RelaxationVRrelaxBFNCT07064629
Training of Relaxation Breathing in Virtual Reality Using Biofeedback: Comparison Study
A study testing Relaxation in virtual reality with biofeedback. and Relaxation in virtual reality without biofeedback in people with Relaxation and Anxiety Disorders, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relaxation, Anxiety Disorders, Biofeedback Training
- What is being tested?
- Relaxation in virtual reality with biofeedback. and Relaxation in virtual reality without biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Anxiety disorders
Who cannot join
- severe neurological disease (e.g. epilepsia)
- psychiatric disorders other then Anxiety disorder
- serious somatic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
National Institute of Mental Health
Klecany, Czech Republic, 250 67
About this study
Official title: DigiWell - Relaxation Breathing in Virtual Reality Using Biofeedback
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."
Read the detailed description
This study evaluates the efficacy of a virtual reality (VR)-based relaxation intervention incorporating real-time respiratory biofeedback, delivered via a standalone Meta Quest 2 headset. This study uses a randomized crossover design in which all participants undergo two sessions of virtual reality (VR) relaxation with biofeedback, followed by two sessions without biofeedback, or vice versa. The order of conditions is randomized to control for order effects. The randomization is done via an online randomization tool.
The intervention utilizes a custom-developed application-BreezeTerraVR-designed by the research team at the Center for Virtual Reality Research in Mental Health and Neuroscience, part of the National Institute of Mental Health (NIMH), Czech Republic. BreezeTerraVR is a structured and modifiable VR application specifically built to facilitate training in slow-paced, rhythmic breathing, allowing flexible adjustments to the inhalation, exhalation, and breath-hold phases according to research needs or participant abilities.
The virtual environment represents a calming natural meadow, surrounded by trees. Participants are immersed in this nature scene and guided to practice square (box) breathing, consisting of 4 seconds inhale, 4 seconds hold, 4 seconds exhale, and 4 seconds hold. The target breathing rhythm is visualized through a colored mist moving between two concentric mushroom-shaped circles in the visual field.
Two distinct biofeedback modalities are integrated into the VR experience for the intervention condition with BF:
- Real-time biofeedback is represented by an animated deer walking in front of the user. The deer's exhalation is visualized with visible steam from its nostrils, mirroring the participant's actual breathing rhythm as measured by a Go Direct® Respiration Belt (Vernier).
- Targeted biofeedback is represented by a tree located at the center of the mushroom circle. This tree dynamically grows or shrinks depending on how closely the participant's breathing matches the set rhythm. The feedback difficulty can be adjusted to four levels (0-3), the study protocol applied Level 2 (moderate): Accurate rhythm required for growth; the tree can shrink if the breathing is out of a given rhythm.
In the control condition (Intervention 2), participants engage with the same VR environment and breathing pattern but without biofeedback elements: the deer and the tree are not present. Visual and auditory guidance is still provided via the mist and voice instructions, but there is no adaptive feedback.
All recruited participants sign an Informed consent to participate in the study.
The study duration is three weeks with 4 relaxation sessions in total. The participants complete two VR relaxations per week (e.g.Tuesdays and Thursdays). After the first week of interventions, a one-week break is implemented. The third week the same protocol with two additional sessions is completed. This means the participants complete one of the interventions (conditions) in the first week and the other intervention in the third week.
Each study session takes no longer than 25 minutes per participant. Each of the 4 sessions includes a pre-intervention baseline assessment, a standardized VR breathing session (5 minutes duration) with 3 additional minutes before and 3 minutes after the relaxation spent in the VR environment to measure the pre/post respiratory rate, and a post-intervention assessment. The participants complete the given questionnaires on tablets or computers.
The primary outcomes measured before and after each session include:
- Subjective change in anxiety
- Self-reported relaxation state
- Objective physiological change in respiratory rate (measured for 3 minutes before and after the relaxation).
Secondary outcomes completed only once, immediately after the final Session 4, include the sense of presence and cybersickness measures.
