Clinical trial NCT03428035: The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery
Keywords: Randomized controlled trial
package insert
nocebo
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2018-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Number of patient reported adverse events
timeFrame: 6-9 days after surgery
Secondary outcomes:
measure: Adherence
timeFrame: 6-9 days after surgery
measure: Resource use
timeFrame: 6-9 days after surgery
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
state: North-Rhine-Westfalia
Study officials:
affiliation: Witten/Herdecke University
name: Tim Mathes, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.