N/A
N=133
Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain
Placebo · Expectations
Bottom Line
View on ClinicalTrials.gov: NCT05425563 ↗Enrolled (actual)
133
Serious AEs
—
Results posted
Nov 2023
Primary outcome: Primary: Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues — 8.20 units on a scale — p=< .001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pain Expectancy Cues (Behavioral); Vicarious Pain Expectancy Cues (Behavioral); Cognitive Effort Expectancy Cues (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trustees of Dartmouth College
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues |
8.20 | < .001 sig |
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues |
7.72 | < .001 sig |
| PRIMARY Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues |
8.02 | < .001 sig |
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues |
70.22 | — |
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues |
61.69 | — |
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues |
30.66 | — |
| PRIMARY Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues |
22.78 | — |
| PRIMARY Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues |
32.35 | — |
| PRIMARY Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues |
24.31 | — |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues |
35.06 | < .001 sig |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues |
33.02 | .001 sig |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues |
30.76 | < .001 sig |
| SECONDARY Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following High Cues |
79.46 | — |
| SECONDARY Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following Low Cues |
44.65 | — |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Cues |
48.21 | — |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following Low Cues |
14.96 | — |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Cues |
49.39 | — |
| SECONDARY Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following Low Cues |
18.60 | — |
| SECONDARY Physiological: Within Participant Changes in Skin Conductance Response Measured With a Physiological Data Acquisition Device |
— | — |
| SECONDARY Physiological: Within Participant Changes in Skin Conductance Rate Measured With a Physiological Data Acquisition Device |
— | — |
| SECONDARY Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of Stimulus Intensity |
— | — |
| SECONDARY Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of High vs Low Cue |
— | — |
Summary
The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. The experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. In the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3D objects are the same or different when rotated along the y-axis. Each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience.
There are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating.
First, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). Although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). Then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") After providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). Once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). For the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.
Eligibility Criteria
Inclusion Criteria
- Capable of performing experimental tasks (e.g., are able to read, can tolerate the maximum level of thermal pain stimuli).
- Fluent or native speakers of English
Exclusion Criteria
- Contraindications to magnetic resonance scanning (e.g., metal in body, claustrophobia, pregnancy)
- Substance abuse within the last six months
- Current or recent history of pathological pain
- Current or recent history of neurological disorders
- Currently or recent history of chronic pain
- Left-handed only
Data sourced from ClinicalTrials.gov (NCT05425563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.