search
Back to results

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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Music with Binaural Beats
Music
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University General Hospital of Thessaloniki AHEPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Binaural Beats

Placebo

Arm Description

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

Music: Relaxing music without the binaural beat component, in a crossover design

Outcomes

Primary Outcome Measures

Effect on pain severity
Comparing pre- and post-intervention perceived pain levels, using a Numeric Rating Scale (NRS) 0-10
Effect on analgesic medication use
Comparing analgesic medication active substance quantity used, documented on patient diary recordings

Secondary Outcome Measures

Effect on electroencephalogram (EEG)
Evaluating differences in post-intervention EEG rhythm, using advanced biomedical signal processing, compared to baseline EEG rhythm

Full Information

First Posted
May 17, 2017
Last Updated
July 2, 2019
Sponsor
Aristotle University Of Thessaloniki
search

1. Study Identification

Unique Protocol Identification Number
NCT03160300
Brief Title
The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Binaural Beats
Arm Type
Experimental
Arm Description
Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Music: Relaxing music without the binaural beat component, in a crossover design
Intervention Type
Device
Intervention Name(s)
Music with Binaural Beats
Intervention Description
Relaxing music with embedded binaural beats at a frequency of 5 Hz
Intervention Type
Device
Intervention Name(s)
Music
Intervention Description
Relaxing music without a binaural beat component
Primary Outcome Measure Information:
Title
Effect on pain severity
Description
Comparing pre- and post-intervention perceived pain levels, using a Numeric Rating Scale (NRS) 0-10
Time Frame
After 30 minutes of listening to binaural beat signals or sham intervention
Title
Effect on analgesic medication use
Description
Comparing analgesic medication active substance quantity used, documented on patient diary recordings
Time Frame
One week on an "as needed" basis intervention use to alleviate pain, keeping a diary
Secondary Outcome Measure Information:
Title
Effect on electroencephalogram (EEG)
Description
Evaluating differences in post-intervention EEG rhythm, using advanced biomedical signal processing, compared to baseline EEG rhythm
Time Frame
30 minutes of listening to binaural beat signals or sham intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Kouvelas, Professor
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloníki
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs