Investigating Hope and Expectations in Open-Label Placebos

NCT03517644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-23

No results posted yet for this study

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). In this study, the investigators examine hope and expectations as components of open-label placebos in an experimental study investigating pain..

Conditions

Interventions

OTHER

DP

Participants are informed that they are about to receive an effective analgesic cream. They are instructed to apply the cream using a cotton pad.

OTHER

OLP Hope

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.

OTHER

OLP Expectation

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.

OTHER

Placebo cream

The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).

OTHER

Heat pain

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.

Sponsors & Collaborators

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Tobias Kube, M. Sc. · Philipps University Marburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-10
Primary Completion
2018-06-30
Completion
2018-08-21

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517644 on ClinicalTrials.gov