Consciousness Studies and Cardiovascular Health

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07620639
Status
Not Yet Recruiting

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Conditions

  • Blood Pressure
  • Relaxation
  • Virtual Reality

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Virtual Reality Relaxation Group
    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
  • Experimental: Video Meditation Group
    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
  • Experimental: Live Guided Relaxation Group
    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.
  • No Intervention: Quiet Waiting Group
    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.

Primary Outcome Measure

Change in Self-Reported Stress [ Time Frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Priscilla Valls
[email protected]
3052438937

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By research site
University of Miami· Miami, FL

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