Actively Recruiting
Decreasing Preoperative Stress to Prevent Postoperative Delirium and Cognitive Decline in Cardiac Surgical Patients Using Virtual Reality and Binaural Beats
Led by Heart and Brain Research Group, Germany · Updated on 2026-02-17
125
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to reduce preoperative anxiety and stress in patients undergoing elective cardiac surgery, as these factors can increase the risk of postoperative delirium, cognitive decline, and other complications. The study evaluates whether relaxation interventions using virtual reality and binaural beats can help prevent these mental health issues after surgery. It is a randomized controlled trial conducted at a single center involving 125 patients. Participants are randomly assigned to one of five groups: four groups receive a 30-minute relaxation session before surgery with different combinations of natural sounds, binaural beats, and virtual reality nature scenes, while one group follows the standard procedure without any intervention. The relaxation interventions are delivered via headphones and, for some groups, a head-mounted display for the virtual reality experience. During the study, patients undergo neuropsychological exams and quality of life assessments before surgery, with stress markers like heart rate variability and saliva cortisol measured during the intervention. After surgery, daily delirium screenings are performed, and cognitive tests are repeated at hospital discharge and three months later. Researchers monitor various physiological and cognitive outcomes to assess the effects of the relaxation interventions on postoperative brain function and recovery.
CONDITIONS
Brief Title
Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective cardiac surgery including coronary artery bypass, aortic or mitral valve replacement/reconstruction, or combination surgery with standardized extracorporeal circulation
- Sufficient knowledge of German to complete neuropsychological tests
You will not qualify if you...
- History of acute clinically relevant cognitive impairment such as dementia, depression, stroke, or multiple sclerosis
- Contraindications to binaural beats or visual stimuli, including epilepsy
- Significant hearing loss or astigmatism affecting perception of auditory or visual stimuli
- Taking sedatives on the day of surgery
- Unwillingness to participate in relaxation or neuropsychological testing due to health, motivation, or other reasons
- Participation in interventions altering cognitive or emotional function that cannot be controlled by the study team
- Participation in another interventional study under AMG/MPG regulations
- Missing informed consent
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for neuropsychological and health-related quality of life examinations
Duration - Approximately 30 minutes on the day of surgery admission
Participants undergo a preoperative stress-reducing relaxation intervention lasting approximately 30 minutes involving natural sounds, binaural beats, and/or virtual reality depending on group assignment.
1 visit (in-person) including intervention and stress measurements immediately before surgery
Duration - Approximately 1 to 2 days post-surgery
Participants undergo elective cardiac surgery with extracorporeal circulation followed by intensive care unit stay for 1 to 2 days and monitoring for postoperative delirium.
Daily delirium screenings during intensive care unit stay
Duration - Approximately 1 week post-intensive care unit
Participants are monitored during their stay on the normal ward for about 1 week with continued delirium assessments and neuropsychological examination at discharge.
Daily delirium screenings and 1 neuropsychological examination at discharge
Duration - 3 months post-surgery
Participants undergo a neuropsychological examination and health-related quality of life assessment approximately 3 months after surgery to evaluate cognitive function and recovery.
1 follow-up visit (in-person) at 3 months after surgery
Trial Site Locations
Total: 1 location
1
Kerckhoff Heart Center, Heart and Brain Research Group
Bad Nauheim, Hesse, Germany, 61231
Actively Recruiting
Research Team
R
Rolf Meyer, M.Sc.-Psych.
M
Marius Butz, Dipl.-Psych.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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