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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160300
• Other study ID #: Binaural Beats Pain
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Music with Binaural Beats
Relaxing music with embedded binaural beats at a frequency of 5 Hz
• Music
Relaxing music without a binaural beat component

Locations

Country	Name	City	State
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

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