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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Relaxation Group | Experimental | 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 |
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| Video Meditation Group | Experimental | 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 |
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| Live Guided Relaxation Group | Experimental | 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. |
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| Quiet Waiting Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Relaxation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priscilla Valls | Contact | 3052438937 | ptv7@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Martinez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| Video Meditation | Behavioral | 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. |
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| Live Guided | Behavioral | 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. |
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| 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 |
| 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. | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) |