Use of Binaural Beats for Colonoscopy

August 18, 2021 updated by: Alessandro Tani, Azienda USL Toscana Nord Ovest

Evaluation of Pain and Patient Satisfaction Using Binaural Beats in Patients Submitted to Colonoscopy

Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in sedation. Although the use of sedative drugs is effective in relieving anxiety and pain such drugs can cause significant side-effects.

This study examines the effect of Binaural Beats stimulation on pain perception during colonscopy.

Binaural Beats is a simple technique, described for the first time since by Gerald Oster , that include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies.

These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .

Binaural Beats have already been used in humans undergoing outpatient surgery in urogynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery . In this study the investigators evaluate the use of Binaural Beat in outpatients to undergo colonoscopy to reduce pain .

A total of 100 patients divided into two groups, 50 treatment and 50 control will be considered.

Both patient groups will be invited to wear headphones regardless of whether they have been randomized to Binaural Beats with white noise or white noise only to ensure blindness of participation The headphones will be worn ten minutes before and throughout the procedure. Pain will be measured by VAS scale and satisfaction by Likert scale after the procedure in both groups. Blood pressure and heart rate will be monitored before, during, and after the procedure.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pisa
      • Volterra, Pisa, Italy, 56048
        • Santa Maria Maddalena Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for outpatient colonoscopy
  • Valid consent expression to the study participation
  • Good collaboration in activities provided by the study

Exclusion Criteria:

  • Insufficient degree of collaboration
  • Abnormal hearing
  • Denial of informed consent to participate in the study
  • Previous colon resection surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Binaural Beats
Group A : use of stereo headphones that generate sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise
Device: Binaural Beats
Device: Sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise
No Intervention: No sounds
Group B : use of stereo headphones with a white background noise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception evaluated with VAS
Time Frame: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)
Comparison between the two groups of pain perceived during the procedure by VAS scale. The Visual Analogue Scale (VAS) is a validated scale for measuring pain on 11 points, from 0 to 10, in which the patient indicates the maximum perceived pain.
5 minutes after completing the procedure (complete withdrawal of the colonoscope)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the two groups of the level of satisfaction: Likert scale
Time Frame: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)

Comparison between the two groups of the level of satisfaction of the entire procedure measured with a Likert scale . Likert scale is a scale which is used to allow the individual to express how much they agree or disagree with a particular statement patient satisfaction rated as: not at all, very low, moderate satisfaction, complete satisfaction; (b) willingness to repeat the procedure in the future:

not at all, very low, barely yes, yes;
5 minutes after completing the procedure (complete withdrawal of the colonoscope)
Blood pressure assessment
Time Frame: 3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);
Systolic and diastolic blood pressure evaluation measured in millimeters of Hg
3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);
Heart rate assessment
Time Frame: 3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);
Heart rate evaluation measured in beats/min.
3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope);
comparison on the number of subjects who could not complete the exam
Time Frame: at the end of the planned study in a year
comparison on the number of subjects between the two groups who could not complete the exam due to intolerance
at the end of the planned study in a year
comparison on the use of drugs during the procedure
Time Frame: at the end of the planned study in a year
comparison between the two groups on the use of atropine during the procedure to reduce vagal effects
at the end of the planned study in a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Toscana Nord Ovest

Investigators

  • Principal Investigator: Alessandro Tani, MD, USL AREA VASTA TOSCANA NORDOVEST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

July 29, 2021

Study Completion (Actual)

August 16, 2021

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • usl toscana nordovest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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