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Consciousness Studies and Cardiovascular Health

NCT07620639 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

  • Blood Pressure
  • Relaxation
  • Virtual Reality

Interventions

BEHAVIORAL

Virtual 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.

BEHAVIORAL

Video 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.

BEHAVIORAL

Live 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 & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Claudia Martinez, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620639 on ClinicalTrials.gov