Status:
RECRUITING
Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
Lead Sponsor:
Heart and Brain Research Group, Germany
Conditions:
Preoperative Stress
Postoperative Cognitive Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients undergoing cardiac surgery often complain of anxiety before a major operation and the resulting stress. This circumstance is a risk factor for mental problems that may occur after the operati...
Detailed Description
Preoperative anxiety and stress are risk factors for postoperative delirium (PD), postoperative cognitive decline (POCD), morbidity, and mortality. The primary objective of this study is to reduce the...
Eligibility Criteria
Inclusion Criteria:
- Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation.
- A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent.
Exclusion Criteria:
- History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation.
- Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy),
- Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli.
- Taking sedatives on the day of surgery.
- Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons.
- Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team.
- Participation in an interventional study according to AMG/MPG will also be excluded.
- Patients with missing informed consent.
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05036538
Start Date
July 27 2023
End Date
November 1 2028
Last Update
February 17 2026
Active Locations (1)
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1
Kerckhoff Heart Center, Heart and Brain Research Group
Bad Nauheim, Hesse, Germany, 61231