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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intervention with natural sounds administered via headphones (Device)
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.
干预措施: Intervention with natural sounds and binaural beats administered via headphones (Device)
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.
干预措施: Intervention with natural sounds and virtual reality administered via headphones and head mounted display (Device)
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.
干预措施: Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display (Device)
Control without Intervention
结局指标
主要结局
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-NN50
时间窗: 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%
时间窗: 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-RMSSD
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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%
时间窗: 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
时间窗: 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%
时间窗: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
次要结局
- Amount of remifentanil during induction of narcosis(Immediately pre-induction of narcosis to immediately post-induction of narcosis)
- Change from baseline electro dermal activity (EDA) at the end of intervention as assessed using EDA-NS-SCRs(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)
- 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 bispectral index (BIS) at the end of intervention(Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention)
- Amount of propofol during induction of narcosis(Immediately pre-induction of narcosis to immediately post-induction of narcosis)
- Change from baseline alpha-amylase at the end of intervention as assessed using saliva(Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention)
- 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"(Approximately 1 day pre-surgery to approximately 9 days post-surgery)
- 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.(Immediately post-surgery to 3 months post-surgery)
- Change from baseline visual recognition memory at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Approximately 1 day pre-surgery to 3 months post-surgery)
- 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).(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline depression at 3 months after surgery as assessed using the subscale "Depression" of the "Hospital Anxiety and Depression Scale" (HDS)(Approximately 1 day pre-surgery to 3 months post-surgery)
- 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 cortisol at the end of intervention as assessed using blood sample(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(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(Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention)
- Amount of sufentanil during induction of narcosis(Immediately pre-induction of narcosis to immediately post-induction of narcosis)
- Amount of propofol during surgery phase(Immediately post-induction of narcosis to immediately post-narcosis)
- Amount of sufentanil during surgery phase(Immediately post-induction of narcosis to immediately post-narcosis)
- Amount of remifentanil during surgery phase(Immediately post-induction of narcosis to immediately post-narcosis)
- Change from baseline verbal free recall at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline verbal recognition memory at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Duration of stay at intensive care unit(Immediately post-surgery to approximately 1-2 days post-surgery)
- 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(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline visual free recall at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline verbal immediate memory span at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Duration of stay at normal ward(Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
- Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)(Immediately post-surgery to approximately 1-2 days post-surgery)
- Change from baseline visual immediate memory span at 3 months post-surgery as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline cognitive flexibility at 3 months post-surgery as assessed using the "Trail Making Test B" (TMT-B)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)(Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
- 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.(Immediately post-surgery to 3 months post-surgery)
- Change from baseline selective attention at 3 months post-surgery as assessed using the "Trail Making Test A" (TMT-A)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline inhibition at 3 months post-surgery as assessed using the "Syndrom-Short Test/Inhibition" (in german: Syndrom-Kurz Test, SKT-7)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline category word fluency at 3 months post-surgery as assessed using the "Regensburger Wordfluency-Test" (RWT)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline spatial imagination at 3 months post-surgery as assessed using the "Performance Testing System" (in german: "Leistungsprüfsystem", LPS-9)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline recognition of emotions at 3 months post-surgery as assessed using the "Penn Emotion Recognition Test" (ER40).(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline verbal working memory at 3 months post-surgery as assessed using the "Letter Number Span Test" (LNS)(Approximately 1 day pre-surgery to 3 months post-surgery)
- Change from baseline phonetic word fluency at 3 months post-surgery as assessed using the "Regensburger Wordfluency-Test" (RWT)(Approximately 1 day pre-surgery to 3 months post-surgery)