- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05252507
Art for Hearts/Black Women's Hearts Paint Night
November 16, 2022 updated by: Virginia Commonwealth University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: 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.
|
Baseline to 8 weeks
|
Change in psychological state
Time Frame: Baseline to 8 weeks
|
Participants will complete a survey regarding their psychological state at baseline at the conclusion of their 8-week series.
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Baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anika L Hines, PhD, MPH, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 6, 2022
Primary Completion (ACTUAL)
October 4, 2022
Study Completion (ACTUAL)
October 4, 2022
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
February 14, 2022
First Posted (ACTUAL)
February 23, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 16, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HM20021891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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