MedPath

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

Not Applicable
Not yet recruiting
Conditions
Hypertension
Stress
Interventions
Behavioral: Education Control
Other: VR Stress Management
Registration Number
NCT06544902
Lead Sponsor
University of Miami
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • self-identified as a Black woman
  • at least 21 years of age
  • fluency in English
  • International Classification of Diseases (ICD)10 diagnosis of hypertension
  • being a South Florida resident
  • willing to be audio-recorded
Exclusion Criteria
  • History of psychosis disorders
  • absence of vision and cognitive impairment
  • absence of epilepsy disorders
  • absence of motion sickness.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Education Control GroupEducation ControlParticipants in this group will be exposed to standard care through educational materials for up to 6 months.
VR-Stress Management GroupVR Stress ManagementParticipants in this group will receive VR intervention for up to 6 months
Primary Outcome Measures
NameTimeMethod
Change in discrimination as measured by Intersectional Discrimination Index (InDI)Baseline and up to 6 months

scores ranging from 0 to 4; higher scores indicate greater anticipated intersectional discrimination.

Change in Traumatic stress as measured by Life Events ChecklistBaseline and up to 6 months

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."

Change in stress as measured by the Giscombe Superwoman Schema QuestionnaireBaseline and up to 6 months

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

Change in stress as measured by Perceived Stress Scale (PSS)Baseline and up to 6 months

scores ranging from 0 (no symptoms) to 40 (highest severity).

Change in stress as measured by the chronic stress scaleBaseline and up to 6 months

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).

Change in stress as measured by the Stress in Context (SIC) QuestionnaireBaseline and up to 6 months

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).

Secondary Outcome Measures
NameTimeMethod
Change in blood pressureBaseline and up to 3 months after intervention

Measured by millimeter of mercury

Change in objective sleep health as measured by Sleep Health ObjectiveBaseline and up to 6 months

Sleep will be assessed using actigraphy measured in hours.

Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)Baseline and up to 6 months

Scores range from 0-40 higher scores indicate higher resiliency

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

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