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

NCT05036538 | Recruiting

• 1 other identifier: 110/21
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Stress; Postoperative Cognitive Dysfunction; Postoperative Delirium

Keywords

Cardiac Surgery; Postoperative Cognitive Decline; Postoperative Delirium; Preoperative Stress; Relaxation Intervention; Virtual Reality; Binaural Beats

Outcome Measures

Primary Outcomes (12)

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-pNN50

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF%

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-VLF

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-VLF%

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF%

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF/HF

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-SD1

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-SD2

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Secondary Outcomes (41)

• Change from baseline cortisol at the end of intervention as assessed using saliva

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline oxytocin at the end of intervention as assessed using saliva

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline alpha-amylase at the end of intervention as assessed using saliva

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline cortisol at the end of intervention as assessed using blood sample

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

• Change from baseline oxytocin at the end of intervention as assessed using blood sample

  Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention

Study Arms (5)

Relaxation intervention with natural sounds

EXPERIMENTAL

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

Device: Intervention with natural sounds administered via headphones

Relaxation intervention with natural sounds and binaural beats

EXPERIMENTAL

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.

Device: Intervention with natural sounds and binaural beats administered via headphones

Relaxation intervention with natural sounds and virtual reality

EXPERIMENTAL

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.

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

Relaxation intervention with natural sounds, binaural beats and virtual reality

EXPERIMENTAL

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.

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

Control without Intervention

NO INTERVENTION

Interventions

Intervention with natural sounds administered via headphones 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

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

Relaxation intervention with natural sounds, binaural beats and virtual reality

Intervention with natural sounds and binaural beats administered via headphones 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 binaural beats

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation.
• Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy),
• Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli.
• Taking sedatives on the day of surgery.
• Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons.
• Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team.
• Participation in an interventional study according to AMG/MPG will also be excluded.
• Patients with missing informed consent.

Sponsors & Collaborators

• Heart and Brain Research Group, Germany: lead

Study Sites (1)

Kerckhoff Heart Center, Heart and Brain Research Group

Bad Nauheim, Hesse, 61231, Germany

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Interventions

Methods; Smart Glasses

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Rolf Meyer, M.Sc.-Psych.

CONTACT

+496032 996 2557; r.meyer@kerckhoff-klinik.de

Marius Butz, Dipl.-Psych.

CONTACT

+496032 996 5812; m.butz@kerckhoff-klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons, neurologists, and neuropsychologists who will be involved in the assessment of outcome variables will be blinded for randomization status. The intervention sessions will be conducted by a psychological supervisor who is not involved in the evaluation of outcome parameters to ensure blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled intervention study

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 5, 2021
• Study Start: July 27, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Up to one year after publication of the data
• Access Criteria: IPD will be available on reasonable request.

Locations

DE (1)