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

July 2, 2019 updated by: Vasileios Gkolias, Aristotle University Of Thessaloniki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

21

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

  • Greece
      • Thessaloníki, Greece, 54636
        • University General Hospital of Thessaloniki AHEPA

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 30 minutes of listening to binaural beat signals or sham intervention
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
One week on an "as needed" basis intervention use to alleviate pain, keeping a diary

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes of listening to binaural beat signals or sham intervention

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Director: Dimitrios Kouvelas, Professor, Aristotle University Of Thessaloniki

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)

May 15, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 18, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Binaural Beats Pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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