Kerckhoff Heart Center, Heart and Brain Research Group
Bad Nauheim, Hesse, 61231, Germany
Location status: Recruiting
NCT Number: NCT05036538
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bad Nauheim, Hesse, 61231, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.
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.
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.
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.
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Time frame: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Time frame: Immediately post-surgery to approximately 1-2 days post-surgery
Time frame: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
Time frame: Immediately post-surgery to approximately 1-2 days post-surgery
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) records the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation and speech.
Time frame: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) records the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation and speech.
Time frame: Approximately 1 day pre-surgery to approximately 9 days post-surgery
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
The objective neuropsychological parameters measure cognitive domains such as immediate memory span, free recall, recognition memory, selective attention, working memory, word fluency, inhibition, spatial imagination, visuoconstructive ability, and recognition of emotions. These cognitive domains will be measured with the following instruments: "Verbal Learning and Memory Test (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wordfluency-Test" (RWT), "Syndrom-Short Test/Inhibition" (in german: Syndrom-Kurz Test, SKT-7), "Performance Testing System" (in german: "Leistungsprüfsystem", LPS-9), "3-D Figure/Montreal Cognitive Assessment" (MOCA-3-D-Figure), and "Penn Emotion Recognition Test" (ER40).
Time frame: Immediately post-surgery to 3 months post-surgery
The "Subjective Postoperative Cognitive Decline" (POCD-S) questionnaire assesses the occurrence of postoperative cognitive deficits (memory, attention, executive functions, language, and orientation) that appeared specifically as a result of the cardiac surgery.
Time frame: Immediately post-surgery to 3 months post-surgery
The "Instrumental Activity of Daily Living" (IADL) questionnaire assesses the occurrence of deficits in the domains of cooking, telephoning, shopping, light and heavy housework, and organizing (finances, taking medications).
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Verbal Learning and Memory Test" (VLMT), a list of words is learned over five learning trials. After an interference word list, the initial word list is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Verbal Learning and Memory Test" (VLMT), a list of words is learned over five learning trials. After an interference word list, the initial word list is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Verbal Learning and Memory Test" (VLMT), a list of words is learned over five learning trials. After an interference word list, the initial word list is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Trail Making Test A" (TMT-A), the patient has to connect numbers in ascending order on a test sheet as fast as possible.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Letter Number Span Test" (LNS), the patient is supposed to rearrange a mixed sequence of letters and numbers through mental reorganization in such a way that first all numbers and then all letters are to be named in ascending order.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
With the "Trail Making Test B" (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Syndrom-Short Test/Inhibition" (in german: Syndrom-Kurz Test, SKT-7), the patient has to rename a series of letters (e.g., "A" instead of "B," and vice versa).
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Regensburger Wordfluency-Test" (RWT), the patient has to name in 1 minute as many words as possible from a certain category.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Regensburger Wordfluency-Test" (RWT), the patient has to name in 1 minute as many words as possible with a certain initial letter.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Performance Testing System" (in german: "Leistungsprüfsystem", LPS-9), the patient has to count in 3 minutes as many surfaces of a 3-D geometric figure as possible.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the subtest "3-D figure copy" of the "Montreal Cognitive Assessment" (MOCA), the patient has to copy a 3 dimensional geometric figure.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
In the "Penn Emotion Recognition Test" (ER40), the patient has to select the correct emotion label (joy, sadness, anger, fear, and neutral) for each facial expression.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
The "Cognitive Failures Questionnaire" (CFQ) measures the frequency of failures in daily living in terms of memory, attention, action, and perception.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
The subscale "Depression" of the "Hospital Anxiety and Depression Scale" (HDS) includes 7 questions covering core features of typical depressive symptoms.
Contact information is provided by the study sponsor or research team.
Marius Butz, Dipl.-Psych.
CONTACT
Rolf Meyer, M.Sc.-Psych.
CONTACT
Heart and Brain Research Group, Germany
Other
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.
Acronym: DESTRESS-SURG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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