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Protocol Details

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-AT-0155

Sponsoring Institute

National Center for Complementary and Integrative Health (NCCIH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking

Keywords

Pain;
Visual Analogue Pain Scale;
Healthy Volunteer;
EYE TRACKING;
Eye Movement

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology;
Healthy Volunteers;
Pain

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: Medoc thermal stimulator
Device: Electric shock stimulator
Device: Cold water bath
Behavioral: Pain assessment performance feedback

Supporting Site

National Center for Complementary and Integrative Health

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.

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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

-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, 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

Sub-study 4, FMRI sub-study:

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lauren Y. Atlas, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health
Building 10
Room 4-1741
10 Center Drive
Bethesda, Maryland 20892
(301) 827-0214
lauren.atlas@nih.gov

Adebisi O. Ayodele, C.R.N.P.
National Center for Complementary and Integrative Health (NCCIH)
NIHBC 10 - CLINICAL CENTER BG RM 2A21
10 CENTER DR
BETHESDA MD 20892
(240) 593-4226
bisi.ayodele@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03258580

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