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临床试验/NCT05425563
NCT05425563已完成不适用

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

Trustees of Dartmouth College1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2020年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
1
主要终点
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Cue-established expectations

Experimental

Prior to experiencing the stimuli from three tasks (somatic pain/cognitive effort/vicarious pain), the participant is presented with an expectancy cue. The cue depicts 10 data points on a semi-circular scale (0-180 degrees) with categorical labels ranging from "no effort" to "strongest effort of any kind." Subsequently, participants report expectation ratings and outcome ratings.

干预措施: Pain Expectancy Cues (Behavioral)

Cue-established expectations

Experimental

Prior to experiencing the stimuli from three tasks (somatic pain/cognitive effort/vicarious pain), the participant is presented with an expectancy cue. The cue depicts 10 data points on a semi-circular scale (0-180 degrees) with categorical labels ranging from "no effort" to "strongest effort of any kind." Subsequently, participants report expectation ratings and outcome ratings.

干预措施: Vicarious Pain Expectancy Cues (Behavioral)

Cue-established expectations

Experimental

Prior to experiencing the stimuli from three tasks (somatic pain/cognitive effort/vicarious pain), the participant is presented with an expectancy cue. The cue depicts 10 data points on a semi-circular scale (0-180 degrees) with categorical labels ranging from "no effort" to "strongest effort of any kind." Subsequently, participants report expectation ratings and outcome ratings.

干预措施: Cognitive Effort Expectancy Cues (Behavioral)

结局指标

主要结局

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues

时间窗: 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 the difference between these averages, forming a contrast score that reflects the average difference in perceived cognitive effort as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort..

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues

时间窗: 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 reflects the average difference in perceived pain as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues

时间窗: 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 cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived vicarious pain as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues

时间窗: 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 cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.

Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues

时间窗: 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. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues

时间窗: 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 high cue and after low cue. Reported here is the average subjective outcome rating post high cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.

Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues

时间窗: 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 high cue and after low cue. Reported here is the average subjective outcome rating post low cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues

时间窗: 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 cue. Reported here is the average subjective outcome rating post high cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort.

Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues

时间窗: 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 cue. Reported here is the average subjective outcome rating post low cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort.

次要结局

  • Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of High vs Low Cue(Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.)
  • Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of Stimulus Intensity(Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.)
  • Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues(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.)
  • Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues(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.)
  • Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues(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.)
  • Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following Low Cues(Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of low cue exposure.)
  • Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Cues(Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.)
  • Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following Low Cues(Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.)
  • Physiological: Within Participant Changes in Skin Conductance Response Measured With a Physiological Data Acquisition Device(Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.)
  • Physiological: Within Participant Changes in Skin Conductance Rate Measured With a Physiological Data Acquisition Device(Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.)
  • Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following High Cues(Within trials, outcome ratings are collected pre-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 cue exposure.)
  • Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following Low Cues(Within trials, outcome ratings are collected pre-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 low cue exposure.)
  • Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Cues(Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of high cue exposure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Wager

Principal Investigator

Trustees of Dartmouth College

研究点 (1)

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