The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Orthopedic Surgery

Intervention / Treatment
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* Other: Package Insert


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Package Insert<br>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. | Other: Package Insert<br>* Modified package insert of Ibuprofen given postprocedural as pain medication<br>* Other names: Patient Education;|
| No Intervention: Verbal Information<br>The patient is informed verbally about side effects and does not receive any package insert. | |
| Active Comparator: Control<br>Package insert according to EU Directive 2001/83 / EC (usual package insert) | Other: Package Insert<br>* Modified package insert of Ibuprofen given postprocedural as pain medication<br>* Other names: Patient Education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient reported adverse events | Any reported adverse events | 6-9 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Correct initiation of therapy, correct intake amount, premature discontinuation of therapy | 6-9 days after surgery | 
| Resource use | e.g. provider contacts | 6-9 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, package insert, nocebo