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NCT05425563 · ClinicalTrials.gov registry record · NA

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

A NA study of Placebo and Expectations, sponsored by Trustees of Dartmouth College.

Completed
Registry status
NA
Development phase
133
Enrollment target
1
Study location

NCT05425563: Completed NA study of Placebo and Expectations, sponsored by Trustees of Dartmouth College.

NCT05425563 is a NA study of Placebo and Expectations that has completed, run by Trustees of Dartmouth College. The registered enrollment target is 133 participants, below the 170-participant average among 5 other Placebo trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05425563, a NA study of Placebo and Expectations, has completed, sponsored by Trustees of Dartmouth College.

COMPLETED
Registry status
NA
Development phase
133 participants
Enrollment target
1
Study location

Study 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 experi

Primary Outcome

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

Conditions Studied

Interventions

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

Study Locations (1)

New Hampshire

  • Dartmouth College - Hanover

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2020-11-23
Est. Completion 2023-01-19
Phase NA
Trustees of Dartmouth College

31 total trials

What the finished NCT05425563 record still lists

NCT05425563 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 170-participant average among 5 other Placebo trials with a reported enrollment target (22% lower).

The record links to 2 conditions, with Placebo appearing as the primary indexed condition, and to 3 interventions - of which Pain Expectancy Cues is the first listed.

NCT05425563 reports a single indexed study location in New Hampshire.

Frequently Asked Questions

What is clinical trial NCT05425563 about?

NCT05425563 is a clinical study titled "Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain". 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) vi...

What is the current status of trial NCT05425563?

This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2020-11-23. Estimated completion is 2023-01-19.

What conditions does trial NCT05425563 study?

This clinical trial studies the following conditions: Placebo, Expectations.

What interventions are being tested in trial NCT05425563?

The interventions under investigation include: Pain Expectancy Cues (BEHAVIORAL), Vicarious Pain Expectancy Cues (BEHAVIORAL), Cognitive Effort Expectancy Cues (BEHAVIORAL).

Who is sponsoring clinical trial NCT05425563?

This trial is sponsored by Trustees of Dartmouth College, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05425563 being conducted?

This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05425563, the US trial registry maintained by the National Library of Medicine. NCT05425563 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.