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New treatment option for Preoperative Stress
Official title Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
ClinicalTrials.gov ID: NCT05036538
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with...
- A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent.
You likely can't join if
- History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair...
- 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.
See the full eligibility 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.
- 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 treatment study according to AMG/MPG will also be excluded.
- Patients with missing informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Bad Nauheim, Hesse, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bad Nauheim, Hesse, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.