An interventional study of Virtual Reality Relaxation and Video Meditation in Blood Pressure, Relaxation and Virtual Reality, sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
The objective of the study is to evaluate whether a virtual reality (VR) based intervention combining binaural beats, photic stimulation, and real-time biofeedback reduces stress and improves physiological markers compared to non-VR interventions and usual care in patients that go to cardiology clinic.
University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria:
Participants assigned to this arm will complete one relaxation session during a single cardiology clinic visit. The session will last approximately 8-12 minutes, with one-time exposure only. Total participation time is approximately 30 minutes
Behavioral: Virtual Reality Relaxation
Participants assigned to this arm will complete one guided meditation session during a single cardiology clinic visit. The session will last approximately 8-12 minutes, with a one-time exposure. Total participation time is approximately 30 minutes
Behavioral: Video Meditation
Participants assigned to this arm will complete one live relaxation session during a single clinic visit. The session lasts approximately 8-12 minutes, with one-time exposure only. Total participation time is approximately 30 minutes.
Behavioral: Live Guided
Participants assigned to this arm will remain seated quietly in the clinic room without exposure to any active intervention during a single clinic visit. Total participation time is approximately 30 minutes.
Participants will wear a virtual reality headset delivering a guided relaxation experience. The VR program includes: immersive visual environments designed to induce calmness, binaural audio beats engineered to promote relaxation, and photic (light) stimulation synchronized with audio and breath cues. The intervention is designed to support autonomic down-regulation and enhance the participant's relaxation response.
Participants will view a guided meditation video displayed on a screen. The video includes: soothing visual imagery, gentle narration guiding breath and awareness, calming background music. This intervention is intended to facilitate psychological relaxation through traditional audiovisual meditation techniques.
Participants will receive a live, instructor-led relaxation session conducted by a trained study team member. The facilitator will guide the participant through: controlled breathing exercises, progressive muscle relaxation, calming verbal prompts, and mindfulness-based awareness techniques. The goal is to induce relaxation through direct interpersonal guidance.
Change in Self-Reported Stress
Change in self-reported perceived stress using a validated stress assessment tool PSS-10 (Perceived Stress Scale). This scale is a widely used 10-item questionnaire that measures the degree to which situations in life are appraised as stressful over the past month. It evaluates how unpredictable, uncontrollable, and overloaded respondents find their lives over the previous month, with scores from 0-40 (higher = more stress).
Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Change in Heart Rate Variability (HRV)
Change in Heart Rate Variability (HRV) will be measured using wearable-based physiological monitoring or electrocardiogram (ECG). HRV will be quantified in milliseconds using standard HRV metrics.
Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Change in Galvanic Skin Response (GSR)
Change in Galvanic Skin Response (GSR), measured in microsiemens (µS), reflecting changes in sympathetic autonomic arousal. GSR will be collected using skin-conductance sensors placed on the fingers/palm
Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Change in Electroencephalogram (EEG)-Derived Neural Activity
Change in EEG spectral power measured in microvolts squared (µV²), collected using a noninvasive headband EEG sensor and analyzed using predefined spectral power metrics based on the study's EEG signal-processing protocol.
Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Plan to share: No
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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