Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeart and Brain Research Group, Germany
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
Virtual Reality-Based Natural Environment
BehavioralParticipants 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
Binaural Auditory Stimulation
BehavioralParticipants 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.
Control Condition (No Relaxation Intervention)
BehavioralParticipants complete standardized control tasks without exposure to any relaxation intervention.
Auditory Stimulation
BehavioralParticipants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes.
Treatment groups
52 Participants
are divided into 5 treatment groupsGroup A: VR + Binaural BeatsExperimental treatment 2 interventions
Group B: VR OnlyExperimental treatment 1 intervention
Group C: Audio + Binaural BeatsExperimental treatment 1 intervention
Group D: Audio OnlyExperimental treatment 1 intervention
Group E: ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in High-Frequency Power of Heart Rate Variability (HF-HRV)
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.
Time frame
Pre- and post-intervention within a single 30-minute study sessionSecondary outcomes
1
Change in Heart Rate Variability Parameters (RMSSD, NN50, pNN50, HF, HF%)
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.
Time frame
Pre- and post-intervention within a single 30-minute study session2
Change in Self-Reported Stress (Visual Analog Scale)
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.
Time frame
Pre- and post-intervention within a single 30-minute study session3
Change in State Anxiety (STAI-6)
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.
Time frame
Pre- and post-intervention within a single 30-minute study session4
Change in Cognitive Flexibility (SKT)
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.
Time frame
Pre- and post-intervention within a single 30-minute study sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov