<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03258580</url>
  </required_header>
  <id_info>
    <org_study_id>170155</org_study_id>
    <secondary_id>17-AT-0155</secondary_id>
    <nct_id>NCT03258580</nct_id>
  </id_info>
  <brief_title>Sociocultural &amp; Biobehavioral Influences on Pain Expression and Assessment</brief_title>
  <official_title>Sociocultural &amp; Biobehavioral Influences on Pain Expression and Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      People can feel different levels of pain. This may depend on social, cultural, and biological&#xD;
      factors. These factors can also influence how people respond to each other, and how they&#xD;
      judge other people s experiences. Researchers want to learn more about these relationships.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study if social and cultural factors lead to differences in pain experience and how pain&#xD;
      is interpreted by other individuals.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy adults ages 18-60&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will have 1 or 2 visits.&#xD;
&#xD;
      Participants will be screened with a medical history and nursing assessment.&#xD;
&#xD;
      Participants may have the following:&#xD;
&#xD;
      Electric shock through small sticky pads on the arm, leg, or foot.&#xD;
&#xD;
      Thermal stimulation. A device called a thermode will be placed on the arm, leg, or foot. A&#xD;
      computer controls the thermode temperature.&#xD;
&#xD;
      Lowering their hand into very cold water.&#xD;
&#xD;
      Videos or pictures of the face will recorded while participants get painful stimulation.&#xD;
&#xD;
      A test to record heart electrical activity. Small metal disc or sticky pad electrodes will be&#xD;
      placed on the chest.&#xD;
&#xD;
      Pulse rate and breathing measured. Sweating will be measured with two small sensors stuck on&#xD;
      the hand.&#xD;
&#xD;
      A test to measure the electrical activity of facial muscles. Small metal disk or sticky pad&#xD;
      electrodes will be attached to the skin.&#xD;
&#xD;
      Viewing pictures and/or videos of other people who get painful and nonpainful stimulation.&#xD;
&#xD;
      Participants will make decisions about the images. They will respond by keyboard, mouse, or&#xD;
      button.&#xD;
&#xD;
      Eye tracking. A camera will measure participants pupil size and follow their eye movements.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      The current proposal investigates behavioral, psychophysiological, and social processes that&#xD;
      may help explain biases and disparate outcomes in pain. Health disparities, or health&#xD;
      outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many&#xD;
      diseases and symptoms, including pain. Pain is the number one reason individuals seek medical&#xD;
      treatment. Health disparities in pain encompass both differences in pain experience and&#xD;
      treatment for pain. For instance, research indicates that Black individuals report increased&#xD;
      pain and have reduced pain tolerance relative to White individuals, yet doctors are less&#xD;
      likely to treat minority patients pain and underestimate their pain experience. This project&#xD;
      aims to address this systemic discrepancy by focusing on interpersonal processes that may&#xD;
      contribute to these disparities, including socially-relevant responses to pain (i.e. pain&#xD;
      expression) and pain assessment (e.g. visual attention). The proposed research aims to&#xD;
      determine whether the study of pain expressions and their assessment can yield insights on&#xD;
      how social factors shape pain and its treatment. Further, we test the efficacy of potential&#xD;
      interventions designed to improve accuracy and reduce biases in pain assessment. If&#xD;
      successful, this work will form the foundation of a new research program that will link the&#xD;
      field of pain research with the field of social neuroscience, and forge new insights on the&#xD;
      critical problem of health disparities in pain.&#xD;
&#xD;
      Study population&#xD;
&#xD;
      We will accrue up to 600 total healthy volunteers to target 212 completers&#xD;
&#xD;
      Design&#xD;
&#xD;
      Our overall aim is to understand how social factors influence the assessment and management&#xD;
      of pain, and to gain insight into psychosocial processes that may underlie health disparities&#xD;
      in pain. We propose a series of studies designed to test these links. First, we will measure&#xD;
      pain perception and physiological responses to painful stimuli in a diverse group of&#xD;
      individuals to test for sociocultural and biological influences on pain and pain-related&#xD;
      responses. In subsequent studies, new participants (&quot;perceivers&quot;) will view images of these&#xD;
      initial participants (&quot;targets&quot;) and will provide estimates of targets' pain experience. We&#xD;
      will measure a) whether perceivers can accurately estimate targets' pain experience; b)&#xD;
      whether accuracy differs as a function of similarity between target and perceiver (ingroup vs&#xD;
      outgroup); and c) whether individuals can improve accuracy through feedback.&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
      Primary outcome measures for all experiments will be decisions about pain (experienced by&#xD;
      self or other) measured with visual analogue scales, reaction time, and/or categorical&#xD;
      judgments (pain/no pain). We will also measure physiological responses (e.g., facial muscle&#xD;
      response, skin conductance, pupil dilation) as secondary outcome measures. We will test&#xD;
      whether pain and pain-related responses varies as a function of sociocultural/demographic&#xD;
      factors (e.g. race, ethnicity, gender) and whether accuracy in assessing others pain is&#xD;
      influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g.&#xD;
      performance-related feedback).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 9, 2018</start_date>
  <completion_date type="Anticipated">June 17, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 17, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)</measure>
    <time_frame>Every visit</time_frame>
    <description>We measure facial responses to painful stimuli in substudy 1 and eye position in substudy 2 and 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain perception (pain ratings)</measure>
    <time_frame>Every visit</time_frame>
