Virtual Reality Relaxation for High Blood Pressure

PV
Overseen ByPriscilla Valls
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual reality (VR) relaxation can reduce stress and improve health markers in people with high blood pressure. Participants may experience VR relaxation, video meditation, live guided relaxation, or simply sitting quietly. The trial aims to determine which method most effectively helps patients feel more relaxed during a cardiology clinic visit. Individuals with high blood pressure who take certain medications for mood or focus and can handle a VR headset and small skin sensors may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative relaxation techniques that could enhance well-being.

Do I have to stop taking my current medications for the trial?

The trial allows participants to continue taking certain medications like SSRIs, SNRIs, and ADHD meds, but recent use of sedatives or changes in beta blocker doses are not allowed. The protocol does not specify other medication restrictions, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this virtual reality relaxation technique is safe for reducing stress in cardiology patients?

Past studies have shown that virtual reality (VR) safely reduces stress and lowers blood pressure. Participants reported no serious problems while using VR. One study found that people felt comfortable with VR and were willing to use it again.

Research indicates that video meditation can lower blood pressure without causing serious side effects. People generally find meditation safe and helpful for reducing stress.

Live guided relaxation shows similar safety results. Studies suggest it can lower blood pressure, and people often report feeling better without negative effects.

Overall, these relaxation techniques are considered safe, generally well-tolerated, and do not cause serious problems.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage high blood pressure using relaxation techniques. Unlike standard treatments like medication (e.g., ACE inhibitors or beta-blockers), these methods focus on stress reduction through different experiences. Virtual Reality Relaxation immerses participants in a calming environment using VR technology, offering a unique way to unwind. Video Meditation provides a guided mindfulness experience that helps in stress management. Live Guided Relaxation offers a personalized touch with real-time interaction, enhancing the relaxation experience. These methods could provide quick, accessible ways to help control blood pressure without the need for pharmaceuticals.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

This trial will compare the effects of different relaxation techniques on high blood pressure. Research has shown that virtual reality (VR) for relaxation, which participants in the Virtual Reality Relaxation Group will experience, can lower blood pressure and reduce stress. One study found that a short VR session significantly lowered systolic blood pressure. VR relaxation also alleviates anxiety and creates a calming environment, improving heart rate and blood pressure.

Participants in the Video Meditation Group will experience video meditation, which studies have shown can effectively lower both systolic and diastolic blood pressure. Mindfulness and meditation techniques offer proven benefits for people with high blood pressure, leading to noticeable improvements.

The Live Guided Relaxation Group will experience live guided relaxation, which also shows promise. Research indicates that various relaxation techniques, including live guided sessions, can reduce blood pressure. These methods help lower stress, which in turn benefits blood pressure levels.678910

Who Is on the Research Team?

CM

Claudia Martinez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults who visit a cardiology clinic and may have high blood pressure or stress. People with certain medical conditions, severe vision or hearing problems, or those unable to use VR equipment likely cannot participate.

Inclusion Criteria

Stable vitals: heart rate 55-100 bpm, systolic blood pressure 90-160 mmHg, afebrile
Willing to abstain from caffeine, nicotine, heavy exercise for 6 hours pre-session
Willing to tolerate EEG headband, GSR electrodes, and VR headset
See 4 more

Exclusion Criteria

Alcohol or recreational drug use within 12 hours
Severe visual or hearing impairment
Cognitive impairment
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Intervention

Participants undergo a single session of either VR relaxation, video meditation, live guided relaxation, or quiet waiting

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in stress and physiological markers immediately after the intervention

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Live Guided
  • Video Meditation
  • Virtual Reality Relaxation

Trial Overview

The study compares three ways to help reduce stress: a virtual reality relaxation program using sounds and lights with biofeedback, video meditation sessions, and live guided relaxation. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality Relaxation GroupExperimental Treatment1 Intervention
Group II: Video Meditation GroupExperimental Treatment1 Intervention
Group III: Live Guided Relaxation GroupExperimental Treatment1 Intervention
Group IV: Quiet Waiting GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Current Perspectives on the Use of Meditation to Reduce ...

Transcendental meditation and mindfulness-based stress reduction may produce clinically significant reductions in systolic and diastolic blood pressure. More ...

Effect of mindfulness-based meditation on blood pressure ...

MBM is beneficial in lowering both SBP and DBP among adults with elevated BP or hypertension. Eight studies reported MBM to be helpful in reducing SBP.

Newsweek reports on the results of a small study ...

Patients with high blood pressure who learned the Transcendental Meditation program showed a significant reduction of systolic and diastolic ...

Mindfulness effects on lifestyle behavior and blood pressure

34 Our study results suggest that adding a mindful meditation approach with health education improves lifestyle behavior changes among adults ...

Mindfulness shows promise as an effective intervention to ...

Adults with elevated blood pressure who participated in a mindfulness behavior program for eight weeks had significantly lower blood pressure ...

The impact of guided meditations and mindfulness on blood ...

This paper examines the effects of guided meditations and mindfulness techniques on blood pressure regulation and their potential to enhance cardiac biomarkers, ...

Effects of mindfulness meditation on blood pressure and ...

Secondary outcomes included laboratory tests conducted before the intervention and 12 weeks after: anaemia and iron metabolism indicators (Hb, SF), inflammation ...

Meditation to Boost Health and Well-Being

Practicing mindfulness and meditation may help you manage stress and high blood pressure, sleep better, feel more balanced and connected and even lower your ...

Yes, Meditation Can Help Lower Your Blood Pressure

Some studies have shown that patients who regularly meditate may be less likely to need blood pressure medication or eventually transition to lower doses. While ...

Relaxation techniques may help lower high blood pressure ...

Our review findings suggest that many different forms of relaxation can lower blood pressure for people with hypertension, at least up to three months.