About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nature-Based Virtual Reality With Binaural Beats