C61 F41.3
Conditions
Interventions
Group 1: Educational sheet with short and factual language and information content
Group 2: Information sheet with detailed and sensitive language usage and information content
Sponsors
Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
Eligibility
Sex/Gender
Male
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: Subjects will only be included in the study if they meet all of the following criteria: General inclusion criteria: • Subjects: male, aged 45-85 • Clinical suspicion of prostate cancer and MR-fusion biopsy recommended to subject. • Subject is able to follow the study instructions and likely to comply with all necessary study visits (compliance). • Subject has given written consent to participate in the study. Indication-specific inclusion criteria: none
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: General Exclusion Criteria: • Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial •Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial • Known or persistent abuse of medication, drugs or alcohol • Contraindications for magnetic resonance imaging
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients suffering from perioperative mild, moderate and severe pain and anxiety depending on the preoperative given information | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage of patients with low self efficacy suffering from perioperative mild, moderate and severe pain and anxiety • Percentage of patients with high perceived stress suffering from perioperative mild, moderate and severe pain and anxiety | — |
Countries
Germany
Contacts
Public ContactPhilipp Krausewitz
Universitätsklinikum Bonn Klinik und Kinderklinik für Urologie
Outcome results
None listed