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Psychological Factors in Cardiac Surgery

NCT04766125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-04-06

No results posted yet for this study

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.

Conditions

  • Heart Conditions

Interventions

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mette Sieg · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2023-12-15
Completion
2024-06-12

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766125 on ClinicalTrials.gov