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PainNCT04372511

Use of Binaural Beats for Colonoscopy

A study testing Binaural Beats in people with Pain, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain
What is being tested?
Binaural Beats
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
1 Sep 2020to 16 Aug 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Santa Maria Maddalena Hospital

    Volterra, Pisa, 56048

Other trials in Italy

About this study

Official title: 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 .

Read the 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.

Conditions
Pain
Being tested
Binaural Beats
Keywords
Binaural Beats, Colonscopy
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Binaural BeatsDevice

    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

Study groups in NCT04372511
Study groupRoleWhat they receive
Binaural BeatsExperimentalGroup 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
Receives: Device: Binaural Beats
No soundsNo interventionGroup B : use of stereo headphones with a white background noise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain perception evaluated with VAS

    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.

    Measured: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)

Secondary outcomes (5)

  1. Comparison between the two groups of the level of satisfaction: Likert scale

    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;

    Measured: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)

  2. Blood pressure assessment

    Systolic and diastolic blood pressure evaluation measured in millimeters of Hg

    Measured: 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);

  3. Heart rate assessment

    Heart rate evaluation measured in beats/min.

    Measured: 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);

  4. comparison on the number of subjects who could not complete the exam

    comparison on the number of subjects between the two groups who could not complete the exam due to intolerance

    Measured: at the end of the planned study in a year

  5. comparison on the use of drugs during the procedure

    comparison between the two groups on the use of atropine during the procedure to reduce vagal effects

    Measured: at the end of the planned study in a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start1 Sep 2020
  3. Primary completion29 Jul 2021
  4. Study completion16 Aug 2021

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04372511
Sponsor's protocol ID
usl toscana nordovest
Status last verified
Aug 2021
First submitted
26 Apr 2020
Last updated
19 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7.

    PubMed 20452299

  • Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19.

    PubMed 25139786

  • Rudin D, Kiss A, Wetz RV, Sottile VM. Music in the endoscopy suite: a meta-analysis of randomized controlled studies. Endoscopy. 2007 Jun;39(6):507-10. doi: 10.1055/s-2007-966362.

    PubMed 17554644

  • Lembo T, Fitzgerald L, Matin K, Woo K, Mayer EA, Naliboff BD. Audio and visual stimulation reduces patient discomfort during screening flexible sigmoidoscopy. Am J Gastroenterol. 1998 Jul;93(7):1113-6. doi: 10.1111/j.1572-0241.1998.00339.x.

    PubMed 9672340

  • Garcia-Argibay M, Santed MA, Reales JM. Efficacy of binaural auditory beats in cognition, anxiety, and pain perception: a meta-analysis. Psychol Res. 2019 Mar;83(2):357-372. doi: 10.1007/s00426-018-1066-8. Epub 2018 Aug 2.

    PubMed 30073406

  • Tani A, Vagheggini G, Moretti F, Del Colombo V, Lehle J, Campana S, Labate A, Tomaiuolo F. Binaural Beats Reduce Postoperative Morphine Consumption in Older adults After Total Knee Replacement Surgery. Altern Ther Health Med. 2021 Mar;27(2):27-30.

    PubMed 32412916

Questions about this trial

What is this clinical trial studying?

A study testing Binaural Beats in people with Pain, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.

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 3 inclusion and 4 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 19 Aug 2021. 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 Italy. 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. 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?

Pain perception evaluated with VAS (time frame: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04372511, which also lists 6 linked publications.

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 19 Aug 2021.

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