Use of Binaural Beat Premedication in Elderly Submitted to Major Orthopedic Surgery
Condition: Anxiety; Postoperative Pain; Morphine Consumption
MeSH terms: Pain, Postoperative
Study type: Interventional

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.
    

Intervention name(s): Sound with Binaural Beats; Sound without Binaural Beats
Intervention type(s): Device; Device
Intervention description(s): 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; Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binaural Beat; Elderly; preoperative medication; postoperative merphine consumption; postoperative pain