Pain, AcuteNCT06113926
Racial Discrimination, Pain, and the Buffering Influences of Acknowledgment
A study testing Bystander Acknowledgment in people with Pain, Acute, run by George Washington University at 1 site in United States.
Trial summary
Black young adults (aged 18-30; N = 92) were racially included (i.e., received the ball an equal number of times) or excluded (i.e., received the ball only once) by other White players in a ball-tossing computer game called Cyberball; White experimenters acknowledged the exclusion for half of the excluded… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Bystander Acknowledgment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Jan 2023
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants identify as Black/African American
- Age 18-30
Who cannot join
- Past 30-day persistent pain
- Cardiovascular or circulatory disorders
- Diabetes
- Current pregnancy
- Open sores/frostbite on nondominant hand
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University
Washington D.C., District of Columbia, 20052
About this study
Black young adults (aged 18-30; N = 92) were racially included (i.e., received the ball an equal number of times) or excluded (i.e., received the ball only once) by other White players in a ball-tossing computer game called Cyberball; White experimenters acknowledged the exclusion for half of the excluded participants. Participants completed a cold-pressor task twice to measure pain sensitivity (threshold, tolerance, and unpleasantness): immediately prior, and after the Cyberball (and acknowledgment) manipulation. Participants also completed a post-manipulation survey examining the psychological effects of racial exclusion and acknowledgment (i.e., psychological needs satisfaction, negative affect, control).
- Conditions
- Pain, Acute
- Being tested
- Bystander Acknowledgment
- Keywords
- discrimination, racism
- Medical subject headings
- Acute Pain, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bystander AcknowledgmentOther
The experimenter said "That is so messed up that they excluded you in the task. And honestly, I would say it was racist…" acknowledgment of the participants experience, "…this shouldn't have happened, and I'm really sorry it did…" an apology, and "…I'm going to talk to the primary investigators of the study to figure out how we can make sure that this won't happen to other people" a plan of action.
| Study group | Role | What they receive |
|---|---|---|
| Exclusion by White "Players" | No intervention | Excluded by White "players" in an online ball-tossing game (Cyberball). |
| Inclusion by White "Players" | No intervention | Included by White "players" in an online ball-tossing game (Cyberball). |
| Exclusion by White "Players" with Bystander Acknowledgment | Experimental | Excluded by White "players" in an online ball-tossing game (Cyberball) with a White bystander acknowledging the exclusion. Receives: Other: Bystander Acknowledgment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Threshold measured with a cold pressor task
Time (in seconds) from the participant places their hand in cold water, to telling the experimenter they are experiencing pain.
Measured: Measured immediately after the manipulation (within minutes).
Pain Tolerance
Time (in seconds) from the participant places their hand in cold water, to when they remove their hand from the water.
Measured: Measured immediately after the manipulation (within minutes).
Pain unpleasantness
Measured with a the McGill-Pain Questionnaire Short Form, the degree of unpleasantness the participant reports from the pain.
Measured: Measured immediately after the manipulation (within minutes).
Secondary outcomes (4)
Psychological Needs Satisfaction; Self Control subscale
Needs-Satisfaction Scale (Zadro et al., 2004)
Measured: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Belongingness subscale
Needs-Satisfaction Scale (Zadro et al., 2004)
Measured: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Meaningful Existence subscale
Needs-Satisfaction Scale (Zadro et al., 2004)
Measured: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Self esteem subscale
Needs-Satisfaction Scale (Zadro et al., 2004)
Measured: Measured immediately after the manipulation (within minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Sep 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by George Washington 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three independent groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Psi Chi, Society for the Psychological Study of Social Issues, D.C. Psychological Association
- Responsible party
- Principal investigator, Katarina AuBuchon, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113926
- Sponsor's protocol ID
- 224125
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Shared data will be available on OSF
Publications
AuBuchon KE, Stock ML, Mathur VA, Attey B, Bowleg L. Bystander Acknowledgment Mitigates the Psychological and Physiological Pain of Racial Discrimination for Black Young Adults: A Randomized Controlled Trial. J Pain. 2024 Sep;25(9):104560. doi: 10.1016/j.jpain.2024.104560. Epub 2024 May 11.
