Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults

NCT07387107 | Recruiting

• 2 other identifiers: 110/21-DESTUDDESTRESS (NCT05036538)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Relaxation; Virtual Reality; Binaural Beats

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (6)

• 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

Study Arms (5)

VR + Binaural Beats

EXPERIMENTAL

Participants receive a virtual reality-based natural environment combined with binaural auditory stimulation for approximately 30 minutes.

Behavioral: Virtual Reality-Based Natural Environment; Behavioral: Binaural Auditory Stimulation

VR Only

EXPERIMENTAL

Participants receive a virtual reality-based natural environment without binaural auditory stimulation for approximately 30 minutes.

Behavioral: Virtual Reality-Based Natural Environment

Audio + Binaural Beats

EXPERIMENTAL

Participants receive natural soundscapes combined with binaural auditory stimulation without exposure to virtual reality for approximately 30 minutes.

Behavioral: Binaural Auditory Stimulation

Audio Only

EXPERIMENTAL

Participants receive natural soundscapes without binaural auditory stimulation and without virtual reality exposure for approximately 30 minutes.

Behavioral: Auditory Stimulation

Control

EXPERIMENTAL

Participants complete standardized control activities without any relaxation intervention for approximately 30 minutes.

Behavioral: Control Condition (No Relaxation Intervention)

Interventions

Virtual Reality-Based Natural Environment BEHAVIORAL

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

VR + Binaural Beats; VR Only

Binaural Auditory Stimulation BEHAVIORAL

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.

Audio + Binaural Beats; VR + Binaural Beats

Auditory Stimulation BEHAVIORAL

Participants receive auditory stimulation via headphones consisting of natural soundscapes over approximately 30 minutes.

Audio Only

Control Condition (No Relaxation Intervention) BEHAVIORAL

Participants complete standardized control tasks without exposure to any relaxation intervention.

Control

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 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

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) 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

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead

Study Sites (1)

Kerckhoff-Clinic

Bad Nauheim, 61231, Germany

RECRUITING

MeSH Terms

Interventions

Acoustic Stimulation

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Marius Butz, PhD, M.Sc.

  Heart&Brain Research Group, Kerckhoff-Clinic, Bad Nauheim, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Butz, PhD, M.Sc.

CONTACT

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

Rolf Meyer, M.Sc.

CONTACT

Tel.: +49(0)6032/996 2557; r.meyer@kerckhoff-klinik.de

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: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 4, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

DE (1)