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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Music; Device: Music with Binaural Beats

• Registration Number: NCT03160300
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

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 Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Music	Music: Relaxing music without the binaural beat component, in a crossover design
Binaural Beats	Music with Binaural Beats	Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design

Primary Outcome Measures

Name	Time	Method
Effect on pain severity	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	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 Outcome Measures

Name	Time	Method
Effect on electroencephalogram (EEG)	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

Trial Locations

Locations (1)

University General Hospital of Thessaloniki AHEPA; 🇬🇷 Thessaloníki, Greece