Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:16 AM
Study NCT ID:
NCT07431918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study. Due to the nature of the interventions, participants and investigators are not blinded to group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized counterbalanced within-subject cross-over design. Each participant undergoes both conditions: a 30-minute virtual reality relaxation intervention with binaural beats and a control condition without relaxation. The order of conditions is randomized and separated by a 1 day intervention-free interval to minimize carryover effects.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Successful independent completion of the intervention based on pictorial instructions', 'timeFrame': 'Postprocedural / Postintervention. Immediately at the end of the 30-minute intervention session', 'description': 'Binary outcome (Yes/No) indicating whether participants are able to independently set up, start, and correctly terminate the virtual reality intervention without assistance using only pictorial instructions.'}, {'measure': 'Usability rating of the pictorial instruction', 'timeFrame': 'Postprocedual / Postintervention. Within 5 minutes after the end of the 30-minute intervention session.', 'description': 'Participants rate the usability and comprehensibility of the pictorial instruction after completing the intervention on a 5-point Likert scale ranging from 1 (very difficult to understand/use) to 5 (very easy to understand/use).'}], 'primaryOutcomes': [{'measure': 'Change in High-Frequency Power of Heart Rate Variability (HF Power)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Root Mean Square of Successive Differences (RMSSD)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': 'RMSSD of normal-to-normal heart beat intervals, measured in milliseconds (ms). Higher values indicate greater parasympathetic (vagal) activity and lower physiological stress. Changes in RMSSD will be assessed during the intervention or control condition.'}, {'measure': 'Change in Number of Successive NN Interval Differences Greater Than 50 ms (NN50)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': 'Number of pairs of successive normal-to-normal (NN) intervals differing by more than 50 milliseconds. Higher values indicate increased parasympathetic activity. Changes in NN50 will be assessed during the intervention or control condition.'}, {'measure': 'Change in Proportion of NN50 (pNN50)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': 'Percentage of successive normal-to-normal intervals differing by more than 50 ms (%). Higher values indicate increased parasympathetic activity and reduced physiological stress. Changes in pNN50 will be assessed during the intervention or control condition.'}, {'measure': 'Change in Relative High-Frequency Power (HF%)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': 'Relative proportion of high-frequency power as percentage of total spectral power (%). Higher values indicate parasympathetic dominance. Changes in HF% will be assessed during the intervention or control condition.'}, {'measure': 'Change in Self-Reported Stress (Visual Analog Scale)', 'timeFrame': 'Pre- and post-intervention within a single 30-minute study session', 'description': 'Participants rate their perceived stress on a visual analog scale ranging from 0 (no stress) to 10 (maximum stress). The outcome is defined as the change from pre- to post-intervention, with lower scores indicating lower perceived stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Binaural Beats', 'Heart Rate Variability', 'Stress Reduction', 'Relaxation Intervention', 'Non-Clinical Population'], 'conditions': ['Stress', 'Relaxation', 'Virtual Reality', 'Binaural Beats']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Ability to understand study procedures and provide written informed consent\n* Sufficient proficiency in the German language to complete questionnaires and follow study instructions\n* Willingness to participate in a single approximately 60-minute study session\n\nExclusion Criteria:\n\n* Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy)\n* Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones\n* History of adverse reactions to virtual reality'}, 'identificationModule': {'nctId': 'NCT07431918', 'acronym': 'VRELAX', 'briefTitle': 'Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation', 'organization': {'class': 'OTHER', 'fullName': 'Heart and Brain Research Group, Germany'}, 'officialTitle': 'Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study', 'orgStudyIdInfo': {'id': '110/21-VRELAX'}, 'secondaryIdInfos': [{'id': 'DESTRESS (NCT05036538)', 'type': 'OTHER', 'domain': 'Heart and Brain Research Group, Germany'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR + Binaural Beats', 'description': 'Participants receive a 30-minute immersive nature-based virtual reality relaxation intervention combined with binaural beats.', 'interventionNames': ['Behavioral: Nature-Based Virtual Reality With Binaural Beats']}, {'type': 'NO_INTERVENTION', 'label': 'Control Condition', 'description': 'Participants undergo a control condition involving everyday cognitive activities without relaxation intervention.'}], 'interventions': [{'name': 'Nature-Based Virtual Reality With Binaural Beats', 'type': 'BEHAVIORAL', 'description': 'A 30-minute immersive virtual reality exposure to natural environments combined with binaural auditory stimulation gradually decreasing from alpha to delta frequency range (10-1 Hz).', 'armGroupLabels': ['VR + Binaural Beats']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marius Butz, PhD, M.Sc.', 'role': 'CONTACT', 'email': 'm.butz@kerckhoff-klinik.de', 'phone': 'Tel.: +49(0)6032/996 5812'}, {'name': 'Nicole Schmidt-Bodensohn, PhD, M.Sc.', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart and Brain Research Group, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marius Butz, PhD, M.Sc.', 'investigatorAffiliation': 'Heart and Brain Research Group, Germany'}}}}