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

Orthopedic Surgery Clinical Trial

— NEUPANO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03428035
• Other study ID #: V01-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2018
• Source: University of Witten/Herdecke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopedic Surgery

Intervention

Other:
• Package Insert
Modified package insert of Ibuprofen given postprocedural as pain medication

Locations

Country	Name	City	State
Germany	Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim	Cologne	North-Rhine-Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
University of Witten/Herdecke	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient reported adverse events	Any reported adverse events	6-9 days after surgery
Secondary	Adherence	Correct initiation of therapy, correct intake amount, premature discontinuation of therapy	6-9 days after surgery
Secondary	Resource use	e.g. provider contacts	6-9 days after surgery