Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

Pain Clinical Trial

Official title:

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03258580
• Other study ID #: 170155
• Secondary ID: 17-AT-0155
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: May 17, 2025

Study information

• Verified date: May 28, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Adebisi O Ayodele, C.R.N.P.
• Phone: (240) 593-4226
• Email: bisi.ayodele[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

...

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 17, 2025
• Est. primary completion date: May 17, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• 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 and NIMH employees or fellows

• 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-studies 2-3, Healthy Volunteers:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers
• Normal Physiology
• Pain

Intervention

Device:
• Medoc thermal stimulator
Heat pain stimulation for substudy 1
• Electric shock stimulator
Electric pain stimulation for substudy 1
• Cold water bath
Cold pain stimulation for substudy 1

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.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain perception (pain ratings)	Individuals report their perceived pain or the pain they associate with other people they are viewing.	Every visit
Secondary	Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)	We collect measures of identity and endorsement of beliefs about pain.	Every visit

External Links

•   NIH Clinical Center Detailed Web Page