Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia

Not Applicable

Recruiting

• Conditions: Preoperative Anxiety; Perioperative Complication
• Interventions: Other: Binaural Beat Stimulation

• Registration Number: NCT05533112
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-08
• Study Start: 2022-11-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preop Stimulation	Binaural Beat Stimulation	Binaural Beat Stimulation preoperatively
Pre- & Postop Stimulation	Binaural Beat Stimulation	Binaural Beat Stimulation pre- and postoperatively
Postop Stimulation	Binaural Beat Stimulation	Binaural Beat Stimulation postoperatively

Primary Outcome Measures

Name	Time	Method
Reduction of preoperative anxiety	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

Secondary Outcome Measures

Name	Time	Method
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	2. Reduced preoperative anxiety and/or increased or stabilized alpha oscillations during anesthesia emergence are correlated with a lower incidence of perioperative neurocognitive disorders.
Increase of EEG alpha-band power during anesthesia emergence	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.

Trial Locations

Locations (1)

Technische Universität München; 🇩🇪 München, München (Stadt), Germany