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Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

NCT ID: NCT05533112

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preoperative Anxiety Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Control Group, no Intervention received

Group Type NO_INTERVENTION

No interventions assigned to this group

Preop Stimulation

Binaural Beat Stimulation preoperatively

Group Type EXPERIMENTAL

Binaural Beat Stimulation

Intervention Type 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

Binaural Beat Stimulation postoperatively

Group Type EXPERIMENTAL

Binaural Beat Stimulation

Intervention Type 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

Pre- & Postop Stimulation

Binaural Beat Stimulation pre- and postoperatively

Group Type EXPERIMENTAL

Binaural Beat Stimulation

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Kratzer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie und Intensivmedizin

Gerhard Schneider, Prof.

Role: STUDY_CHAIR

Klinik für Anästhesiologie und Intensivmedizin

Matthias Kreuzer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie und Intensivmedizin

Locations

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Technische Universität München

München, München (Stadt), Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julian Ostertag, MSc

Role: CONTACT

Phone: +4941408681

Email: [email protected]

Facility Contacts

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Julian Ostertag, MSc

Role: primary

Other Identifiers

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2022-332-S-NP

Identifier Type: -

Identifier Source: org_study_id