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

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital92 enrolled

Overview

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

It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Anxiety State Patient Satisfaction Tolerance

Interventions

binaural musicOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Between 18-70 years old who had scheduled colonoscopy appointments Exclusion Criteria: * Anxiety and panic disorders * Urgent endoscopic intervention * Advanced dementia * Hearing problems * Anatomical or inflammatory disorders in the external ear canals

Locations (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

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

VAS-pain

Time frame: 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.

Time frame: During the procedure

Secondary Outcomes

Patient satisfaction

After the procedure, the patients were asked a series of questions for procedure evaluation (worse than expected, as expected, better than expected) and their willingness to have endoscopy again for their health (no, yes). The binaural music group was asked a three-item question with "yes-not sure-no" responses, inquiring whether the music increased relaxation and if they would like to listen to the same music again during a repeat procedure.

Data from ClinicalTrials.gov

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