Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Relaxation Interventions Via Virtual Reality and Binaural Beats.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Kerckhoff Heart Center, Heart and Brain Research Group
RECRUITING
Bad Nauheim
Contact Information
Primary
Rolf Meyer, M.Sc.-Psych.
r.meyer@kerckhoff-klinik.de
+496032 996 2557
Backup
Marius Butz, Dipl.-Psych.
m.butz@kerckhoff-klinik.de
+496032 996 5812
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2025-11
Participants
Target number of participants: 125
Treatments
Experimental: Relaxation intervention with natural sounds
The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.
Experimental: Relaxation intervention with natural sounds and binaural beats
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.
Experimental: Relaxation intervention with natural sounds and virtual reality
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.
Experimental: Relaxation intervention with natural sounds, binaural beats and virtual reality
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.
No_intervention: Control without Intervention
Related Therapeutic Areas
Sponsors
Leads: Heart and Brain Research Group, Germany