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RecruitingNCT03258580Updated Sep 23, 2026

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

An interventional study of Medoc thermal stimulator and Electric shock stimulator in Normal Physiology, Healthy Volunteers and Pain, sponsored by National Center for Complementary and Integrative Health (NCCIH). Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 325 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).

Read the detailed description

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 325 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).

02

Conditions studied

  • Normal Physiology
  • Healthy Volunteers
  • Pain

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Keywords

  • Pain
  • Visual Analogue Pain Scale
  • Healthy Volunteer
  • EYE TRACKING
  • Eye Movement
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

All Sub-Studies:

  • Healthy
  • Between 18 and 60 years old
  • Fluent in English
  • Able to provide written informed consent

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Substudy 1: All participants

    Measuring facial response to painful stimulation.

    Device: Medoc thermal stimulator · Device: Electric shock stimulator · Device: Cold water bath

  • No intervention
    Substudy 2: Healthy volunteers

    Measuring pain assessment accuracy

  • No intervention
    Substudy 3: Control

    Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).

  • Experimental
    Substudy 3: Feedback Group

    Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.

    Behavioral: Pain assessment performance feedback

Interventions

  • DeviceMedoc thermal stimulator

    Heat pain stimulation for substudy 1

  • DeviceElectric shock stimulator

    Electric pain stimulation for substudy 1

  • DeviceCold water bath

    Cold pain stimulation for substudy 1

  • BehavioralPain assessment performance feedback

    Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every visit

  2. Pain perception (pain ratings)

    Individuals report their perceived pain or the pain they associate with other people they are viewing.

    Time frame: Every visit

Secondary outcomes

  1. Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)

    We collect measures of identity and endorsement of beliefs about pain.

    Time frame: Every visit

06

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact · prpl@cc.nih.gov · 800-411-1222
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03258580
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Responsible party
Sponsor
First posted
Aug 23, 2017
Start date
May 9, 2018
Primary completion
May 17, 2027 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Adebisi O Ayodele, C.R.N.P.
Contact
bisi.ayodele@nih.gov
(240) 593-4226
Lauren Y Atlas, Ph.D.
Contact
lauren.atlas@nih.gov
(301) 827-0214
Lauren Y Atlas, Ph.D.
principal investigator · National Center for Complementary and Integrative Health (NCCIH)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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