Psychological Factors in Cardiac Surgery

University of Aarhus

Status: Completed

Conditions: Heart Conditions

Treatments: Behavioral: Adverse event information

Study type: Interventional

Funder types: Other

Identifiers

NCT04766125

AUPsych

Details and patient eligibility

About

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.

Full description

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

Enrollment: 103 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups

Standard adverse event information

Other group

Treatment:

Behavioral: Adverse event information

Elaborated adverse event information

Other group

Treatment:

Behavioral: Adverse event information