Psychological Factors in Cardiac Surgery

Heart Conditions Clinical Trial

Official title:

Psychological Factors in Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04766125
• Other study ID #: AUPsych
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Conditions

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Assessed on day four
Secondary	Number of adverse events		Assessed on day 30, 90, and 180
Secondary	Intensity of experienced adverse events		Assessed on day four, 30, 90, and 180
Secondary	Hospital readmission		Assessed on day 180
Secondary	Occurrence of specific adverse events		Assessed on day four, 30, 90, and 180