Status:

RECRUITING

Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.

Lead Sponsor:

Heart and Brain Research Group, Germany

Conditions:

Preoperative Stress

Postoperative Cognitive Dysfunction

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 operati...

Detailed Description

Preoperative anxiety and stress are risk factors for postoperative delirium (PD), postoperative cognitive decline (POCD), morbidity, and mortality. The primary objective of this study is to reduce the...

Eligibility 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.

Key Trial Info

Start Date :

July 27 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2028

Estimated Enrollment :

125 Patients enrolled

Trial Details

Trial ID

NCT05036538

Start Date

July 27 2023

End Date

November 1 2028

Last Update

February 17 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kerckhoff Heart Center, Heart and Brain Research Group

Bad Nauheim, Hesse, Germany, 61231