Blood Pressure, Relaxation, Virtual Reality
Conditions
Brief summary
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.
Interventions
BEHAVIORALVirtual Reality Relaxation
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.
BEHAVIORALVideo Meditation
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.
BEHAVIORALLive Guided
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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 and older * Able to provide informed consent (English only for pilot) * Chronic Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) or Attention Deficit/ Hyperactivity Disorder (ADHD) meds allowed (recorded) * Normal vision and hearing * Stable vitals (HR 55-100 bpm, Systolic Blood Pressure (SBP) 90-160mmHg (millimeters of mercury, afebrile) * Willing to abstain 6 hours pre-session from caffeine, nicotine, heavy exercise * Willing to tolerate electroencephalogram (EEG) headband, Galvanic Skin Response (GSR) electrodes are small sensors placed on the skin (usually fingers or palm) and virtual reality (VR) headset
Exclusion criteria
* History of seizure disorder or photosensitive epilepsy * Migraine with visual aura * Retinal disease sensitive to flicker * Unstable cardiac disease * Dysautonomia * Recent sedative use (benzodiazepines, opioids) * Beta blocker dose changes within last 7 days * Alcohol or recreational drugs within 12 hours * Active panic disorder * Severe motion sickness * Scalp conditions preventing EEG contact * Severe visual or hearing impairment Cognitive impairment * Non-English speakers (pilot in English only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Stress | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) | 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. |
| Change in Galvanic Skin Response (GSR) | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) | 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 |
| Change in Electroencephalogram (EEG)-Derived Neural Activity | Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) | 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. |
Countries
United States
Contacts
CONTACTPriscilla Valls
PRINCIPAL_INVESTIGATORClaudia Martinez, MD
University of Miami
Outcome results
None listed