Reducing preoperative stress to prevent cognitive issues after heart surgery
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.
This study is testing if using virtual reality and sound therapy before heart surgery can help reduce stress and prevent memory problems afterward for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart and Brain Research Group, Germany Academic / other |
| Locations | 1 site (Bad Nauheim, Hesse) |
| Trial ID | NCT05036538 on ClinicalTrials.gov |
What this trial studies
This study aims to address the anxiety and stress experienced by patients undergoing cardiac surgery, which can lead to postoperative complications such as delirium and cognitive decline. It employs a preoperative relaxation intervention using a combination of virtual reality environments and binaural beats to reduce stress levels. The study is a monocenter, 5-arm randomized controlled intervention involving 125 patients, with various groups receiving different combinations of auditory and visual stimuli. Neuropsychological assessments and stress indicators will be measured before and after surgery to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective cardiac surgery who have a good understanding of German.
Not a fit: Patients with significant cognitive impairments, contraindications to binaural beats or visual stimuli, or those taking sedatives on the day of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium and cognitive decline in cardiac surgery patients.
How similar studies have performed: While the approach of using virtual reality and binaural beats is innovative, similar studies have shown promise in reducing preoperative anxiety and improving postoperative outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bad Nauheim, Hesse
- Kerckhoff Heart Center, Heart and Brain Research Group — Bad Nauheim, Hesse, Germany (Recruiting)
Study contacts
- Study coordinator: Rolf Meyer, M.Sc.-Psych.
- Email: r.meyer@kerckhoff-klinik.de
- Phone: +496032 996 2557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.