Psychological Factors in Cardiac Surgery
Not Applicable
Completed
- Conditions
- Heart Conditions
- Interventions
- Behavioral: Adverse event information
- Registration Number
- NCT04766125
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elaborated adverse event information Adverse event information - Standard adverse event information Adverse event information -
- Primary Outcome Measures
Name Time Method Number of adverse events Assessed on day four
- Secondary Outcome Measures
Name Time Method Number of adverse events Assessed on day 30, 90, and 180 Occurrence of specific adverse events Assessed on day four, 30, 90, and 180 Intensity of experienced adverse events Assessed on day four, 30, 90, and 180 Hospital readmission Assessed on day 180
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus, Denmark