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

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Completed

CT.gov ID

NCT03160300

Collaborator

(none)

Enrollment

Location

Arms

19.5

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Music with Binaural Beats Device: Music	N/A

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 Design

Study Type:

Interventional

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 :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Binaural Beats

Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design

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

Device: Music

Relaxing music without a binaural beat component

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital of Thessaloniki AHEPA	Thessaloníki		Greece	54636

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Investigators

Study Director: Dimitrios Kouvelas, Professor, Aristotle University Of Thessaloniki

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Jul 5, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Jul 5, 2019