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

NCT07431918 | Not Yet Recruiting

• 2 other identifiers: 110/21-VRELAXDESTRESS (NCT05036538)
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stress; Relaxation; Virtual Reality; Binaural Beats

Keywords

Virtual Reality; Binaural Beats; Heart Rate Variability; Stress Reduction; Relaxation Intervention; Non-Clinical Population

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre- and post-intervention within a single 30-minute study session

Secondary Outcomes (5)

• Change in Root Mean Square of Successive Differences (RMSSD)

  Pre- and post-intervention within a single 30-minute study session

• Change in Number of Successive NN Interval Differences Greater Than 50 ms (NN50)

  Pre- and post-intervention within a single 30-minute study session

• Change in Proportion of NN50 (pNN50)

  Pre- and post-intervention within a single 30-minute study session

• Change in Relative High-Frequency Power (HF%)

  Pre- and post-intervention within a single 30-minute study session

• Change in Self-Reported Stress (Visual Analog Scale)

  Pre- and post-intervention within a single 30-minute study session

Other Outcomes (2)

• Successful independent completion of the intervention based on pictorial instructions

  Postprocedural / Postintervention. Immediately at the end of the 30-minute intervention session

• Usability rating of the pictorial instruction

  Postprocedual / Postintervention. Within 5 minutes after the end of the 30-minute intervention session.

Study Arms (2)

VR + Binaural Beats

EXPERIMENTAL

Participants receive a 30-minute immersive nature-based virtual reality relaxation intervention combined with binaural beats.

Behavioral: Nature-Based Virtual Reality With Binaural Beats

Control Condition

NO INTERVENTION

Participants undergo a control condition involving everyday cognitive activities without relaxation intervention.

Interventions

Nature-Based Virtual Reality With Binaural Beats BEHAVIORAL

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).

VR + Binaural Beats

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead

Central Study Contacts

Marius Butz, PhD, M.Sc.

CONTACT

Tel.: +49(0)6032/996 5812; m.butz@kerckhoff-klinik.de

Nicole Schmidt-Bodensohn, PhD, M.Sc.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the interventions, participants and investigators are not blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized counterbalanced within-subject cross-over design. Each participant undergoes both conditions: a 30-minute virtual reality relaxation intervention with binaural beats and a control condition without relaxation. The order of conditions is randomized and separated by a 1 day intervention-free interval to minimize carryover effects.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 25, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share