Clinical trial NCT05036538: Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Stress
Postoperative Cognitive Dysfunction
Postoperative Delirium
Keywords: Cardiac Surgery
Postoperative Cognitive Decline
Postoperative Delirium
Preoperative Stress
Relaxation Intervention
Virtual Reality
Binaural Beats
Lead sponsor: Heart and Brain Research Group, Germany
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled intervention study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-pNN50
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-HF%
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-VLF
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-VLF%
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF%
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-LF/HF
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-SD1
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-SD2
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Secondary outcomes:
measure: Change from baseline cortisol at the end of intervention as assessed using saliva
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline oxytocin at the end of intervention as assessed using saliva
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline alpha-amylase at the end of intervention as assessed using saliva
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline cortisol at the end of intervention as assessed using blood sample
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline oxytocin at the end of intervention as assessed using blood sample
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline alpha-amylase at the end of intervention as assessed using blood sample
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline electro dermal activity (EDA) at the end of intervention as assessed using EDA-SCL
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline electro dermal activity (EDA) at the end of intervention as assessed using EDA-NS-SCRs
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Change from baseline bispectral index (BIS) at the end of intervention
timeFrame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
measure: Amount of propofol during induction of narcosis
timeFrame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
measure: Amount of sufentanil during induction of narcosis
timeFrame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
measure: Amount of remifentanil during induction of narcosis
timeFrame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
measure: Amount of propofol during surgery phase
timeFrame: Immediately post-induction of narcosis to immediately post-narcosis
measure: Amount of sufentanil during surgery phase
timeFrame: Immediately post-induction of narcosis to immediately post-narcosis
measure: Amount of remifentanil during surgery phase
timeFrame: Immediately post-induction of narcosis to immediately post-narcosis
measure: Duration of stay at intensive care unit
timeFrame: Immediately post-surgery to approximately 1-2 days post-surgery
measure: Duration of stay at normal ward
timeFrame: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
measure: Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
timeFrame: Immediately post-surgery to approximately 1-2 days post-surgery
measure: Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
timeFrame: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
measure: Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
timeFrame: Approximately 1 day pre-surgery to approximately 9 days post-surgery
measure: Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Number of participants with subjective postoperative cognitive decline (POCD-S) at 3 months after surgery, defined as a subjective decrease between pre- and postoperative examinations of one cognitive function.
timeFrame: Immediately post-surgery to 3 months post-surgery
measure: Number of participants with deficits in instrumental activity of daily living (IADL) at 3 months after surgery, defined as the occurrence of at least one deficit.
timeFrame: Immediately post-surgery to 3 months post-surgery
measure: Change from baseline visual immediate memory span at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline visual free recall at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline visual recognition memory at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline verbal immediate memory span at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline verbal free recall at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline verbal recognition memory at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline selective attention at 3 months post-surgery as assessed using the "Trail Making Test A" (TMT-A)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline verbal working memory at 3 months post-surgery as assessed using the "Letter Number Span Test" (LNS)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline cognitive flexibility at 3 months post-surgery as assessed using the "Trail Making Test B" (TMT-B)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline inhibition at 3 months post-surgery as assessed using the "Syndrom-Short Test/Inhibition" (in german: Syndrom-Kurz Test, SKT-7)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline category word fluency at 3 months post-surgery as assessed using the "Regensburger Wordfluency-Test" (RWT)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline phonetic word fluency at 3 months post-surgery as assessed using the "Regensburger Wordfluency-Test" (RWT)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline spatial imagination at 3 months post-surgery as assessed using the "Performance Testing System" (in german: "Leistungsprüfsystem", LPS-9)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline visuoconstructive ability at 3 months post-surgery as assessed using the subtest "3-D figure copy" of the "Montreal Cognitive Assessment" (MOCA).
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline recognition of emotions at 3 months post-surgery as assessed using the "Penn Emotion Recognition Test" (ER40).
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
measure: Change from baseline depression at 3 months after surgery as assessed using the subscale "Depression" of the "Hospital Anxiety and Depression Scale" (HDS)
timeFrame: Approximately 1 day pre-surgery to 3 months post-surgery
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Heart Center, Heart and Brain Research Group
state: Hessen
Study officials:
References: