Chronic PainNCT03160300
The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
A study testing Music with Binaural Beats and Music in people with Chronic Pain, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Music with Binaural Beats and Music
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGreece
- Study dates
- 15 May 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain
- Regular analgesic medication use
Who cannot join
- Malignant pain
- Headache as the cause of chronic pain
- Hearing disability
- Neuropsychiatric disease
- Previous experience with binaural beats
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Music with Binaural Beats, Music
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music with Binaural BeatsDevice
Relaxing music with embedded binaural beats at a frequency of 5 Hz
MusicDevice
Relaxing music without a binaural beat component
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats | Experimental | Music with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design Receives: Device: Music with Binaural Beats |
| Placebo | Sham comparator | Music: Relaxing music without the binaural beat component, in a crossover design Receives: Device: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on pain severity
Comparing pre- and post-intervention perceived pain levels, using a Numeric Rating Scale (NRS) 0-10
Measured: After 30 minutes of listening to binaural beat signals or sham intervention
Effect on analgesic medication use
Comparing analgesic medication active substance quantity used, documented on patient diary recordings
Measured: One week on an "as needed" basis intervention use to alleviate pain, keeping a diary
Secondary outcomes (1)
Effect on electroencephalogram (EEG)
Evaluating differences in post-intervention EEG rhythm, using advanced biomedical signal processing, compared to baseline EEG rhythm
Measured: 30 minutes of listening to binaural beat signals or sham intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Gkolias, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Kouvelas, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160300
- Sponsor's protocol ID
- Binaural Beats Pain
- Status last verified
- Jul 2019
- First submitted
- 17 May 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03160300
- Acronym / sponsor ID
- Binaural Beats Pain
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats | Experimental | Device: Music with Binaural BeatsMusic with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design |
| Placebo | Sham comparator | Device: MusicMusic: Relaxing music without the binaural beat component, in a crossover design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic pain
- Regular analgesic medication use
Key exclusion criteria (5 listed)
- Malignant pain
- Headache as the cause of chronic pain
- Hearing disability
- Neuropsychiatric disease
- Previous experience with binaural beats
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music with Binaural BeatsRelaxing music with embedded binaural beats at a frequency of 5 Hz | Device | Binaural Beats |
| MusicRelaxing music without a binaural beat component | Device | Placebo |
Primary outcome
Effect on pain severity
Time frame: 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
Time frame: 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
1 secondary outcome
Effect on electroencephalogram (EEG)
Time frame: 30 minutes of listening to binaural beat signals or sham intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Kouvelas, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music with Binaural Beats and Music in people with Chronic Pain, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on pain severity (time frame: After 30 minutes of listening to binaural beat signals or sham intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.