Preoperative Anxiety, Perioperative Complication
Conditions
Brief summary
We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.
Interventions
During binaural beats stimulation both ears receive a tone which varies slightly in its frequency. If the left ear is stimulated with a sinusoidal wave of 98 Hz and the right ear with a sinusoidal wave of 108 Hz, the brain will perceive this stimulation as a single tone at the mean frequency of 103 Hz. The amplitude of the perceived tone will fluctuate with a frequency that is equal to the difference of the two initial tones, i.e., 10 Hz
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fluent in German (Munich) or Portuguese (Porto) * Scheduled for elective minor or intermediate risk procedure
Exclusion criteria
* ASA status 4 * History of drug abuse * Pre-existing neurocognitive or psychiatric disorders * Auditory Impairments, vision diseases or other diagnosed cognitive impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of preoperative anxiety | Assessments will take place one day before surgery as well as before administration of the intervention | Binaural beat stimulation before surgery can reduce preoperative anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase of EEG alpha-band power during anesthesia emergence | Analysis will include the last 20 minutes of surgical procedure until patients are responsive again | Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power. |
| Lower incidence of perioperative neurocognitive disorders | Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery | 2\. Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a lower incidence of perioperative neurocognitive disorders. |
Countries
Germany
Contacts
Primary ContactJulian Ostertag, MSc
Outcome results
None listed