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

Not Applicable

Completed

• Conditions: Tolerance; Patient Satisfaction; Anxiety State
• Interventions: Other: binaural music

• Registration Number: NCT06187233
• Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2023-10-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Last Update Submitted: 2023-12-17
• Study First Posted: 2024-01-02
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
binaural music group	binaural music	The music group listened to music containing binaural beats during the colonoscopy

Primary Outcome Measures

Name	Time	Method
The Modified Gloucester Comfort Scale	During the procedure	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.
VAS-anxiety	immediately before being taken into the procedure room and 5 minutes after the procedure	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
VAS-pain	5 minutes after the procedure	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

Secondary Outcome Measures

Name	Time	Method
withdrawal time (minutes)	during the procedure	Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient.
polyp detection rate	during the procedure	It will be assessed by recording the encountered polyps during colonoscopy.
Patient satisfaction	5 minutes after the procedure	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.
Heart rate	Within 20 minutes pre-procedure and 5 minutes after the procedure	The comparison of heart rate in the music and control groups
Blood pressure	Within 20 minutes pre-procedure and 5 minutes after the procedure	The comparison of systolic and diastolic blood pressure in the music and control groups
cecal insertion time(minutes)	during the procedure	Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice.

Trial Locations

Locations (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital; 🇹🇷 Ankara, Turkey