Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

NCT05533112 | Unknown

• 1 other identifier: 2022-332-S-NP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety; Perioperative Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Increase of EEG alpha-band power during anesthesia emergence

  Analysis will include the last 20 minutes of surgical procedure until patients are responsive again

• 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

Study Arms (4)

Control

NO INTERVENTION

Control Group, no Intervention received

Preop Stimulation

EXPERIMENTAL

Binaural Beat Stimulation preoperatively

Other: Binaural Beat Stimulation

Postop Stimulation

EXPERIMENTAL

Binaural Beat Stimulation postoperatively

Other: Binaural Beat Stimulation

Pre- & Postop Stimulation

EXPERIMENTAL

Binaural Beat Stimulation pre- and postoperatively

Other: Binaural Beat Stimulation

Interventions

Binaural Beat Stimulation OTHER

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

Postop Stimulation; Pre- & Postop Stimulation; Preop Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in German (Munich) or Portuguese (Porto)
• Scheduled for elective minor or intermediate risk procedure

You may not qualify if:

• ASA status 4
• History of drug abuse
• Pre-existing neurocognitive or psychiatric disorders
• Auditory Impairments, vision diseases or other diagnosed cognitive impairments

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technische Universität München

München, München (Stadt), 80686, Germany

RECRUITING

Study Officials

• Stephan Kratzer, Dr.

  Klinik für Anästhesiologie und Intensivmedizin

  PRINCIPAL INVESTIGATOR

• Gerhard Schneider, Prof.

  Klinik für Anästhesiologie und Intensivmedizin

  STUDY CHAIR

• Matthias Kreuzer, Dr.

  Klinik für Anästhesiologie und Intensivmedizin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Ostertag, MSc

CONTACT

+4941408681; julian.ostertag@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 8, 2022
• Study Start: November 10, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available starting March 2023.
• Access Criteria: Researchers who agree to collaborate on the project will have access to our protected server and can access all recorded data.

Locations

DE (1)