Orthopedic Surgery Clinical Trial
Official title:
Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence
Background The nocebo effect describes the association between the expectation of negative
effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have
shown that the nocebo effect can be influenced by (risk) communication. Till today there is
no study that compares different types of information on adverse events regarding the
strength of the nocebo effect.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of
different communication types on the frequency and intensity of adverse events and adherence.
To increase the relevance and applicability of the results the study intervention builds up
on package inserts because these are the most widespread form of information on side effects.
Methods Patients It is planned to include 60 patients in the study.
Intervention
- Modified package insert: simplified and focused on neutral risk perception. The
representations and formulations are based on the findings from research on
evidence-based patient information and risk communication. The package insert contains
the same information as the statutory package insert to ensure that it complies with the
legal requirements.
- Verbal information about side effects: The patient is informed verbally about side
effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European
Commission) (usual package insert).
Outcomes
- Number of patient reported adverse events (primary outcome).
- Adherence (correct initiation of therapy, correct intake amount, premature
discontinuation of therapy).
- Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
n/a
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