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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.

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.

Is virtual reality safe for stress and high blood pressure management?

Research shows that virtual reality (VR) is generally safe for managing 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 been used safely in various settings to reduce stress and anxiety. ^{1 2 3 4 5}

How does the VR Stress Management treatment differ from other treatments for stress and high blood pressure?

VR Stress Management is unique because it uses virtual reality to create immersive environments that help reduce stress and potentially influence blood pressure by engaging the nervous system in a novel way. Unlike traditional methods, it combines relaxation techniques with interactive virtual experiences, which can be more engaging and effective for some individuals. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment VR Stress Management for stress and high blood pressure?

Research shows that virtual reality (VR) can help reduce stress and anxiety, which are linked to high blood pressure. VR has been effective in lowering stress reactions and anxiety in various settings, suggesting it might also help manage stress-related high blood pressure. ^{1 3 4 7 8}

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.

Fluency in English

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

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]

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]

Citations

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

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

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

Automated Stress Recognition Using Supervised Learning Classifiers by Interactive Virtual Reality Scenes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2022]

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

Review of Psychophysiological and Psychotherapeutic Studies of Stress Using Virtual Reality Technologies. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Relaxation for Patients With a Psychiatric Disorder: Crossover Randomized Controlled Trial. [2021]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

Virtual reality relaxation for people with mental health conditions: a systematic review. [2023]