Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preoperative Anxiety; Perioperative Complication
• Intervention / Treatment: Other: Binaural Beat Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Ostertag, MSc; Phone Number: +4941408681; Email: julian.ostertag@tum.de

Study Locations

• Germany
  • München (Stadt)
    • München, München (Stadt), Germany, 80686
      • Recruiting
      • Technische Universität München
      • Contact: Julian Ostertag, MSc; Phone Number: +4941408681; Email: julian.ostertag@tum.de
      • Principal Investigator: Stephan Kratzer, Dr.
      • Principal Investigator: Matthias Kreutzer, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control Group, no Intervention received
Experimental: Preop Stimulation; Binaural Beat Stimulation preoperatively	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
Experimental: Postop Stimulation; Binaural Beat Stimulation postoperatively	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
Experimental: Pre- & Postop Stimulation; Binaural Beat Stimulation pre- and postoperatively	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Stephan Kratzer, Dr., Klinik für Anästhesiologie und Intensivmedizin; Study Chair: Gerhard Schneider, Prof., Klinik für Anästhesiologie und Intensivmedizin; Principal Investigator: Matthias Kreuzer, Dr., Klinik für Anästhesiologie und Intensivmedizin

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022-332-S-NP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All recorded data may be shared with collaborating researchers
• IPD Sharing Time Frame: Data will be available starting March 2023.
• IPD Sharing Access Criteria: Researchers who agree to collaborate on the project will have access to our protected server and can access all recorded data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No