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

NCT ID: NCT05036538

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2025-11-30

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 operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.

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 preoperative stress response through the combined presentation of a virtual reality environment with natural landscape and binaural beats. The proposed study is a monocenter, 5-arm prospective randomized controlled intervention of 125 patients undergoing elective cardiac surgery using extracorporeal circulation. A 360 ° video sequence including natural sounds (with and without binaural beats) are presented to 2 groups, and 2 groups receive only natural sounds (with and without binaural beats); a group without stimuli (standard procedure) represents the control group.

On the day of admission to the acute care clinic, a detailed examination of neuropsychological functions and health-related quality of life (HQL) is scheduled. Cortisol-saliva, heart rate variability and electrodermal activity as indicators for stress and relaxation are measured during the intervention phase (duration: approximately 30 minutes), which leads directly into the narcosis phase.

To investigate postoperative neurocognitive dysfunctions, daily delirium screenings will be performed after surgery, and a neuropsychological examination will be performed at the time of discharge from the acute hospital and at 3 months after surgery. Changes in HQL will also be completed at 3 months post-surgery.

Conditions

Preoperative Stress; Postoperative Cognitive Dysfunction; Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention with natural sounds administered via headphones

Intervention Type: DEVICE

The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.

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.

Group Type: EXPERIMENTAL

Intervention with natural sounds and binaural beats administered via headphones

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Intervention with natural sounds and virtual reality administered via headphones and head mounted display

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display

Intervention Type: DEVICE

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.

Control without Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention with natural sounds administered via headphones

The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.

Intervention Type: DEVICE

Intervention with natural sounds and binaural beats administered via headphones

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.

Intervention Type: DEVICE

Intervention with natural sounds and virtual reality administered via headphones and head mounted display

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.

Intervention Type: DEVICE

Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Brain Research Group, Germany

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kerckhoff Heart Center, Heart and Brain Research Group

Bad Nauheim, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Rolf Meyer, M.Sc.-Psych.

Role: CONTACT

r.meyer@kerckhoff-klinik.de

+496032 996 2557

Marius Butz, Dipl.-Psych.

Role: CONTACT

m.butz@kerckhoff-klinik.de

+496032 996 5812

Facility Contacts

Marius Butz, Dipl.-Psych.

Role: primary

m.butz@kerckhoff-klinik.de

Rolf Meyer, M.Sc.

Role: backup

r.meyer@kerckhoff-klinik.de

Other Identifiers

110/21

Identifier Type: -

Identifier Source: org_study_id