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Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258580
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )

Brief Summary:

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.

...


Condition or disease Intervention/treatment Phase
Normal Physiology Healthy Volunteers Pain Device: Medoc thermal stimulator Device: Electric shock stimulator Device: Cold water bath Behavioral: Instructions about pain assessment Behavioral: Pain assessment performance feedback Not Applicable

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 600 total healthy volunteers to target 257 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 and directed attention differ as a function of similarity between target and perceiver (ingroup vs outgroup) for both healthcare providers and non-medical volunteers; and c) whether individuals can improve accuracy through feedback and/or instruction.

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. health practitioners versus na(SqrRoot) ve volunteers; performance-related feedback).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sociocultural &Amp;Amp; Biobehavioral Influences on Pain Expression and Assessment
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : January 17, 2021
Estimated Study Completion Date : February 17, 2021

Arm Intervention/treatment
Experimental: Substudy 1: All participants
Measuring facial response to painful stimulation.
Device: Medoc thermal stimulator
Heat pain stimulation for substudy 1

Device: Electric shock stimulator
Electric pain stimulation for substudy 1

Device: Cold water bath
Cold pain stimulation for substudy 1

Behavioral: Instructions about pain assessment
Participants in substudy 3's Instructed Group will be informed about facial features that are most predictive of pain.

Behavioral: Pain 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.

No Intervention: Substudy 2: Healthy volunteers
Measuring pain assessment accuracy
No Intervention: Substudy 2: Medical providers
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
Subjects will receive feedback about assessment accuracy after every trial.
Behavioral: Pain 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.

Experimental: Substudy 3: Instructed Group
Subjects will be informed at the beginning of the taskwhich facial regions are the most predictive of pain.
Behavioral: Instructions about pain assessment
Participants in substudy 3's Instructed Group will be informed about facial features that are most predictive of pain.




Primary Outcome Measures :
  1. 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.

  2. Pain perception (pain ratings) [ Time Frame: Every visit ]
    Individuals report their perceived pain or the pain they associate with other people they are viewing.


Secondary Outcome Measures :
  1. Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire) [ Time Frame: Every visit ]
    We collect measures of identity and endorsement of beliefs about pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis)
  • NCCIH employee or fellow
  • NIH employee who is a subordinate/relative/co-worker of any investigator on the protocol

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, neurological or psychiatric conditions (including stroke and blindness or deafness, a history of brain damage, substance or alcohol dependence or abuse or psychosis) 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 such as scars or burns in the testing region, or has had a tattoo in the testing region within the previous 4 weeks 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
  • 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 2, Medical Providers:

-Use of bi-focal lenses and any uncorrected atypical eye movement or refraction symptoms (e.g., astigmatism)

Sub-studies 2-3, Healthy Volunteers:

  • Use of bi-focal lenses and any uncorrected atypical eye movement or refraction symptoms (e.g., astigmatism)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258580


Contacts
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Contact: Adebisi O Ayodele, C.R.N.P. (301) 827-0415 bisi.ayodele@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Lauren Y Atlas, Ph.D. National Center for Complementary and Integrative Health (NCCIH)
Additional Information:
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Responsible Party: National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier: NCT03258580    
Other Study ID Numbers: 170155
17-AT-0155
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 20, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) ):
Pain
Visual Analogue Pain Scale
Healthy Volunteer
EYE TRACKING
Eye Movement