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OpenTrials
Completed

NCT Number: NCT04766125

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.

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Key information

Conditions

Heart Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adverse event information

Behavioral

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

Primary outcomes

  1. Number of adverse events

    Time frame: Assessed on day four

Secondary outcomes

  1. Number of adverse events

    Time frame: Assessed on day 30, 90, and 180

  2. Intensity of experienced adverse events

    Time frame: Assessed on day four, 30, 90, and 180

  3. Hospital readmission

    Time frame: Assessed on day 180

  4. Occurrence of specific adverse events

    Time frame: Assessed on day four, 30, 90, and 180

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 23, 2021
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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