Developmenet, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty
Not Applicable
- Conditions
- total knee arthroplasty
- Registration Number
- DRKS00022571
- Lead Sponsor
- Institut für Forschung in der Operativen Medizin (IFOM) der Privaten Universität Witten/Herdecke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
Schedule for an elective total knee arthroplasty surgery,
Ability to understand and speak German,
Minimum age of 18 years,
Mental competence to give consent and answer questions
Exclusion Criteria
revision or posttraumatic osteoarthritis
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anxiety:<br>- subjective fear/anxiety of adverse events possibly caused by surgery or anesthesia<br>- Measuring instrument: numeric rating scale 0-10 and surgical fear questionnaire <br>- Time point: 4 weeks before surgery (baseline) and one day before surgery;<br><br>Nocebo-effect:<br>- patient reported adverse events (e.g. headache after anesthesia)<br>- Measuring instrument: questionnaire (including closed and open questions) <br>- Time point: 3 days after hospital discharge
- Secondary Outcome Measures
Name Time Method satisfaction with patient-practitioner-conversation<br>- Patients subjective satisfaction with the patient-practitioner-conversation<br>- Measuring instrument: numeric rating scale (0-10)<br>- Time point: One day before surgery;<br><br>risk perception<br>- Knowledge about benefits and harms of the procedure<br>- Measuring instrument: questionnaie (knowledge questions will be derived from developing the informed consent forms)<br>- Time point: One day before surgery;<br><br>Quality of life:<br>-Measuring instrument: numeric rating sclae (0-10)<br>- Time point: 4 weeks after hospital discharge;<br><br>pain and function (of the knee):<br>- Measuring instrument: Oxford Knee Score (questionnaire)<br>- Time point: 4 weeks after hospital discharge