StressVRELAXNCT07431918
Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation
A study testing Nature-Based Virtual Reality With Binaural Beats in people with Stress and Relaxation, run by Heart and Brain Research Group, Germany.
Trial summary
The VRELAX study is a non-clinical sub-study within the "Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients"- research program (DESTRESS; NCT05036538), which investigates non-pharmacological relaxation interventions using virtual reality… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Relaxation, Virtual Reality
- What is being tested?
- Nature-Based Virtual Reality With Binaural Beats
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2026to 20 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Ability to understand study procedures and provide written informed consent
- Sufficient proficiency in the German language to complete questionnaires and follow study instructions
- Willingness to participate in a single approximately 60-minute study session
Who cannot join
- Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy)
- Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones
- History of adverse reactions to virtual reality
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nicole Schmidt-Bodensohn, PhD, M.Sc. contact
About this study
Official title: Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study
The VRELAX study is a non-clinical sub-study within the "Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients"- research program (DESTRESS; NCT05036538), which investigates non-pharmacological relaxation interventions using virtual reality and binaural auditory stimulation. In a randomized counterbalanced within-subject design, non-clinical adult participants complete two sessions separated by a 1 day intervention-free interval. A 30-minute immersive nature-based virtual reality exposure combined with gradually decreasing binaural beats (10-1 Hertz (Hz)), and a control condition without relaxation. Heart rate variability (HRV) is recorded continuously, and subjective stress is assessed before and after each condition. The primary outcome is parasympathetic activation operationalized as high-frequency (HF) power of heart rate variability. Secondary outcomes include additional HRV parameters and self-reported stress ratings. The study aims to characterize short-term relaxation effects and evaluate the feasibility of independent use in everyday settings, supporting interpretation of clinical findings of the DESTRESS trial.
Read the detailed description
Psychological stress contributes to cardiovascular risk through dysregulation of the autonomic nervous system. Immersive virtual reality environments and binaural auditory stimulation have each shown stress-reducing effects, but their combined physiological impact remains insufficiently investigated. The DESTRESS research program (NCT05036538) evaluates these interventions in cardiac surgical patients. To isolate intervention-specific mechanisms independent of medical conditions, the VRELAX study was designed as a non-clinical sub-study with a randomized cross-over design in adult participants. Each participant undergoes two experimental conditions in counterbalanced order. A 30-minute immersive nature-based virtual reality exposure combined with binaural beats decreasing from alpha to delta frequency range (10-1 Hz). And a everyday cognitive activities without relaxation intervention. Sessions are separated by a 1 day intervention-free interval to reduce carryover effects. Heart rate variability is continuously measured using a validated chest-strap sensor. Subjective stress is assessed pre- and post-condition visual analogue scales. The primary outcome is HF-power of heart rate variability as an indicator of parasympathetic activation and physiological relaxation. Secondary outcomes are additional HRV parameters (root mean square of successive differences (RMSSD), number of successive normal-to-normal intervals differing by more than 50 milliseconds (NN50), percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50), normalized high-frequency power of heart rate variability (HF%)), subjective stress ratings, and feasibility of independent intervention use based on participant instruction. By investigating physiological relaxation mechanisms in a non-clinical population, the study allows interpretation of intervention-specific effects independent of disease, medication, or perioperative factors. The findings will provide mechanistic context for the clinical DESTRESS trial and evaluate whether an easily implementable immersive relaxation procedure may serve as a preventive approach for reducing everyday and work-related stress.
