Use of Binaural Beats for Colonoscopy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372511
• Other study ID #: usl toscana nordovest
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: Azienda USL Toscana Nord Ovest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 16, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Italy	Santa Maria Maddalena Hospital	Volterra	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Toscana Nord Ovest

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tinè 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes after completing the procedure (complete withdrawal of the colonoscope)
Secondary	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;	5 minutes after completing the procedure (complete withdrawal of the colonoscope)
Secondary	Blood pressure assessment	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);
Secondary	Heart rate assessment	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);
Secondary	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	at the end of the planned study in a year
Secondary	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	at the end of the planned study in a year