Investigating Hope and Expectations in Open-Label Placebos (I-HELP)

Philipps University

Status: Completed

Conditions: Pain

Treatments: Other: OLP Expectation; Other: OLP Hope; Other: Heat pain; Other: DP; Other: Placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03517644

2017-58v

Details and patient eligibility

About

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..

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• sufficient German language knowledge
• at least 18 years old

Exclusion criteria

• current mental disorder
• current medical disease
• studying psychology or medicine
• pregnancy or breastfeeding period
• intake of drugs
• severely visually impaired

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Deceptive Placebo (DP)

Experimental group

Description:

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.

Treatment:

Other: Heat pain

Other: DP

Other: Placebo cream

OLP with Hope (OLP Hope)

Experimental group

Description:

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.

Treatment:

Other: Heat pain

Other: Placebo cream

Other: OLP Hope

OLP with Expectations (OLP Expectation)

Experimental group

Description:

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.

Treatment:

Other: Heat pain

Other: Placebo cream

Other: OLP Expectation

Control

Experimental group

Description:

After pretreatment heat pain assessment, this group does not receive an intervention targeting pain sensation prior to the posttreatment pain assessment.

Treatment:

Other: Heat pain