StressDESTUDNCT07387107
Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults
A study testing Virtual Reality-Based Natural Environment, Binaural Auditory Stimulation and Auditory Stimulation in people with Stress and Relaxation, run by Heart and Brain Research Group, Germany at 1 site in Germany.
Trial summary
This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. 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?
- Virtual Reality-Based Natural Environment, Binaural Auditory Stimulation and Auditory Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2026to 15 Jul 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
- 1. Adults aged 18 years or older 2. Ability to understand study procedures and provide written informed consent 3. Sufficient proficiency in the German language to complete questionnaires and follow study instructions 4. Willingness to participate in a single approximately 60-minute study session
Who cannot join
- 1. Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy) 2. Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones 3. History of adverse reactions to virtual reality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kerckhoff-Clinic
Bad Nauheim, 61231
Marius Butz, PhD, M.Sc., +49(0)6032/996 5812, m.butz@kerckhoff-klinik.de
About this study
Official title: Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults: A Randomized Controlled Study.
This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences.
Participants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention.
The primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.
Read the detailed description
This study is conducted as a non-clinical substudy within the DESTRESS research program (Decreasing preoperative stress to prevent postoperative delirium and postoperative cognitive decline in cardiac surgical patients: A randomized controlled trial on relaxation interventions via virtual reality and binaural beats; NCT05036538). In contrast to the main clinical trial, which investigates cardiac surgical patients, this study focuses on non-clinical adult participants who are not undergoing medical or surgical treatment and are not enrolled as patients of the Kerckhoff-Clinic Bad Nauheim (Germany).
The purpose of this substudy is to examine the effects of relaxation interventions under controlled conditions, independent of disease-related, perioperative, or pharmacological confounding factors. The results are intended to provide a reference framework for interpreting and contextualizing findings from the clinical DESTRESS trial.
Participants are randomly assigned to one of five experimental conditions: (1) natural soundscapes, (2) natural soundscapes combined with binaural beats, (3) virtual reality-based natural environments, (4) virtual reality-based natural environments combined with binaural beats, or (5) a control condition without any relaxation intervention. Each participant completes a single session lasting approximately 30 minutes.
During the intervention or control condition, physiological parameters, including heart rate variability and electrodermal activity, are continuously recorded using non-invasive sensors. Neurocognition and subjective stress levels are assessed using standardized tests and self-report questionnaires administered before and after the session.
This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of virtual reality- and audio-based relaxation interventions in a non-clinical population. The findings are expected to contribute to a better understanding of the mechanisms and generalizability of stress-reduction approaches and to inform the interpretation of outcomes in the overarching DESTRESS research program.
- Conditions
- Stress, Relaxation, Virtual Reality, Binaural Beats
- Being tested
- Virtual Reality-Based Natural Environment, Binaural Auditory Stimulation, Control Condition (No Relaxation Intervention), Auditory Stimulation
- Keywords
- Virtual Reality, Binaural Beats, Heart Rate Variability, Stress Reduction, Relaxation Intervention, Non-Clinical Population, Electrodermal Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Natural EnvironmentBehavioural
Participants are exposed to immersive virtual reality-based natural landscapes using a head-mounted display for approximately 30 minutes. The content consists of non-animated 360° natural environments
Binaural Auditory StimulationBehavioural
Participants receive auditory stimulation via headphones consisting of natural soundscapes combined with binaural beats. The binaural beat frequency is gradually reduced from the alpha range (10 Hz) to the delta range (1 Hz) over approximately 30 minutes.
Control Condition (No Relaxation Intervention)Behavioural
Participants complete standardized control tasks without exposure to any relaxation intervention.
