The nocebo effect Not Applicable
Conditions
Interventions
We will conduct a randomised controlled trial in which healthy volunteers will be randomised to receive an intervention or control patient information leaflet for a placebo tablet, before taking the t
Sponsors
King’s College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Over 18 years of age 3. Healthy 4. English speakers and writers
Exclusion criteria
Exclusion criteria: We will exclude participants: 1. With any chronic or acute illnesses which are currently causing symptoms 2. Who are pregnant, might be pregnant or are breastfeeding 3. Who list any allergies to any of the substances in the placebo tablet 4. Who have taken any painkillers within 4 hours before taking part in the study 5. Who have been drinking alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of patient information leaflets on side effect reporting as assessed by the symptom report questionnaire delivered one hour following ingestion of the placebo. 1. Incidence of side effects - number of participants between the two conditions who experience side effects 2. Number of side effects - the sum of confirmed symptoms which are tablet attributed 3. Severity of side effects - sum of all symptom scores that are tablet attributed | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of personality features and personal beliefs on the number of side effects reported and/or the severity of side effects reported. This will be measured by delivering questionnaires at baseline that measure modern health worries, pessimism, somatizitation, anxiety, beliefs about medicines, perceived sensitivity to medicines, and somatosensory amplification to see if scores on these measures predict scores on the symptom report questionnaire delivered 1 hour following ingestion of the placebo. | — |
Countries
United Kingdom
Outcome results
None listed