About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Intervention with natural sounds administered via headphones
DeviceThe preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.
Intervention with natural sounds and binaural beats administered via headphones
DeviceThe preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds and binaural beats.
Intervention with natural sounds and virtual reality administered via headphones and head mounted display
DeviceThe preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds.
Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display
DeviceThe preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds and binaural beats.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-pNN50
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF
Secondary outcomes
Change from baseline cortisol at the end of intervention as assessed using saliva
Change from baseline oxytocin at the end of intervention as assessed using saliva
Change from baseline alpha-amylase at the end of intervention as assessed using saliva
Change from baseline cortisol at the end of intervention as assessed using blood sample
Sponsors and contacts
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