The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation

NCT06187233 | Completed

• 1 other identifier: colonoscopybinaural
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation

Conditions

Anxiety State; Patient Satisfaction; Tolerance

Outcome Measures

Primary Outcomes (3)

• VAS-anxiety

  The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety

  immediately before being taken into the procedure room and 5 minutes after the procedure

• VAS-pain

  The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety

  5 minutes after the procedure

• The Modified Gloucester Comfort Scale

  The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points.

  During the procedure

Secondary Outcomes (6)

• Patient satisfaction

  5 minutes after the procedure

• Heart rate

  Within 20 minutes pre-procedure and 5 minutes after the procedure

• Blood pressure

  Within 20 minutes pre-procedure and 5 minutes after the procedure

• cecal insertion time(minutes)

  during the procedure

• withdrawal time (minutes)

  during the procedure

Study Arms (2)

binaural music group

EXPERIMENTAL

The music group listened to music containing binaural beats during the colonoscopy

Other: binaural music

control

NO INTERVENTION

The control group had headphones without sound during the procedure.

Interventions

binaural music OTHER

In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied during the procedure.

binaural music group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Between 18-70 years old who had scheduled colonoscopy appointments

You may not qualify if:

• Anxiety and panic disorders
• Urgent endoscopic intervention
• Advanced dementia
• Hearing problems
• Anatomical or inflammatory disorders in the external ear canals

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (3)

• Tani A, Tartarisco G, Vagheggini G, Vaccaro C, Campana S, Tomaiuolo F. Binaural beats reduce feeling of pain and discomfort during colonoscopy procedure in not-sedated patients: A randomized control trial. Complement Ther Clin Pract. 2022 Aug;48:101605. doi: 10.1016/j.ctcp.2022.101605. Epub 2022 May 21.

  PMID: 35623152 RESULT

• Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.

  PMID: 28325532 RESULT

• 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 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• selim demirci

  clinical physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: All elective colonoscopies were performed by an experienced endoscopists who were unaware of the group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical physician

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: October 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)