- Conditions
- Stress, Relaxation, Virtual Reality, Binaural Beats
- Being tested
- Nature-Based Virtual Reality With Binaural Beats
- Keywords
- Virtual Reality, Binaural Beats, Heart Rate Variability, Stress Reduction, Relaxation Intervention, Non-Clinical Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-Based Virtual Reality With Binaural BeatsBehavioural
A 30-minute immersive virtual reality exposure to natural environments combined with binaural auditory stimulation gradually decreasing from alpha to delta frequency range (10-1 Hz).
| Study group | Role | What they receive |
|---|---|---|
| VR + Binaural Beats | Experimental | Participants receive a 30-minute immersive nature-based virtual reality relaxation intervention combined with binaural beats. Receives: Behavioral: Nature-Based Virtual Reality With Binaural Beats |
| Control Condition | No intervention | Participants undergo a control condition involving everyday cognitive activities without relaxation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High-Frequency Power of Heart Rate Variability (HF Power)
Spectral power in the high-frequency band (0.15-0.40 Hz) of heart rate variability measured in ms². Higher values reflect greater parasympathetic activity. The primary outcome is defined as the pre- to post-intervention change in HF-HRV measured continuously during the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Secondary outcomes (5)
Change in Root Mean Square of Successive Differences (RMSSD)
RMSSD of normal-to-normal heart beat intervals, measured in milliseconds (ms). Higher values indicate greater parasympathetic (vagal) activity and lower physiological stress. Changes in RMSSD will be assessed during the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Number of Successive NN Interval Differences Greater Than 50 ms (NN50)
Number of pairs of successive normal-to-normal (NN) intervals differing by more than 50 milliseconds. Higher values indicate increased parasympathetic activity. Changes in NN50 will be assessed during the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Proportion of NN50 (pNN50)
Percentage of successive normal-to-normal intervals differing by more than 50 ms (%). Higher values indicate increased parasympathetic activity and reduced physiological stress. Changes in pNN50 will be assessed during the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Relative High-Frequency Power (HF%)
Relative proportion of high-frequency power as percentage of total spectral power (%). Higher values indicate parasympathetic dominance. Changes in HF% will be assessed during the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Self-Reported Stress (Visual Analog Scale)
Participants rate their perceived stress on a visual analog scale ranging from 0 (no stress) to 10 (maximum stress). The outcome is defined as the change from pre- to post-intervention, with lower scores indicating lower perceived stress.
Measured: Pre- and post-intervention within a single 30-minute study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized counterbalanced within-subject cross-over design. Each participant undergoes both conditions: a 30-minute virtual reality relaxation intervention with binaural beats and a control condition without relaxation. The order of conditions is randomized and separated by a 1 day intervention-free interval to minimize carryover effects.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Brain Research Group, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Butz, PhD, M.Sc., Heart and Brain Research Group, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431918
- Sponsor's protocol ID
- 110/21-VRELAX
- Other IDs
- DESTRESS (NCT05036538)
- Acronym
- VRELAX
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study
- ClinicalTrials.gov ID
- NCT07431918
- Acronym / sponsor ID
- VRELAX / 110/21-VRELAX
- Conditions
- Stress, Relaxation, Virtual Reality, Binaural Beats
- Keywords
- Virtual Reality, Binaural Beats, Heart Rate Variability, Stress Reduction, Relaxation Intervention, Non-Clinical Population
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Heart and Brain Research Group, GermanyUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
The VRELAX study is a non-clinical sub-study within the "Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients"- research program (DESTRESS; NCT05036538), which investigates non-pharmacological relaxation interventions using virtual reality and binaural auditory stimulation. In a randomized counterbalanced within-subject design, non-clinical adult participants complete two sessions separated by a 1 day intervention-free interval. A 30-minute immersive nature-based virtual reality exposure combined with gradually decreasing binaural beats (10-1 Hertz (Hz)), and a control condition without relaxation. Heart rate variability (HRV) is recorded continuously, and subjective stress is assessed before and after each condition. The primary outcome is parasympathetic activation operationalized as high-frequency (HF) power of heart rate variability. Secondary outcomes include additional HRV parameters and self-reported stress ratings. The study aims to characterize short-term relaxation effects and evaluate the feasibility of independent use in everyday settings, supporting interpretation of clinical findings of the DESTRESS trial.
