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The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain

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ClinicalTrials.gov Identifier: NCT03160300
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Vasileios Gkolias, Aristotle University Of Thessaloniki

Study Description
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Brief Summary:
This study evaluates the effect of binaural beats on pain perception and subsequent need for analgesic medication use in patients suffering from diseases causing chronic pain. All patients will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Music with Binaural Beats Device: Music Not Applicable

Detailed Description:

Binaural beats consist of two artificially produced sound waves, differing in wave frequency, presented simultaneously and separately to each ear. The brain, following binaural beat processing, synchronizes to the frequency difference between the two waves. Therefore, using a 5 Hz frequency difference (theta rhythm), which promotes relaxation, we could alleviate pain perception and subsequent analgesic medication use.

Patients suffering from chronic pain will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.

Electroencephalogram (EEG) recordings will be used to confirm brain frequency synchronization, whereas pain severity scales and a diary recording analgesic medication use will be used to identify differences between intervention and placebo arms.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled, Randomized, Double-Blind Trial on the Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Binaural Beats
Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
 Device: Music with Binaural Beats
Relaxing music with embedded binaural beats at a frequency of 5 Hz
Sham Comparator: Placebo
Music: Relaxing music without the binaural beat component, in a crossover design
 Device: Music
Relaxing music without a binaural beat component


Outcome Measures
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Primary Outcome Measures :
  1. Effect on pain severity [ Time Frame: After 30 minutes of listening to binaural beat signals or sham intervention ]
    Comparing pre- and post-intervention perceived pain levels, using a Numeric Rating Scale (NRS) 0-10

  2. Effect on analgesic medication use [ Time Frame: One week on an "as needed" basis intervention use to alleviate pain, keeping a diary ]
    Comparing analgesic medication active substance quantity used, documented on patient diary recordings


Secondary Outcome Measures :
  1. Effect on electroencephalogram (EEG) [ Time Frame: 30 minutes of listening to binaural beat signals or sham intervention ]
    Evaluating differences in post-intervention EEG rhythm, using advanced biomedical signal processing, compared to baseline EEG rhythm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pain
  • Regular analgesic medication use

Exclusion Criteria:

  • Malignant pain
  • Headache as the cause of chronic pain
  • Hearing disability
  • Neuropsychiatric disease
  • Previous experience with binaural beats
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160300


Contacts
Contact: Vasileios Gkolias, MD, Msc +306977056411 vassilisgolias@yahoo.gr
Contact: Dimitrios Kouvelas, Professor +302310999335 kouvelas@auth.gr

Locations
Greece
University General Hospital of Thessaloniki AHEPA Recruiting
Thessaloníki, Greece, 54636
Contact: Gkolias Vasileios, MD, Msc    +306977056411    vassilisgolias@yahoo.gr   
Contact: Aikaterini Amaniti, Ass Professor    +302313303346    aamaniti@auth.gr   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Director: Dimitrios Kouvelas, Professor Aristotle University Of Thessaloniki
More Information
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Responsible Party: Vasileios Gkolias, MD, MSc, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03160300     History of Changes
Other Study ID Numbers: Binaural Beats Pain
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs