About this trial
Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.
Aim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.
Methodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (\>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.
Potential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic or hemorrhagic stroke >6 months before inclusion
Anxiety-HAD score at inclusion >= 8
Disqualifiers
Blindness
Deafness
Photo-sensitive epilepsy
unstable psychiatric condition
Trial design
Sequential
Treatments tested in this trial
Virtual-reality hypnotherapy device
Device10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device
Treatment groups
Trial outcomes
Primary outcomes
HAD-Anxiety
Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale
Sponsors and contacts
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Nicolas Nicastro
Lead sponsor
University Hospital, Geneva
Sponsor institution
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