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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeart and Brain Research Group, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention with natural sounds administered via headphones

    Device

    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 headphones

    Device

    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 display

    Device

    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 display

    Device

    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.

Treatment groups

125 Participants
are divided into 5 treatment groups
Group A: Relaxation intervention with natural soundsExperimental treatment 1 intervention
Group B: Relaxation intervention with natural sounds and binaural beatsExperimental treatment 1 intervention
Group C: Relaxation intervention with natural sounds and virtual realityExperimental treatment 1 intervention
Group D: Relaxation intervention with natural sounds, binaural beats and virtual realityExperimental treatment 1 intervention
Group E: Control without InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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