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Clinical Trial

Virtual Reality-based Mindfulness Training for Mental Health After Stroke

NCT: NCT07614373 · NOT_YET_RECRUITING

NCT IDNCT07614373
StatusNOT_YET_RECRUITING
Start Date2027-04-01
Completion2029-03-31

Brief Summary

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.

Frequently Asked Questions

What is Virtual Reality-based Mindfulness Training for Mental Health After Stroke?

Virtual Reality-based Mindfulness Training for Mental Health After Stroke is a clinical trial registered under NCT07614373. Current status: NOT_YET_RECRUITING.

What is the status of NCT07614373?

The current status of NCT07614373 (Virtual Reality-based Mindfulness Training for Mental Health After Stroke) is: NOT_YET_RECRUITING.

When did Virtual Reality-based Mindfulness Training for Mental Health After Stroke start?

Virtual Reality-based Mindfulness Training for Mental Health After Stroke started on 2027-04-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.