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Clinical Trials/NCT05533112
NCT05533112
Recruiting
N/A

Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia

Technical University of Munich1 site in 1 country120 target enrollmentNovember 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preoperative Anxiety
Sponsor
Technical University of Munich
Enrollment
120
Locations
1
Primary Endpoint
Reduction of preoperative anxiety
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2022
End Date
October 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)
  • Increase of EEG alpha-band power during anesthesia emergence(Analysis will include the last 20 minutes of surgical procedure until patients are responsive again)

Study Sites (1)

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