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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binaural Beats | Experimental | Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design |
|
| Placebo | Sham Comparator | Music: Relaxing music without the binaural beat component, in a crossover design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music with Binaural Beats | Device | Relaxing music with embedded binaural beats at a frequency of 5 Hz |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitrios Kouvelas, Professor | Aristotle University Of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Thessaloniki AHEPA | Thessaloniki | 54636 | Greece |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music | Device | Relaxing music without a binaural beat component |
|
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |