It is not a direct illness that is being investigated, but rather the effect of modulated symptom expectations resulting from appropriate medical information on the feeling of illness after vaccination.
Conditions
Interventions
Group 1: Standard information (treatment as usual): Informed consent in a rational, matter-of-fact style by the physician. N=50 healthy patients.
Group 2: Optimised education by study physician (eleme
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with chronic conditions such as high blood pressure, diabetes, chronic kidney disease
Exclusion criteria
Exclusion criteria: Lack of ability to provide information, severe allergic reactions in the past, ibuprofen intolerance, acute infection, patients with a blood clotting disorder, history of immunosuppressive treatment or current immunosuppressive treatment according to a doctor's letter, and continuous use of immunosuppressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom expectation, symptom-related fears, self-reported physical and psychological sickness symptoms (physical symptoms, negative mood, anxiety, fatigue) using standardised questionnaires. On day 1, the patient is vaccinated in the morning and receives the baseline questionnaires. The first data collection then takes place at 3 p.m., at 8 p.m. in the evening, and at 8 a.m. on day 2, and data collection continues until the end of day 3. On day 7, a single new measurement is taken (around 8 a.m.). The procedure is repeated after the second vaccination with the same measurement intervals on days 1, 2 and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Immunological and neuroendocrine parameters: pro- and anti-inflammatory cytokines including TNF-a, IL-6, IL-10; CRP, interferon Y - Physiological parameters: Blood pressure, heart rate, body temperature - Subjective need for treatment, number of ibuprofen prescriptions filled, perceived effectiveness of anti-inflammatory medication, symptom recall using standardised questionnaires (see appendix) - Treatment adherence: number of patients who show up for the second vaccination (exploratory study objective due to small sample size) | — |
Countries
Germany
Contacts
Public ContactHana Rohn
Universitätsklinikum Essen
Outcome results
None listed