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

NCT03428035 | Unknown

• 1 other identifier: V01-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthopedic Surgery

Keywords

Randomized controlled trial; package insert; nocebo

Outcome Measures

Primary Outcomes (1)

• Number of patient reported adverse events

  Any reported adverse events

  6-9 days after surgery

Secondary Outcomes (2)

• Adherence

  6-9 days after surgery

• Resource use

  6-9 days after surgery

Study Arms (3)

Modified Package Insert

EXPERIMENTAL

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

Verbal Information

NO INTERVENTION

The patient is informed verbally about side effects and does not receive any package insert.

Control

ACTIVE COMPARATOR

Package insert according to EU Directive 2001/83 / EC (usual package insert)

Other: Package Insert

Interventions

Package Insert OTHER

Modified package insert of Ibuprofen given postprocedural as pain medication

Also known as: Patient Education

Control; Modified Package Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• German Research Foundation: collaborator

Study Sites (1)

Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim

Cologne, North-Rhine-Westfalia, 51109, Germany

Location

Related Publications (1)

• Prediger B, Meyer E, Buchter R, Mathes T. Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial. Trials. 2019 Jul 26;20(1):458. doi: 10.1186/s13063-019-3565-3.

  PMID: 31349865 DERIVED

MeSH Terms

Interventions

Product Labeling; Patient Education as Topic

Intervention Hierarchy (Ancestors)

Product Packaging; Industry; Technology, Industry, and Agriculture; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tim Mathes, Dr.

  Witten/Herdecke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tim Mathes

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: April 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2019
• Access Criteria: Will be published as electronic supplement with the journal publication

Locations

DE (1)