Chronic Pain Clinical Trial
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
Verified date | July 2019 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital of Thessaloniki AHEPA | Thessaloníki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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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