Preoperative StressDESTRESS-SURGNCT05036538
Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.
A study testing Intervention with natural sounds administered via headphones, Intervention with natural sounds and binaural beats administered via headphones and Intervention with natural sounds and virtual reality administered via headphones and head mounted display in people with Preoperative Stress and Postoperative Cognitive Dysfunction, run by Heart and Brain Research Group, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Stress, Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Intervention with natural sounds administered via headphones, Intervention with natural sounds and binaural beats administered via headphones and Intervention with natural sounds and virtual reality administered via headphones and head mounted display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jul 2023to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kerckhoff Heart Center, Heart and Brain Research Group
Bad Nauheim, Hesse, 61231
Marius Butz, Dipl.-Psych., m.butz@kerckhoff-klinik.de
Rolf Meyer, M.Sc., r.meyer@kerckhoff-klinik.de
About this study
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.
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.
Read the 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.
- Being tested
- 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
- Keywords
- Cardiac Surgery, Postoperative Cognitive Decline, Postoperative Delirium, Preoperative Stress, Relaxation Intervention, Virtual Reality, Binaural Beats
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with natural sounds administered via headphonesDevice
The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.
Intervention with natural sounds and binaural beats administered via headphonesDevice
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.
Intervention with natural sounds and virtual reality administered via headphones and head mounted displayDevice
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.
Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted displayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display |
| Control without Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-RMSSD
Measured: 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
Measured: 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
Measured: 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
Measured: 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%
Measured: 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
Measured: 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%
Measured: 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
Measured: 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%
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Change from baseline oxytocin at the end of intervention as assessed using saliva
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Change from baseline alpha-amylase at the end of intervention as assessed using saliva
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Change from baseline cortisol at the end of intervention as assessed using blood sample
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Change from baseline oxytocin at the end of intervention as assessed using blood sample
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Change from baseline bispectral index (BIS) at the end of intervention
Measured: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
Amount of propofol during induction of narcosis
Measured: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Amount of sufentanil during induction of narcosis
Measured: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Amount of remifentanil during induction of narcosis
Measured: Immediately pre-induction of narcosis to immediately post-induction of narcosis
Amount of propofol during surgery phase
Measured: Immediately post-induction of narcosis to immediately post-narcosis
Amount of sufentanil during surgery phase
Measured: Immediately post-induction of narcosis to immediately post-narcosis
Amount of remifentanil during surgery phase
Measured: Immediately post-induction of narcosis to immediately post-narcosis
Duration of stay at intensive care unit
Measured: Immediately post-surgery to approximately 1-2 days post-surgery
Duration of stay at normal ward
Measured: 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)
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.
Measured: Immediately post-surgery to approximately 1-2 days post-surgery
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
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.
Measured: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
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"
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Measured: Approximately 1 day pre-surgery to approximately 9 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
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).
Measured: Approximately 1 day pre-surgery to 3 months 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.
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.
Measured: Immediately post-surgery to 3 months post-surgery
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.
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).
Measured: Immediately post-surgery to 3 months 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)
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.
Measured: 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)
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.
Measured: Approximately 1 day pre-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)
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.
Measured: 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)
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.
Measured: Approximately 1 day pre-surgery to 3 months post-surgery
Change from baseline verbal free recall at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)
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.
Measured: 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)
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.
Measured: Approximately 1 day pre-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)
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.
Measured: 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)
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.
Measured: 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)
With the "Trail Making Test B" (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.
Measured: 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)
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).
Measured: 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)
In the "Regensburger Wordfluency-Test" (RWT), the patient has to name in 1 minute as many words as possible from a certain category.
Measured: 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)
In the "Regensburger Wordfluency-Test" (RWT), the patient has to name in 1 minute as many words as possible with a certain initial letter.
Measured: 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)
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.
Measured: 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).
In the subtest "3-D figure copy" of the "Montreal Cognitive Assessment" (MOCA), the patient has to copy a 3 dimensional geometric figure.
Measured: 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).
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.
Measured: 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)
The "Cognitive Failures Questionnaire" (CFQ) measures the frequency of failures in daily living in terms of memory, attention, action, and perception.
Measured: 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)
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.
Measured: 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)
The subscale "Depression" of the "Hospital Anxiety and Depression Scale" (HDS) includes 7 questions covering core features of typical depressive symptoms.
Measured: Approximately 1 day pre-surgery to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start27 Jul 2023
- Primary completionAug 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled intervention study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Brain Research Group, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036538
- Sponsor's protocol ID
- 110/21
- Acronym
- DESTRESS-SURG
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participants' data analyzed during the current study will be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05036538
- Acronym / sponsor ID
- DESTRESS-SURG / 110/21
- Keywords
- Cardiac Surgery, Postoperative Cognitive Decline, Postoperative Delirium, Preoperative Stress, Relaxation Intervention, Virtual Reality, Binaural Beats
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Heart and Brain Research Group, GermanyUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| Relaxation intervention with natural sounds | Experimental | Device: Intervention with natural sounds administered via headphonesThe 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 and binaural beats | Experimental | Device: Intervention with natural sounds and binaural beats administered via headphonesThe 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 virtual reality | Experimental | Device: Intervention with natural sounds and virtual reality administered via headphones and head mounted displayThe 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, binaural beats and virtual reality | Experimental | Device: Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted displayThe 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. |
| Control without Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with natural sounds administered via headphonesThe preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds. | Device | Relaxation intervention with natural sounds |
| Intervention with natural sounds and binaural beats administered via headphonesThe 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 | Relaxation intervention with natural sounds and binaural beats |
| Intervention with natural sounds and virtual reality administered via headphones and head mounted displayThe 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 | Relaxation intervention with natural sounds and virtual reality |
| Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted displayThe 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 | Relaxation intervention with natural sounds, binaural beats and virtual reality |
Primary outcome
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
Change from baseline heart rate variability (HRV) at the end of intervention as assessed using ECG-SD1
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-SD2
Time frame: Approximately 30 minutes. Immediately pre-intervention to Immediately post-intervention
41 secondary outcomes
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
Amount of propofol during surgery phase
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Amount of sufentanil during surgery phase
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Amount of remifentanil during surgery phase
Time frame: Immediately post-induction of narcosis to immediately post-narcosis
Duration of stay at intensive care unit
Time frame: Immediately post-surgery to approximately 1-2 days post-surgery
Duration of stay at normal ward
Time frame: 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)
Time frame: Immediately post-surgery to approximately 1-2 days post-surgery
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
Time frame: Immediately post-intensive care unit to approximately 1 week post-intensive care unit
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"
Time frame: Approximately 1 day pre-surgery to approximately 9 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
Time frame: Approximately 1 day pre-surgery to 3 months 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.
Time frame: Immediately post-surgery to 3 months post-surgery
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.
Time frame: Immediately post-surgery to 3 months 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)
Time frame: 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)
Time frame: Approximately 1 day pre-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)
Time frame: 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)
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
Change from baseline verbal free recall at 3 months post-surgery as assessed using the "Verbal Learning and Memory Test" (VLMT)
Time frame: 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)
Time frame: Approximately 1 day pre-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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: Approximately 1 day pre-surgery to 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified participants' data analyzed during the current study will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with natural sounds administered via headphones, Intervention with natural sounds and binaural beats administered via headphones and Intervention with natural sounds and virtual reality administered via headphones and head mounted display in people with Preoperative Stress and Postoperative Cognitive Dysfunction, run by Heart and Brain Research Group, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rolf Meyer, M.Sc.-Psych. (+496032 996 2557, r.meyer@kerckhoff-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.