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Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
RECRUITINGN/ASponsored by Heart and Brain Research Group, Germany
Actively Recruiting
PhaseN/A
SponsorHeart and Brain Research Group, Germany
Started2023-07-27
Est. completion2028-08
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05036538
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 operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation. 2. A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent. Exclusion Criteria: 1. History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation. 2. Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy), 3. Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli. 4. Taking sedatives on the day of surgery. 5. Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons. 6. Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team. 7. Participation in an interventional study according to AMG/MPG will also be excluded. 8. Patients with missing informed consent.
Conditions4
Heart DiseasePostoperative Cognitive DysfunctionPostoperative DeliriumPreoperative Stress
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Actively Recruiting
PhaseN/A
SponsorHeart and Brain Research Group, Germany
Started2023-07-27
Est. completion2028-08
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05036538