Art for Hearts/Black Women's Hearts Paint Night

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05252507
• Collaborator: Association of Black Cardiologists (ABC) (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress; Blood Pressure	Behavioral: Paint Night	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Art for Hearts/Black Women's Hearts Paint Night
• Actual Study Start Date: Apr 6, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Paint Night

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).

Outcome Measures

Primary Outcome Measures

1. Change in blood pressure [Baseline to 8 weeks]

   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.

2. Change in psychological state [Baseline to 8 weeks]

   Participants will complete a survey regarding their psychological state at baseline at the conclusion of their 8-week series.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• Association of Black Cardiologists (ABC)

Investigators

• Principal Investigator: Anika L Hines, PhD, MPH, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT05252507
• Other Study ID Numbers: HM20021891
• First Posted: Feb 23, 2022
• Last Update Posted: Apr 15, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 15, 2022