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NCT Number: NCT03160300

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music with Binaural Beats

Device

Relaxing music with embedded binaural beats at a frequency of 5 Hz

Music

Device

Relaxing music without a binaural beat component

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 19, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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