Data will be analyzed using appropriate statistical methods based on sample size and distribution characteristics. Parametric or non-parametric tests (e.g., t-tests, ANOVA, LLM, Mann-Whitney U, or Wilcoxon signed-rank tests) will be used to evaluate within- and between-group differences in anxiety reduction, relaxation level, and physiological measures. Additional analyses may explore interactions between biofeedback accuracy, presence, and outcome effectiveness.
- Conditions
- Relaxation, Anxiety Disorders, Biofeedback Training
- Being tested
- Relaxation in virtual reality with biofeedback., Relaxation in virtual reality without biofeedback
- Keywords
- Virtual reality, relaxation, breathing techniques, anxiety disorders, biofeedback
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation in virtual reality with biofeedback.Behavioural
Also called withBF
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.
Relaxation in virtual reality without biofeedbackBehavioural
Also called withoutBF
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relaxation in virtual reality with biofeedback.; Behavioral: Relaxation in virtual reality without biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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).
Measured: - 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).
Measured: - Baseline/pre-intervention (each session) - and immediately after the intervention (each session).
Secondary outcomes (2)
Simulator sickness
With the Simulation Sickness Questionnaire (SSQ), the potential cybersickness symptoms are measured. Higher scores indicate higher cybersickness. The total score is the sum of subscores from all 16 items and can range from 0 (no symptoms) to 48 (highest symptom intensity).
Measured: Immediately after finishing the final intervention session (Session 4).
Sense of presence
With the iGroup Presence Questionnaire (IPQ), we measure the perceived ability to be immersed in the virtual environment. The total IPQ score is calculated by averaging the responses to all 14 items on the questionnaire. The lowest possible mean score is -3, while the highest mean score is 3. Higher scores indicate a higher sense of presence.
Measured: Immediately after finishing the final intervention session (Session 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start21 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelaxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iveta Fajnerová, National Institute of Mental Health, Czech Republic
- Investigators
- Iveta Fajnerova, PhD., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064629
- Sponsor's protocol ID
- DigiWell_Relax_01
- Other IDs
- CZ.02.01.01/00/22_008/0004583
- Acronym
- VRrelaxBF
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (primary outcome measures) that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DigiWell - Relaxation Breathing in Virtual Reality Using Biofeedback
- ClinicalTrials.gov ID
- NCT07064629
- Acronym / sponsor ID
- VRrelaxBF / DigiWell_Relax_01
- Conditions
- Relaxation, Anxiety Disorders, Biofeedback Training
- Keywords
- Virtual reality, relaxation, breathing techniques, anxiety disorders, biofeedback
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Detailed description
This study evaluates the efficacy of a virtual reality (VR)-based relaxation intervention incorporating real-time respiratory biofeedback, delivered via a standalone Meta Quest 2 headset. This study uses a randomized crossover design in which all participants undergo two sessions of virtual reality (VR) relaxation with biofeedback, followed by two sessions without biofeedback, or vice versa. The order of conditions is randomized to control for order effects. The randomization is done via an online randomization tool.
The intervention utilizes a custom-developed application-BreezeTerraVR-designed by the research team at the Center for Virtual Reality Research in Mental Health and Neuroscience, part of the National Institute of Mental Health (NIMH), Czech Republic. BreezeTerraVR is a structured and modifiable VR application specifically built to facilitate training in slow-paced, rhythmic breathing, allowing flexible adjustments to the inhalation, exhalation, and breath-hold phases according to research needs or participant abilities.
The virtual environment represents a calming natural meadow, surrounded by trees. Participants are immersed in this nature scene and guided to practice square (box) breathing, consisting of 4 seconds inhale, 4 seconds hold, 4 seconds exhale, and 4 seconds hold. The target breathing rhythm is visualized through a colored mist moving between two concentric mushroom-shaped circles in the visual field.
Two distinct biofeedback modalities are integrated into the VR experience for the intervention condition with BF:
- Real-time biofeedback is represented by an animated deer walking in front of the user. The deer's exhalation is visualized with visible steam from its nostrils, mirroring the participant's actual breathing rhythm as measured by a Go Direct® Respiration Belt (Vernier).
