Normal PhysiologyNCT03258580
Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
A study testing Medoc thermal stimulator, Electric shock stimulator and Cold water bath in people with Normal Physiology and Healthy Volunteers, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology, Healthy Volunteers, Pain
- What is being tested?
- Medoc thermal stimulator, Electric shock stimulator and Cold water bath
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Sub-Studies:
- Healthy
- Between 18 and 60 years old
- Fluent in English
- Able to provide written informed consent
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
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.
Read more
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).
- Conditions
- Normal Physiology, Healthy Volunteers, Pain
- Being tested
- Medoc thermal stimulator, Electric shock stimulator, Cold water bath, Pain assessment performance feedback
- Keywords
- Pain, Visual Analogue Pain Scale, Healthy Volunteer, EYE TRACKING, Eye Movement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medoc thermal stimulatorDevice
Heat pain stimulation for substudy 1
Electric shock stimulatorDevice
Electric pain stimulation for substudy 1
Cold water bathDevice
Cold pain stimulation for substudy 1
Pain assessment performance feedbackBehavioural
Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1: All participants | Experimental | Measuring facial response to painful stimulation. Receives: Device: Medoc thermal stimulator; Device: Electric shock stimulator; Device: Cold water bath |
| Substudy 2: Healthy volunteers | No intervention | Measuring pain assessment accuracy |
| Substudy 3: Control | No intervention | Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication). |
| Substudy 3: Feedback Group | Experimental | Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain. Receives: Behavioral: Pain assessment performance feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every visit
Pain perception (pain ratings)
Individuals report their perceived pain or the pain they associate with other people they are viewing.
Measured: 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.
Measured: Every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start9 May 2018
- Primary completion17 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lauren Y Atlas, Ph.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258580
- Sponsor's protocol ID
- 170155
- Other IDs
- 17-AT-0155
- Status last verified
- 16 Oct 2026
- First submitted
- 22 Aug 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociocultural & Biobehavioral Influences on Pain Expression and Assessment
- ClinicalTrials.gov ID
- NCT03258580
- Acronym / sponsor ID
- 170155
- Conditions
- Normal Physiology, Healthy Volunteers, Pain
- Keywords
- Pain, Visual Analogue Pain Scale, Healthy Volunteer, EYE TRACKING, Eye Movement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 9 May 2018 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 23 Aug 2017 (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.
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)....
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Substudy 1: All participants | Experimental | Device: Medoc thermal stimulator, Device: Electric shock stimulator, Device: Cold water bathMeasuring facial response to painful stimulation. |
| Substudy 2: Healthy volunteers | No intervention | –Measuring pain assessment accuracy |
| Substudy 3: Control | No intervention | –Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication). |
| Substudy 3: Feedback Group | Experimental | Behavioral: Pain assessment performance feedbackParticipants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Between 18 and 60 years old
- Fluent in English
- Able to provide written informed consent
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| Medoc thermal stimulatorHeat pain stimulation for substudy 1 | Device | Substudy 1: All participants |
| Electric shock stimulatorElectric pain stimulation for substudy 1 | Device | Substudy 1: All participants |
| Cold water bathCold pain stimulation for substudy 1 | Device | Substudy 1: All participants |
| Pain assessment performance feedbackParticipants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain. | Behavioural | Substudy 3: Feedback Group |
Primary outcome
Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)
Time frame: Every visit
We measure facial responses to painful stimuli in substudy 1 and eye position in substudy 2 and 3.
Pain perception (pain ratings)
Time frame: Every visit
Individuals report their perceived pain or the pain they associate with other people they are viewing.
1 secondary outcome
Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)
Time frame: Every visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Lauren Y Atlas, Ph.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medoc thermal stimulator, Electric shock stimulator and Cold water bath in people with Normal Physiology and Healthy Volunteers, run by National Center for Complementary and Integrative Health (NCCIH) 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 5 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adebisi O Ayodele, C.R.N.P. ((301) 827-0415, bisi.ayodele@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position) (time frame: Every visit). 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 20 Oct 2026.