    <description>Individuals report their perceived pain or the pain they associate with other people they are viewing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)</measure>
    <time_frame>Every visit</time_frame>
    <description>We collect measures of identity and endorsement of beliefs about pain.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Normal Physiology</condition>
  <condition>Healthy Volunteers</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Substudy 1: All participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measuring facial response to painful stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Substudy 2: Healthy volunteers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Measuring pain assessment accuracy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Substudy 3: Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Substudy 3: Feedback Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medoc thermal stimulator</intervention_name>
    <description>Heat pain stimulation for substudy 1</description>
    <arm_group_label>Substudy 1: All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electric shock stimulator</intervention_name>
    <description>Electric pain stimulation for substudy 1</description>
    <arm_group_label>Substudy 1: All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold water bath</intervention_name>
    <description>Cold pain stimulation for substudy 1</description>
    <arm_group_label>Substudy 1: All participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain assessment performance feedback</intervention_name>
    <description>Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.</description>
    <arm_group_label>Substudy 3: Feedback Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        All Sub-Studies:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Between 18 and 60 years old&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        All Sub-Studies:&#xD;
&#xD;
          -  Unable to comply with study procedures&#xD;
&#xD;
          -  Has a major-medical condition or medical history that in a clinician's assessment&#xD;
             could affect ability to comply with study procedures, including neurological or&#xD;
             psychiatric conditions (including stroke and blindness or deafness, a history of brain&#xD;
             damage, substance or alcohol dependence or abuse or psychosis)&#xD;
&#xD;
          -  NCCIH and NIMH employees or fellows&#xD;
&#xD;
          -  NIH employee who is a subordinate/relative/co-worker of any investigator on the&#xD;
             protocol&#xD;
&#xD;
        Sub-study 1:&#xD;
&#xD;
          -  Has a major-medical condition or medical history that in a clinician's assessment&#xD;
             could affect heat sensitivity or pain thresholds. This may include cardiovascular,&#xD;
             autonomic, neurological or psychiatric conditions (including stroke and blindness or&#xD;
             deafness, a history of brain damage, substance or alcohol dependence or abuse or&#xD;
             psychosis) or a chronic systemic disease (e.g., diabetes)&#xD;
&#xD;
          -  Has a medical condition that in a clinician's assessment might affect somatosensation&#xD;
             (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder)&#xD;
&#xD;
          -  Has a current chronic pain condition or has had chronic pain in the past (painful&#xD;
             condition lasting more than six months)&#xD;
&#xD;
          -  Has a dermatological condition such as scars or burns in the testing region, or has&#xD;
             had a tattoo in the testing region within the previous 4 weeks that might influence&#xD;
             cutaneous sensibility&#xD;
&#xD;
          -  Regular use of prescription medication that has a significant effect on pain or heat&#xD;
             perception. Excluded medications include central-acting agents such as opiates&#xD;
             (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran),&#xD;
             anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines),&#xD;
             hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine),&#xD;
             antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine,&#xD;
             carisoprodol). Use of analgesic medications, such as non-steroidal&#xD;
             anti-inflammatories, salicylates, and acetaminophen, taken on an &quot;as needed&quot; basis is&#xD;
             acceptable as long as the last dose was not taken was within 5 half-lives of testing.&#xD;
&#xD;
          -  Is left handed&#xD;
&#xD;
          -  Is born outside of the states or territories of the United States of America&#xD;
&#xD;
          -  Does not currently reside in a state or territory of the United States of America&#xD;
&#xD;
        Sub-studies 2-3, Healthy Volunteers:&#xD;
&#xD;
          -  Is born outside of the states or territories of the United States of America&#xD;
&#xD;
          -  Does not currently reside in a state or territory of the United States of America&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren Y Atlas, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Center for Complementary and Integrative Health (NCCIH)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adebisi O Ayodele, C.R.N.P.</last_name>
    <phone>(240) 593-4226</phone>
    <email>bisi.ayodele@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lauren Y Atlas, Ph.D.</last_name>
    <phone>(301) 827-0214</phone>
    <email>lauren.atlas@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-AT-0155.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>August 7, 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Visual Analogue Pain Scale</keyword>
  <keyword>Healthy Volunteer</keyword>
  <keyword>EYE TRACKING</keyword>
  <keyword>Eye Movement</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.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.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Face stimuli are available following completion for viewing by other study participants. Deidentified data will be made available upon publication.</ipd_time_frame>
    <ipd_access_criteria>please see above.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03258580
org study id: 170155
secondary id: 17-AT-0155
nct id: NCT03258580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      People can feel different levels of pain. This may depend on social, cultural, and biological
      factors. These factors can also influence how people respond to each other, and how they
      judge other people s experiences. Researchers want to learn more about these relationships.

