Health TrialsbyHealthPanel

Consciousness Studies and Cardiovascular Health

ConditionsBlood PressureRelaxationVirtual Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of seizure disorder or photosensitive epilepsy

Migraine with visual aura

Retinal disease sensitive to flicker

Unstable cardiac disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Virtual Reality Relaxation GroupExperimental treatment 1 intervention
Group B: Video Meditation GroupExperimental treatment 1 intervention
Group C: Live Guided Relaxation GroupExperimental treatment 1 intervention
Group D: Quiet Waiting GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: