The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
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
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 5, 2019
July 1, 2019
1.6 years
May 17, 2017
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Effect on electroencephalogram (EEG)
30 minutes of listening to binaural beat signals or sham intervention
Study Arms (2)
Binaural Beats
EXPERIMENTALMusic with Binaural Beats: Binaural beat signals embedded in relaxing music, in a crossover design
Placebo
SHAM COMPARATORMusic: Relaxing music without the binaural beat component, in a crossover design
Interventions
Relaxing music with embedded binaural beats at a frequency of 5 Hz
Eligibility Criteria
You may qualify if:
- Chronic pain
- Regular analgesic medication use
You may not qualify if:
- Malignant pain
- Headache as the cause of chronic pain
- Hearing disability
- Neuropsychiatric disease
- Previous experience with binaural beats
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dimitrios Kouvelas, Professor
Aristotle University Of Thessaloniki
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 19, 2017
Study Start
May 15, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 5, 2019
Record last verified: 2019-07