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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 : Completed
First Posted : May 19, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Vasileios Gkolias, Aristotle University Of Thessaloniki

Tracking Information
First Submitted Date  ICMJE May 17, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Device: Music with Binaural Beats
    Relaxing music with embedded binaural beats at a frequency of 5 Hz
  • Device: Music
    Relaxing music without a binaural beat component
Study Arms  ICMJE
  • Experimental: Binaural Beats
    Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
    Intervention: Device: Music with Binaural Beats
  • Sham Comparator: Placebo
    Music: Relaxing music without the binaural beat component, in a crossover design
    Intervention: Device: Music
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
20
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03160300
Other Study ID Numbers  ICMJE Binaural Beats Pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Vasileios Gkolias, Aristotle University Of Thessaloniki
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dimitrios Kouvelas, Professor Aristotle University Of Thessaloniki
PRS Account Aristotle University Of Thessaloniki
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP