Menu
Not yet recruiting NCT07620639

Consciousness Studies and Cardiovascular Health

No phase Interventional Blood Pressure Relaxation Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Relaxation, Video Meditation, Live Guided.
Who it may be relevant to
Registry conditions: Blood Pressure, Relaxation, Virtual Reality. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Change in Self-Reported Stress [Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]
Secondary outcome measures (3)
  • Change in Heart Rate Variability (HRV) [Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]
  • Change in Galvanic Skin Response (GSR) [Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]
  • Change in Electroencephalogram (EEG)-Derived Neural Activity [Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07620639 · 20251394

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