Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- Change in High-Frequency Power of Heart Rate Variability (HF Power)
研究概览
简要总结
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.
详细描述
Psychological stress contributes to cardiovascular risk through dysregulation of the autonomic nervous system. Immersive virtual reality environments and binaural auditory stimulation have each shown stress-reducing effects, but their combined physiological impact remains insufficiently investigated. The DESTRESS research program (NCT05036538) evaluates these interventions in cardiac surgical patients. To isolate intervention-specific mechanisms independent of medical conditions, the VRELAX study was designed as a non-clinical sub-study with a randomized cross-over design in adult participants. Each participant undergoes two experimental conditions in counterbalanced order. A 30-minute immersive nature-based virtual reality exposure combined with binaural beats decreasing from alpha to delta frequency range (10-1 Hz). And a everyday cognitive activities without relaxation intervention. Sessions are separated by a 1 day intervention-free interval to reduce carryover effects. Heart rate variability is continuously measured using a validated chest-strap sensor. Subjective stress is assessed pre- and post-condition visual analogue scales. The primary outcome is HF-power of heart rate variability as an indicator of parasympathetic activation and physiological relaxation. Secondary outcomes are additional HRV parameters (root mean square of successive differences (RMSSD), number of successive normal-to-normal intervals differing by more than 50 milliseconds (NN50), percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50), normalized high-frequency power of heart rate variability (HF%)), subjective stress ratings, and feasibility of independent intervention use based on participant instruction. By investigating physiological relaxation mechanisms in a non-clinical population, the study allows interpretation of intervention-specific effects independent of disease, medication, or perioperative factors. The findings will provide mechanistic context for the clinical DESTRESS trial and evaluate whether an easily implementable immersive relaxation procedure may serve as a preventive approach for reducing everyday and work-related stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study. Due to the nature of the interventions, participants and investigators are not blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VR + Binaural Beats
Participants receive a 30-minute immersive nature-based virtual reality relaxation intervention combined with binaural beats.
干预措施: Nature-Based Virtual Reality With Binaural Beats (Behavioral)
Control Condition
Participants undergo a control condition involving everyday cognitive activities without relaxation intervention.
结局指标
主要结局
Change in High-Frequency Power of Heart Rate Variability (HF Power)
时间窗: Pre- and post-intervention within a single 30-minute study session
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.
次要结局
- 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)
研究者
Marius Butz, PhD, M.Sc.
Principal Investigator
Heart and Brain Research Group, Germany
