NCT05036538 Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
| NCT ID | NCT05036538 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart and Brain Research Group, Germany |
| Condition | Preoperative Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-07-27 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2023-07-27 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05036538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Preoperative Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05036538 currently recruiting?
Yes, NCT05036538 is actively recruiting participants. Contact the research team at r.meyer@kerckhoff-klinik.de for enrollment information.
Where is the NCT05036538 trial being conducted?
This trial is being conducted at Bad Nauheim, Germany.
Who is sponsoring the NCT05036538 clinical trial?
NCT05036538 is sponsored by Heart and Brain Research Group, Germany. The trial plans to enroll 125 participants.