Auditory StimulationBehavioural
Participants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| VR + Binaural Beats | Experimental | Participants receive a virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes. Receives: Behavioral: Virtual Reality-Based Natural Environment; Behavioral: Binaural Auditory Stimulation |
| VR Only | Experimental | Participants receive a virtual reality-based natural environment without binaural auditory stimulation for approximately 30 minutes. Receives: Behavioral: Virtual Reality-Based Natural Environment |
| Audio + Binaural Beats | Experimental | Participants receive natural soundscapes combined with binaural auditory stimulation without exposure to virtual reality for approximately 30 minutes. Receives: Behavioral: Binaural Auditory Stimulation |
| Audio Only | Experimental | Participants receive natural soundscapes without binaural auditory stimulation and without virtual reality exposure for approximately 30 minutes. Receives: Behavioral: Auditory Stimulation |
| Control | Experimental | Participants complete standardized control activities without any relaxation intervention for approximately 30 minutes. Receives: Behavioral: Control Condition (No 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-HRV)
High-frequency (HF) power of heart rate variability will be used as an index of 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 (6)
Change in Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, HF%)
Changes in time- and frequency-domain heart rate variability parameters, including RMSSD, NN50, pNN50, HF power, and HF percentage, 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)
Self-reported stress levels will be assessed using a visual analog scale (VAS). The outcome is defined as the pre- to post-intervention change in perceived stress within the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in State Anxiety (STAI-6)
State anxiety will be assessed using the short form of the State-Trait Anxiety Inventory (STAI-6). The outcome is defined as the pre- to post-intervention change in anxiety scores within the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Cognitive Flexibility (SKT)
Cognitive flexibility will be assessed using the Syndrom-Kurztest (SKT-7). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Verbal Fluency (Regensburger Word Fluency Test, RWT)
Verbal fluency will be assessed using the Regensburger Wortflüssigkeitstest (RWT). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition.
Measured: Pre- and post-intervention within a single 30-minute study session
Change in Attention and Processing Speed (Trail Making Test A and B)
Attention and processing speed will be assessed using the Trail Making Test parts A and B (TMT A/B). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition.
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 posted4 Feb 2026
- Study start5 Mar 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 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
- Factorial
- Model description
- This study uses a randomized factorial, multi-arm design to evaluate the main effects and interaction of two intervention components: virtual reality-based natural environments (VR) and binaural auditory stimulation (binaural beats). Participants are randomly assigned to one of five parallel groups: (1) VR with binaural beats, (2) VR without binaural beats, (3) natural soundscapes with binaural beats, (4) natural soundscapes without binaural beats, or (5) a control condition without any relaxation intervention.
- Masking
- None (open label)
- Enrolment
- 52 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
- Investigators
- Marius Butz, PhD, M.Sc., Principal investigator, Heart&Brain Research Group, Kerckhoff-Clinic, Bad Nauheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387107
- Sponsor's protocol ID
- 110/21-DESTUD
- Other IDs
- DESTRESS (NCT05036538)
- Acronym
- DESTUD
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07387107
- Acronym / sponsor ID
- DESTUD / 110/21-DESTUD
- Conditions
- Stress, Relaxation, Virtual Reality, Binaural Beats
- Keywords
- Virtual Reality, Binaural Beats, Heart Rate Variability, Stress Reduction, Relaxation Intervention, Non-Clinical Population, Electrodermal Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Heart and Brain Research Group, GermanyUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 4 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.
This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences.
Participants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention.
The primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.
Detailed description
This study is conducted as a non-clinical substudy within the DESTRESS research program (Decreasing preoperative stress to prevent postoperative delirium and postoperative cognitive decline in cardiac surgical patients: A randomized controlled trial on relaxation interventions via virtual reality and binaural beats; NCT05036538). In contrast to the main clinical trial, which investigates cardiac surgical patients, this study focuses on non-clinical adult participants who are not undergoing medical or surgical treatment and are not enrolled as patients of the Kerckhoff-Clinic Bad Nauheim (Germany).
The purpose of this substudy is to examine the effects of relaxation interventions under controlled conditions, independent of disease-related, perioperative, or pharmacological confounding factors. The results are intended to provide a reference framework for interpreting and contextualizing findings from the clinical DESTRESS trial.
Participants are randomly assigned to one of five experimental conditions: (1) natural soundscapes, (2) natural soundscapes combined with binaural beats, (3) virtual reality-based natural environments, (4) virtual reality-based natural environments combined with binaural beats, or (5) a control condition without any relaxation intervention. Each participant completes a single session lasting approximately 30 minutes.