- Targeted biofeedback is represented by a tree located at the center of the mushroom circle. This tree dynamically grows or shrinks depending on how closely the participant's breathing matches the set rhythm. The feedback difficulty can be adjusted to four levels (0-3), the study protocol applied Level 2 (moderate): Accurate rhythm required for growth; the tree can shrink if the breathing is out of a given rhythm.
In the control condition (Intervention 2), participants engage with the same VR environment and breathing pattern but without biofeedback elements: the deer and the tree are not present. Visual and auditory guidance is still provided via the mist and voice instructions, but there is no adaptive feedback.
All recruited participants sign an Informed consent to participate in the study.
The study duration is three weeks with 4 relaxation sessions in total. The participants complete two VR relaxations per week (e.g.Tuesdays and Thursdays). After the first week of interventions, a one-week break is implemented. The third week the same protocol with two additional sessions is completed. This means the participants complete one of the interventions (conditions) in the first week and the other intervention in the third week.
Each study session takes no longer than 25 minutes per participant. Each of the 4 sessions includes a pre-intervention baseline assessment, a standardized VR breathing session (5 minutes duration) with 3 additional minutes before and 3 minutes after the relaxation spent in the VR environment to measure the pre/post respiratory rate, and a post-intervention assessment. The participants complete the given questionnaires on tablets or computers.
The primary outcomes measured before and after each session include:
- Subjective change in anxiety
- Self-reported relaxation state
- Objective physiological change in respiratory rate (measured for 3 minutes before and after the relaxation).
Secondary outcomes completed only once, immediately after the final Session 4, include the sense of presence and cybersickness measures.
Data will be analyzed using appropriate statistical methods based on sample size and distribution characteristics. Parametric or non-parametric tests (e.g., t-tests, ANOVA, LLM, Mann-Whitney U, or Wilcoxon signed-rank tests) will be used to evaluate within- and between-group differences in anxiety reduction, relaxation level, and physiological measures. Additional analyses may explore interactions between biofeedback accuracy, presence, and outcome effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality relaxation breathing with/without biofeedback | Experimental | Behavioral: Relaxation in virtual reality with biofeedback., Behavioral: Relaxation in virtual reality without biofeedbackIntervention group 1: use of VR application for relaxation breathing in the first two sessions with biofeedback, followed by two sessions without biofeedback. |
| Virtual reality relaxation breathing without/with biofeedback | Active comparator | Behavioral: Relaxation in virtual reality with biofeedback., Behavioral: Relaxation in virtual reality without biofeedbackIntervention group 2: use of VR application for relaxation breathing in the first two sessions without biofeedback, followed by two sessions with biofeedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with Anxiety disorders
Key exclusion criteria (3 listed)
- severe neurological disease (e.g. epilepsia)
- psychiatric disorders other then Anxiety disorder
- serious somatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation in virtual reality with biofeedback.Also: withBFIn 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. | Behavioural | Virtual reality relaxation breathing with/without biofeedback, Virtual reality relaxation breathing without/with biofeedback |
| Relaxation in virtual reality without biofeedbackAlso: withoutBFIn 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). | Behavioural | Virtual reality relaxation breathing with/without biofeedback, Virtual reality relaxation breathing without/with biofeedback |
Primary outcome
Respiratory rate
Time frame: - baseline/pre-intervention (for 3 minutes) - during the intervention (for 5 minutes) - immediately after the intervention (for 3 minutes)
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.
Acute symptoms of anxiety
Time frame: - baseline/pre-intervention (before each session) - and immediately after the intervention (after each session)
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).
State of relaxation
Time frame: - Baseline/pre-intervention (each session) - and immediately after the intervention (each session).
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).
2 secondary outcomes
Simulator sickness
Time frame: Immediately after finishing the final intervention session (Session 4).
Sense of presence
Time frame: Immediately after finishing the final intervention session (Session 4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD (primary outcome measures) that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iveta Fajnerova, PhD. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation in virtual reality with biofeedback. and Relaxation in virtual reality without biofeedback in people with Relaxation and Anxiety Disorders, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory rate (time frame: - baseline/pre-intervention (for 3 minutes) - during the intervention (for 5 minutes) - immediately after the intervention (for 3 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.