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.

Inclusion Criteria:

• elective orthopaedic surgery
• planned intake of ibuprofen 600 mg to treat postoperative pain
• postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)
• at least 18 years
• able to speak German
• no cognitive deficits
• written informed consent

Exclusion Criteria:

• serious comorbidity
• pain medication prior to surgery
• other medication with similar side effects
• polytrauma
• planned inpatient rehabilitation > one week after hospital discharge

Study protocol and clinical study report will be shared as supplement with the journal publication

2019

Will be published as electronic supplement with the journal publication