Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06544902
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VR Stress Management — OTHER
    Realist Women program is a five-week wellness program that comprises of multiple modules, each lasting between 10 and 20 minutes, participants will complete modules weekly in person. Each module will teach participants about values-based goal setting/ behavioral activation, and cognitive restructuring.
  • Education Control — BEHAVIORAL
    Participants in this group will receive one-time educational material regarding stress. The participants can review the material remotely. American Heart Association (AHA) brochures and infographics regarding chronic stress and women's health, heart disease and mental health among black women, healthy for good sleep well, among other useful resources.

Study Details

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.

Key Dates

Start date
May 13, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VR-Stress Management Group
    Participants in this group will receive VR intervention for up to 6 months
  • Active Comparator: Education Control Group
    Participants in this group will be exposed to standard care through educational materials for up to 6 months.

Primary Outcome Measure

Change in stress as measured by Perceived Stress Scale (PSS) [ Time Frame: Baseline and up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Miami· Miami, FL

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