Use of Binaural Beats for Colonoscopy

NCT04372511 | Completed

• 1 other identifier: usl toscana nordovest
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Binaural Beats; Colonscopy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Comparison between the two groups of the level of satisfaction: Likert scale

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

• Blood pressure assessment

  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

  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

  at the end of the planned study in a year

• comparison on the use of drugs during the procedure

  at the end of the planned study in a year

Study Arms (2)

Binaural Beats

EXPERIMENTAL

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

No sounds

NO INTERVENTION

Group B : use of stereo headphones with a white background noise

Interventions

Binaural Beats DEVICE

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

Binaural Beats

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead

Study Sites (1)

Santa Maria Maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (6)

• 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.

  PMID: 20452299 BACKGROUND

• 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.

  PMID: 25139786 BACKGROUND

• 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.

  PMID: 17554644 BACKGROUND

• 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.

  PMID: 9672340 BACKGROUND

• 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.

  PMID: 30073406 BACKGROUND

• 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.

  PMID: 32412916 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro Tani, MD

  USL AREA VASTA TOSCANA NORDOVEST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 4, 2020
• Study Start: September 1, 2020
• Primary Completion: July 29, 2021
• Study Completion: August 16, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)