Training of Relaxation Breathing in Virtual Reality Using Biofeedback: Comparison Study

This study aims to evaluate the effectiveness of a VR-based relaxation breathing training with biofeedback compared to a non-biofeedback version in patients with anxiety disorders. The randomized controlled trial will include at least 30 participants (15 per group) diagnosed with an anxiety disorder (DSM-5 or ICD-10 criteria). The intervention will use BreezeTerraVR, a custom-built virtual reality (VR) application developed by VR research center team members at NIMH. This app provides training in deep relaxation breathing technique with or without biofeedback (BF - visual elements reflecting real-time breathing patterns measured via breathing belt) in a virtual nature environment. This study compares two subgroups of anxiety patients, both completing four 20-minute intervention sessions, two sessions with BF and two without BF (in randomized order). This study will assess the feasibility of the VR intervention, estimate effect sizes, and provide preliminary insights into its impact on relaxation training in individuals with anxiety disorders. This study is funded by the European Union's co-financed project "Research of Excellence on Digital Technologies and Wellbeing CZ.02.01.01/00/22\_008/0004583."

NCT Number	NCT07064629
Lead Sponsor	National Institute of Mental Health, Czech Republic
Conditions	Relaxation, Anxiety Disorders, Biofeedback Training
Enrollment	30 participants
Start Date	2025-01-21
Primary Completion	2025-12-30 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-18