Use of Binaural Beat Premedication in Elderly Submitted to Major Orthopedic Surgery

March 29, 2019 updated by: Alessandro Tani, Azienda USL Toscana Nord Ovest

Use of Binaural Beat Premedication Reduces Post-operative Morphine Consumption in Elderly Patient Submitted to Knee Surgery

The Investigators verify the effectiveness of "Binaural Beats" as premedication instrument in elderly patients submitted to orthopedic surgery to reduce anxiety , post operative pain and morphine consumption

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Need for surgery is increasing among elderly population, for increase in average life expectancy and for improved in surgical and anesthetic techniques.

A big problem in this kind of patients is the high incidence of delirium and cognitive impairment in post-operative period , which increase with age, depending on the type of intervention (especially Orthopaedics and Cardiac Surgery) and the administration of some agents, particularly sedatives and opioids .

Premedication is usually carried using anxiolytic and / or narcotic drugs in order to reduce anxiety and discomfort related to the intervention and anesthesia. The preoperative anxiety in fact increases the demand for intra and post operative anesthetics and analgesics and contribute to increase the post operative pain. For this reason the use of a pharmacological premedication is controversial in elderly patient, for the risk of side effects of drugs on one side, and for the other to the discomfort resulting from the increased level of anxiety in absence of premedication. .

Some recent surgical guidelines warn against premedication drug in patients over sixty-five, considering that occurrence of delirium and cognitive impairment may worsen the prognosis, limiting the use of such drugs to what is strictly necessary and only in the immediacy of the surgical act.

To reduce perioperative pain and anxiety , some authors used "Binaural Beats". This simple technique , described for the first time since by Gerald Oster , include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies. These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .

Binaural Beats have already been used in humans undergoing outpatient surgery in uro-gynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery .

In this study, we applied BBs as premedication in elderly patients who underwent major orthopaedic surgery aimed to reduce anxiety , postoperative pain and morphine consumption.

Feeling/level of anxiety is evaluated using STAI Y1 . This scale is a psychological inventory that consists of 20 questions on a self-report of anxiety about an event.

Feeling/level of pain is evaluated with the use of Numerical Rating Scale (NRS) .It consist to asking the patients to report her/his feeling of pain using an eleven-point scale : 0 = no pain, 10 most severe imaginable pain.

Cumulative morphine consumpion is evaluated through PCA registration. Patient Controlled Analgesia (PCA) is an electronic device that allows a patients to activate intravenous administration of morphine to themselves during the post-operative period. Each request and drug administration is automatically recorded by the device.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pisa
      • Volterra, Pisa, Italy, 56048
        • Santa maria maddalena Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects over 65 years aged candidated to elective major orthopedic surgery
  • Stable hemodynamic and clinical conditions (ASA 1/2, Goldman Desky Class 1)
  • Absence of cognitive impairment (MMSE greater than 24)
  • Valid consent expression to the study participation
  • No history of epilepsy and other chronic neurological diseases that may interfere with the study procedures.
  • Good collaboration in activities provided by the study
  • No abnormalities at audiometric testing for the frequencies between 256 and 260 Hz.

Exclusion Criteria:

  • Insufficient level of cooperation or hearing loss
  • Contraindications to the use of binaural beats (a history of epilepsy)
  • Treatment with anti-anxiety drugs or major tranquillizers
  • Clinical Instability defined as the inclusion criteria
  • Denial of informed consent to participate in the study
  • Presence of cognitive impairment (MMSE less than or equal to 24)
  • Presence of neurological diseases or neurological damage that interfere with the study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A : Sound with Binaural Beats
Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz through generated by the software "Gnaural" in stereo option
Device: Sound with Binaural Beats
Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz generated by the special program Gnaural in stereo option
Active Comparator: Group B : Sound without Binaural Beats
Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the software "Gnaural" in mono option
Device: Sound without Binaural Beats
Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction on postoperative morphine consumption
Time Frame: in the first post-operative day
Difference of cumulative morphine consumption between Binaural Beat group vs Control group through patient-controlled analgesia device (PCA)
in the first post-operative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the level of preoperative anxiety assessed by State Anxiety inventory (STAI-1)
Time Frame: at 20 minutes after a binaural beat listening session

Measurement of anxiety assessed by STAI-1 after a 20 minutes of binaural beat listening session and comparison between the two groups . The State- Trait Anxiety Inventory is a validated 40-item self-report measure that contains 20 items measuring state anxiety (STAI-1) and 20 items measuring trait anxiety (STAI-2).Scores for state and trait components each range from 20 to 80 with a higher score corresponding to higher anxiety levels.

The anxiety level is considered low when the STAI is between 20 and 40, moderate between 41 and 60, high between 61 and 80
at 20 minutes after a binaural beat listening session

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain reduction
Time Frame: NRS mesurements at 8, 16 and 24 hours after surgery

Comparison of the mean value of Numerical Rating Scale (NRS) in three measurements on the first post-operative day between the treated group and control. Numerical Rating Scale (NRS) method consist to asking the patients to report her/his feeling of pain using an eleven-point scale : 0 = no pain, 10 most severe imaginable pain.

NRS scores ≤ 3 correspond to mild, scores of 4-6 to moderate and scores ≥7 to severe pain
NRS mesurements at 8, 16 and 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Toscana Nord Ovest

Investigators

  • Principal Investigator: Alessandro Tani, MD, Usl Area Vasta Nord Ovest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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