An interventional study of Package Insert in Orthopedic Surgery, sponsored by University of Witten/Herdecke. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Health services research
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
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
Exclusion Criteria:
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
The patient is informed verbally about side effects and does not receive any package insert.
Package insert according to EU Directive 2001/83 / EC (usual package insert)
Other: Package Insert
Modified package insert of Ibuprofen given postprocedural as pain medication
Also known as: Patient Education
Number of patient reported adverse events
Any reported adverse events
Time frame: 6-9 days after surgery
Adherence
Correct initiation of therapy, correct intake amount, premature discontinuation of therapy
Time frame: 6-9 days after surgery
Resource use
e.g. provider contacts
Time frame: 6-9 days after surgery
Plan to share: Yes — Study protocol and clinical study report will be shared as supplement with the journal publication
Supporting information: Study protocol, Csr
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Witten/Herdecke