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 range18 Years

SexALL

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.
✕. 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.

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

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

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 range18 Years

SexALL

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.
✕. 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.