Consciousness Studies and Cardiovascular Health

NCT07620639 | Not Yet Recruiting

• 1 other identifier: 20251394
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Relaxation; Virtual Reality

Outcome Measures

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).

  Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

Secondary Outcomes (3)

• Change in Heart Rate Variability (HRV)

  Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

• Change in Galvanic Skin Response (GSR)

  Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

• Change in Electroencephalogram (EEG)-Derived Neural Activity

  Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

Study Arms (4)

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

Behavioral: Virtual Reality Relaxation

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

Behavioral: Video Meditation

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.

Behavioral: Live Guided

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.

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.

Virtual Reality Relaxation Group

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.

Video Meditation Group

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.

Live Guided Relaxation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Claudia Martinez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla Valls

CONTACT

3052438937; ptv7@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)