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

NCT ID: NCT03428035

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Package Insert

Intervention Type: OTHER

Modified package insert of Ibuprofen given postprocedural as pain medication

Verbal Information

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control

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

Group Type: ACTIVE_COMPARATOR

Package Insert

Intervention Type: OTHER

Modified package insert of Ibuprofen given postprocedural as pain medication

Interventions

Package Insert

Modified package insert of Ibuprofen given postprocedural as pain medication

Intervention Type: OTHER

Other Intervention Names

Patient Education

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Tim Mathes

Dr. Tim Mathes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim Mathes, Dr.

Role: PRINCIPAL_INVESTIGATOR

Witten/Herdecke University

Locations

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

Cologne, North-Rhine-Westfalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31349865 (View on PubMed)

Other Identifiers

V01-01

Identifier Type: -

Identifier Source: org_study_id