PainI-HELPNCT03517644
Investigating Hope and Expectations in Open-Label Placebos
A study testing DP, OLP Hope and OLP Expectation in people with Pain, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- DP, OLP Hope and OLP Expectation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2018to 21 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sufficient German language knowledge
- at least 18 years old
Who cannot join
- current mental disorder
- current medical disease
- studying psychology or medicine
- pregnancy or breastfeeding period
- intake of drugs
- severely visually impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hope and Expectations as Components of Open-Label Placebos: An Experimental Study Investigating Pain
Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine hope and expectations as components of open-label placebos in an experimental study investigating pain..
Read the detailed description
A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials. However, research identifying the specific mechanisms underlying OLP is lacking. Therefore, the current study aims to examine hope and expectations as components of OLP in pain.
For this purpose, experimentally induced heat pain is examined. First, all participants receive heat pain stimuli and evaluate them. Next, participants are randomly assigned to one of four groups: (1) a traditional deceptive placebo (DP) group, which is told that they receive an effective analgesic cream, (2) an OLP group inducing hope among the participants that the placebo cream could help them tolerating painful stimuli (OLP hope), (3) and OLP group raising the expectation that the placebo cream will help participants tolerating heat pain (OLP expectation), (4) a control group receiving no cream. Finally, participants receive and evaluate heat pain again.
- Conditions
- Pain
- Being tested
- DP, OLP Hope, OLP Expectation, Placebo cream, Heat pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPOther
Participants are informed that they are about to receive an effective analgesic cream. They are instructed to apply the cream using a cotton pad.
OLP HopeOther
Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. Therefore, participants are supposed to evaluate the subjective probability for a positive effect of the cream as rather low. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect for them because this placebo cream did have a positive among some former participants who were similar to the current participant. The emphasis of this similarity (regarding age and sex) aims to induce a feeling of connectedness to previous participants who reported positive effects of the placebo cream.
OLP ExpectationOther
Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, participants are told that placebos have been shown to contribute substantially to clinical outcomes such as pain intensity/unpleasantness. This positive effect of placebos is reasoned by explaining learning mechanisms such as classical conditioning. We anticipated that after hearing this instruction, participants would consider it to be likely that the placebo has a positive effect for them.
Placebo creamOther
The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).
Heat painOther
Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
| Study group | Role | What they receive |
|---|---|---|
| Deceptive Placebo (DP) | Experimental | After pretreatment heat pain assessment, participants are informed that they are about to receive an effective analgesic cream. In fact, they receive a placebo cream. Next, the posttreatment pain assessment is conducted. Receives: Other: DP; Other: Placebo cream; Other: Heat pain |
| OLP with Hope (OLP Hope) | Experimental | After pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect. Next, the posttreatment pain assessment is conducted. Receives: Other: OLP Hope; Other: Placebo cream; Other: Heat pain |
| OLP with Expectations (OLP Expectation) | Experimental | After pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to raise expectations among the participants that the cream will have a positive effect. Next, the posttreatment pain assessment is conducted. Receives: Other: OLP Expectation; Other: Placebo cream; Other: Heat pain |
| Control | Experimental | After pretreatment heat pain assessment, this group does not receive an intervention targeting pain sensation prior to the posttreatment pain assessment. Receives: Other: Heat pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity scale
Change in subjective pain intensity assessed using a visual analogue scale (ranging from 0 to 100, with higher values reflecting more pain intensity)
Measured: Baseline and 45 minutes
Secondary outcomes (3)
Change in pain unpleasantness scale
Change in subjective pain unpleasantness assessed using a visual analogue scale (ranging from 0 to 100, with higher values reflecting more pain unpleasantness)
Measured: Baseline and 45 minutes
Change in physiological heat pain threshold
Change in the individual heat pain threshold (the point when the stimulus changes from being warm to being painful)
Measured: Baseline and 45 minutes
Change in physiological heat pain tolerance
Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)
Measured: Baseline and 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start10 Feb 2018
- Primary completion30 Jun 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of four experimental groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Kube, M. Sc., Principal investigator, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517644
- Sponsor's protocol ID
- 2017-58v
- Acronym
- I-HELP
- Status last verified
- Aug 2018
- First submitted
- 7 Mar 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hope and Expectations as Components of Open-Label Placebos: An Experimental Study Investigating Pain
- ClinicalTrials.gov ID
- NCT03517644
- Acronym / sponsor ID
- I-HELP / 2017-58v
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 7 May 2018 (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.
Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine hope and expectations as components of open-label placebos in an experimental study investigating pain..
Detailed description
A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials. However, research identifying the specific mechanisms underlying OLP is lacking. Therefore, the current study aims to examine hope and expectations as components of OLP in pain.
For this purpose, experimentally induced heat pain is examined. First, all participants receive heat pain stimuli and evaluate them. Next, participants are randomly assigned to one of four groups: (1) a traditional deceptive placebo (DP) group, which is told that they receive an effective analgesic cream, (2) an OLP group inducing hope among the participants that the placebo cream could help them tolerating painful stimuli (OLP hope), (3) and OLP group raising the expectation that the placebo cream will help participants tolerating heat pain (OLP expectation), (4) a control group receiving no cream. Finally, participants receive and evaluate heat pain again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are assigned to one of four experimental groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Deceptive Placebo (DP) | Experimental | Other: DP, Other: Placebo cream, Other: Heat painAfter pretreatment heat pain assessment, participants are informed that they are about to receive an effective analgesic cream. In fact, they receive a placebo cream. Next, the posttreatment pain assessment is conducted. |
| OLP with Hope (OLP Hope) | Experimental | Other: OLP Hope, Other: Placebo cream, Other: Heat painAfter pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect. Next, the posttreatment pain assessment is conducted. |
| OLP with Expectations (OLP Expectation) | Experimental | Other: OLP Expectation, Other: Placebo cream, Other: Heat painAfter pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to raise expectations among the participants that the cream will have a positive effect. Next, the posttreatment pain assessment is conducted. |
| Control | Experimental | Other: Heat painAfter pretreatment heat pain assessment, this group does not receive an intervention targeting pain sensation prior to the posttreatment pain assessment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sufficient German language knowledge
- at least 18 years old
Key exclusion criteria (6 listed)
- current mental disorder
- current medical disease
- studying psychology or medicine
- pregnancy or breastfeeding period
- intake of drugs
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 |
|---|---|---|
| DPParticipants are informed that they are about to receive an effective analgesic cream. They are instructed to apply the cream using a cotton pad. | Other | Deceptive Placebo (DP) |
| OLP HopeParticipants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. Therefore, participants are supposed to evaluate the subjective probability for a positive effect of the cream as rather low. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect for them because this placebo cream did have a positive among some former participants who were similar to the current participant. The emphasis of this similarity (regarding age and sex) aims to induce a feeling of connectedness to previous participants who reported positive effects of the placebo cream. | Other | OLP with Hope (OLP Hope) |
| OLP ExpectationParticipants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, participants are told that placebos have been shown to contribute substantially to clinical outcomes such as pain intensity/unpleasantness. This positive effect of placebos is reasoned by explaining learning mechanisms such as classical conditioning. We anticipated that after hearing this instruction, participants would consider it to be likely that the placebo has a positive effect for them. | Other | OLP with Expectations (OLP Expectation) |
| Placebo creamThe participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy). | Other | Deceptive Placebo (DP), OLP with Expectations (OLP Expectation), OLP with Hope (OLP Hope) |
| Heat painParticipant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects. | Other | Control, Deceptive Placebo (DP), OLP with Expectations (OLP Expectation), OLP with Hope (OLP Hope) |
Primary outcome
Change in pain intensity scale
Time frame: Baseline and 45 minutes
Change in subjective pain intensity assessed using a visual analogue scale (ranging from 0 to 100, with higher values reflecting more pain intensity)
3 secondary outcomes
Change in pain unpleasantness scale
Time frame: Baseline and 45 minutes
Change in physiological heat pain threshold
Time frame: Baseline and 45 minutes
Change in physiological heat pain tolerance
Time frame: Baseline and 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: No. No IPD will be shared
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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. This study is not recruiting at the moment.
Tobias Kube, M. Sc. principal investigator
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DP, OLP Hope and OLP Expectation in people with Pain, run by Philipps University Marburg at 1 site in Germany.
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 6 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: finished, as of the sponsor's last update on 23 Aug 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity scale (time frame: Baseline and 45 minutes). 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 23 Aug 2018.