PubMed 38735424
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Discrimination, Pain, and the Buffering Influences of Acknowledgment
- ClinicalTrials.gov ID
- NCT06113926
- Acronym / sponsor ID
- 224125
- Conditions
- Pain, Acute
- Keywords
- discrimination, racism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Psi Chi, Society for the Psychological Study of Social Issues, D.C. Psychological Association
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 2 Nov 2023 (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.
Black young adults (aged 18-30; N = 92) were racially included (i.e., received the ball an equal number of times) or excluded (i.e., received the ball only once) by other White players in a ball-tossing computer game called Cyberball; White experimenters acknowledged the exclusion for half of the excluded participants. Participants completed a cold-pressor task twice to measure pain sensitivity (threshold, tolerance, and unpleasantness): immediately prior, and after the Cyberball (and acknowledgment) manipulation. Participants also completed a post-manipulation survey examining the psychological effects of racial exclusion and acknowledgment (i.e., psychological needs satisfaction, negative affect, control).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three independent groups
| Arm | Type | Receives |
|---|---|---|
| Exclusion by White "Players" | No intervention | –Excluded by White "players" in an online ball-tossing game (Cyberball). |
| Inclusion by White "Players" | No intervention | –Included by White "players" in an online ball-tossing game (Cyberball). |
| Exclusion by White "Players" with Bystander Acknowledgment | Experimental | Other: Bystander AcknowledgmentExcluded by White "players" in an online ball-tossing game (Cyberball) with a White bystander acknowledging the exclusion. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants identify as Black/African American
- Age 18-30
Key exclusion criteria (5 listed)
- Past 30-day persistent pain
- Cardiovascular or circulatory disorders
- Diabetes
- Current pregnancy
- Open sores/frostbite on nondominant hand
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 |
|---|---|---|
| Bystander AcknowledgmentThe experimenter said "That is so messed up that they excluded you in the task. And honestly, I would say it was racist…" acknowledgment of the participants experience, "…this shouldn't have happened, and I'm really sorry it did…" an apology, and "…I'm going to talk to the primary investigators of the study to figure out how we can make sure that this won't happen to other people" a plan of action. | Other | Exclusion by White "Players" with Bystander Acknowledgment |
Primary outcome
Pain Threshold measured with a cold pressor task
Time frame: Measured immediately after the manipulation (within minutes).
Time (in seconds) from the participant places their hand in cold water, to telling the experimenter they are experiencing pain.
Pain Tolerance
Time frame: Measured immediately after the manipulation (within minutes).
Time (in seconds) from the participant places their hand in cold water, to when they remove their hand from the water.
Pain unpleasantness
Time frame: Measured immediately after the manipulation (within minutes).
Measured with a the McGill-Pain Questionnaire Short Form, the degree of unpleasantness the participant reports from the pain.
4 secondary outcomes
Psychological Needs Satisfaction; Self Control subscale
Time frame: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Belongingness subscale
Time frame: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Meaningful Existence subscale
Time frame: Measured immediately after the manipulation (within minutes).
Psychological Needs Satisfaction; Self esteem subscale
Time frame: Measured immediately after the manipulation (within minutes).
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 2 Nov 2023.
- Derived from this study: PubMed 38735424AuBuchon KE, Stock ML, Mathur VA, Attey B, Bowleg L. Bystander Acknowledgment Mitigates the Psychological and Physiological Pain of Racial Discrimination for Black Young Adults: A Randomized Controlled Trial. J Pain. 2024 Sep;25(9):104560. doi: 10.1016/j.jpain.2024.104560. Epub 2024 May 11.
- OSF PreregistrationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Shared data will be available on OSF
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bystander Acknowledgment in people with Pain, Acute, run by George Washington 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 5 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 2 Nov 2023. 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?
Pain Threshold measured with a cold pressor task (time frame: Measured immediately after the manipulation (within minutes).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113926, which also lists 1 linked publication.
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 2 Nov 2023.