Psychological Factors in Cardiac Surgery

• Sponsor: University of Aarhus (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04766125
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33.4
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Conditions	Behavioral: Adverse event information	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Psychological Factors in Cardiac Surgery
• Actual Study Start Date: Feb 18, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard adverse event information	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
Other: Elaborated adverse event information	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

Outcome Measures

Primary Outcome Measures

1. Number of adverse events [Assessed on day four]

Secondary Outcome Measures

1. Number of adverse events [Assessed on day 30, 90, and 180]

2. Intensity of experienced adverse events [Assessed on day four, 30, 90, and 180]

3. Hospital readmission [Assessed on day 180]

4. Occurrence of specific adverse events [Assessed on day four, 30, 90, and 180]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• Aarhus University Hospital

Investigators

• Principal Investigator: Mette Sieg, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04766125
• Other Study ID Numbers: AUPsych
• First Posted: Feb 23, 2021
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 18, 2022