NCT04766125

Psychological Factors in Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Heart Conditions

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-18
• Primary completion: 2023-12-15
• Completion: 2024-06-12
• First posted: 2021-02-23
• Last updated: 2025-04-06

Locations

1 site across 1 country: Denmark