The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety State
- Sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- The Modified Gloucester Comfort Scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
selim demirci
Clinical physician
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
The Modified Gloucester Comfort Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- withdrawal time (minutes)(during the procedure)
- polyp detection rate(during the procedure)
- 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)