Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
Recruiting now · Not applicable
Conditions studied: Preoperative Stress, Postoperative Cognitive Dysfunction, Postoperative Delirium
In brief
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.
Key facts
- Study ID
- NCT05036538
- Run by
- Heart and Brain Research Group, Germany
- People needed
- 125
- Starts
- 2023-07-27
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kerckhoff Heart Center, Heart and Brain Research Group — Bad Nauheim, Hesse, Germany (enrolling)
Full record on ClinicalTrials.gov
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