Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study
NCT Number: NCT06544902
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Hypertension
Interventions: OTHER: VR Stress Management|BEHAVIORAL: Education Control
Sponsor: University of Miami
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-06-30
Locations: University of Miami, Miami, Florida, 33136, United States

Summary:
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.

Primary Outcome Measures: Change in stress as measured by Perceived Stress Scale (PSS), scores ranging from 0 (no symptoms) to 40 (highest severity)., Baseline and up to 6 months|Change in discrimination as measured by Intersectional Discrimination Index (InDI), scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination., Baseline and up to 6 months|Change in Traumatic stress as measured by Life Events Checklist, This self-report checklist screens for potentially traumatic events in an individual's lifetime. Scores range from 1 to 17, higher scores indicate higher traumatic exposures. It consists of 17 questions with responses such as "happened to me," "witnessed it," "learned about it," "part of my job," "not sure," and "doesn't apply.", Baseline and up to 6 months|Change in stress as measured by the chronic stress scale, The Chronic Stress Scale is a 51-item scale that evaluates the perceived experience of chronic stress. Scores range from 0 (not true) to 2 (very true)., Baseline and up to 6 months|Change in stress as measured by the Stress in Context (SIC) Questionnaire, The SIC Questionnaire is a 21-item survey assessing stress perception in specific contexts (e.g., home, work, social relationships), with scoring from 1 (never) to 4 (usually)., Baseline and up to 6 months|Change in stress as measured by the Giscombe Superwoman Schema Questionnaire, It contains 35 statements rated from 0 (not true) to 4 (true all the time) across the 5 subscales. subscale items are summed to create one Super Woman Schema (SWS) total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS, Baseline and up to 6 months
Secondary Outcome Measures: Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC), Scores range from 0-40 higher scores indicate higher resiliency, Baseline and up to 6 months|Change in objective sleep health as measured by Sleep Health Objective, Sleep will be assessed using actigraphy measured in hours., Baseline and up to 6 months|Change in blood pressure, Measured by millimeter of mercury, Baseline and up to 3 months after intervention