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Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

Primary Purpose

Preoperative Anxiety, Perioperative Complication

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Binaural Beat Stimulation
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preoperative Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Technische Universität MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Preop Stimulation

Postop Stimulation

Pre- & Postop Stimulation

Arm Description

Control Group, no Intervention received

Binaural Beat Stimulation preoperatively

Binaural Beat Stimulation postoperatively

Binaural Beat Stimulation pre- and postoperatively

Outcomes

Primary Outcome Measures

Reduction of preoperative anxiety
Binaural beat stimulation before surgery can reduce preoperative anxiety

Secondary Outcome Measures

Increase of EEG alpha-band power during anesthesia emergence
Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power.
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.

Full Information

First Posted
September 6, 2022
Last Updated
November 22, 2022
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT05533112
Brief Title
Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia
Official Title
Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety, Perioperative Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Group, no Intervention received
Arm Title
Preop Stimulation
Arm Type
Experimental
Arm Description
Binaural Beat Stimulation preoperatively
Arm Title
Postop Stimulation
Arm Type
Experimental
Arm Description
Binaural Beat Stimulation postoperatively
Arm Title
Pre- & Postop Stimulation
Arm Type
Experimental
Arm Description
Binaural Beat Stimulation pre- and postoperatively
Intervention Type
Other
Intervention Name(s)
Binaural Beat Stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of preoperative anxiety
Description
Binaural beat stimulation before surgery can reduce preoperative anxiety
Time Frame
Assessments will take place one day before surgery as well as before administration of the intervention
Secondary Outcome Measure Information:
Title
Increase of EEG alpha-band power during anesthesia emergence
Description
Binaural beat stimulation during anesthesia emergence can increase or stabilize EEG alpha-band power.
Time Frame
Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
Title
Lower incidence of perioperative neurocognitive disorders
Description
2. Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julian Ostertag, MSc
Phone
+4941408681
Email
julian.ostertag@tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Kratzer, Dr.
Organizational Affiliation
Klinik für Anästhesiologie und Intensivmedizin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerhard Schneider, Prof.
Organizational Affiliation
Klinik für Anästhesiologie und Intensivmedizin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthias Kreuzer, Dr.
Organizational Affiliation
Klinik für Anästhesiologie und Intensivmedizin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität München
City
München
State/Province
München (Stadt)
ZIP/Postal Code
80686
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julian Ostertag, MSc
Phone
+4941408681
Email
julian.ostertag@tum.de
First Name & Middle Initial & Last Name & Degree
Stephan Kratzer, Dr.
First Name & Middle Initial & Last Name & Degree
Matthias Kreutzer, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

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