      Objective:

      To study if social and cultural factors lead to differences in pain experience and how pain
      is interpreted by other individuals.

      Eligibility:

      Healthy adults ages 18-60

      Design:

      Participants will have 1 or 2 visits.

      Participants will be screened with a medical history and nursing assessment.

      Participants may have the following:

      Electric shock through small sticky pads on the arm, leg, or foot.

      Thermal stimulation. A device called a thermode will be placed on the arm, leg, or foot. A
      computer controls the thermode temperature.

      Lowering their hand into very cold water.

      Videos or pictures of the face will recorded while participants get painful stimulation.

      A test to record heart electrical activity. Small metal disc or sticky pad electrodes will be
      placed on the chest.

      Pulse rate and breathing measured. Sweating will be measured with two small sensors stuck on
      the hand.

      A test to measure the electrical activity of facial muscles. Small metal disk or sticky pad
      electrodes will be attached to the skin.

      Viewing pictures and/or videos of other people who get painful and nonpainful stimulation.

      Participants will make decisions about the images. They will respond by keyboard, mouse, or
      button.

      Eye tracking. A camera will measure participants pupil size and follow their eye movements.

      ...
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 600 total healthy volunteers to target 212 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) 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, gender) and whether accuracy in assessing others pain is
      influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g.
      performance-related feedback).
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)
time frame: Every visit
description: We measure facial responses to painful stimuli in substudy 1 and eye position in substudy 2 and 3.
measure: Pain perception (pain ratings)
time frame: Every visit
description: Individuals report their perceived pain or the pain they associate with other people they are viewing.
measure: Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)
time frame: Every visit
description: We collect measures of identity and endorsement of beliefs about pain.
arm group label: Substudy 1: All participants
arm group type: Experimental
description: Measuring facial response to painful stimulation.
arm group label: Substudy 2: Healthy volunteers
arm group type: No Intervention
description: Measuring pain assessment accuracy
arm group label: Substudy 3: Control
arm group type: No Intervention
description: Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).
arm group label: Substudy 3: Feedback Group
arm group type: Experimental
description: Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
intervention type: Device
intervention name: Medoc thermal stimulator
description: Heat pain stimulation for substudy 1
arm group label: Substudy 1: All participants
intervention type: Device
intervention name: Electric shock stimulator
description: Electric pain stimulation for substudy 1
arm group label: Substudy 1: All participants
intervention type: Device
intervention name: Cold water bath
description: Cold pain stimulation for substudy 1
arm group label: Substudy 1: All participants
intervention type: Behavioral
intervention name: Pain assessment performance feedback
description: Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
arm group label: Substudy 3: Feedback Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lauren Y Atlas, Ph.D.
role: Principal Investigator
affiliation: National Center for Complementary and Integrative Health (NCCIH)
last name: Adebisi O Ayodele, C.R.N.P.
phone: (240) 593-4226
email: bisi.ayodele@nih.gov
last name: Lauren Y Atlas, Ph.D.
phone: (301) 827-0214
email: lauren.atlas@nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-AT-0155.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
sharing ipd: Yes
ipd description: .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.
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Face stimuli are available following completion for viewing by other study participants. Deidentified data will be made available upon publication.
ipd access criteria: please see above.