NCT03517644

Investigating Hope and Expectations in Open-Label Placebos

Hope and Expectations as Components of Open-Label Placebos: An Experimental Study Investigating Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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..

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-10
• Primary completion: 2018-06-30
• Completion: 2018-08-21
• First posted: 2018-05-07
• Last updated: 2018-08-23

Locations

1 site across 1 country: Germany