NCT05425563

Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain

Completed NA Results posted Last updated 30 November 2023

What this trial tests

NA trial testing Pain Expectancy Cues in Placebo in 133 participants. Completed in 19 January 2023.

Timeline

23 November 2020

Primary endpoint
8 July 2022

19 January 2023

Quick facts

Lead sponsor	Trustees of Dartmouth College
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	133
Start date	23 November 2020
Primary completion	8 July 2022
Estimated completion	19 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Pain Expectancy Cues
• Vicarious Pain Expectancy Cues
• Cognitive Effort Expectancy Cues

Conditions studied

• Placebo — all drugs for Placebo →
• Expectations — all drugs for Expectations →

Sponsor

Trustees of Dartmouth College

Who can join

Adults 18 to 55, any sex, with Placebo or Expectations. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived pain as a function of high low cue exposure.

The outcome measure is the "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that refl

Group	Value	95% CI
Pain Task; Cue-modulated Stimulus Intensity	8.20	± 0.89

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived vicarious pain as a function of high low cue exposure.

The outcome measure is the "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cu

Group	Value	95% CI
Vicarious Pain Task; Cue-modulated Stimulus Intensity	7.72	± 0.66

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived cognitive effort as a function of high low cue exposure.

The outcome measure is the "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. The final outcome is

Group	Value	95% CI
Cognitive Effort Task; Cue-modulated Stimulus Intensity	8.02	± 0.70

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.

This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating, post-high c

Group	Value	95% CI
Pain Task; Cue-modulated Stimulus Intensity	70.22	± 2.85

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.

This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating post-low cue

Group	Value	95% CI
Pain Task; Cue-modulated Stimulus Intensity	61.69	± 2.86

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.

The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after

Group	Value	95% CI
Vicarious Pain Task; Cue-modulated Stimulus Intensity	30.66	± 1.21

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.

The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after

Group	Value	95% CI
Vicarious Pain Task; Cue-modulated Stimulus Intensity	22.78	± 1.04

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.

The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low

Group	Value	95% CI
Cognitive Effort Task; Cue-modulated Stimulus Intensity	32.35	± 1.38

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues Primary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.

The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low

Group	Value	95% CI
Cognitive Effort Task; Cue-modulated Stimulus Intensity	24.31	± 1.19

Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues Secondary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of high low cue exposure.

The outcome measure is the "expectation rating" for upcoming pain. In each session, participants undergo pain tasks with multiple thermal stimuli. Before each stimulus, participants see a high or low cue and rate their pain expectation on a semi-circular scale (0-180°). Higher angles indicate greater pain expectations. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. The final outcome is the difference between these averages, forming a

Group	Value	95% CI
Pain Task; Cue-established Expectations	35.06	± 1.99

Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues Secondary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of vicarious pain as a function of high low cue exposure.

The outcome measure is the "expectation rating" for upcoming vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. Prior to each stimulus, participants see a high or low cue and rate their expectation of perceived vicarious pain for an upcoming stimulus experience on a semi-circular scale (0-180°). Higher angles suggest participants anticipate viewing videos of patients experiencing greater pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessi

Group	Value	95% CI
Vicarious Pain Task; Cue-modulated Expectations	33.02	± 1.52

Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues Secondary · Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of cognitive effort as a function of high low cue exposure.

The outcome measure is the "expectation rating" for upcoming cognitive effort. In each session, participants undergo cognitive effort tasks where images of mentally rotated figures are presented. Before each stimulus, participants see a high or low cue and rate their expectations on cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater expectations of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high c

Group	Value	95% CI
Cognitive Effort Task; Cue-established Expectations	30.76	± 1.53

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.