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

University of Witten/Herdecke

Status: Unknown

Conditions: Orthopedic Surgery

Treatments: Other: Package Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT03428035

V01-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Modified Package Insert

Experimental group

Description:

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.

Treatment:

Other: Package Insert

Verbal Information

No Intervention group

Description:

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

Control

Active Comparator group

Description:

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

Treatment:

Other: Package Insert