Detailed description
Psychological stress contributes to cardiovascular risk through dysregulation of the autonomic nervous system. Immersive virtual reality environments and binaural auditory stimulation have each shown stress-reducing effects, but their combined physiological impact remains insufficiently investigated. The DESTRESS research program (NCT05036538) evaluates these interventions in cardiac surgical patients. To isolate intervention-specific mechanisms independent of medical conditions, the VRELAX study was designed as a non-clinical sub-study with a randomized cross-over design in adult participants. Each participant undergoes two experimental conditions in counterbalanced order. A 30-minute immersive nature-based virtual reality exposure combined with binaural beats decreasing from alpha to delta frequency range (10-1 Hz). And a everyday cognitive activities without relaxation intervention. Sessions are separated by a 1 day intervention-free interval to reduce carryover effects. Heart rate variability is continuously measured using a validated chest-strap sensor. Subjective stress is assessed pre- and post-condition visual analogue scales. The primary outcome is HF-power of heart rate variability as an indicator of parasympathetic activation and physiological relaxation. Secondary outcomes are additional HRV parameters (root mean square of successive differences (RMSSD), number of successive normal-to-normal intervals differing by more than 50 milliseconds (NN50), percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50), normalized high-frequency power of heart rate variability (HF%)), subjective stress ratings, and feasibility of independent intervention use based on participant instruction. By investigating physiological relaxation mechanisms in a non-clinical population, the study allows interpretation of intervention-specific effects independent of disease, medication, or perioperative factors. The findings will provide mechanistic context for the clinical DESTRESS trial and evaluate whether an easily implementable immersive relaxation procedure may serve as a preventive approach for reducing everyday and work-related stress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized counterbalanced within-subject cross-over design. Each participant undergoes both conditions: a 30-minute virtual reality relaxation intervention with binaural beats and a control condition without relaxation. The order of conditions is randomized and separated by a 1 day intervention-free interval to minimize carryover effects.
| Arm | Type | Receives |
|---|---|---|
| VR + Binaural Beats | Experimental | Behavioral: Nature-Based Virtual Reality With Binaural BeatsParticipants receive a 30-minute immersive nature-based virtual reality relaxation intervention combined with binaural beats. |
| Control Condition | No intervention | –Participants undergo a control condition involving everyday cognitive activities without relaxation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Ability to understand study procedures and provide written informed consent
- Sufficient proficiency in the German language to complete questionnaires and follow study instructions
- Willingness to participate in a single approximately 60-minute study session
Key exclusion criteria (3 listed)
- Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy)
- Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones
- History of adverse reactions to virtual reality
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 |
|---|---|---|
| Nature-Based Virtual Reality With Binaural BeatsA 30-minute immersive virtual reality exposure to natural environments combined with binaural auditory stimulation gradually decreasing from alpha to delta frequency range (10-1 Hz). | Behavioural | VR + Binaural Beats |
Primary outcome
Change in High-Frequency Power of Heart Rate Variability (HF Power)
Time frame: Pre- and post-intervention within a single 30-minute study session
Spectral power in the high-frequency band (0.15-0.40 Hz) of heart rate variability measured in ms². Higher values reflect greater parasympathetic activity. The primary outcome is defined as the pre- to post-intervention change in HF-HRV measured continuously during the intervention or control condition.
5 secondary outcomes
Change in Root Mean Square of Successive Differences (RMSSD)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Number of Successive NN Interval Differences Greater Than 50 ms (NN50)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Proportion of NN50 (pNN50)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Relative High-Frequency Power (HF%)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Self-Reported Stress (Visual Analog Scale)
Time frame: Pre- and post-intervention within a single 30-minute study session
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 25 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Nicole Schmidt-Bodensohn, PhD, M.Sc. contact
Questions about this trial
What is this clinical trial studying?
A study testing Nature-Based Virtual Reality With Binaural Beats in people with Stress and Relaxation, run by Heart and Brain Research Group, Germany.
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 4 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: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Marius Butz, PhD, M.Sc. (Tel.: +49(0)6032/996 5812, m.butz@kerckhoff-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in High-Frequency Power of Heart Rate Variability (HF Power) (time frame: Pre- and post-intervention within a single 30-minute study session). 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 25 Feb 2026.