Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults (DESTUD)

March 11, 2026 updated by: Marius Butz, PhD, M.Sc., Heart and Brain Research Group, Germany

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Recruiting
        • Kerckhoff-Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR + Binaural Beats
Participants receive a virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes.
Behavioral: Virtual Reality-Based Natural Environment
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
Behavioral: Binaural Auditory Stimulation
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.
Experimental: VR Only
Participants receive a virtual reality-based natural environment without binaural auditory stimulation for approximately 30 minutes.
Behavioral: Virtual Reality-Based Natural Environment
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
Experimental: Audio + Binaural Beats
Participants receive natural soundscapes combined with binaural auditory stimulation without exposure to virtual reality for approximately 30 minutes.
Behavioral: Binaural Auditory Stimulation
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.
Experimental: Audio Only
Participants receive natural soundscapes without binaural auditory stimulation and without virtual reality exposure for approximately 30 minutes.
Behavioral: Auditory Stimulation
Participants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes.
Experimental: Control
Participants complete standardized control activities without any relaxation intervention for approximately 30 minutes.
Behavioral: Control Condition (No Relaxation Intervention)
Participants complete standardized control tasks without exposure to any relaxation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre- and post-intervention within a single 30-minute study session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, HF%)
Time Frame: Pre- and post-intervention within a single 30-minute study session
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Pre- and post-intervention within a single 30-minute study session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart and Brain Research Group, Germany

Investigators

  • Principal Investigator: Marius Butz, PhD, M.Sc., Heart&Brain Research Group, Kerckhoff-Clinic, Bad Nauheim, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110/21-DESTUD
  • DESTRESS (NCT05036538) (Other Identifier: Heart and Brain Research Group, Germany)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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