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Sociocultural Influences on Pain Assessment

N/A

Recruiting

Led By Lauren Y Atlas, Ph.D.

Research Sponsored by National Center for Complementary and Integrative Health (NCCIH)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All Sub-Studies: Between 18 and 60 years old

Be between 18 and 65 years old

Must not have

Sub-study 1: Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is exploring if social and cultural factors play a role in how people experience pain and how others interpret it. Eligible participants will be asked to complete a series of tests that may include electric shock, thermal stimulation, and viewing images of others in pain.

Who is the study for?

Healthy adults aged 18-60 who speak English fluently and can consent to participate are eligible for this study. Excluded are those with chronic pain conditions, certain medical issues affecting sensation or pain perception, employees of NCCIH and NIMH, non-US residents, and individuals taking specific prescription medications.

What is being tested?

The trial investigates how social and cultural factors influence the experience of pain and its assessment by others. It involves electric shocks, thermal stimulation via a thermode device, cold water immersion tests, facial expression recording during painful stimuli, heart activity monitoring, sweat measurement sensors on the hand, facial muscle electrical activity testing through electrodes attached to the skin.

What are the potential side effects?

Participants may experience temporary discomfort from electric shocks or thermal stimulations. Cold water immersion could cause brief numbness or tingling in the hand. The adhesive from pads used for monitoring might irritate some people's skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had chronic pain for more than six months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and every visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain perception (pain ratings)

Physiological responses (facial muscle movement, skin conductance, respiration, pupil dilation, eye gaze position)

Secondary study objectives

Questionnaire measures (e.g. Fear of Pain questionnaire, McGill pain questionnaire)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Substudy 3: Feedback GroupExperimental Treatment1 Intervention

Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.

Group II: Substudy 1: All participantsExperimental Treatment3 Interventions

Measuring facial response to painful stimulation.

Group III: Substudy 2: Healthy volunteersActive Control1 Intervention

Measuring pain assessment accuracy

Group IV: Substudy 3: ControlActive Control1 Intervention

Subjects will judge stimuli with the same instructions as Sub-Study 2 (which provides a test of replication).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cold water bath

2014