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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05252507
Other study ID # HM20021891
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2022
Est. completion date October 4, 2022

Study information

Verified date November 2022
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to learn about different techniques that can be used to increase self-reflection, reduce stress, manage high blood pressure in Black women.


Description:

The researchers want to know how Black women process stress and cope with it during the pandemic, and if managing stress related through a tailored stress reduction activity/art program affect psychological and blood pressure outcomes over the course of 2 months. It is possible that this information may help people reduce their stress and get treatment for high blood pressure sooner, which can help prevent other heart problems over time.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 4, 2022
Est. primary completion date October 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - self-identify as African American or black - have a measured blood pressure (BP) of <140/90 mmHg Exclusion Criteria: - Are experiencing cognitive impairment - Report an untreated psychotic disorder, bipolar disorder, any organic brain syndromes, or substance abuse disorder that the study team believes may result in being a threat to themselves or others - Report hospitalization for any psychiatric disorder within the past 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Paint Night
There will be 8 Sessions (4 paint nights and 4 educational sessions alternating weeks). For the painting sessions, participants will paint for 45 minutes and then participate in a combined presentation/discussion session (45 minutes). For the educational sessions, they will attend a 30-minute presentation presented by a researcher on heart health and then have the opportunity to discuss with the researcher and other members of the group (60 minutes).

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Association of Black Cardiologists (ABC)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in blood pressure Participants will take their BP at least once a week (with at least 7 days separating the first and last reading each month) for eight consecutive weeks. Baseline to 8 weeks
Primary Change in psychological state Participants will complete a survey regarding their psychological state at baseline at the conclusion of their 8-week series. Baseline to 8 weeks
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