Virtual Reality for Hypertension and Anxiety

Overseen By Tia Wilkes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Epilepsy, Dementia, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a calming virtual reality (VR) experience can lower blood pressure and reduce anxiety in adults. It targets individuals who may experience anxiety at the doctor's office, leading to higher blood pressure readings, a condition known as "white coat hypertension." Researchers will check participants' blood pressure and anxiety levels before and after a 5-minute VR session. Ideal candidates are adults who currently use a device to monitor blood pressure at home and do not have conditions like epilepsy or severe vision problems. The trial occurs during a routine clinic visit and adds about 30 minutes to the appointment. As an unphased trial, this study allows participants to contribute to innovative research that could enhance anxiety management in clinical settings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications, so it's best to check with the trial coordinators.

What prior data suggests that this virtual reality experience is safe for reducing blood pressure and anxiety?

Past research has shown that virtual reality (VR) offers a safe way to manage stress and anxiety. Studies suggest that VR can improve anxiety and stress levels without major side effects. For instance, creating a calm environment through VR can help individuals relax and feel less anxious.

VR is generally considered low-risk. One study noted its safety and non-reliance on medication, making it a gentle option for stress relief. Another study found that VR helps people relax by blocking out the real world and creating a peaceful setting.

Overall, VR is well-tolerated, with little evidence of negative effects. It serves as a safe and simple tool that might help lower stress and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for hypertension and anxiety because it offers a new, immersive way to potentially reduce stress and blood pressure. Unlike traditional treatments that often involve medication, VR provides a non-invasive, drug-free alternative that could appeal to those seeking holistic approaches. The calming VR sessions have the potential to deliver immediate emotional relief and might improve blood pressure readings in a clinical setting. This innovative approach could revolutionize how we manage these conditions by integrating technology with health care.

What evidence suggests that this virtual reality intervention is effective for reducing hypertension and anxiety?

Research shows that virtual reality (VR) therapy can help reduce anxiety. Studies have found that VR experiences lower anxiety levels in people with anxiety disorders. A review of several studies found that VR therapy slightly reduced stress and anxiety in patients in intensive care units (ICUs). While some studies didn't find a significant effect on blood pressure, others suggest VR can improve emotional well-being. In this trial, participants will undergo a 5-minute calming VR session to evaluate its effect on blood pressure and anxiety levels in a clinical setting. These findings offer hope that a calming VR session might lower anxiety and possibly affect blood pressure. ^{1 2 6 7 8}

Who Is on the Research Team?

Lyle W Baker, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults at Mayo Clinic in Florida who may have 'white coat hypertension'—where blood pressure rises in a clinical setting—or anxiety. They must be scheduled for an ambulatory blood pressure monitoring device return visit.

Inclusion Criteria

Able and willing to provide informed consent

Undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic Florida for any clinical indication

Exclusion Criteria

Current pregnancy

Significant cognitive impairment (e.g., dementia, Alzheimer's disease)

I have a stable neck without injuries affecting VR use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a 5-minute calming virtual reality (VR) session with blood pressure and anxiety levels measured before and after VR exposure

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in home-clinic blood pressure difference and anxiety levels after VR exposure

Next day follow-up

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The study tests if a 5-minute calming VR session can lower office blood pressure and self-reported anxiety levels during clinic visits, and if it reduces the gap between home and clinic blood pressure readings.

How Is the Trial Designed?

Group I: Virtual Reality Intervention Experimental Treatment 1 Intervention

Participants undergoing ambulatory blood pressure monitoring (ABPM) will receive a 5-minute calming virtual reality (VR) session. Blood pressure and anxiety levels will be measured before and after VR exposure to evaluate its effect on office blood pressure and emotional response in a clinical setting.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 40 children aged 12 to 17 undergoing elective surgery, preoperative virtual reality (VR) significantly reduced heart rates and anxiety levels compared to a control group, indicating its efficacy in managing preoperative anxiety.

The VR group reported a much more positive experience in the operating room, with higher relaxation scores and no adverse events related to the VR intervention, suggesting it is a safe and effective tool for anxiety relief in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. Esposito, C., Autorino, G., Iervolino, A., et al.[2022]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

Virtual reality (VR) biofeedback significantly reduces self-reported anxiety and heart rate in individuals, based on a systematic review of 7 studies involving 191 participants, including 5 randomized controlled trials.

While VR biofeedback showed promise in lowering anxiety and heart rate compared to waiting list controls, it did not demonstrate significant differences in outcomes when compared to traditional 2D biofeedback, indicating the need for further research in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. Kothgassner, OD., Goreis, A., Bauda, I., et al.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06960057

NCT06960057 | Virtual Reality as a Tool to Lower Blood ...

This clinical trial aims to evaluate whether a calming virtual reality (VR) experience can reduce office blood pressure (OBP) and anxiety in adults ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12327699/

Novel Virtual Reality Intervention for Stress Reduction Among ...

The aim of this study is to assess safety and preliminarily explore how a VR experience can aid in stress reduction among patients with or at ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11904249/

Effectiveness of virtual reality therapy in the treatment ...

The current findings suggest that VR therapy interventions have a positive effect on improving the anxiety state of patients with anxiety disorders.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0883944125001510

The impact of virtual reality interventions on stress and ...

This systematic review and meta-analysis found that VR interventions were associated with a modest reduction in stress and anxiety among ICU patients, although ...

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frontiersin.org

frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2021.695449/full

The Use of Virtual Reality Technologies to Reduce Anxiety ...

There was no significant difference in blood pressure, pain levels, feeling upset, or worried. A majority of participants preferred to have VR ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11526413/

Psychological and physiological health outcomes of virtual ...

Psychological benefits include improved anxiety, mindfulness, emotions, disease patterns, affect, stress, (presleep) arousal, meditation and others.

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sciencedirect.com

sciencedirect.com/science/article/pii/S1532046421000502

Exploring the effect of virtual reality relaxation environment ...

VR provides an effective approach to avoid WCH in BP measurement by visually and aurally isolating the real environment and assisting relaxation.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07032935

The Effect of Virtual Reality Glasses on Vital Signs and ...

VR is considered a cost-effective, safe, and non-pharmacological intervention. Several studies support its efficacy. For example, in a study comparing the ...