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ENROLLING BY INVITATION
NCT07064629
NA

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

Sponsor: National Institute of Mental Health, Czech Republic

View on ClinicalTrials.gov

Summary

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."

Official title: DigiWell - Relaxation Breathing in Virtual Reality Using Biofeedback

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-01-21

Completion Date

2025-12-30

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

BEHAVIORAL

Relaxation in virtual reality with biofeedback.

In this intervention, biofeedback is provided based on the respiratory rate measured by a Vernier Go respiration belt. This belt sends signals (respiratory effort) to the application that calculates the level of synchronisation and gives the visual biofeedback in two forms: 1) a deer simultanously breathing with the participant (realtime biofeedback, present in the initial phase only), 2) a growing tree - if breathing is regulated following a given rhytm, a growing tree is giving the targeted biofeedback.

BEHAVIORAL

Relaxation in virtual reality without biofeedback

In this control intervention, participants' respiratory rate is still being measured by the respiratory belt VernierGo; however, they are not receiving any visual biofeedback inside the virtual relaxation application (no deer is present, the tree is constantly growing regardless of the breathing pattern of the participant).

Locations (1)

National Institute of Mental Health

Klecany, Czech Republic, Czechia