Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

December 21, 2023 updated by: Technical University of Munich

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • München (Stadt)
      • München, München (Stadt), Germany, 80686
        • Recruiting
        • Technische Universität München
        • Contact:
        • Principal Investigator:
          • Stephan Kratzer, Dr.
        • Principal Investigator:
          • Matthias Kreutzer, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of preoperative anxiety
Time Frame: 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
Assessments will take place one day before surgery as well as before administration of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Increase of EEG alpha-band power during anesthesia emergence
Time Frame: 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.
Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
Lower incidence of perioperative neurocognitive disorders
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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