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.
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
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
Crossover
Nature-Based Virtual Reality With Binaural Beats
BehavioralA 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.
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.
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.
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.
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.
Successful independent completion of the intervention based on pictorial instructions
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.
Usability rating of the pictorial instruction
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).
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