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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeart and Brain Research Group, Germany

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

Treatment groups

18 Participants
are divided into 2 treatment groups

Locations

This trial has no locations