RecruitingNot Applicable

Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.

Germany125 participantsStarted 2023-07-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD

Timeframe: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50

Timeframe: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-pNN50

Timeframe: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF

Timeframe: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF%

Timeframe: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-VLF

Trial details

NCT IDNCT05036538

SponsorHeart and Brain Research Group, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Rolf Meyer, M.Sc.-Psych.

+496032 996 2557 r.meyer@kerckhoff-klinik.de

View on ClinicalTrials.gov More Preoperative Stress trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.