Psychological Factors in Cardiac Surgery

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 Overview

• Status: Completed
• Conditions: Heart Conditions
• Intervention / Treatment: Behavioral: Adverse event information

Detailed Description

If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard adverse event information	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
Other: Elaborated adverse event information	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	Assessed on day four

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Mette Sieg, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AUPsych

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No