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

Study Overview
=================
Brief Summary
-----------------
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

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.

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

Conditions
-----------------
Anxiety, Postoperative Pain, Morphine Consumption

Intervention / Treatment
-----------------
* Device: Sound with Binaural Beats
* Device: Sound without Binaural Beats


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : Sound with Binaural Beats<br>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<br>* 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<br>|
| Active Comparator: Group B : Sound without Binaural Beats<br>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<br>* Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction on postoperative morphine consumption | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Binaural Beat, Elderly, preoperative medication, postoperative merphine consumption, postoperative pain