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Recruiting NCT03258580

NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

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Clinical Trial Summary
NCT ID NCT03258580
Status Recruiting
Phase
Sponsor National Center for Complementary and Integrative Health (NCCIH)
Condition Normal Physiology
Study Type INTERVENTIONAL
Enrollment 700 participants
Start Date 2018-05-09
Primary Completion 2027-05-17

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 60 Years
Study Type INTERVENTIONAL
Interventions
Medoc thermal stimulatorElectric shock stimulatorCold water bath

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 700 participants in total. It began in 2018-05-09 with a primary completion date of 2027-05-17.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Objective The current proposal investigates behavioral, psychophysiological, and social processes that may help explain biases and disparate outcomes in pain. Health disparities, or health outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many diseases and symptoms, including pain. Pain is the number one reason individuals seek medical treatment. Health disparities in pain encompass both differences in pain experience and treatment for pain. For instance, research indicates that Black individuals report increased pain and have reduced pain tolerance relative to White individuals, yet doctors are less likely to treat minority patients pain and underestimate their pain experience. This project aims to address this systemic discrepancy by focusing on interpersonal processes that may contribute to these disparities, including socially-relevant responses to pain (i.e. pain expression) and pain assessment (e.g. visual attention). The proposed research aims to determine whether the study of pain expressions and their assessment can yield insights on how social factors shape pain and its treatment. Further, we test the efficacy of potential interventions designed to improve accuracy and reduce biases in pain assessment. If successful, this work will form the foundation of a new research program that will link the field of pain research with the field of social neuroscience, and forge new insights on the critical problem of health disparities in pain. Study population We will accrue up to 700 total healthy volunteers to target 240 completers Design Our overall aim is to understand how social factors influence the assessment and management of pain, and to gain insight into psychosocial processes that may underlie health disparities in pain. We propose a series of studies designed to test these links. First, we will measure pain perception and physiological responses to painful stimuli in a diverse group of individuals to test for sociocultural and biological influences on pain and pain-related responses. In subsequent studies, new participants ("perceivers") will view images of these initial participants ("targets") and will provide estimates of 'targets' pain experience. We will measure a) whether perceivers can accurately estimate 'targets' pain experience; b) whether accuracy differs as a function of similarity between target and perceiver (ingroup vs outgroup); and c) whether individuals can improve accuracy through feedback. Outcome measures Primary outcome measures for all experiments will be decisions about pain (experienced by self or other) measured with visual analogue scales, reaction time, and/or categorical judgments (pain/no pain). We will also measure physiological responses (e.g., facial muscle response, skin conductance, pupil dilation) and brain responses using functional magnetic resonance imaging (fMRI) as secondary outcome measures. We will test whether pain and pain-related responses varies as a function of sociocultural/demographic factors (e.g. race, ethnicity, sex) and whether accuracy in assessing others' pain is influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g. performance-related feedback)....

Eligibility Criteria

* INCLUSION CRITERIA: All Sub-Studies: * Healthy * Between 18 and 60 years old * Fluent in English * Able to provide written informed consent EXCLUSION CRITERIA: All Sub-Studies: * Unable to comply with study procedures * Has a major-medical condition or medical history that in a clinician's assessment could affect ability to comply with study procedures, including neurological conditions (including stroke, blindness or deafness, or a history of brain damage) * Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes. * NIH staff member who is a subordinate/relative/co-worker of any investigator on the protocol * Prior completion of a different sub-study within this protocol. * Is born outside of the states or territories of the United States of America * Does not currently reside in a state or territory of the United States of America Sub-study 1: * Has a major-medical condition or medical history that in a clinician's assessment could affect heat sensitivity or pain thresholds. This may include cardiovascular, autonomic, or neurological conditions or a chronic systemic disease (e.g., diabetes) * Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud's disease, peripheral neuropathy, or circulatory disorder) * Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months) * Has a dermatological condition affecting the testing region, such as scars, burns, or recent tattoos that might influence cutaneous sensibility * Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an "as needed" basis is acceptable as long as the last dose was not taken was within 5 half-lives of testing. * Is left handed Sub-study 4, FMRI participants: * Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months) * Is left-handed * Any FMRI contraindications, including: * Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body. * Implanted cardiac pacemaker or auto-defibrillator. * Insulin pump. * Irremovable body piercing. * Pregnant women (based on urine test completed within 24 hours prior to scan). * Those with an abnormality on a structural MRI that has functional consequences based on clinician assessment.

Contact & Investigator

Central Contact

Adebisi O Ayodele, C.R.N.P.

✉ bisi.ayodele@nih.gov

📞 (240) 593-4226

Principal Investigator

Lauren Y Atlas, Ph.D.

PRINCIPAL INVESTIGATOR

National Center for Complementary and Integrative Health (NCCIH)

Frequently Asked Questions

Who can join the NCT03258580 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Normal Physiology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT03258580 currently recruiting?

Yes, NCT03258580 is actively recruiting participants. Contact the research team at bisi.ayodele@nih.gov for enrollment information.

Where is the NCT03258580 trial being conducted?

This trial is being conducted at Bethesda, United States.

Who is sponsoring the NCT03258580 clinical trial?

NCT03258580 is sponsored by National Center for Complementary and Integrative Health (NCCIH). The principal investigator is Lauren Y Atlas, Ph.D. at National Center for Complementary and Integrative Health (NCCIH). The trial plans to enroll 700 participants.

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