Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
2 other identifiers
interventional
700
1 country
1
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)....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedStudy Start
First participant enrolled
May 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
April 24, 2026
December 1, 2025
9 years
August 22, 2017
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)
We measure facial responses to painful stimuli in substudy 1 and eye position in substudy 2 and 3.
Every visit
Pain perception (pain ratings)
Individuals report their perceived pain or the pain they associate with other people they are viewing.
Every visit
Secondary Outcomes (1)
Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)
Every visit
Study Arms (4)
Substudy 1: All participants
EXPERIMENTALMeasuring facial response to painful stimulation.
Substudy 2: Healthy volunteers
NO INTERVENTIONMeasuring pain assessment accuracy
Substudy 3: Control
NO INTERVENTIONSubjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).
Substudy 3: Feedback Group
EXPERIMENTALParticipants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
Interventions
Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
Eligibility Criteria
You may qualify if:
- All Sub-Studies:
- Healthy
- Between 18 and 60 years old
- Fluent in English
- Able to provide written informed consent
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Y Atlas, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 23, 2017
Study Start
May 9, 2018
Primary Completion (Estimated)
May 17, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
April 24, 2026
Record last verified: 2025-12-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF, CSR, ANALYTIC CODE
- Time Frame
- Face stimuli are available following completion for viewing by other study participants. Deidentified data will be made available upon publication.
- Access Criteria
- please see above.
Deidentified data will be shared with other researchers as per the protocol. Identifiable data (i.e. images of faces) from participants who consent to data sharing may be shared with other researchers. Finally, identifiable data from participants who opt to be included in a stimulus set through the sub-study 1 consent form can be shown to other participants and in other studies to measure evaluation of facial responses to pain.