Clinical Trial

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

Study acronym: VRELAX
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07431918
Lead Sponsor Heart and Brain Research Group, Germany
Conditions Stress, Relaxation, Virtual Reality, Binaural Beats
Enrollment 18 participants
Start Date 2026-02-25
Primary Completion 2026-12-20 (estimated)
Study Completion 2026-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-25