Clinical trial NCT03517644: Investigating Hope and Expectations in Open-Label Placebos
Official title: Hope and Expectations as Components of Open-Label Placebos: An Experimental Study Investigating Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of four experimental groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity scale
timeFrame: Baseline and 45 minutes
Secondary outcomes:
measure: Change in pain unpleasantness scale
timeFrame: Baseline and 45 minutes
measure: Change in physiological heat pain threshold
timeFrame: Baseline and 45 minutes
measure: Change in physiological heat pain tolerance
timeFrame: Baseline and 45 minutes
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-University of Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Tobias Kube, M. Sc.
role: PRINCIPAL_INVESTIGATOR
References: