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

200 Participants Needed

Trial Summary

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.

Is virtual reality safe for use in humans?

Research shows that virtual reality (VR) is generally safe for use in humans. Studies have found no increase in adverse events when using VR for anxiety and blood pressure management, and it has been safely used in both adults and children to reduce anxiety in various settings. ^{1 2 3 4 5}

How does the virtual reality treatment for hypertension and anxiety differ from other treatments?

Virtual reality (VR) is unique because it uses immersive environments to distract and relax patients, helping to manage anxiety and blood pressure without medication. Unlike traditional treatments that may involve drugs or physical interventions, VR provides a non-invasive, engaging experience that can reduce anxiety and stabilize blood pressure by isolating patients from stressful real-world environments. ^{2 3 5 6 7}

What is the purpose of this trial?

This clinical trial aims to evaluate whether a calming virtual reality (VR) experience can reduce office blood pressure (OBP) and anxiety in adults undergoing ambulatory blood pressure monitoring (ABPM) at Mayo Clinic in Florida. The main questions it aims to answer are: 1. Does a 5-minute calming VR session reduce office blood pressure in patients with suspected white coat hypertension or white coat effect? 2. Does VR exposure reduce self-reported anxiety levels in the clinical setting? 3. Does VR reduce the difference between home (ABPM) and clinic blood pressure readings? Participants will: 1. Complete two short electronic surveys (before and after VR exposure) on a clinic-provided device. 2. Undergo a 5-minute virtual reality (VR) relaxation session. 3. Have their blood pressure measured before and after the VR session. Participation will occur during the participant's scheduled ABPM device return visit and will add approximately 30 minutes to the visit. This is a single-arm, pre-post interventional study where each participant serves as their own control.

Research Team

Lyle W Baker, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Virtual reality biofeedback interventions for treating anxiety : A systematic review, meta-analysis and future perspective. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of VR Technology in Eliciting State Anxiety Changes While Walking in Older Women. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality for Hypertension in Tooth Extraction: A Randomized Trial. [2022]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of instructed meditation augmented by computer-rendered artificial virtual environment on heart rate variability. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Exploring the effect of virtual reality relaxation environment on white coat hypertension in blood pressure measurement. [2021]