StressNCT05252507
Art for Hearts/Black Women's Hearts Paint Night
A study testing Paint Night in people with Stress and Blood Pressure, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Blood Pressure
- What is being tested?
- Paint Night
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 4 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as African American or black
- have a measured blood pressure (BP) of <140/90 mmHg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Stress, Blood Pressure
- Being tested
- Paint Night
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paint NightBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Paint Night | Experimental | Not described Receives: Behavioral: Paint Night |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Change in psychological state
Participants will complete a survey regarding their psychological state at baseline at the conclusion of their 8-week series.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start6 Apr 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Black Cardiologists (ABC)
- Responsible party
- Sponsor
- Investigators
- Anika L Hines, PhD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252507
- Sponsor's protocol ID
- HM20021891
- Status last verified
- Nov 2022
- First submitted
- 14 Feb 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art for Hearts/Black Women's Hearts Paint Night
- ClinicalTrials.gov ID
- NCT05252507
- Acronym / sponsor ID
- HM20021891
- Conditions
- Stress, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Association of Black Cardiologists (ABC)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paint Night | Experimental | Behavioral: Paint Night |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-identify as African American or black
- have a measured blood pressure (BP) of <140/90 mmHg
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paint NightThere 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). | Behavioural | Paint Night |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anika L Hines, PhD, MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paint Night in people with Stress and Blood Pressure, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Baseline to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.