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

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University of Miami

Status

Begins enrollment in 2 months

Conditions

Hypertension
Stress

Treatments

Behavioral: Education Control
Other: VR Stress Management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06544902
20240402
1K01HL175286-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Judite Blanc, PhD

Data sourced from clinicaltrials.gov

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