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Recruiting NCT05036538

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

No phase Interventional Preoperative Stress Postoperative Cognitive Dysfunction Postoperative Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention with natural sounds administered via headphones, Intervention with natural sounds and binaural beats administered via headphones, Intervention with natural sounds and virtual reality administered via headphones and head mounted display, Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display.
Who it may be relevant to
Registry conditions: Preoperative Stress, Postoperative Cognitive Dysfunction, Postoperative Delirium. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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.

Interventions

  • Device 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.
  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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% [Time frame: 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 [Time frame: 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% [Time frame: 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 [Time frame: 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% [Time frame: 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 [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
Secondary outcome measures (12)
  • Change from baseline cortisol at the end of intervention as assessed using saliva [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline oxytocin at the end of intervention as assessed using saliva [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline alpha-amylase at the end of intervention as assessed using saliva [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline cortisol at the end of intervention as assessed using blood sample [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline oxytocin at the end of intervention as assessed using blood sample [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline alpha-amylase at the end of intervention as assessed using blood sample [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline electro dermal activity (EDA) at the end of intervention as assessed using EDA-SCL [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline electro dermal activity (EDA) at the end of intervention as assessed using EDA-NS-SCRs [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Change from baseline bispectral index (BIS) at the end of intervention [Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention]
  • Amount of propofol during induction of narcosis [Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis]
  • Amount of sufentanil during induction of narcosis [Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis]
  • Amount of remifentanil during induction of narcosis [Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Kerckhoff Heart Center, Heart and Brain Research Group — Bad Nauheim

Identifiers

NCT: NCT05036538 · 110/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