Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

Technical University of Munich

Status: Enrolling

Conditions: Perioperative Complication; Preoperative Anxiety

Treatments: Other: Binaural Beat Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05533112

2022-332-S-NP

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Control

No Intervention group

Description:

Control Group, no Intervention received

Preop Stimulation

Experimental group

Description:

Binaural Beat Stimulation preoperatively

Treatment:

Other: Binaural Beat Stimulation

Postop Stimulation

Experimental group

Description:

Binaural Beat Stimulation postoperatively

Treatment:

Other: Binaural Beat Stimulation

Pre- & Postop Stimulation

Experimental group

Description:

Binaural Beat Stimulation pre- and postoperatively

Treatment:

Other: Binaural Beat Stimulation