Intervention with natural sounds administered via headphonesIntervention with natural sounds and binaural beats administered via headphonesIntervention with natural sounds and virtual reality administered via headphones and head mounted displayIntervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display
Intervention with natural sounds administered via headphones: The 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: The 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: The 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: The 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD — 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 — 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 — 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 — 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% — 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 — 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% — 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-LF — 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-LF% — 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-LF/HF — 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-SD1 — 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-SD2 — Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Trial sites (1)
Facility
City
Region
Status
Kerckhoff Heart Center, Heart and Brain Research Group
Bad Nauheim
Hesse
Recruiting
More Heart and Brain Research Group, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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