {03601315 (ISSN)},

year  = {2023},

date = {2023-01-01},

journal = {Computers and Education},

volume = {200},

publisher = {Elsevier Ltd},

abstract = {Effective oral communication skills are essential to ensure optimal teaching while preserving the teacher's vocal health. Training these skills in representative settings is expected to promote their generalization. Since the implementation of such training in actual school situations is challenging, virtual reality (VR) may represent a solution.This study evaluated the effects of VR simulations on trainee teachers’ oral communication skills. Based on our Theoretical Framework for Teachers’ Vocal Behavior, we developed and empirically assessed a voice-related prevention program including noisy communicative situations in a virtual classroom. In a randomized controlled trial, the participants were assigned to one of two conditions: (1) individual voice training including simulations in the virtual classroom and a group information session (experimental group},

note = {Publisher: Elsevier Ltd},

keywords = {Background noise, Computer aided instruction, Control groups, E-learning, Experimental groups, Oral communication, Oral communication skills, Personnel training, randomized controlled trial, Self Efficacy, Speech communication, Teacher training, Teachers', Virtual Classroom, virtual reality, Voice},

pubstate = {published},

tppubtype = {article}

}

@article{seon_virtual_2023,

title = {A Virtual Reality-Assisted Cognitive Behavioral Therapy for and With Inuit in Québec: Protocol for a Proof-of-Concept Randomized Controlled Trial},

author = {Q. Seon and N. Mady and M. Yang and M. Karia and M. Lashley and C. Sescu and M. Lalonde and S. Puskas and J. Outerbridge and E. Parent-Racine and C. Pagiatakis and L. Gomez-Cardona and D. Jiang and S. Bouchard and O. Linnaranta},

url = {https://www.scopus.com/inward/record.uri?eid=2-s2.0-85162096695&doi=10.2196%2f40236&partnerID=40&md5=81cbdc49f182df3c2a0062b0de21e496},

doi = {10.2196/40236},

issn = {19290748 (ISSN)},

year  = {2023},

date = {2023-01-01},

journal = {JMIR Research Protocols},

volume = {12},

publisher = {JMIR Publications Inc.},

abstract = {Background: Emotion regulation is an ability related to psychological well-being; when dysregulated, individuals may have psychiatric symptoms and maladapted physiological responses. Virtual reality-assisted cognitive behavioral therapy (VR-CBT) is an effective psychotherapy to target and strengthen emotion regulation; however, it currently lacks cultural sensitivity and can be improved by adapting it to the cultural context of service users. During previous participatory research, we co-designed a culturally adapted cognitive behavioral therapy (CBT) manual and 2 virtual reality (VR) environments to function as a complement to therapy (VR-CBT) for Inuit who would like to access psychotherapy. Emotion regulation skill building will occur in virtual environments that have interactive components such as heart rate biofeedback. Objective: We describe a protocol for a proof-of-concept 2-arm randomized controlled trial (RCT) with Inuit (n=40) in Québec. The primary aims of this research are to investigate the feasibility, benefits, and challenges of the culturally adapted VR-CBT intervention versus an established VR self-management that is available commercially. We will also investigate self-rated mental well-being and objective psychophysiological measures. Finally, we will use proof-of-concept data to identify suitable primary outcome measures, conduct power calculations in a larger trial for efficacy, and collect information about preferences for on-site or at-home treatment. Methods: Trial participants will be randomly assigned to an active condition or active control condition in a 1:1 ratio. Inuit aged 14 to 60 years will receive a culturally adapted and therapist-guided VR-CBT with biofeedback or a VR relaxation program with nonpersonalized guided components over a 10-week period. We will collect pre- and posttreatment measures of emotion regulation and biweekly assessments over the treatment and at 3-month follow-up. The primary outcome will be measured by the Difficulties in Emotion Regulation Scale (DERS-16) and a novel psychophysiological reactivity paradigm. Secondary measures include psychological symptoms and well-being via rating scales (eg, anxiety or depressive symptoms). Results: As this is the prospective registration of an RCT protocol, we do not yet report any results from the trial. Funding was confirmed in January 2020, and recruitment is expected to start in March 2023 and is set to finish in August 2025. The expected results are to be published in spring 2026. Conclusions: The proposed study responds to the community's desire for accessible and appropriate resources for psychological well-being, as it was developed in active collaboration with the Inuit community in Québec. We will test feasibility and acceptance by comparing a culturally adapted, on-site psychotherapy with a commercial self-management program while incorporating novel technology and measurement in the area of Indigenous health. We also aim to fulfill the needs for RCT evidence of culturally adapted psychotherapies that are lacking in Canada. © Quinta Seon, Noor Mady, Michelle Yang, Maharshee Karia, Myrna Lashley, Claudia Sescu, Maud Lalonde, Stephen Puskas, Joy Outerbridge, Echo Parent-Racine, Catherine Pagiatakis, Liliana Gomez-Cardona, Di Jiang, Stéphane Bouchard, Outi Linnaranta. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.05.2023. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.},

note = {Publisher: JMIR Publications Inc.},

keywords = {Biofeedback, co-design, cognitive behavioral therapy, cultural adaptation, emotion regulation, Indigenous, Inuit health, randomized controlled trial, virtual reality},

pubstate = {published},

tppubtype = {article}

}

@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},

publisher = {JMIR Publications Inc.},

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}

}