- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04669093
Individual Differences in Placebo Analgesic Effects
Person by Situation Interaction: Matching Suggestions to Participants' Motivational Styles
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tor D Wager, PhD
- Phone Number: (603)-646-2196
- Email: Tor.D.Wager@Dartmouth.edu
Study Locations
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New Hampshire
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Hanover, New Hampshire, United States, 03755
- Dartmouth College
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Contact:
- Bethany Hunt, BA
- Email: bethany.j.hunt@dartmouth.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy participants
- Dominant promotion focus or dominant prevention focus (based on our screening)
Exclusion Criteria:
- Currently or recently suffered from chronic pain (based on screening)
- Cannot tolerate heat pain applied to the forearm, based on a calibration task at the beginning of the experiment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Placebo
All participants will participate in two sessions, one with a placebo suggestion that matches the participant's motivational style, and one with placebo suggestion that does not match their motivational style, in a pseudo-random order.
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Over-the-counter hand cream will be applied to participants' skin, but they will be told that they are given a highly efficient topical analgesic cream.
The suggestion will be based on a "promotion" approach (promoting good feelings).
Over-the-counter hand cream will be applied to participants' skin, but they will be told that they are given a highly efficient topical analgesic cream.
The suggestion will be based on a "prevention" approach (preventing pain).
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|
Experimental: Control
Each session will also include a control phase, in which the same cream will be applied, and participants will be instructed that the cream has no analgesic effects.
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In a control condition, with the same cream as in the placebo interventions, participants will be instructed that the cream is a control cream with no effects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in subjective ratings of acute thermal pain
Time Frame: Measured repeatedly, immediately after thermal stimuli on the day of participation. Averaged and compared across interventions.
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Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale.
Ratings are based on the angle (0-180), with higher angle representing higher pain ratings.
We will average and compare the pain ratings within participant across interventions.
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Measured repeatedly, immediately after thermal stimuli on the day of participation. Averaged and compared across interventions.
|
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Changes in subjective ratings of pain expectations
Time Frame: Measured repeatedly, immediately before thermal stimuli on the day of participation. Averaged and compared across interventions.
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Before each thermal stimulus, participants are asked to rate how painful they expect the next stimulus to be, on a semi-circular computerized scale.
Ratings are based on the angle (0-180), with higher angle representing higher expectations ratings.
We will average and compare the expectation ratings within participant across interventions.
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Measured repeatedly, immediately before thermal stimuli on the day of participation. Averaged and compared across interventions.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial expressions
Time Frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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We will obtain facial video recordings of participants with a video camera.
We will analyze these data according to Facial Action Units (facial expressions) that are known to be related to pain, and compare them across interventions.
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Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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Thermal imaging of the face
Time Frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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We will obtain thermal recordings of participant's face with an infrared camera, and compare the heat signature of the face (the temperature in different parts of the face) across interventions.
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Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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Changes in skin conductance response measured with a Biopac device
Time Frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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Skin conductance will be measured.
We will compare the skin conductance response to pain stimuli within participant across interventions.
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Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
|
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Changes in heart rate measured with a Biopac device
Time Frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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Heart rate will be measured.
We will compare the heart rate in response to pain stimuli within participant across interventions.
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Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tor D Wager, PhD, Dartmouth College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 230138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
These data would generally be made available to any qualified investigator for neuroimaging studies only including:
i. Research on any brain phenomenon; ii. Neuroimaging research on non-disease traits (intelligence, behavioral traits); iii. Methods development research.
The requesting investigator must provide documentation of local IRB approval.
These data would not be made available to:
i. Any criminal justice organization, because data may not be used for any criminal justice applications; ii. Any commercial entity, because use of the data is limited to not-for-profit organizations and data may not be used for any commercial purposes.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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