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

NCT07064629 | Enrolling By Invitation

• 2 other identifiers: DigiWell_Relax_01CZ.02.01.01/00/22_008/0004583
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Virtual reality; relaxation; breathing techniques; anxiety disorders; biofeedback

Outcome Measures

Primary Outcomes (3)

• Respiratory rate

  Data from the breathing pattern (respiration effort and respiration rate) measured at the baseline before the beginning of the relaxation, during the relaxation, and a period after the relaxation. The measure is repeated in each session 1-4.

  - baseline/pre-intervention (for 3 minutes) - during the intervention (for 5 minutes) - immediately after the intervention (for 3 minutes)

• Acute symptoms of anxiety

  Using the short version of the State-Trait Anxiety Inventory (STAI-6) questionnaire, measures of acute anxiety symptoms before and after each relaxation session (sessions 1-4). Higher scores indicate higher anxiety. The lowest possible score is 6 (minimum anxiety), and the highest is 24 (maximum anxiety).

  - baseline/pre-intervention (before each session) - and immediately after the intervention (after each session)

• State of relaxation

  With the Relaxation State Questionnaire (RSQ), measured before and after each relaxation session (sessions 1-4). Higher scores imply higher subjective perception of being relaxed. The lowest possible score is 10 (the least relaxed), and the highest is 50 (maximum relaxation).

  - Baseline/pre-intervention (each session) - and immediately after the intervention (each session).

Secondary Outcomes (2)

• Simulator sickness

  Immediately after finishing the final intervention session (Session 4).

• Sense of presence

  Immediately after finishing the final intervention session (Session 4).

Study Arms (2)

Virtual reality relaxation breathing with/without biofeedback

EXPERIMENTAL

Intervention group 1: use of VR application for relaxation breathing in the first two sessions with biofeedback, followed by two sessions without biofeedback.

Behavioral: Relaxation in virtual reality with biofeedback.; Behavioral: Relaxation in virtual reality without biofeedback

Virtual reality relaxation breathing without/with biofeedback

ACTIVE COMPARATOR

Intervention group 2: use of VR application for relaxation breathing in the first two sessions without biofeedback, followed by two sessions with biofeedback.

Behavioral: Relaxation in virtual reality with biofeedback.; Behavioral: Relaxation in virtual reality without biofeedback

Interventions

Relaxation in virtual reality with biofeedback. BEHAVIORAL

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.

Also known as: withBF

Virtual reality relaxation breathing with/without biofeedback; Virtual reality relaxation breathing without/with biofeedback

Relaxation in virtual reality without biofeedback BEHAVIORAL

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).

Also known as: withoutBF

Virtual reality relaxation breathing with/without biofeedback; Virtual reality relaxation breathing without/with biofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with Anxiety disorders

You may not qualify if:

• severe neurological disease (e.g. epilepsia)
• psychiatric disorders other then Anxiety disorder
• serious somatic disease

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead

Study Sites (1)

National Institute of Mental Health

Klecany, Czech Republic, 250 67, Czechia

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Iveta Fajnerova, PhD.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 15, 2025
• Study Start: January 21, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared after the study publication, for at least 5 years.
• Access Criteria: The anonymized preprocessed behavioral data will be shared using an open access repository. Additional raw data access requests will be reviewed using an online form. Requestors will be required to sign a data access agreement.

Locations

CZ (1)