Heart Conditions
Conditions
Brief summary
The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.
Detailed description
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.
Interventions
BEHAVIORALAdverse event information
All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Exclusion criteria
* Patients who have previously had cardiac surgery * Cardiac surgery with deep hypothermia (\<32 degrees Celsius) * Acute surgery * Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol * Patients who do not speak/read Danish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | Assessed on day four |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | Assessed on day 30, 90, and 180 |
| Intensity of experienced adverse events | Assessed on day four, 30, 90, and 180 |
| Hospital readmission | Assessed on day 180 |
| Occurrence of specific adverse events | Assessed on day four, 30, 90, and 180 |
Countries
Denmark
Outcome results
None listed