Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

Perioperative Complication Clinical Trial

Official title:

Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533112
• Other study ID #: 2022-332-S-NP
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: Technical University of Munich
• Contact: Julian Ostertag, MSc
• Phone: +4941408681
• Email: julian.ostertag[@]tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Perioperative Complication
• Preoperative Anxiety

Intervention

Other:
• Binaural Beat Stimulation
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

Locations

Country	Name	City	State
Germany	Technische Universität München	München	München (Stadt)

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of preoperative anxiety	Binaural beat stimulation before surgery can reduce preoperative anxiety	Assessments will take place one day before surgery as well as before administration of the intervention
Secondary	Increase of EEG alpha-band power during anesthesia emergence	Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power.	Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
Secondary	Lower incidence of perioperative neurocognitive disorders	2. Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a 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