HealthyNCT04669093
Individual Differences in Placebo Analgesic Effects
A study of Healthy, run by Trustees of Dartmouth College at 1 site in United States.
Trial summary
This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Dominant promotion focus or dominant prevention focus (based on our screening)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth College
Hanover, New Hampshire, 03755
Bethany Hunt, BA, bethany.j.hunt@dartmouth.edu
About this study
Official title: Person by Situation Interaction: Matching Suggestions to Participants' Motivational Styles
This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research.
- Conditions
- Healthy
- Being tested
- Placebo cream- "promotion" suggestion, Placebo cream- "prevention" suggestion, Control cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo cream- "promotion" suggestionBehavioural
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).
Placebo cream- "prevention" suggestionBehavioural
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).
Control creamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | 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. Receives: Behavioral: Placebo cream- "promotion" suggestion; Behavioral: Placebo cream- "prevention" suggestion |
| Control | Experimental | 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. Receives: Behavioral: Control cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in subjective ratings of acute thermal pain
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.
Measured: Measured repeatedly, immediately after thermal stimuli on the day of participation. Averaged and compared across interventions.
Changes in subjective ratings of pain expectations
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.
Measured: Measured repeatedly, immediately before thermal stimuli on the day of participation. Averaged and compared across interventions.
Secondary outcomes (4)
Facial expressions
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.
Measured: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
Thermal imaging of the face
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.
Measured: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
Changes in skin conductance response measured with a Biopac device
Skin conductance will be measured. We will compare the skin conductance response to pain stimuli within participant across interventions.
Measured: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
Changes in heart rate measured with a Biopac device
Heart rate will be measured. We will compare the heart rate in response to pain stimuli within participant across interventions.
Measured: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a within-participant design. Each participant will participate in two sessions. In both sessions, an over-the-counter hand cream will be applied to their skin, accompanied by a placebo suggestion that the cream is analgesic. In one session, the suggestion will match the participant's motivational style, and in the other session the suggestion will not match their motivational style. The order of sessions will be counterbalanced across participants. Each session will also include a control condition, in which participants will be told that the cream has no affect. The same over-the-counter hand cream will be used in all sessions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Wager, Trustees of Dartmouth College
- Investigators
- Tor D Wager, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669093
- Sponsor's protocol ID
- 230138
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2020
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data will be publicly shared via public online platforms such as the Open Science Framework (OSF) and Github, and the NIMH Data Archive (NDA), according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute\_data\_sharing\_regimen.html). Identifying information will not be released, including the facial videos, of which only non-identifiable features will be extracted and shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person by Situation Interaction: Matching Suggestions to Participants' Motivational Styles
- ClinicalTrials.gov ID
- NCT04669093
- Acronym / sponsor ID
- 230138
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effects of placebo suggestions tailored to match or mismatch individual participants' motivational styles-an issue of person-situation 'fit' with important effects in public health settings, but which has been ignored in past research.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a within-participant design. Each participant will participate in two sessions. In both sessions, an over-the-counter hand cream will be applied to their skin, accompanied by a placebo suggestion that the cream is analgesic. In one session, the suggestion will match the participant's motivational style, and in the other session the suggestion will not match their motivational style. The order of sessions will be counterbalanced across participants. Each session will also include a control condition, in which participants will be told that the cream has no affect. The same over-the-counter hand cream will be used in all sessions.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Behavioral: Placebo cream- "promotion" suggestion, Behavioral: Placebo cream- "prevention" suggestionAll 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. |
| Control | Experimental | Behavioral: Control creamEach 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy participants
- Dominant promotion focus or dominant prevention focus (based on our screening)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo cream- "promotion" suggestionOver-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). | Behavioural | Placebo |
| Placebo cream- "prevention" suggestionOver-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). | Behavioural | Placebo |
| Control creamIn 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. | Behavioural | Control |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Facial expressions
Time frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
Thermal imaging of the face
Time frame: Immediate response measured during painful stimulation on the day of participation. Averaged and compared across interventions.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. All de-identified data will be publicly shared via public online platforms such as the Open Science Framework (OSF) and Github, and the NIMH Data Archive (NDA), according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute_data_sharing_regimen.html). Identifying information will not be released, including the facial videos, of which only non-identifiable features will be extracted and shared.
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tor D Wager, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tor D Wager, PhD ((603)-646-2196, Tor.D.Wager@Dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.