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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Music with Binaural Beats
* Device: Music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binaural Beats<br>Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design | Device: Music with Binaural Beats<br>* Relaxing music with embedded binaural beats at a frequency of 5 Hz<br>|
| Sham Comparator: Placebo<br>Music: Relaxing music without the binaural beat component, in a crossover design | Device: Music<br>* Relaxing music without a binaural beat component<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on pain severity | 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 | 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) | 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 |