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
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Condition or disease | Intervention/treatment | Phase |
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Chronic Pain | Device: Music with Binaural Beats Device: Music | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | May 15, 2017 |
Actual Primary Completion Date : | December 31, 2018 |
Actual Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
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Experimental: Binaural Beats
Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
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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
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Device: Music
Relaxing music without a binaural beat component |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160300
Greece | |
University General Hospital of Thessaloniki AHEPA | |
Thessaloníki, Greece, 54636 |
Study Director: | Dimitrios Kouvelas, Professor | Aristotle University Of Thessaloniki |
Responsible Party: | Vasileios Gkolias, MD, MSc, Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT03160300 |
Other Study ID Numbers: |
Binaural Beats Pain |
First Posted: | May 19, 2017 Key Record Dates |
Last Update Posted: | July 5, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Pain Pain Neurologic Manifestations |