Psychological Factors in Cardiac Surgery
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 15, 2023
Detailed Description
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.
Interventions
- Behavioral: Adverse 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
Arms, Groups and Cohorts
- Other: Standard adverse event information
- Other: Elaborated adverse event information
Clinical Trial Outcome Measures
Primary Measures
- Number of adverse events
- Time Frame: Assessed on day four
Secondary Measures
- Number of adverse events
- Time Frame: Assessed on day 30, 90, and 180
- Intensity of experienced adverse events
- Time Frame: Assessed on day four, 30, 90, and 180
- Hospital readmission
- Time Frame: Assessed on day 180
- Occurrence of specific adverse events
- Time Frame: Assessed on day four, 30, 90, and 180
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Aarhus
- Collaborator
- Aarhus University Hospital
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Mette Sieg, Principal Investigator, University of Aarhus
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