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

NCT07064629 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-18

No results posted yet for this study

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."

Conditions

  • Relaxation
  • Anxiety Disorders
  • Biofeedback Training

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).

Sponsors & Collaborators

  • National Institute of Mental Health, Czech Republic

    lead OTHER

Principal Investigators

  • Iveta Fajnerova, PhD. · National Institute of Mental Health (NIMH)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064629 on ClinicalTrials.gov