Virtual Reality for Stress and High Blood Pressure

Overseen By Judite Blanc, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Psychosis, Vision impairment, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can help Black women manage stress and improve heart health. Researchers aim to determine if VR use affects sleep, stress levels, and overall stress relief effectiveness. Participants will either use VR tools (VR Stress Management) or receive standard educational materials for up to six months. Black women living in South Florida who speak English and have high blood pressure may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore innovative stress management techniques and contribute to research that could benefit others in the future.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual reality program is safe for stress management?

Research shows that using virtual reality (VR) to manage stress is generally safe and easy to handle. Studies have found that VR can help lower stress and anxiety without causing major side effects. For instance, one study found that people felt less stressed immediately after using a VR program. Another study suggested that VR could safely reduce stress and blood pressure. Participants in these studies did not report any serious issues when using VR. This suggests that VR could be a safe way to manage stress and improve heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VR stress management for high blood pressure because it offers a novel approach compared to current standard treatments like medication, lifestyle changes, and stress management techniques. Unlike traditional methods, VR provides an immersive experience that can help users practice relaxation techniques in a controlled, interactive environment. This method may enhance engagement and adherence, potentially leading to better stress reduction and blood pressure control. Additionally, VR can be personalized to suit individual needs, making it a flexible and innovative tool in managing high blood pressure.

What evidence suggests that VR Stress Management could be effective for stress and high blood pressure?

This trial will compare a VR Stress Management intervention with an Education Control Group. Studies have shown that virtual reality (VR) can help reduce stress and lower blood pressure. For example, one study found that VR managed blood pressure and heart rate during dental procedures without causing extra side effects. Another study found that VR relaxation reduced stress in highly stressed individuals. Research also shows that VR can lower stress and anxiety in hospital patients compared to standard treatments. Overall, VR appears promising as a tool for managing stress and improving heart health. ^{1 3 4 6 7}

Who Is on the Research Team?

Judite Blanc, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Black women who are experiencing high blood pressure and stress. Participants should be interested in using virtual reality (VR) as a tool to manage stress. The study will focus on the impact of VR on heart health, sleep quality, and overall stress levels.

Inclusion Criteria

I identify as a Black woman.

I am at least 21 years old.

I am willing to be audio-recorded.

Exclusion Criteria

Absence of motion sickness

History of psychosis disorders

My vision and thinking abilities are normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either VR intervention or standard care through educational materials for up to 6 months

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for changes in stress, resiliency, sleep health, and blood pressure

3 months

What Are the Treatments Tested in This Trial?

Interventions

• VR Stress Management

Trial Overview The Realist Women Study is testing whether a VR program can reduce stress and improve heart health among Black women. It compares the effects of standard educational materials (control group) with an immersive VR experience designed for stress management.

How Is the Trial Designed?

Group I: VR-Stress Management Group Experimental Treatment 1 Intervention

Participants in this group will receive VR intervention for up to 6 months

Group II: Education Control Group Active Control 1 Intervention

Participants in this group will be exposed to standard care through educational materials for up to 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

This study will evaluate a new virtual reality (VR) relaxation environment against a control group using self-chosen relaxation methods, involving 100 healthy participants to assess its effectiveness in reducing stress after a standardized stress induction.

The VR environment is designed to be immersive with multi-sensory features, potentially enhancing relaxation efficacy during acute stress situations without requiring prior training, which could lead to practical applications in stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating relaxation and stress reduction in healthy participants through a virtual reality intervention: study protocol for a non-inferiority randomized controlled trial. Kampa, M., Finke, J., Stalder, T., et al.[2022]

A study involving 50 psychiatric patients showed that the VR relaxation tool (VRelax) significantly reduced negative affective states, such as anxiety and sadness, more effectively than standard relaxation exercises.

Both VRelax and standard relaxation improved overall mood, but VRelax provided a greater immediate benefit in specific emotional states, suggesting it could be a valuable self-management tool for enhancing psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. Veling, W., Lestestuiver, B., Jongma, M., et al.[2021]

A systematic review of 18 studies involving 848 participants found that virtual reality (VR) relaxation is a feasible and acceptable intervention that can effectively promote relaxation and reduce stress in adults with mental health conditions, particularly those experiencing anxiety and stress-related issues.

The studies utilized various nature-based virtual environments, demonstrating short-term effectiveness, and the methodological quality of most studies was rated as 'strong', indicating reliable evidence for the benefits of VR relaxation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality relaxation for people with mental health conditions: a systematic review. Riches, S., Jeyarajaguru, P., Taylor, L., et al.[2023]

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]

Citations

1. 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 was to determine whether stress levels could be reduced immediately after experiencing a novel VR intervention in patients ...

2. withpower.com withpower.com/trial/phase-hypertension-8-2024-bd6d3

Virtual Reality for Stress and High Blood Pressure In a study with patients undergoing tooth extraction, VR helped control blood pressure and heart rate without increasing adverse events. Additionally, VR has ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0883944125001510

The impact of virtual reality interventions on stress and ... We hypothesised that VR interventions would be associated with a measurable reduction in stress and anxiety levels in ICU patients, when compared to standard ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.614539/full

Effect of Virtual Reality on Stress Reduction and Change ... VR relaxation was effective in reducing subjectively reported stress in individuals with high stress.

5. journals.physiology.org journals.physiology.org/doi/10.1152/advan.00014.2025

Virtual reality breaks for stress reduction among graduate ... Virtual reality (VR) has been proposed as an effective tool for reducing stress but has not been tested among trainees experiencing high academic pressures.

6. 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 ...

7. mdpi.com mdpi.com/2076-3417/12/14/7309

The Advances of Immersive Virtual Reality Interventions for ... The results suggest that VR-based interventions can facilitate positive changes in subjective stress levels and stress-related biomarkers.