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

NCT03428035 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-09

No results posted yet for this study

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

Interventions

OTHER

Package Insert

Modified package insert of Ibuprofen given postprocedural as pain medication

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • University of Witten/Herdecke

    lead OTHER

Principal Investigators

  • Tim Mathes, Dr. · Witten/Herdecke University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428035 on ClinicalTrials.gov