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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
18
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).
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.
Time frame: Pre- and post-intervention within a single 30-minute study session
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre- and post-intervention within a single 30-minute study session
Nicole Schmidt-Bodensohn, PhD, M.Sc.
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