During the intervention or control condition, physiological parameters, including heart rate variability and electrodermal activity, are continuously recorded using non-invasive sensors. Neurocognition and subjective stress levels are assessed using standardized tests and self-report questionnaires administered before and after the session.
This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of virtual reality- and audio-based relaxation interventions in a non-clinical population. The findings are expected to contribute to a better understanding of the mechanisms and generalizability of stress-reduction approaches and to inform the interpretation of outcomes in the overarching DESTRESS research program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This study uses a randomized factorial, multi-arm design to evaluate the main effects and interaction of two intervention components: virtual reality-based natural environments (VR) and binaural auditory stimulation (binaural beats). Participants are randomly assigned to one of five parallel groups: (1) VR with binaural beats, (2) VR without binaural beats, (3) natural soundscapes with binaural beats, (4) natural soundscapes without binaural beats, or (5) a control condition without any relaxation intervention.
| Arm | Type | Receives |
|---|---|---|
| VR + Binaural Beats | Experimental | Behavioral: Virtual Reality-Based Natural Environment, Behavioral: Binaural Auditory StimulationParticipants receive a virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes. |
| VR Only | Experimental | Behavioral: Virtual Reality-Based Natural EnvironmentParticipants receive a virtual reality-based natural environment without binaural auditory stimulation for approximately 30 minutes. |
| Audio + Binaural Beats | Experimental | Behavioral: Binaural Auditory StimulationParticipants receive natural soundscapes combined with binaural auditory stimulation without exposure to virtual reality for approximately 30 minutes. |
| Audio Only | Experimental | Behavioral: Auditory StimulationParticipants receive natural soundscapes without binaural auditory stimulation and without virtual reality exposure for approximately 30 minutes. |
| Control | Experimental | Behavioral: Control Condition (No Relaxation Intervention)Participants complete standardized control activities without any relaxation intervention for approximately 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adults aged 18 years or older 2. Ability to understand study procedures and provide written informed consent 3. Sufficient proficiency in the German language to complete questionnaires and follow study instructions 4. Willingness to participate in a single approximately 60-minute study session
Key exclusion criteria (1 listed)
- 1. Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy) 2. Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones 3. 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 |
|---|---|---|
| Virtual Reality-Based Natural EnvironmentParticipants are exposed to immersive virtual reality-based natural landscapes using a head-mounted display for approximately 30 minutes. The content consists of non-animated 360° natural environments | Behavioural | VR + Binaural Beats, VR Only |
| Binaural Auditory StimulationParticipants receive auditory stimulation via headphones consisting of natural soundscapes combined with binaural beats. The binaural beat frequency is gradually reduced from the alpha range (10 Hz) to the delta range (1 Hz) over approximately 30 minutes. | Behavioural | Audio + Binaural Beats, VR + Binaural Beats |
| Control Condition (No Relaxation Intervention)Participants complete standardized control tasks without exposure to any relaxation intervention. | Behavioural | Control |
| Auditory StimulationParticipants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes. | Behavioural | Audio Only |
Primary outcome
Change in High-Frequency Power of Heart Rate Variability (HF-HRV)
Time frame: Pre- and post-intervention within a single 30-minute study session
High-frequency (HF) power of heart rate variability will be used as an index of 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.
6 secondary outcomes
Change in Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, 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
Change in State Anxiety (STAI-6)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Cognitive Flexibility (SKT)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Verbal Fluency (Regensburger Word Fluency Test, RWT)
Time frame: Pre- and post-intervention within a single 30-minute study session
Change in Attention and Processing Speed (Trail Making Test A and B)
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 13 Mar 2026.
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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.
Marius Butz, PhD, M.Sc. principal investigator
Heart&Brain Research Group, Kerckhoff-Clinic, Bad Nauheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Natural Environment, Binaural Auditory Stimulation and Auditory Stimulation in people with Stress and Relaxation, run by Heart and Brain Research Group, Germany at 1 site in 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. 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 Germany. 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?
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-HRV) (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 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.