Reducing preoperative stress to prevent cognitive issues after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.