Status:
UNKNOWN
The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.
Lead Sponsor:
University of Witten/Herdecke
Collaborating Sponsors:
German Research Foundation
Conditions:
Orthopedic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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 noceb...
Eligibility Criteria
Inclusion
- 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
- serious comorbidity
- pain medication prior to surgery
- other medication with similar side effects
- polytrauma
- planned inpatient rehabilitation \> one week after hospital discharge
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03428035
Start Date
April 1 2018
End Date
December 31 2018
Last Update
October 9 2018
Active Locations (1)
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1
Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
Cologne, North-Rhine-Westfalia, Germany, 51109