Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in High-Frequency Power of Heart Rate Variability (HF-HRV)
研究概览
简要总结
This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences.
Participants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention.
The primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.
详细描述
This study is conducted as a non-clinical substudy within the DESTRESS research program (Decreasing preoperative stress to prevent postoperative delirium and postoperative cognitive decline in cardiac surgical patients: A randomized controlled trial on relaxation interventions via virtual reality and binaural beats; NCT05036538). In contrast to the main clinical trial, which investigates cardiac surgical patients, this study focuses on non-clinical adult participants who are not undergoing medical or surgical treatment and are not enrolled as patients of the Kerckhoff-Clinic Bad Nauheim (Germany).
The purpose of this substudy is to examine the effects of relaxation interventions under controlled conditions, independent of disease-related, perioperative, or pharmacological confounding factors. The results are intended to provide a reference framework for interpreting and contextualizing findings from the clinical DESTRESS trial.
Participants are randomly assigned to one of five experimental conditions: (1) natural soundscapes, (2) natural soundscapes combined with binaural beats, (3) virtual reality-based natural environments, (4) virtual reality-based natural environments combined with binaural beats, or (5) a control condition without any relaxation intervention. Each participant completes a single session lasting approximately 30 minutes.
During the intervention or control condition, physiological parameters, including heart rate variability and electrodermal activity, are continuously recorded using non-invasive sensors. Neurocognition and subjective stress levels are assessed using standardized tests and self-report questionnaires administered before and after the session.
This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of virtual reality- and audio-based relaxation interventions in a non-clinical population. The findings are expected to contribute to a better understanding of the mechanisms and generalizability of stress-reduction approaches and to inform the interpretation of outcomes in the overarching DESTRESS research program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •1. 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
- •1. 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 virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes.
干预措施: Virtual Reality-Based Natural Environment (Behavioral)
VR + Binaural Beats
Participants receive a virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes.
干预措施: Binaural Auditory Stimulation (Behavioral)
VR Only
Participants receive a virtual reality-based natural environment without binaural auditory stimulation for approximately 30 minutes.
干预措施: Virtual Reality-Based Natural Environment (Behavioral)
Audio + Binaural Beats
Participants receive natural soundscapes combined with binaural auditory stimulation without exposure to virtual reality for approximately 30 minutes.
干预措施: Binaural Auditory Stimulation (Behavioral)
Audio Only
Participants receive natural soundscapes without binaural auditory stimulation and without virtual reality exposure for approximately 30 minutes.
干预措施: Auditory Stimulation (Behavioral)
Control
Participants complete standardized control activities without any relaxation intervention for approximately 30 minutes.
干预措施: Control Condition (No Relaxation Intervention) (Behavioral)
结局指标
主要结局
Change in High-Frequency Power of Heart Rate Variability (HF-HRV)
时间窗: Pre- and post-intervention within a single 30-minute study session
High-frequency (HF) power of heart rate variability will be used as an index of 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 Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, 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)
- Change in State Anxiety (STAI-6)(Pre- and post-intervention within a single 30-minute study session)
- Change in Cognitive Flexibility (SKT)(Pre- and post-intervention within a single 30-minute study session)
- Change in Verbal Fluency (Regensburger Word Fluency Test, RWT)(Pre- and post-intervention within a single 30-minute study session)
- Change in Attention and Processing Speed (Trail Making Test A and B)(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