Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07431918

Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nature-Based Virtual Reality With Binaural Beats

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Root Mean Square of Successive Differences (RMSSD)

    Time frame: Pre- and post-intervention within a single 30-minute study session

    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.

  2. 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

    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.

  3. Change in Proportion of NN50 (pNN50)

    Time frame: Pre- and post-intervention within a single 30-minute study session

    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.

  4. Change in Relative High-Frequency Power (HF%)

    Time frame: Pre- and post-intervention within a single 30-minute study session

    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.

  5. Change in Self-Reported Stress (Visual Analog Scale)

    Time frame: Pre- and post-intervention within a single 30-minute study session

    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.

Other outcomes

  1. Successful independent completion of the intervention based on pictorial instructions

    Time frame: Postprocedural / Postintervention. Immediately at the end of the 30-minute intervention session

    Binary outcome (Yes/No) indicating whether participants are able to independently set up, start, and correctly terminate the virtual reality intervention without assistance using only pictorial instructions.

  2. Usability rating of the pictorial instruction

    Time frame: Postprocedual / Postintervention. Within 5 minutes after the end of the 30-minute intervention session.

    Participants rate the usability and comprehensibility of the pictorial instruction after completing the intervention on a 5-point Likert scale ranging from 1 (very difficult to understand/use) to 5 (very easy to understand/use).

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Butz, PhD, M.Sc.

CONTACT

[email protected]

Tel.: +49(0)6032/996 5812

Nicole Schmidt-Bodensohn, PhD, M.Sc.

CONTACT

Sponsors and collaborators

Lead sponsor

Heart and Brain Research Group, Germany

Other

Registry information

Official study title

Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study

Acronym: VRELAX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.