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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