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

NCT ID: NCT03160300

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Binaural Beats

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

Group Type EXPERIMENTAL

Music with Binaural Beats

Intervention Type DEVICE

Relaxing music with embedded binaural beats at a frequency of 5 Hz

Placebo

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

Group Type SHAM_COMPARATOR

Music

Intervention Type DEVICE

Relaxing music without a binaural beat component

Interventions

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Music with Binaural Beats

Relaxing music with embedded binaural beats at a frequency of 5 Hz

Intervention Type DEVICE

Music

Relaxing music without a binaural beat component

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Vasileios Gkolias

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitrios Kouvelas, Professor

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

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University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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Binaural Beats Pain

Identifier Type: -

Identifier Source: org_study_id

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