Stress, Relaxation, Virtual Reality, Binaural Beats
Conditions
Keywords
Virtual Reality, Binaural Beats, Heart Rate Variability, Stress Reduction, Relaxation Intervention, Non-Clinical Population, Electrodermal Activity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual Reality-Based Natural Environment
Participants are exposed to immersive virtual reality-based natural landscapes using a head-mounted display for approximately 30 minutes. The content consists of non-animated 360° natural environments
BEHAVIORALBinaural Auditory Stimulation
Participants receive auditory stimulation via headphones consisting of natural soundscapes combined with binaural beats. The binaural beat frequency is gradually reduced from the alpha range (10 Hz) to the delta range (1 Hz) over approximately 30 minutes.
BEHAVIORALControl Condition (No Relaxation Intervention)
Participants complete standardized control tasks without exposure to any relaxation intervention.
BEHAVIORALAuditory Stimulation
Participants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes.
Sponsors
Heart and Brain Research Group, Germany
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study. Due to the nature of the interventions, participants and investigators are not blinded to group assignment.
Intervention model description
This study uses a randomized factorial, multi-arm design to evaluate the main effects and interaction of two intervention components: virtual reality-based natural environments (VR) and binaural auditory stimulation (binaural beats). Participants are randomly assigned to one of five parallel groups: (1) VR with binaural beats, (2) VR without binaural beats, (3) natural soundscapes with binaural beats, (4) natural soundscapes without binaural beats, or (5) a control condition without any relaxation intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\. Adults aged 18 years or older 2. Ability to understand study procedures and provide written informed consent 3. Sufficient proficiency in the German language to complete questionnaires and follow study instructions 4. Willingness to participate in a single approximately 60-minute study session
Exclusion criteria
1\. Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy) 2. Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones 3. History of adverse reactions to virtual reality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in High-Frequency Power of Heart Rate Variability (HF-HRV) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, HF%) | Pre- and post-intervention within a single 30-minute study session | Changes in time- and frequency-domain heart rate variability parameters, including RMSSD, NN50, pNN50, HF power, and HF percentage, will be assessed during the intervention or control condition. |
| Change in Self-Reported Stress (Visual Analog Scale) | Pre- and post-intervention within a single 30-minute study session | Self-reported stress levels will be assessed using a visual analog scale (VAS). The outcome is defined as the pre- to post-intervention change in perceived stress within the intervention or control condition. |
| Change in State Anxiety (STAI-6) | Pre- and post-intervention within a single 30-minute study session | State anxiety will be assessed using the short form of the State-Trait Anxiety Inventory (STAI-6). The outcome is defined as the pre- to post-intervention change in anxiety scores within the intervention or control condition. |
| Change in Cognitive Flexibility (SKT) | Pre- and post-intervention within a single 30-minute study session | Cognitive flexibility will be assessed using the Syndrom-Kurztest (SKT-7). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition. |
| Change in Verbal Fluency (Regensburger Word Fluency Test, RWT) | Pre- and post-intervention within a single 30-minute study session | Verbal fluency will be assessed using the Regensburger Wortflüssigkeitstest (RWT). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition. |
| Change in Attention and Processing Speed (Trail Making Test A and B) | Pre- and post-intervention within a single 30-minute study session | Attention and processing speed will be assessed using the Trail Making Test parts A and B (TMT A/B). The outcome is defined as the pre- to post-intervention change in test performance within the intervention or control condition. |
Countries
Germany
Contacts
CONTACTMarius Butz, PhD, M.Sc.
CONTACTRolf Meyer, M.Sc.
PRINCIPAL_INVESTIGATORMarius Butz, PhD, M.Sc.
Heart&Brain Research Group, Kerckhoff-Clinic, Bad Nauheim, Germany
Outcome results
None listed