Blood PressureNCT07620639
Consciousness Studies and Cardiovascular Health
A study testing Virtual Reality Relaxation, Video Meditation and Live Guided in people with Blood Pressure and Relaxation, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Relaxation, Virtual Reality
- What is being tested?
- Virtual Reality Relaxation, Video Meditation and Live Guided
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33136
Priscilla Valls, 3052438937, ptv7@med.miami.edu
About this study
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
- Being tested
- Virtual Reality Relaxation, Video Meditation, Live Guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality RelaxationBehavioural
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 MeditationBehavioural
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 GuidedBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Secondary outcomes (3)
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.
Measured: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
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
Measured: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
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.
Measured: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Martinez, University of Miami
- Investigators
- Claudia Martinez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620639
- Sponsor's protocol ID
- 20251394
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consciousness Studies and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07620639
- Acronym / sponsor ID
- 20251394
- Conditions
- Blood Pressure, Relaxation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Relaxation Group | Experimental | Behavioral: Virtual Reality RelaxationParticipants 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 |
| Video Meditation Group | Experimental | Behavioral: Video MeditationParticipants 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 |
| Live Guided Relaxation Group | Experimental | Behavioral: Live GuidedParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- History of seizure disorder or photosensitive epilepsy
- Migraine with visual aura
- Retinal disease sensitive to flicker
- Unstable cardiac disease
- Dysautonomia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality RelaxationParticipants 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. | Behavioural | Virtual Reality Relaxation Group |
| Video MeditationParticipants 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. | Behavioural | Video Meditation Group |
| Live GuidedParticipants 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. | Behavioural | Live Guided Relaxation Group |
Primary outcome
Change in Self-Reported Stress
Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Martinez, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Relaxation, Video Meditation and Live Guided in people with Blood Pressure and Relaxation, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priscilla Valls (3052438937, ptv7@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.